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Federal Housing Finance Agency.
Final rule.
Section 1209 of the Housing and Economic Recovery Act of 2008 (HERA) amended section 26 of the Federal Home Loan Bank Act (Bank Act) to permit any Federal Home Loan Bank (Bank) to merge with another Bank with the approval of its board of directors, its members, and the Director of the Federal Housing Finance Agency (FHFA). This final rule establishes the conditions and procedures for the consideration and approval of voluntary Bank mergers.
The final rule is effective on December 28, 2011.
John P. Foley, Senior Financial Analyst, Policy and Program Development,
The 12 regional Banks are instrumentalities of the United States organized under the Bank Act.
Section 1209 of HERA added new paragraphs (b)(1) and (b)(2) to section 26 of the Bank Act to address voluntary mergers of Banks. Section 26(b)(1) authorizes any Bank to merge voluntarily with another Bank with the approval of the Director of FHFA (Director) and the boards of directors of the Banks involved in the merger. Section 26(b)(2) requires FHFA to promulgate regulations establishing the conditions and procedures for the consideration and approval of voluntary mergers, including approval by Bank members.
As required by section 26(b)(2), the final rule establishes the conditions and procedures for the consideration and approval of voluntary mergers of Banks. The rule does not relate to liquidations, reorganizations, conservatorships, or receiverships undertaken by the Director pursuant to the authority set forth at section 26(a) of the Bank Act and section 1367 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act).
On November 26, 2010, FHFA published in the
The proposed rule would have established procedures for Banks to follow in order to consummate a merger, including: Execution of a written merger agreement that has been authorized by each merging Bank's board of directors; joint submission of a merger application to FHFA by the merging Banks; preliminary approval of the terms of the merger by the Director; ratification of the merger by the merging Banks' member institutions; and final approval by the Director. In developing the proposed rule, FHFA looked for guidance to governance practices that are common under general principles of corporate law, disclosure practices that are required under the federal securities laws, and the approval standards required under federal banking laws relating to mergers of insured depository institutions.
Section 1313 of the Safety and Soundness Act, as amended by HERA, requires the Director, when promulgating regulations relating to the Banks, to consider the following differences between the Banks and the Enterprises (Fannie Mae and Freddie Mac) with respect to the Banks' cooperative ownership structure; mission of providing liquidity to members; affordable housing and community development mission; capital structure; and joint and several liability.
FHFA received six comment letters in response to the proposed rule. All twelve Banks jointly submitted one
FHFA considered all of the comments in developing the final rule, which establishes merger conditions and procedures that are substantially similar to those that were proposed, except that the two-step preliminary/final FHFA approval process embodied in the proposed rule has been replaced with a single-step approval in the final version, as suggested by some commenters. FHFA has made a number of minor revisions to the rule in order to address concerns raised by commenters, as well as to provide greater clarity. Specific comments, FHFA's responses, and changes adopted in the final rule are described in greater detail below in the sections describing the relevant rule provisions.
Proposed § 1278.1 set forth definitions of terms used in proposed part 1278. With two minor exceptions, all of these definitions have been adopted as proposed and are set forth in § 1278.1 of the final rule. A definition for the term “Financial Statements” has been added to the final rule to refer to statements of condition, income, capital, and cash flows, with explanatory notes, in such form as the Banks are required to include in their filings made under the Securities and Exchange Act of 1934 (Exchange Act).
Section 1278.2 of the proposed rule would have authorized any two or more Banks to merge, provided that they satisfied the various procedural and substantive requirements of proposed part 1278 relating to the merger agreement, merger application, approval by the Director, ratification by the members, and final consummation of the merger. Proposed § 1278.1 defined the words “merge” and “merger” broadly to include not only a traditional merger (where one surviving entity absorbs another disappearing entity), but also a consolidation, a purchase and assumption transaction, and any other type of business combination that could occur between or among Banks. The intent behind proposed § 1278.2 was to permit each Bank wide latitude to pursue beneficial business combinations with other Banks, subject to the proviso that any such combination could be consummated only with the express approval of the Director, obtained in accordance with the conditions and procedures set forth in proposed part 1278. The Banks expressed support for the broad definition of “merge” and “merger,” and no commenters opposed the definition, which the final rule retains without change.
In the final rule, the introductory paragraph of § 1278.2 has been revised to make clear that the provisions of part 1278 apply only to voluntary mergers undertaken pursuant to section 26(b) of the Bank Act.
Section 1278.3 of the proposed rule would have required that any merger of Banks be consummated only pursuant to a written merger agreement meeting the requirements of paragraphs (a) and (b) of that section, which addressed the authorization of the agreement by the Constituent Banks' boards of directors and the contents of the agreement, respectively.
Specifically, proposed § 1278.3(a) would have required that a merger agreement be authorized by the affirmative vote of a simple majority of a quorum of the board of directors of each Constituent Bank at a meeting on the record and that it be executed by authorized signing officers of each Constituent Bank. FHFA requested comment upon whether a standard other than a majority vote of a quorum of the boards of directors would be appropriate. The Banks opposed the imposition of a regulatory standard for board authorization of a merger agreement, preferring instead that each Bank be permitted to establish board voting requirements under its bylaws, which they asserted is consistent with the approach taken by most state corporation statutes. One commenter questioned the sufficiency of a simple majority of a quorum of the board of directors to authorize a merger agreement, and advocated that the final rule instead require a supermajority of the full board of each Constituent Bank.
As discussed in the proposed rule, section 26(b) of the Bank Act, while requiring a board vote as part of the merger process, does not address specific requirements with respect to such a vote. Although the absence of statutory requirements would allow FHFA to include in the final rule either of those suggestions, FHFA has decided to retain this provision as proposed. As a matter of policy, FHFA believes that a uniform standard for board authorization is preferable to allowing each Bank to set its own approval standard. Unlike general business corporations, all of the Banks are very similar in business model and operations, as governed by the Bank Act and the regulations adopted thereunder, and they were created to further uniform purposes. Given those circumstances, FHFA believes that each Bank should also be subject to the same approval standards in determining whether to enter into a merger agreement. In addition, FHFA has concluded that the appropriate uniform standard is one that corresponds with the manner in which board decisions currently are made under the bylaws of all of the Banks—that is, by vote of a majority of a quorum of the board.
Proposed § 1278.3(b) addressed the minimum content for a merger agreement. It would have required generally that the agreement set forth all material terms and conditions of the merger, and would have further required that the agreement include provisions addressing nine specified matters. FHFA proposed to require agreement on those matters early in the merger process because, in the agency's judgment, they would be the central issues to be negotiated between Constituent Banks under most merger scenarios, and are matters of major regulatory concern to the agency. The nine matters enumerated in the proposed rule were: (1) The proposed Effective Date of the merger; (2) the proposed organization certificate and bylaws of the Continuing Bank; (3) the proposed capital structure plan for the Continuing Bank; (4) the proposed size and structure of the board of directors for the Continuing Bank; (5) the formula to be used to exchange the stock of the Constituent Banks for the stock of the Continuing Bank; (6) any conditions that must be satisfied prior to the Effective Date of the proposed merger; (7) a statement of any representations or warranties; (8) a description of any legal opinions or rulings; and (9) a statement that the board of directors of a Constituent Bank can terminate the merger agreement before the Effective Date upon a determination that certain events have occurred. FHFA's intent in including these provisions in the proposed rule was to ensure that a merger agreement reflects the understandings that the Banks have reached with respect to each of these critical matters. The agency did not intend to require that the documents that may be necessary to implement these understandings be prepared at the same time as the merger agreement.
FHFA received a number of comments regarding the nine specific matters to be addressed in a merger agreement. The agency has made some minor revisions to § 1278.3(b) in response to some of these comments, which are discussed below, and has also made a few minor wording changes for greater clarity and consistency.
Paragraph (1) of proposed § 1278.3(b) would have required that a merger agreement set forth the proposed Effective Date of the merger. In the proposed rule, the term “Effective Date” was defined as the date on which the Constituent Banks consummate the merger, or, in the case of a merger encompassing two or more component transactions, the date on which the relevant Constituent Banks consummate each component transaction. As discussed below, § 1278.7 has been revised in order to provide greater specificity as to the time that the organization certificate of the Continuing Bank, and consequently the consummation of the merger, becomes legally effective. In conjunction with this change, the definition of “Effective Date” has been revised to refer to the date on which the organization certificate of the Continuing Bank (or Banks) becomes effective as provided under § 1278.7. As stated in the
In the final rule, paragraph (1) of § 1278.3(b) has been revised to require that, in addition to the proposed Effective Date, the merger agreement set forth the proposed acquisition date for purposes of accounting for the transaction under GAAP, if that date is to be different from the Effective Date. Under GAAP, a business combination is recorded as of the “acquisition date.” Thus, among other things, the fair value of the assets acquired, liabilities assumed, and consideration exchanged is measured as of that date. The acquirer also begins to consolidate the acquired entity's financial position, results of operations, and cash flows as of that date. Under GAAP, the “acquisition date” is considered to be the date on which the acquirer obtains control of the acquiree. Typically, this would be the date on which the acquirer legally transfers the consideration, acquires the assets, and assumes the liabilities of the acquiree—
Paragraphs (2) and (3) of proposed § 1278.3(b) would have required that a merger agreement describe, respectively, the proposed organization certificate and bylaws, and the proposed capital structure plan, for the Continuing Bank. In their joint comment letter, the Banks stated that the rule should not require descriptions of these items, but should instead require the items to be attached to the merger agreement. FHFA has considered this suggestion, but has decided to adopt these requirements in their proposed form. In all cases, the types of material understandings that are required to be addressed in the merger agreement must precede the preparation of the detailed documents that are intended ultimately to implement those understandings. Although, in practice, the Constituent Banks may choose to negotiate the specifics of the capital structure plan, organization certificate, and bylaws prior to executing a final merger agreement, FHFA can discern no compelling reason to require these documents to be prepared contemporaneously with the agreement. In a legal sense, the understandings memorialized in the merger agreement will determine the scope and content of these implementing documents. FHFA believes that the better approach is the one embodied in the proposed rule, which requires that the merger agreement reflect the material understandings that the Banks have reached with respect to each of these matters. That approach allows the Banks the opportunity to prepare related documents contemporaneously with the merger agreement if they so desire, but also affords them the flexibility to agree in principle as part of the merger agreement how certain matters, such as the organization certificate, bylaws, or capital structure plan, are to be addressed, but leave the drafting of those documents to a later date.
The final rule requires that a merger agreement set forth all material terms and conditions of the merger. As
Proposed § 1278.3(b)(4) would have required that a merger agreement address the proposed size and structure of the board of directors for the Continuing Bank. The proposed rule also requested comments on how best to address the transition from the separate boards of the Constituent Banks to the combined board of the Continuing Bank, and the manner in which FHFA should establish the size and composition of the board for the Continuing Bank. In their joint comment letter, the Banks requested that Constituent Banks be permitted to include in either a merger agreement or a merger application their proposals as to the size and composition of the board immediately following the merger, and as to the gradual reduction in size of the board over time through FHFA's annual designation of Bank directorships process. The Banks opposed the imposition of any requirement to provide a detailed long-term plan regarding such matters as the number and composition of board committees and the responsibilities to be delegated to those committees, stating that they wish to preserve the flexibility to allow more detailed governance matters to evolve over time. Another commenter also agreed that any reduction in post-merger directorships should be a gradual process effected through the annual designation process.
FHFA has considered these comments and has decided to carry over the language of proposed § 1278.3(b)(4) without change. Final § 1278.3(b)(4) allows the Banks some flexibility with respect to the level of detail that must be included in the merger agreement. At a minimum, the merger agreement must include the Banks' proposal for the size and composition of the board of directors,
Ultimately, the size and composition of the board of the Continuing Bank will be determined by the Director. Section 7 of the Bank Act generally requires the Director to establish the size and structure of the board of directors of each Bank and gives the Director additional discretion to adjust the board size in connection with any Bank merger.
Proposed § 1278.3(b)(7) would have required that a merger agreement contain a statement of the representations or warranties, if any, made or to be made by any Constituent Bank, or its officers, directors, or employees. In their joint letter, the Banks requested clarification that any representations and warranties made by Bank officers, directors, or employees would not be signed in their individual capacities, but on behalf of their respective Banks. The proposed provision was not intended to require that any individual or Bank make any particular representations or warranties in connection with a merger, or to address the capacity in which any individual might make such representations or warranties. Instead, it was intended merely to require that the merger agreement set forth any representations or warranties made by any of the parties in connection with the merger. In recognition of the fact that the parties to the merger agreement will be the Constituent Banks as corporate entities, and in order to avoid any implication that Banks directors, officers, or employees should be making representations or warranties in their individual capacities, as opposed to doing so as a representative of his or her Bank, FHFA has revised § 1278.3(b)(7) in the final rule to remove the reference to Banks' “officers, directors, or employees.” Thus, the text of final § 1278.3(b)(7) requires that the merger agreement include “a statement of the representations or warranties, if any, made or to be made by any Constituent Bank.”
Section 1278.3(b)(8) of the proposed rule would have required that a merger agreement describe any legal opinions or rulings that have been obtained or furnished by any party in connection with the proposed merger. In their joint comment letter, the Banks stated that if legal opinions are required in connection with a merger, they are frequently conditions to consummation and, therefore, are not available until after the merger agreement is signed. Consequently, the Banks suggested that FHFA modify the provision to require that a merger agreement include descriptions of any legal opinions that are required to be obtained as a condition to the consummation of the merger, as well as those that have already been completed at the time the agreement is executed. The Banks further suggested that the rule require that a merger agreement describe any accounting opinions obtained or furnished in connection with the merger. FHFA has accepted both of these suggestions and has revised final § 1278.3(b)(8) to require that a merger agreement describe the legal or accounting opinions or rulings, if any, that are required to be obtained or furnished by any party in connection with the proposed merger.
Section 1278.3(b)(9) of the proposed rule would have required that a merger agreement contain a statement that the board of directors of a Constituent Bank may terminate the agreement before the Effective Date of the merger upon a determination by the Bank, with the concurrence of FHFA, that: (i) The information disclosed to members contained material errors or omissions; (ii) material misrepresentations were
In the final rule, FHFA has removed the requirement for FHFA concurrence with a termination decision, but has otherwise retained the substance of the proposed provision. The intent behind the proposed requirement of FHFA concurrence was primarily to aid FHFA in carrying out its supervisory duties, and to a lesser extent, to decrease the likelihood of a Bank alleging the existence of fraud as a pretext for terminating a merger agreement. FHFA acknowledges that the language of the proposed rule lacked standards for the agency's concurrence, and thus could be construed as authorizing it to compel an unwilling Bank to consummate a merger that the statutory regime intends to be voluntary, even if one of the Banks has concluded that grounds for termination exist, although such a result was not intended.
As in the proposed rule, final § 1278.3(b) states that a written merger agreement must set forth all material terms and conditions of the merger, including, “without limitation,” provisions addressing each of the matters enumerated in paragraphs (b)(1) through (b)(9). While, under paragraph (b)(9), the Constituent Banks are required to include within the merger agreement a provision authorizing a Bank to terminate the agreement for the reasons enumerated in the regulation, nothing in the language of § 1278.3 precludes the Banks from including in the agreement other grounds for termination that may be agreed upon by the respective boards and, in the case of a termination occurring after the member votes, by the members themselves. Thus, to the extent that Banks wish to include within a merger agreement provisions specifying additional grounds for termination of the agreement, they are free to do so under the final rule.
Section 1278.4 of the proposed rule addressed the application process to be followed in order to obtain FHFA approval for any merger of Banks. Proposed § 1278.4(a) would have required that the Constituent Banks submit to FHFA a merger application addressing all material aspects of the merger including, at a minimum: (1) A written statement summarizing the material features of the proposed merger and addressing certain enumerated issues; (2) a copy of the executed merger agreement and certified copies of the board resolutions authorizing the merger agreement; (3) a copy of the proposed organization certificate of the Continuing Bank; (4) a copy of the proposed bylaws of the Continuing Bank; (5) a copy of the proposed capital structure plan of the Continuing Bank; (6) the most recent annual audited financial statements for each Constituent Bank; and (7) pro forma financial statements for the Continuing Bank. No commenter objected to these proposed application requirements, but there were several comments regarding particular aspects of the requirements. Section 1278.4(a) of the final rule retains the proposed requirements, with some minor revisions as noted below.
As a general matter, the Banks expressed concern over the treatment of confidential commercial information that may be included in a merger application and requested that the final rule permit the submission of confidential information in a separate binder, specify that such information is exempt from disclosure under the Freedom of Information Act (FOIA), and give examples of types of information that would be considered confidential. FHFA has adopted only the first of these suggestions. The introductory clause of final § 1278.4(a) has been revised to include a new sentence specifying that a Bank may submit separately any portions of the merger application that it believes contain confidential or privileged trade secrets or commercial or financial information, and that such information will be handled in accordance with FHFA's FOIA regulations set forth at 12 CFR part 1202.
The procedures for the handling of information submitted to FHFA that the submitter believes to be confidential commercial information protected from FOIA disclosure under 5 U.S.C. 552(b)(4) and 12 CFR 1202.4(a)(4) are set forth in 12 CFR 1202.8. Section 1202.8(b) specifies that submitters of commercial information should use good-faith efforts to designate, by appropriate markings, either at the time of submission or at a reasonable time thereafter, those portions of the information they deem to be protected. Once so designated, such information may be released only pursuant to the procedures set forth in 12 CFR 1202.8(c) through (i), which provides in most cases for prior notice to the submitter and an opportunity for the submitter to object to the release of the information. Because the handling of confidential commercial information is addressed directly by FHFA's FOIA regulations, FHFA has declined to address separately in final part 1278 the FOIA status of any materials or information submitted as part of the merger application process.
With regard to the contents of the merger application, proposed § 1278.4(a)(1) would have required a written statement including: (i) A summary of the material features of the proposed merger; (ii) the reasons for the proposed merger; (iii) the effect of the proposed merger on the Constituent Banks and their members; (iv) the planned Effective Date of the merger; (v) a summary of the material features of any related transactions and the bearing that the consummation of, or failure to consummate, the related transactions is expected to have upon the merger; (vi) the names of the persons proposed to serve as directors and senior executive officers of the Continuing Bank; (vii) a description of all proposed material operational changes; (viii) information demonstrating that the Continuing Bank will comply with all applicable capital requirements after the Effective Date; (ix) a statement explaining all officer and director indemnification provisions; and (x) an undertaking that the Constituent Banks will continue to disclose all material information, and update all items, as appropriate. The topics required to be addressed in the application statement under § 1278.4(a)(1) of the final rule are substantially the same as those that were proposed, although the final version reflects a few minor additions and clarifications.
The first of these appears in paragraph (a)(1)(iv), which has been revised to require the statement to include, in addition to the proposed Effective Date: the Record Date established by each Constituent Bank's board of directors for purposes of determining the rights of member institutions to participate in the merger ratification vote (discussed in detail below); and the GAAP acquisition
Second, paragraph (a)(1)(vi), which as proposed would have required the names of the persons to serve as directors and senior officers of the Continuing Bank, has been revised to require the Banks also to include in the merger application information regarding their proposal for the ultimate size and composition of the board of directors,
Third, paragraph (a)(1)(vii), which in its proposed form would have required that the application statement address any staff reductions as part of a discussion of anticipated material operational changes, has been revised to require that the statement address such reductions only to the extent such information is known. This revision was made in response to the Banks' comment that it may be more prudent to defer decisions about specific reductions in staff until after the merger has occurred and management of the Continuing Bank has assessed its staffing needs and that, therefore, the Banks should not be required to provide such specific information at the time the merger application is filed. The fourth revision appears in paragraph (a)(1)(x), and is meant to clarify that the Constituent Banks' undertaking to update “all items,” as appropriate, applies specifically to items required to be included in the merger application.
FHFA has declined to make a requested change to proposed paragraph (a)(1)(vi), which would have required that the merger application set forth the names of the persons proposed to serve as directors and senior executive officers of the Continuing Bank. In their joint comment letter, the Banks expressed concern that the identity of the directors and senior executive officers of the Continuing Bank may not yet be determined at the time that the merger application is submitted, and requested that the rule permit this information to be added later as a supplement to the application. Although FHFA believes that the better practice would be for the Banks to file a complete merger application as a single submission, the rule does not require the Banks to do so, and therefore would allow the Banks to file portions of the required materials as a supplement to their initial merger application. Thus, if the Constituent Banks have not reached agreement as to the identity of the persons who will serve as directors and senior executives of the Bank when they initially file the merger application, they may submit this information as a supplement to the initial merger application. However, if they choose to do so, FHFA will not deem the application to be complete, and the time periods for FHFA review prescribed under § 1278.5 will not commence, until all information required by the final rule has been submitted. Corporate governance of the Continuing Bank is a critical issue, and the Director must know the identity of these individuals in order to determine whether the Continuing Bank will have adequate managerial resources—a factor that the Director is required to consider as part of the decision to approve or deny a merger request under § 1278.5(a).
Paragraphs (2) through (7) of proposed § 1278.4(a) addressed the additional items to be included as part of the merger application. Paragraph (a)(2) would have required that a merger application include a copy of the executed merger agreement, accompanied by a certified copy of the resolution of the board of directors of each Constituent Bank authorizing the execution of the merger agreement. In addition, paragraphs (a)(3) through (a)(5) would have required the Banks to provide, respectively, copies of the proposed organization certificate, the proposed bylaws, and the proposed capital structure plan of the Continuing Bank. These paragraphs have been carried over unchanged in the final rule. As discussed previously, if the items addressed in paragraphs (a)(3) through (a)(5) have already been attached to the merger agreement, additional copies need not be provided so long as the application makes clear that they are so attached.
Proposed paragraph (a)(6) would have required that the Banks include as part of a merger application the most recent annual audited financial statements for each Constituent Bank. In the final rule, this provision has been revised to require that the Banks also provide their quarterly financial statements for the current year-to-date. The most current available financial information for each of the Constituent Banks will obviously be a critical element of the official record to be reviewed by the Director, and the omission of this requirement from the proposed rule was an oversight. As mentioned above, FHFA also has added a definition of the term “Financial Statements” to § 1278.1 to clarify that these are to comprise statements of condition, income, capital, and cash flows, with explanatory notes, in such form as the Banks are required to include in their filings made under the Exchange Act.
Paragraph (a)(7) of proposed § 1278.4 would have required the Banks to include as part of a merger application pro forma financial statements for the Continuing Bank in such form as would be required to be included in the Disclosure Statement that the Banks must provide to their members in connection with the member vote under proposed § 1278.6—
In their joint comment letter, the Banks asserted that Regulation S-X
Having concluded that the Form S-4 requirements are the appropriate template upon which to base the requirements for the Disclosure Statement under part 1278, and given the detailed nature of the Form (including the SEC regulations cross-referenced), FHFA has further concluded that it is best to minimize any variations therefrom with respect to the Disclosure Statement requirements. Accordingly, the final rule continues to require only that the pro forma statements included in the Disclosure Statement correspond with those that would be required under the Form S-4. If a Constituent Bank and its attorneys and accountants conclude that the Form S-4 would require inclusion of only historical pro forma information in a particular case, then it should provide that information in the Disclosure Statement.
However, in order to approve any merger application under § 1278.5 of the final rule, the Director must be provided with information to establish that the Continuing Bank will be viable and will be able to serve its members effectively immediately following the merger and for some period thereafter. The agency also recognizes that the longer the time period covered by a pro forma forecast, the less accurate the forecast is likely to be. With this in mind, the agency has decided to revise § 1278.4(a)(7) to require the Banks to include forward looking pro forma financial statements for the Continuing Bank for each of at least two years following the date of the most recently filed quarterly statement of condition for the Constituent Banks. In order to establish a baseline for these forecasts, final paragraph (a)(7) also requires that the merger application include pro forma financial statements for the Continuing Bank as of the date of the most recently filed quarterly statement of condition for the Constituent Banks. FHFA requires Banks to provide two-year forward looking pro forma statements when they apply for approval of amendments to their capital structure plans,
Section 1278.4(b) of the proposed rule would have authorized FHFA to require the Constituent Banks to submit any additional information that the agency determined was necessary to assess a particular merger. Under the proposed rule, if the agency had determined a merger application to be complete under § 1278.4(c), FHFA could have required the Constituent Banks to submit additional information only with respect to matters derived from or prompted by the materials already submitted, or matters of a material nature that were not reasonably apparent previously. Under proposed § 1278.4(b), FHFA would have been permitted to use a Constituent Bank's failure to provide the required information in a timely manner as grounds to deny a merger application. No commenters objected to these provisions and § 1278.4(b) has been adopted as proposed.
Section 1278.4(c) of the proposed rule addressed the timing for determining whether a merger application is complete. As proposed, FHFA would have had 30 days after the receipt of a merger application to determine whether it was complete or whether any additional information was required. The proposed rule would have required FHFA to inform the Constituent Banks in writing if the agency determined that an application was complete and that it had all information necessary to evaluate the proposed merger, and also if it determined that an application was incomplete or that it required additional information. In the latter case, FHFA would have been required to specify the number of days within which the Constituent Banks must provide any additional information or materials, and within 15 days of receipt of such information or materials, to again determine whether a merger application is complete and so inform the Banks. Again, no commenters objected to this provision and it has been adopted as proposed.
Under the proposed rule, the review and approval of a merger by the Director would have been a two-step process. The first step, addressed by proposed § 1278.5, would have encompassed a review of all substantive aspects of a proposed merger, followed by either a preliminary approval or a denial of the merger application. Merger transactions that had been granted preliminary approval, and which had been ratified by the members of each Constituent Bank, would then have been subject to a final review and approval under § 1278.7 of the proposed rule. At the final review step, the Director would have been permitted to deny final approval of a merger only for limited reasons.
The Banks opposed this two-step process as being overly lengthy and burdensome. They recommended that the rule be revised to provide for a process similar to that which they asserted is employed by the federal depository institution regulators—
Final § 1278.5(a), which establishes standards for approving a merger, has been adopted as proposed and provides that, in deciding whether to approve or deny a merger application, the Director must take into consideration the financial and managerial resources of each of the Constituent Banks, the future prospects of the Continuing Bank, and the effect of the proposed merger on the safety and soundness of the Continuing Bank and the Bank System. These standards are similar to those used by the federal depository institution regulators in considering mergers and acquisitions of federally insured depository institutions.
Section 1278.5(b) of the proposed rule addressed procedural aspects of the merger application process. As proposed, § 1278.5(b) would have permitted the Director 30 days after determining the merger application to be complete to consider the information and materials provided in the application and either grant or deny preliminary approval of the merger. The
In the final rule, § 1278.5(b) has been revised, and a new § 1278.5(c) has been added, to reflect the new one-step approval process. Final § 1278.5(b) continues to require that, within 30 days of FHFA's determination that a merger application is complete, the Director either approve or deny the merger application. This section has been revised to provide that an approval of a merger application may include any conditions the Director determines to be appropriate. While FHFA has not included in the final rule a requirement that the Banks must submit their Disclosure Statements to the agency for review prior to sending the document to their members, the Director will have the ability to require such a review as a condition of approval.
Final § 1278.5(b) also provides that, in every case, approval will be conditioned on each Constituent Bank demonstrating that it has obtained the members' ratification of the merger agreement in accordance with the requirements of § 1278.6 by submitting to FHFA: (1) A certified copy of the members' resolution ratifying the merger agreement, on which the members cast their votes; and (2) a certification of the member vote from the Bank's corporate secretary or from an independent third party. These materials, as well as any others necessary to prove that all conditions of approval have been met, must be provided to FHFA before the Director may effect the consummation of the merger by accepting the organization certificate of the Continuing Bank under § 1278.7 of the rule (discussed below).
Final § 1278.5(c) contains the same notice requirements that appeared in § 1278.5(b) of the proposed rule. Thereunder, FHFA must provide written notice to each Constituent Bank, as well as to each other Bank and the Office of Finance, in the case of either an approval or a denial. As in the proposed rule, a notice of approval must set forth any conditions to that approval and a notice of denial must state the reasons for the denial.
Section 1278.6 of the proposed rule addressed the requirements for the ratification of a merger agreement by vote of the Constituent Banks' member institutions. This section has been adopted substantially as proposed, with the exceptions discussed below.
Proposed § 1278.6(a) would have required that no merger of Banks be consummated unless the merger agreement had been ratified by the members of each Constituent Bank in a voting process meeting the requirements of paragraphs (a)(1) through (a)(4) of that section. As proposed, paragraph (a)(1) would have required that each Constituent Bank deliver a ballot and a Disclosure Statement to each of its members. As defined in § 1278.1 of the proposed rule, a Disclosure Statement would have been required to contain all of the items that the Constituent Bank providing the statement would be required to include in a Form S-4 Registration Statement promulgated by the SEC under the Securities Act of 1933 (or any successor form promulgated by the SEC governing disclosure required for securities issued in business combination transactions) when prepared as a prospectus as directed in Part I of the Form. In addition, proposed paragraph (a)(1) would have required that the Disclosure Statement establish a closing date for the Bank's receipt of completed ballots that was no earlier than 30 days after the date that the ballot and Disclosure Statement were delivered to its members.
In the final rule, paragraph (a)(1) has been revised slightly to require that the enumerated items be delivered to “each institution that was a member as of the Record Date,” as opposed to merely “its members.” This change was made to reflect the fact that the eligibility of an institution to participate in the merger vote is to be determined as of the record date established by the Constituent Bank's board of directors (discussed in more detail below) and that, consequently, it is the institutions that are so eligible that must receive the ballot and the Disclosure Statement.
In addition, the definition of “Disclosure Statement” has been modified slightly in the final rule. In their joint comment letter, the Banks agreed that the Form S-4 is a useful and widely-accepted model for comprehensive shareholder disclosure in a merger transaction. However, the Banks asserted that a number of the Form S-4 requirements are clearly not applicable to the Banks, and requested that the rule make clear that the Form S-4 prospectus information needs to be included only to the extent applicable. Similarly, the Banks asserted that, pursuant to various statutory provisions and SEC no-action letters, the Banks are not required to comply with certain requirements that would otherwise apply in the preparation of their Annual Reports on Form 10-K. They requested that the rule also make clear that, to the extent that these Form 10-K requirements are also Form S-4 requirements, these items need not be included in the Disclosure Statement.
FHFA recognizes that, due to the unique corporate and capital structure of the Banks, certain items regarding the Banks or the transactions that are required to be disclosed in the Form S-4 will be inapplicable. The agency also recognizes that the Banks have been exempted by statute and through SEC no-action letters from a number of disclosure requirements that would otherwise be applicable. The Form S-4 and the SEC regulations that are cross-referenced therein make clear in several places that information need only be furnished to the extent appropriate.
In discussing proposed § 1278.6 in the Supplementary Information to the proposed rule, FHFA stated that, under the terms of the Form S-4, the Banks would be permitted to supply much of the required information through incorporation by reference of their Form 10-Ks and other periodic SEC filings. The Banks supported this option, but pointed out that the incorporation by reference into a Form S-4 is permitted under the SEC's regulatory authority, which would not extend to the Disclosure Statement. They therefore
Paragraph (a)(2) of proposed § 1278.6 addressed the voting rights of shareholders of the Constituent Banks and the requirements for the casting of ballots. With respect to the latter, proposed paragraph (a)(2) would have required that each voting entity cast all of its votes either for or against the ratification of the merger agreement or to abstain with respect to all of its votes, and that each entity's vote be made by resolution of its governing body, either authorizing the specific vote or delegating to an individual the authority to vote. Both of these requirements, which mirror requirements that apply to the election of Bank directors, have been carried over unchanged in the final rule.
However, the approach to the determination of the voting rights of each member of a Constituent Bank in a vote to ratify a merger agreement has been modified from that which appeared in the proposed rule. As proposed, paragraph (a)(2) stated that each member of each Constituent Bank would be entitled to cast the same number of votes that the member may cast in that year's election of Bank directors. By statute, in the election of Bank directors, a member is entitled to cast one vote for each share of Bank stock the member was required to hold as of the record date (set by statute at December 31 of the prior year in the case of elections for Bank directors
Most commenters supported tying members' merger voting rights closely to those that apply to the election of Bank directors, although one requested that the rule permit each Bank to amend its bylaws to govern members' merger voting rights in a way that the Bank's board believes is appropriate. One commenter expressly supported the application of the cap on the number of shares that a member may vote, explaining that this will ensure that small members will continue to have a voice in Bank governance. Another commenter supported the voting cap in theory, but opined that in the case of a district-wide merger vote the cap should be applied uniformly for all of the members within the Bank's district and not on a state-by-state basis, as is done in the case of the election of directors.
FHFA has considered these comments and believes, on balance, that the requirements for the merger voting process should be closely tied to those that are established by statute for the election of Bank directors. This is because the voting process enshrined in the Bank Act is the only manifestation of general Congressional intent on the subject of member voting, and because it is consistent with the cooperative structure of the Bank System and will reduce the possibility that a few large stockholders will control the outcome of a vote on a merger. However, in the light of the comments received, the agency has reconsidered the application of the vote cap and has determined that because a merger ratification vote would be a district-wide “at large” election, the cap on the number of votes that may be cast by a member institution should be calculated based upon the average number of shares held by all members in the Bank's district, as opposed to the average number held by all members within the state in which that member institution is located.
FHFA recognizes that this will result in certain large Bank members being eligible to cast more or fewer votes—in some cases by significant margins—than the member would be eligible to cast in the election of directors. However, it is the agency's view that, as a matter of equity and appropriate corporate governance, the final rule should not permit a result where one Bank member is authorized to vote a materially different number of shares than another similarly-sized member that is located within a different state in the same Bank district. Therefore, paragraph (a)(2) has been revised in the final rule to provide that each member of each Constituent Bank shall be entitled to cast one vote for each share of Bank stock that the member was required to own as of the Record Date, provided that the number of votes that any member may cast shall not exceed the average number of shares of Bank stock required to be held by all members of that Bank, calculated on a district-wide basis, as of the Record Date.
In the Supplementary Information to the proposed rule, FHFA explained that the effect of applying the statutory and regulatory requirements governing the election of Bank directors to the merger ratification vote is that not all Bank stock would carry the right to vote in such an election. For example, stock controlled by a non-member institution as a result of the acquisition of a Bank member, and stock held by a member in excess of the statutory cap applicable to that member's state, could not be voted in a director election and, therefore, could not have been voted in a merger election under the proposal. In their joint comment letter, the Banks expressed concern about both of those examples, pointing out that the long-standing policy of both FHFA and the former Federal Housing Finance Board (Finance Board) has been that: (1) If a non-member institution acquires a Bank member after the record date, but prior to the election, the acquiring non-member may vote the acquired member's shares, despite the fact that it is not a Bank member; and (2) if a member that is subject to the statutory cap in a particular state acquires another member in the same state subsequent to the record date, but prior to the election, the acquiring member is permitted to cast the eligible votes for the acquired member, as well as its own votes, in that year only.
FHFA did not intend to imply in the Supplementary Information to the proposed rule that these policies would not apply also to a merger vote under part 1278. The counter-examples given by the Banks apply to particular situations that may occur due to the fact that voting rights are determined as of the record date (December 31 in the case of director elections), whereas the vote itself may not occur until many months later. During the interim, stock that is eligible to be voted by a member as of the record date may be transferred to another entity—which could be a member or non-member—through the acquisition of the member by the other entity. In these cases, the acquiring entity may vote the shares that were deemed eligible as of the record date as the successor to the disappearing member. Because these voting rights are those of the disappearing member, the status of the acquirer as a non-member or the fact the acquirer may be a member whose own voting power is limited by the vote cap have no bearing
Paragraph (a)(3) of proposed § 1278.6 addressed the Constituent Banks' handling of ballots and the determination of the results of the ratification vote. It would have prohibited each Constituent Bank from reviewing any ballot until after the closing date of the election, counting any ballot received after the closing date, or disclosing how any member voted, while requiring each to tabulate the ballots immediately after the closing date and to retain all ballots for at least two years after the date of the election. Importantly, as proposed, paragraph (a)(3) provided that a merger agreement would be considered to be ratified if a majority of votes cast in the election have been cast in favor of the merger. One commenter, while otherwise supporting the parallel to the director election process, advocated requiring the approval of a supermajority of members for any proposed merger. FHFA has declined to adopt that suggestion because it interprets section 26(b) of the Bank Act as having the purpose of facilitating the ability of the Banks to voluntarily merge, and the imposition of a supermajority requirement would not further that purpose. Accordingly, paragraph (a)(3) has been adopted as proposed.
Paragraph (a)(4) of proposed § 1278.6 would have required that, within 10 calendar days of the election closing date, a Constituent Bank deliver to its members, to each Constituent Bank with which it proposes to merge, and to FHFA a statement of: the total number of eligible votes; the number of members voting in the election; and the total number of votes cast both for and against ratification of the merger agreement, as well as those that were eligible to be cast by members that abstained and by members who failed to return completed ballots. No commenters objected to any aspect of this provision, and it has been adopted as proposed.
Section 1278.6(b) of the proposed rule stated that, in connection with a proposed merger, no Bank, or any director, officer, or employee thereof, shall make any statement, written or oral, which, at the time and in the light of the circumstances under which it is made, is false or misleading with respect to any material fact, or which omits to state any material fact necessary in order to make the statement not false or misleading, or necessary to correct any earlier statement that has become false or misleading. No commenter objected to this provision, and it has also been adopted as proposed.
Section 1278.7 of the final rule governs the process for the consummation of a merger after the members of each Constituent Bank have voted to ratify the merger agreement. As proposed, § 1278.7 would have governed the second step of the preliminary/final approval process that was provided for in the proposed rule. The proposed provision would have required that the Director grant a second, final, approval prior to consummation of the merger, and would have provided the Director with limited authority to deny approval of the merger in cases where: the member vote was not carried out in accordance with the requirements of § 1278.6; one or more Constituent Banks failed to fulfill a condition of the preliminary approval; or an event had occurred since the time of the preliminary approval that would have had a significant adverse impact on the future viability of the Continuing Bank.
For the reasons discussed above, the final rule now requires only one approval by the Director to be obtained, prior to the member votes under § 1278.6. However, because this approval is conditional, § 1278.7 has been retained in revised form as a procedural mechanism to ensure that the merger cannot be consummated until the Director has received satisfactory evidence that the conditions of the approval have been met. Section 1278.7 has also been revised to provide for greater certainty as to the time that the merger becomes effective.
Section 1278.7(a) of the final rule addresses the materials that the Constituent Banks are required submit after their respective member institutions have voted to ratify the merger. Final § 1278.7(a)(1) requires that the Constituent Banks submit to FHFA evidence acceptable to the Director that all conditions imposed in connection with the approval of the merger application have been satisfied, which shall in all cases include for each Bank a certified copy of its members' resolution ratifying the merger agreement and a certification of the member votes from the corporate secretary or from an independent third party. Final § 1278.7(a)(2) requires that the Constituent Banks also submit an organization certificate for the Continuing Bank, “in such form as FHFA may specify” that has been executed by the individuals who will constitute the board of directors of the Continuing Bank. Although FHFA currently has no regulations or guidelines governing the form of a Bank's organization certificate, final § 1278.4(a)(3) requires that the Constituent Banks submit a proposed organization certificate as part of the merger application, and the agency anticipates that it will provide appropriate guidance as to the form and content of the final certificate as part of the merger approval process.
Final § 1278.7(b) governs the method of acceptance and timing of the effectiveness of the Continuing Bank's organization certificate. Under the proposed rule, after obtaining the Director's final approval, the Constituent Banks would have been required to submit to FHFA an organization certificate for the Continuing Bank and, upon its acceptance by the agency, the corporate existence of the Continuing Bank would have commenced “as of the Effective Date.” This approach lacked clarity in a number of respects. First, as discussed above, the proposed rule defined “Effective Date” to mean “the date on which the Constituent Banks consummate the merger,” but left unclear what actions were required for the Banks to consummate the merger. In addition, while the proposed rule would have required FHFA to provide notice of its final approval to all of the Banks, it neither specified any particular overt action to be taken by FHFA to signify “acceptance” of the Continuing Bank's organization certificate, nor provided for any prior or subsequent notice of the fact or timing of such acceptance, or of
Final § 1278.7(b) is intended to provide the specificity that the proposed rule lacked. It states that, upon determining that all conditions of the Director's approval have been satisfied and that the organization certificate has been properly executed and is in the required form, the Director shall accept the organization certificate by endorsing it with the date of acceptance and the Effective Date. Paragraphs (1) and (2) of § 1278.7(b) govern the method by which the Director shall determine the Effective Date. If the merger agreement states a proposed Effective Date (whether expressed in terms of a specific date or a specific number of days after a particular event) and that date has not passed, the Director shall establish that date as the Effective Date. If the merger agreement sets forth a proposed range of dates within which the Effective Date may occur (
Final §§ 1278.7(c)(1) and (2) provide that, after the Director has accepted the organization certificate as provided under § 1278.7(b), the Continuing Bank shall, as of the commencement of the Effective Date specified on the certificate, become or remain a body corporate (depending on the type of transaction) operating under such organization certificate with all powers granted to a Bank under the Bank Act, and shall succeed to all rights, titles, powers, privileges, books, records, assets, and liabilities of the Constituent Bank or Banks, as provided in the merger agreement. In the proposed rule, § 1278.7(b) stated that, after acceptance of the organization certificate, the Continuing Bank would “be a body corporate operating under the new organization certificate.” The Banks expressed concern about this phrasing because they believed that such language may imply that a new corporate entity has been formed even in the case of a traditional merger (where an existing Bank absorbs a disappearing Bank). In response, FHFA has specifically provided in final § 1278.7(c) that, after acceptance of the organization certificate, the Continuing Bank shall “become or remain a body corporate (depending on the type of transaction) operating under such organization certificate.” This phrasing is intended to address both those business combinations where the Continuing Bank is a continuation of one of the existing Constituent Banks, as well as those where the Continuing Bank is considered to be an entirely new entity. Regardless of the form of the transaction, FHFA will not consider the merger to have been legally consummated until the new or revised organization certificate becomes effective.
In addition, final § 1278.7(c)(3) provides that the corporate existence of any Constituent Bank that is not a Continuing Bank shall cease as of the Effective Date of the organization certificate of the Continuing Bank, except as provided in the merger agreement. The latter clause is intended to provide for those cases in which it may be useful or necessary for a disappearing Constituent Bank to continue in existence for a short period following the consummation of a merger—for example, where a “shell” Bank that has transferred its territory and most of its assets and liabilities to another Bank may need time wind down its affairs, or where the disappearing Bank is being acquired by two or more other Banks and the transactions are not to be consummated simultaneously. Section 25 of the Bank Act provides that each Bank shall have succession until dissolved by the Director (or by Act of Congress) and final § 1278.7(c)(3) is intended to make clear that the Director's approval of the merger application and endorsement of the new organization certificate are sufficient to dissolve any non-Continuing Banks without further action in cases where the merger agreement does not provide for the temporary continuation of a disappearing Constituent Bank. In the case of a shell Bank that is winding down its affairs, the Director will issue a separate order of dissolution at the appropriate time. Under the rule, any Constituent Bank that is a party to a merger (as that term is broadly defined in the rule) that continues in existence after the consummation of the merger without specific provision for its eventual disposition (either through dissolution or another merger) will be considered to be a Continuing Bank and will be subject to all applicable requirements.
Final § 1278.7(d) provides that, after the Director accepts the organization certificate for the Continuing Bank, FHFA shall provide prompt written notice of that fact to the Constituent Banks, as well as to each other Bank and the Office of Finance. This notice must include the date of acceptance and the Effective Date of the organization certificate for the Continuing Bank.
The final rule does not contain any collections of information pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The final rule applies only to the Banks, which do not come within the meaning of small entities as defined in the Regulatory Flexibility Act (RFA).
Banks, banking, Federal home loan banks, mergers.
For the reasons stated in the Supplementary Information, the Federal Housing Finance Agency hereby amends chapter XII of title 12 of the Code of Federal Regulations by adding new part 1278 to subchapter D to read as follows:
12 U.S.C. 1432(a), 1446, 4511.
(1) A merger of one or more Banks into another Bank;
(2) A consolidation of two or more Banks resulting in a new Bank;
(3) A purchase of substantially all of the assets, and assumption of substantially all of the liabilities, of one or more Banks by another Bank or Banks; or
(4) Any other business combination of two or more Banks into one or more resulting Banks.
Any two or more Banks may merge voluntarily under authority of section 26(b) of the Bank Act, provided that each of the following requirements has been satisfied:
(a) The Constituent Banks have executed a written merger agreement that satisfies all requirements of § 1278.3;
(b) The Constituent Banks have jointly filed a merger application with FHFA that satisfies all requirements of § 1278.4;
(c) The Director has approved the merger application in accordance with the requirements of § 1278.5;
(d) The members of each Constituent Bank have ratified the merger agreement as provided under § 1278.6; and
(e) The Director has determined that the Constituent Banks have satisfied all conditions imposed in connection with the approval of the merger application, and has accepted the properly executed organization certificate of the Continuing Bank, as provided under § 1278.7.
A merger of Banks under the authority of § 1278.2 shall require a written merger agreement that:
(a) Has been authorized by the affirmative vote of a majority of a quorum of the board of directors of each Constituent Bank at a meeting on the record and has been executed by authorized signing officers of each Constituent Bank; and
(b) Sets forth all material terms and conditions of the merger, including, without limitation, provisions addressing each of the following matters—
(1) The proposed Effective Date and the proposed acquisition date for purposes of accounting for the transaction under GAAP, if that date is to be different from the Effective Date;
(2) The proposed organization certificate and bylaws of the Continuing Bank;
(3) The proposed capital structure plan for the Continuing Bank;
(4) The proposed size and structure of the board of directors for the Continuing Bank;
(5) The formula to be used to exchange the stock of the Constituent Banks for the stock of the Continuing Bank, and a provision prohibiting the issuance of fractional shares of stock;
(6) Any conditions that must be satisfied prior to the Effective Date, which must include approval by the Director and ratification by the members of the Constituent Banks;
(7) A statement of the representations or warranties, if any, made or to be made by any Constituent Bank;
(8) A description of the legal or accounting opinions or rulings, if any, that are required to be obtained or furnished by any party in connection with the proposed merger; and
(9) A statement that the board of directors of a Constituent Bank may terminate the merger agreement before the Effective Date upon a determination that:
(i) The information disclosed to members contained material errors or omissions;
(ii) Material misrepresentations were made to members regarding the impact of the merger;
(iii) Fraudulent activities were used to obtain members' approval; or
(iv) An event occurred subsequent to the members' vote that would have a significant adverse impact on the future viability of the Continuing Bank.
(a)
(1) A written statement that includes—
(i) A summary of the material features of the proposed merger;
(ii) The reasons for the proposed merger;
(iii) The effect of the proposed merger on the Constituent Banks and their members;
(iv) The proposed Effective Date, the proposed acquisition date for purposes of accounting for the transaction under GAAP, if that date is to be different from the Effective Date (including the reasons for designating a different acquisition date), and the Record Date established by each Constituent Bank's board of directors;
(v) If the Constituent Banks contemplate that the proposed merger will be one of two or more related transactions, a summary of the material features of any related transactions and the bearing that the consummation of, or failure to consummate, the related transactions is expected to have upon the proposed merger;
(vi) If not addressed by the merger agreement, the Banks' proposal for the ultimate size and composition of the board of directors for the Continuing Bank and their plan for reducing the board to its ultimate size and composition, as well as the names of the persons proposed to serve as directors and senior executive officers of the Continuing Bank immediately after the merger;
(vii) A description of all proposed material operational changes including, but not limited to, reductions in the existing staffs of the Constituent Banks (to the extent such information is known), whether and how Bank operations will be combined, and whether any Constituent Bank will continue to operate as a branch of the Continuing Bank;
(viii) Information demonstrating that the Continuing Bank will comply with all applicable capital requirements after the Effective Date;
(ix) A statement explaining all officer and director indemnification provisions; and
(x) An undertaking that the Constituent Banks will continue to disclose all material information, and update all items of the application, as appropriate;
(2) A copy of the executed merger agreement and a certified copy of the resolution of the board of directors of each Constituent Bank authorizing the merger agreement;
(3) A copy of the proposed organization certificate of the Continuing Bank;
(4) A copy of the proposed bylaws of the Continuing Bank;
(5) A copy of the proposed capital structure plan of the Continuing Bank;
(6) The most recent annual audited Financial Statements, and any interim quarterly financial statements for the year-to-date, for each Constituent Bank; and
(7) Pro forma Financial Statements for the Continuing Bank as of the date of the most recent statement of condition supplied under paragraph (a)(6) of this section, and forecasted pro forma Financial Statements for each of at least two years following such date.
(b)
(c)
(1) If FHFA determines that the application is complete and that it has all information necessary to evaluate the proposed merger, it shall so inform the Constituent Banks in writing.
(2) If FHFA determines that the application is incomplete, or that it requires additional information in order to evaluate the application, it shall so inform the Constituent Banks in writing, and shall specify the number of days within which the Constituent Banks must provide any additional information or materials. Within 15 days of receipt of the additional information or materials, FHFA shall inform the Constituent Banks in writing whether the merger application is complete.
(a)
(b)
(1) A certified copy of the members' resolution ratifying the merger agreement, on which the members cast their votes; and
(2) A certification of the member vote from the Bank's corporate secretary or from an independent third party.
(c)
(a)
(1)
(i) A ballot that permits the member to vote for or against the ratification of the merger agreement, or to abstain from such vote; and
(ii) A Disclosure Statement that establishes a closing date for the Bank's receipt of completed ballots that is no earlier than 30 days after the date that the ballot and Disclosure Statement are delivered to its members.
(2)
(3)
(4)
(i) The total number of eligible votes;
(ii) The number of members voting in the election; and
(iii) The total number of votes cast both for and against ratification of the merger agreement, as well as those that were eligible to be cast by members that abstained and by members who failed to return completed ballots.
(b)
(a)
(1) Evidence acceptable to the Director that all conditions imposed in connection with the approval of the merger application under § 1278.5 have been satisfied, including the items specified in §§ 1278.5(b)(1) and (2); and
(2) An organization certificate for the Continuing Bank, in such form as FHFA may specify, that has been executed by the individuals who will constitute the board of directors of the Continuing Bank.
(b)
(1) The proposed Effective Date set forth in the merger agreement or, if the merger agreement expresses the proposed Effective Date in terms of a range of dates, a date within the applicable range of dates; or
(2) If the proposed Effective Date set forth in the merger agreement has passed, the earlier of:
(i) The 10th business day following the date of acceptance of the organization certificate by the Director; or
(ii) The last business day preceding any date specified in the merger agreement by which the merger agreement will terminate if the merger has not become effective.
(c)
(1) The Continuing Bank shall become or remain a body corporate (depending on the type of transaction) operating under such organization certificate with all powers granted to a Bank under the Bank Act;
(2) The Continuing Bank shall succeed to all rights, titles, powers, privileges, books, records, assets, and liabilities of the Constituent Banks, as provided in the merger agreement; and
(3) The corporate existence of any Constituent Bank that is not a Continuing Bank shall cease, unless otherwise provided in the merger agreement.
(d)
Federal Aviation Administration (FAA), DOT.
Final rule; correction
This action corrects a final rule published by the FAA in the
Effective date 0901 UTC, December 15, 2011. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Paul Gallant, Airspace, Regulations and ATC Procedures Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591;
On September 19, 2011, the FAA published a final rule in the
Area Navigation Routes are published in paragraph 2006 of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR
Accordingly, pursuant to the authority delegated to me, the coordinates for the CANDR waypoint as published in the
On page 57905, line 38, Remove “CANDR, NJ WP (lat. 40°57′59″ N., long. 74°57′29″ W.)”and insert “CANDR, NJ WP (lat. 40°58′16″ N., long. 74°57′35″ W.)
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class D and Class E airspace at Baltimore, MD, as the Martin Non-Directional Beacon (NDB) has been decommissioned and new Standard Instrument Approach Procedures have been developed at Martin State Airport. This action also updates the geographic coordinates of the Baltimore VORTAC and makes a minor adjustment to the geographic coordinates of the airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, February 9, 2012. The Director of the
John Fornito, Operations SupportGroup, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636,Atlanta, Georgia 30320; telephone (404) 305-6364.
On August 31, 2011, the FAA published in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class D airspace and Class E surface airspace and Class E airspace designated as an extension to Class D surface area. Airspace reconfiguration is necessary due to the decommissioning of the Martin NDB and cancellation of the NDB approach, and for continued safety and management of IFR operations at the airport. The geographic coordinates for the Baltimore VORTAC and Martin State Airport also are adjusted to coincide with the FAA's aeronautical database.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Martin State Airport, Baltimore, MD.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,500 feet MSL within a 5.2-mile radius of Martin State Airport and within 4.4 miles each side of a 14.7-mile radius arc of the Baltimore VORTAC extending clockwise from the Baltimore VORTAC 030° radial to the VORTAC 046° radial, excluding that airspace within the Washington Tri-Area Class B
Within a 5.2-mile radius of Martin State Airport and within 4.4 miles each side of a 14.7-mile radius arc of the Baltimore VORTAC extending clockwise from the Baltimore VORTAC 030° radial to the VORTAC 046° radial, excluding that airspace within the Washington Tri-Area Class B airspace area and Restricted Areas R-4001A and R-4001B when they are in effect. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within 4 miles each side of a 134° bearing from Martin State Airport extending from the 5.2-mile radius of Martin State Airport to 9.2 miles southeast of the airport, excluding that airspace within the Washington Tri-Area Class B airspace area and Restricted Areas R-4001A and R-4001B when they are in effect. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E Airspace at Luray, VA, to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures serving Luray Caverns Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations within the National Airspace System. This action also makes a minor adjustment to the geographic coordinates of the airport.
Effective 0901 UTC, February 9, 2012. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
On August 22, 2011, the FAA published in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface at Luray, VA, to provide the controlled airspace required to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures developed for Luray Caverns Airport. This action also adjusts the geographic coordinates of the airport to be in concert with the FAAs aeronautical database. This action is necessary for the safety and management of IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Luray Caverns Airport, Luray, VA.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 14.5-mile radius of Luray Caverns Airport.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, Thirteenth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the South 11th Street (“Murray Morgan”) Bridge across City Waterway also known as the Thea Foss Waterway, mile 0.6, at Tacoma, WA. The deviation is necessary to perform extensive maintenance and repair work on the bridge, including but not limited to removal and replacement of the roadway surface and the underlying steel stringer substructure as part a major bridge rehabilitation project. This deviation allows the bridge to remain in the closed position during construction activities.This deviation is effective from 8 a.m. on November 14, 2011 through 6 p.m. April 30, 2012.
Documents mentioned in this preamble as being available in the docket are part of docket USCG-2011-1068 and are available online by going to
If you have questions on this rule, call or email the Bridge Administrator, Coast Guard Thirteenth District; telephone (206) 220-7282 email
The City of Tacoma has requested to place the South 11th Street “Murray Morgan” Bridge in the closed or down position and to not open the bridge for vessel traffic to facilitate a major rehabilitation project on the bridge. The South 11th Street Bridge crosses City Waterway mile 0.6 at Tacoma, WA. The South 11th Street Bridge is also known as the Murray Morgan Bridge and City Waterway is also known as Thea Foss Waterway. The South 11th Street Bridge is a vertical lift bridge. During this deviation the bridge will be placed in the close or down position. There will be a debris containment system attached to the underside of the bridge for the duration of construction activities. A minimum vertical clearance of 57 feet above mean high water will be provided beneath the bridge and the attached debris containment system, at all time during the deviation period. Vessels which do not require a bridge opening may continue to transit beneath the bridge during this closure period. Under normal operations the bridge operates under 33 CFR 117.1061 which requires a two hour notice for an opening and allows the bridge to not open during morning and afternoon rush hours. This current deviation states the lift span of the 11th Street South Bridge (Murray Morgan Bridge) across City Waterway (Thea Foss Waterway), mile 0.6, need not open from 8 a.m. November 14, 2011 through 6 p.m. April 30, 2012; except as otherwise outlined in this article and through ongoing coordination with waterway users. The bridge will be able to open during this maintenance period for emergent situations provided 12 hours of advance notification of an opening is given. The bridge will be placed in the open position: November 24-27, 2011; December 24, 2011 through January 1, 2012, and either April 14-15, 2012 or April 21-22, 2012, to be coordinated with the local waterway users. The bridge will also be opened during an additional weekend in January, February, and March to be determined in coordination with local waterway users.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the Illinois River near Morris, Illinois. This zone is intended to restrict vessels from a portion of the Illinois River due to the Truman-Hobbs alteration of the Elgin Joliet & Eastern Railroad Drawbridge. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with the removal of the Elgin Joliet & Eastern Railroad Drawbridge's old bridge piers and pier protection cells.
This rule is effective in the CFR from November 28, 2011 until December 9, 2011. It is effective for purposes of enforcement from 7 a.m. on November 16, 2011 until 7 a.m. on December 9, 2011.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2011-1058 and are available online by going to
If you have questions on this temporary rule, contact or email BM1 Adam Kraft, U.S. Coast Guard Sector Lake Michigan, at (414) 747-7148 or
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when an agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because there is insufficient time for the Coast Guard to wait for a notice and comment period to run. The Coast Guard only recently learned that the bridge project described below will take longer than previously planned and consequently, will continue beyond the expiration of the Coast Guard safety zone previously established. Thus, waiting for a notice and comment period to run would be impracticable and contrary to the public interest in that it would prevent the Coast Guard from protecting the public and vessels on navigable waters from the hazards associated with this ongoing bridge construction project.
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
The Truman-Hobbs alteration of the Elgin Joliet & Eastern Railroad Drawbridge, which consists of the removal of the bridges old piers and pier protection cells had originally scheduled to finish by November 16, 2011. However, it has fallen behind schedule and will now go until December 9, 2011. The falling debris associated with the removal of the bridge's piers and protection cells poses a serious risk of injury to persons and property. As such, the Captain of the Port, Sector Lake Michigan, has determined that the alteration project of the Elgin Joliet & Eastern Railroad Drawbridge poses significant risks to public safety and property and that a safety zone is necessary.
Because of the aforementioned hazards, the Captain of the Port, Sector Lake Michigan, has determined that a safety zone is necessary to protect people and vessels. The safety zone will encompass all U.S. navigable waters of the Illinois River in the vicinity of the Elgin Joliet & Eastern Railroad Drawbridge between Mile Marker 270.1 and Mile Marker 271.5 of the Illinois River in Morris, IL. [DATUM: NAD 83].
All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port, Sector Lake Michigan, or his or her designated representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his or her designated representative. The Captain of the Port, Sector Lake Michigan, or his or her designated representative may be contacted via VHF-FM Channel 16 or at (414) 747-7182.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone around the bridge project will be relatively small and exist for relatively short duration. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port or his or her designated representative.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor on a portion of the Illinois River at various times between 7 a.m. on November 16, 2011 and 7 a.m. on December 9, 2011.
This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will only be enforced while unsafe conditions exist. Recreational Vessel traffic will be minimal due to the time of year and Commercial traffic is well aware of this project since it has been active since October 6, 2011. This rule will simply extend the duration of the safety zone that originally was set to expire at 7 a.m. on November 16, 2011.
In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of The Port, Sector Lake Michigan, or his or her designated representative to transit through the safety zone. The Captain of the Port or his or her representative can be contacted via VHF-FM Channel 16 or at (414) 747-7182. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. 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 calls for no 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 State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
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 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not affect 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 concern 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.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
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 concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a safety zone and is therefore categorically excluded under paragraph 34(g) of the Instruction.
A final environmental analysis checklist and categorical exclusion determination are available in the docket where indicated under
Harbors, Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his or her designated representative.
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port, Sector Lake Michigan, or his or her on-scene representative.
(3) The “designated representative” of the Captain of the Port, Sector Lake Michigan, is any Coast Guard commissioned, warrant, petty officer, or District 8 Bridge Branch Member who has been designated by the Captain of the Port, Sector Lake Michigan, to act on his or her behalf. The designated representative of the Captain of the Port, Sector Lake Michigan, will be reachable via VHF-FM Channel 16 or by calling (414) 747-7182.
(4) Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port, Sector Lake Michigan, or his or her designated representative to obtain permission to do so. The Captain of the Port, Sector Lake Michigan, or his or her designated representative may be contacted via VHF Channel 16 or at (414) 747-7182. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port, Sector Lake Michigan, or his or her designated representative.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing four temporary safety zones during New Year's Eve fireworks displays on certain navigable waterways in Naples, St. Petersburg, Cape Coral, and Sarasota, Florida. These safety zones are necessary to protect the public from the hazards associated with launching fireworks over navigable waters of the United States. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the four safety zones unless authorized by the Captain of the Port St. Petersburg or a designated representative.
This rule is effective from 7 p.m. on December 31, 2011 until 1 a.m. on January 1, 2012.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2011-0958 and are available online by going to
If you have questions on this temporary final rule, call or email Marine Science Technician First Class Nolan L. Ammons, Sector St. Petersburg Prevention Department, Coast Guard; telephone (813) 228-2191, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive necessary information regarding the fireworks displays until October 6, 2011. As a result, the Coast Guard did not have sufficient time to publish an NPRM and to receive public comments prior to the fireworks displays. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize potential danger to the public during the fireworks displays.
The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
The purpose of the rule is to protect the public from the hazards associated with the launching of fireworks over navigable waters of the United States.
Multiple fireworks displays are planned for New Year's Eve celebrations throughout the Captain of the Port St. Petersburg Zone. The fireworks will be launched from land, piers, or barges. Whether launched from land, pier, or barge, such fireworks will explode over navigable waters of the United States.
The Coast Guard is establishing four temporary safety zones for New Year's Eve fireworks displays on navigable waters of the United States that are located in the Captain of the Port St. Petersburg Zone. The safety zones are listed below.
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Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the safety zones unless authorized by the Captain of the Port St. Petersburg or
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
Executive Orders 13563, Regulatory Planning and Review, and 12866, Improving Regulation and Regulatory Review, direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this regulation under Executive Order 12866.
The economic impact of this rule is not significant for the following reasons: (1) The safety zones will be enforced for only six hours; (2) vessel traffic in the areas will be minimal during the enforcement periods; (3) although persons and vessels will not be able to enter, transit through, anchor in, or remain within any of the safety zones without authorization from the Captain of the Port St. Petersburg or a designated representative, they may operate in the surrounding areas during the enforcement periods; (4) persons and vessels may still enter, transit through, anchor in, or remain within the safety zones during the enforcement periods if authorized by the Captain of the Port St. Petersburg or a designated representative; and (5) the Coast Guard will provide advance notification of the safety zones to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. 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 any of the four safety zones established by this regulation during the respective enforcement period. 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 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.
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 calls for no 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 State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
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 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 effect 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
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
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 concluded 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 is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing four temporary safety zones, as described in paragraph 34(g) of the Instruction, that will be enforced for a total of six hours. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(1)
(2)
(3)
(4)
(b)
(c)
(1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated areas unless authorized by the Captain of the Port St. Petersburg or a designated representative.
(2) Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the regulated areas may contact the Captain of the Port St. Petersburg by telephone at (727) 824-7524, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within any of the regulated areas is granted by the Captain of the Port St. Petersburg or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port St. Petersburg or a designated representative.
(3) The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.
(d)
Environmental Protection Agency (EPA).
Direct final rule.
EPA is taking direct final action to approve several State Implementation Plan (SIP) revisions submitted by the South Carolina Department of Health and Environmental Control (SC DHEC). These revisions establish reasonably available control technology (RACT) requirements for the three major sources located in the portion of York County, South Carolina that is within the bi-state
This rule is effective on January 27, 2012 without further notice, unless EPA receives relevant adverse comment by December 28, 2011. If EPA receives such comment, EPA will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2010-0017 and EPA-R04-OAR-2010-0018, by one of the following methods:
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Zuri Farngalo, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Zuri Farngalo may be reached by phone at (404) 562-9152 or by electronic mail address
On April 30, 2004, EPA designated the bi-state Charlotte Area as a moderate nonattainment area with respect to the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS).
Section 183(e) of the CAA directs EPA to: (1) List for regulation those categories of products that account for at least 80 percent of the VOC emissions, on a reactivity-adjusted basis, from consumer and commercial products in ozone nonattainment areas; and (2) divide the list of categories to be regulated into four groups. EPA published the initial list in the
The primary purpose of the CTGs is to satisfy the requirement in CAA section 182(b)(2) that states adopt RACT rules for all areas designated nonattainment for ozone and classified as moderate or above. The three parts to the section 182(b)(2) RACT requirement are: (1) RACT for sources covered by an existing CTG (
A CTG is a guidance document issued by EPA which, in combination with CAA section 182(b)(2), triggers a responsibility for states to submit RACT rules for stationary sources of VOC that are covered by the CTG as part of their SIPs. EPA defines RACT as “the lowest emission limit that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.” 44 FR 53761 (September 17, 1979). Each CTG includes a “presumptive norm” or “presumptive RACT” that EPA believes satisfies the definition of RACT.
If a state submits a RACT rule that is consistent with the presumptive RACT, the state does not need to submit additional support to demonstrate that the rule meets the CAA's RACT requirement. However, if the state decides to submit an alternative emission limit or level of control for a source or source category for which there is a presumptive RACT, the state must submit independent documentation as to why the rule meets the statutory RACT requirement.
Section 182(b)(2) of the CAA addresses moderate and above areas for the 1-hour ozone standard. Further clarification of the RACT requirements for areas classified as moderate or above for the 1997 8-hour ozone NAAQS is provided in EPA's regulations. Specifically, 40 CFR 51.912, entitled “What requirements apply for reasonably available control technology (RACT) and reasonably available control measures (RACM) under the 8-hour NAAQS?” provides the pertinent RACT requirements for areas classified as moderate or above for the 1997 8-hour ozone NAAQS, stating:
(1) For each area subject to subpart 2 in accordance with 51.903 of this part and classified moderate or higher, the State shall submit a SIP revision that meets the nitrogen oxides (NO
(2) The State shall submit the RACT SIP for each area no later than 27 months after designation for the 8-hour ozone NAAQS, except that for a State subject to the requirements of the Clean Air Interstate Rule, the State shall submit NO
(3) The State shall provide for implementation of RACT as expeditiously as practicable but no later than the first ozone season or portion thereof which occurs 30 months after the RACT SIP is due.
The CTGs established by EPA are guidance to the states and provide recommendations only. A state can develop its own strategy for what constitutes RACT for the various CTG categories, and EPA will review that strategy in the context of the SIP process and determine whether it meets the RACT requirements of the CAA and its implementing regulations. If no major sources of VOC or NO
CTGs that were established in 1978 ultimately were required to be adopted by the States by 1990 (see schedule below for details). CAA Section 182(b)(2) provides that a CTG issued after 1990 must specify the date by which a state must submit a SIP revision in response to the CTG. States were required to have the pre-1990 CAA CTG categories and post-1990 CAA CTG categories for applicable areas addressed in their SIPs according to the following schedule:
Following the April 2004 designation of the bi-state Charlotte Area as a moderate ozone nonattainment area, South Carolina had until June 15, 2007, to submit an attainment demonstration, RACT submission (addressing the applicable CTG), and a reasonable further progress plan for the Rock Hill-
South Carolina provided SIP revisions addressing Groups I and II CTG, on August 31, 2007. Subsequent to South Carolina's August 31, 2007, SIP revision, South Carolina provided SIP revisions to address Group III CTG on February 23, 2009, and Group IV CTG on July 9, 2009, for the Rock Hill Fort-Mill Area. Today's action relates to South Carolina's SIP revisions for the Rock Hill-Fort Mill Area regarding Groups, I, II, III and IV CTG requirements, and South Carolina's RACT demonstration for major non-CTG sources in the Rock Hill-Fort Mill Area.
As part of its analysis to support the negative declarations for Groups I, II, III and IV CTG, South Carolina reviewed its permits files and emissions inventory information. After this review, South Carolina determined that there are no stationary sources or emitting facilities located in Rock Hill-Fort Mill Area that are subject to Groups I, II, III and IV CTG. In accordance with CAA requirements, South Carolina prepared SIP revisions with these negative declarations and provided the public with an opportunity to review and provide comment regarding South Carolina's analyses. EPA has reviewed South Carolina's SIP revisions in support of the negative declarations for Groups I, II, III and IV CTG, and has concluded that the Rock Hill-Fort Mill Area in York County, South Carolina has met all the statutory and regulatory requirements for making a negative declaration regarding Groups I, II, III and IV CTG. Further, EPA has determined that South Carolina's August 31, 2007, February 23, 2009, and July 7, 2009, SIP revisions meet the applicable requirements of the CAA and EPA regulations.
With regard to RACT for non-CTG sources, South Carolina identified three major non-CTG sources within the Rock Hill-Fort Mill Area subject to RACT requirements. The three sources are Bowater, Inc., Cytec Carbon Fibers, LLC, and Georgia Pacific Wood Products, LLC. South Carolina determined what constitutes RACT for these facilities using the top-down process used for prevention of significant deterioration and nonattainment new source review. The top-down process provides that all available control technologies be ranked in descending order of control effectiveness. The most stringent technology is analyzed based on the following criteria: Technical considerations, along with energy, environmental, and economic impact. After this analysis is complete a determination is made as to whether the technology is achievable. The most stringent technology may be eliminated in this fashion and then the next most stringent alternative is considered, and so on.
A report submitted by the three facilities concluded that emission control devices would not be economically feasible, and thus, that RACT for these facilities should consist only of work practice requirements. SC DHEC evaluated the RACT analyses submitted by the three facilities which are further discussed below.
Bowater Coated Paper Division (Bowater) produces bleached pulp and paper products and is a major source for both NO
Cytec Carbon Fibers LLC (Cytec) is a title V facility that operates a carbon fiber manufacturing process and is a major source for NO
Georgia Pacific—Catawba Hardboard Plant is a major source for VOC but not for NO
Pursuant to section 110 of the CAA, EPA is approving the revision to South Carolina's SIP revisions addressing negative declarations for applicability of Groups I, II, III and IV CTG for the Rock Hill-Fort Mill Area; and concerning the RACT requirements related to the 1997 8-hour ozone NAAQS for the Rock Hill-Fort Mill Area which is the portion of York County, South Carolina that is included in the bi-state Charlotte-Gastonia-Rock Hill 1997 8-hour ozone nonattainment area. EPA has evaluated South Carolina's August 31, 2007, February 23, 2009, and July 9, 2009, SIP revisions, and has determined that they meet the applicable requirements of the CAA and EPA regulations, and are consistent with EPA policy for negative declarations for Groups I, II, III and IV CTG, and for RACT.
On March 12, 2008, EPA issued a revised ozone NAAQS. See 73 FR 16436. EPA subsequently announced a reconsideration of the 2008 NAAQS, and proposed new 8-hour ozone NAAQS in January 2010. See 75 FR 2938. In September 2011, EPA withdrew the proposed reconsidered NAAQS and began implementation of the 2008 NAAQS. The current action, however, is being taken to address requirements under the 1997 ozone NAAQS. Requirements for the bi-state Charlotte Area under the 2008 NAAQS will be addressed in the future.
EPA is publishing this rule without prior proposal because the Agency views this as a non-controversial amendment and anticipates no adverse comments. However, in the proposed rules section of this
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, 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
• 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
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
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 January 27, 2012. 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
Environmental protection, Air pollution control, Intergovernmental relations, Incorporation by reference, Ozone, Nitrogen Dioxides, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements contained in a final rule published July 27, 2011. The information collection requirements were approved on February 7, 2011, and November 17, 2011, by OMB.
The amendments to 47 CFR 73.624(g), published at 76 FR 44821, July 27, 2011, are effective on November 28, 2011.
For additional information contact Cathy Williams on (202) 418-2918 or via email to:
This document announces that on February 7, 2011 and November 17, 2011, OMB approved, for a period of three years, the information collection requirements contained in 47 CFR 73.624(g). The Commission publishes this document to announce the effective date of this rule section. See, In the Matter of Amendment of Parts 73 and 74 of the Commission's Rules to Establish Rules for Digital Low Power Television, Television Translator, and Television Booster Stations and to Amend Rules for Digital Class A Television Stations, MB Docket No. 03-185; FCC 11-110, 76 FR 44821, July 27, 2011.
As required by the Paperwork Reduction Act of 1995, (44 U.S.C. 3507), the Commission is notifying the public that it received OMB approval on February 7, 2011 and November 17, 2011, for the information collection requirements contained in 47 CFR 73.624(g). Under 5 CFR part 1320, an
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid OMB Control Number.
The OMB Control Number is 3060-0906 and the total annual reporting burdens for respondents for this information collection are as follows:
Section 73.624(g) also adds a new group of respondents to this collection (namely, “low power television, TV translator, and Class A television station DTV stations operating pursuant to STA”). The Commission has also revised FCC Form 317 and its instructions to indicate that low power television, TV translator, and Class A television station DTV stations operating pursuant to STA are required to file FCC Form 317 (which includes reporting their ancillary and supplementary services, making the required payment to the Commission, and retaining the appropriate records).
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Final rule.
This rule increases the rail equipment accident/incident reporting threshold from $9,400 to $9,500 for certain railroad accidents/incidents involving property damage that occur during calendar year 2012. This action is needed to ensure that FRA's reporting requirements reflect cost increases that have occurred since the reporting threshold was last published in December of 2010.
This regulation is effective January 1, 2012.
Kebo Chen, Staff Director, U.S. Department of Transportation, Federal Railroad Administration, Office of Safety Analysis, RRS-22, Mail Stop 25, West Building 3rd Floor, Room W33-314, 1200 New Jersey Ave. SE., Washington, DC 20590 (telephone (202) 493-6079); or Gahan Christenson, Trial Attorney, U.S. Department of Transportation, Federal Railroad Administration, Office of Chief Counsel, RCC-10, Mail Stop 10, West Building 3rd Floor, Room W31-204, 1200 New Jersey Ave. SE., Washington, DC 20590 (telephone (202) 493-1381).
A “rail equipment accident/incident” is a collision, derailment, fire, explosion, act of God, or other event involving the operation of railroad on-track equipment (standing or moving) that results in damages to railroad on-track equipment, signals, tracks, track structures, or roadbed, including labor costs and the costs for acquiring new equipment and material, greater than the reporting threshold for the year in which the event occurs. 49 CFR 225.19(c). Each rail equipment accident/incident must be reported to FRA using the Rail Equipment Accident/Incident Report (Form FRA F 6180.54). 49 CFR 225.19(b) and (c). As revised, effective in 1997, paragraphs (c) and (e) of 49 CFR 225.19 provide that the dollar figure that constitutes the reporting threshold for rail equipment accidents/incidents will be adjusted, if necessary, every year in accordance with the procedures outlined in appendix B to part 225 to reflect any cost increases or decreases.
Approximately one year has passed since the rail equipment accident/incident reporting threshold was revised. 75 FR 75911 (December 7, 2010). Consequently, FRA has recalculated the threshold, as required by § 225.19(c), based on increased costs for labor and increased costs for equipment. FRA has determined that the current reporting threshold of $9,400, which applies to rail equipment accidents/incidents that occur during calendar year 2011, should increase by $100 to $9,500 for equipment accidents/incidents occurring during calendar year 2012, effective January 1, 2012. The specific inputs to the equation set forth in appendix B (
Where:
In this rule, FRA has recalculated the monetary reporting threshold based on the formula discussed in detail and adopted, after notice and comment, in the final rule published December 20, 2005, 70 FR 75414. FRA has found that both the current cost data inserted into this pre-existing formula and the original cost data that they replace were obtained from reliable Federal government sources. FRA has found that this rule imposes no additional burden on any person, but rather provides a benefit by permitting the valid comparison of accident data over time. Accordingly, finding that notice and comment procedures are either impracticable, unnecessary, or contrary to the public interest, FRA is proceeding directly to the final rule.
This rule has been evaluated in accordance with existing policies and procedures, and determined to be non-significant under both Executive Order 12866 and 13563 in addition to DOT policies and procedures (44 FR 11034 (Feb. 26, 1979)).
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires a review of proposed and final rules to assess their impact on small entities, unless the Secretary certifies that the rule will not have a significant economic impact on a substantial number of small entities. Pursuant to Section 312 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), FRA has issued a final policy that formally establishes “small entities” as including railroads that meet the line-haulage revenue requirements of a Class III railroad. 49 CFR part 209, app. C. For other entities, the same dollar limit in revenues governs whether a railroad, contractor, or other respondent is a small entity.
About 721 of the approximately 754 railroads in the United States are considered small entities by FRA. FRA certifies that this final rule will have no significant economic impact on a substantial number of small entities. To the extent that this rule has any impact on small entities, the impact will be neutral or insignificant. The frequency of rail equipment accidents/incidents, and therefore also the frequency of required reporting, is generally proportional to the size of the railroad. A railroad that employs thousands of employees and operates trains millions of miles is exposed to greater risks than one whose operation is substantially smaller. Small railroads may go for months at a time without having a reportable occurrence of any type, and even longer without having a rail equipment accident/incident. For example, current FRA data indicate that 3,000 rail equipment accidents/incidents were reported in 2006, with small railroads reporting 379 of them. Data for 2007 show that 2,694 rail equipment accidents/incidents were reported, with small railroads reporting 368 of them. Data for 2008 show that 2,478 rail equipment accidents/incidents were reported, with small railroads reporting 296 of them. In 2009, 1,905 rail equipment accidents/incidents were reported, and small railroads reported 272 of them. In 2010, 1,888 rail equipment accidents/incidents were reported, with small railroads reporting 258 of them. On average for those five calendar years, small railroads reported about 13% (ranging from 12% to 14%) of the total number of rail equipment accidents/incidents. FRA notes that these data are accurate as of the date of issuance of this final rule, and are subject to minor changes due to additional reporting. Absent this rulemaking (
There are no new information collection requirements associated with this final rule. Therefore, no estimate of a public reporting burden is required.
Executive Order 13132, entitled, “Federalism,” signed on August 4, 1999, requires that each agency “in a separately identified portion of the preamble to the regulation as it is to be issued in the Federal Register, provide[] to the Director of the Office of Management and Budget a federalism summary impact statement, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of the nature of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of the State and local officials have been met * * *.” This rulemaking action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132. This rule will not have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and the responsibilities among the various levels of government, as specified in the Executive Order 13132. Accordingly, FRA has determined that this rule will not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism assessment. Accordingly, a federalism assessment has not been prepared.
FRA has evaluated this regulation in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545 (May 26, 1999)) as required by the National Environmental Policy Act (42 U.S.C. 4321
Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of [$140,800,000 or more (as adjusted for inflation)] in any one year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and Tribal governments and the private sector. The final rule will not result in the expenditure, in the aggregate, of $140,800,000 or more in any one year, and thus preparation of such a statement is not required.
Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355 (May 22, 2001). Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the
Anyone is able to search the electronic form of all our comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Investigations, Penalties, Railroad safety, Reporting and recordkeeping requirements.
In consideration of the foregoing, FRA amends part 225 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:
49 U.S.C. 103, 322(a), 20103, 20107, 20901-02, 21301, 21302, 21311; 28 U.S.C. 2461, note; and 49 CFR 1.49.
(c)
(e) The reporting threshold is $6,700 for calendar years 2002 through 2005, $7,700 for calendar year 2006, $8,200 for calendar year 2007, $8,500 for calendar year 2008, $8,900 for calendar year 2009, $9,200 for calendar year 2010, $9,400 for calendar year 2011 and $9,500 for calendar year 2012. The procedure for determining the reporting threshold for calendar years 2006 and beyond appears as paragraphs 1-8 of appendix B to part 225.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede an existing airworthiness directive (AD) that applies to certain Model 737-300, -400, and -500 series airplanes. The existing AD currently requires repetitive external detailed inspections or non-destructive inspections to detect cracks in the fuselage skin along the chem-mill steps at stringers S-1 and S-2R, between station (STA) 400 and STA 460, and repair if necessary. Since we issued that AD, we have received reports of additional crack findings of the fuselage skin at the chem-mill steps. This proposed AD would add inspections for cracking in additional fuselage skin locations, and repair if necessary. This proposed AD would also reduce the inspection thresholds and repetitive intervals for certain airplanes. We are proposing this AD to detect and correct fatigue cracking of the fuselage skin panels at the chem-mill steps, which could result in sudden fracture and failure of the fuselage skin panels, and consequent rapid decompression of the airplane.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
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•
•
•
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
You may examine the AD docket on the Internet at
Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6447; fax: (425) 917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On September 11, 2008, we issued AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), for certain Model 737-300, -400, and -500 series airplanes. That AD requires repetitive external detailed inspections or non-destructive inspections to detect cracks in the fuselage skin along the chem-mill steps at stringers S-1 and S-2R, between STA 400 and STA 460, and repair if necessary. That AD resulted from reports of cracks in the fuselage skin common to stringers S-1 and S-2R, between STA 400 and STA 460. We issued that AD to detect and correct fatigue cracking of the fuselage skin panels at the chem-mill steps, which could result in sudden fracture and failure of the fuselage skin panels, and consequent rapid decompression of the airplane.
Since we issued AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), we received reports of new findings of cracking in the fuselage skin at the chem-mill steps adjacent to the Air Traffic Control antenna. One reported crack was on the inboard side of S-2R at STA 451; the crack measured one inch long. That airplane had accumulated 52,207 total flight cycles. Another reported crack was on the left-hand side of stringer S-1 at STA 431. That airplane had accumulated 43,565 total flight cycles. Other cracks were located on the left-hand side of stringer S-1, between STA 400 and STA 460 on certain airplanes. The cause of the cracking was fatigue due to high-tension stresses and local bending at the edge of the chem-mill pockets of the bonded skin. It was also determined that the detailed inspection alone (one method required by the existing AD) is not adequate to detect the cracking.
We reviewed Boeing Alert Service Bulletin 737-53A1293, Revision 1,
Boeing Alert Service Bulletin 737-53A1293, Revision 1, dated July 7, 2010, adds an ultrasonic phased array inspection to the options for non-destructive inspections (NDI) specified in Boeing Alert Service Bulletin 737-53A1293, dated August 13, 2008, and combines the detailed inspection and the NDI in lieu of doing either Option 1 (a detailed inspection) or Option 2 (an NDI). Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, clarifies repair instructions for specific findings.
The initial inspection compliance times range between the following, depending on configuration: (1) Before the accumulation 33,000 total flight cycles, or within 500 flight cycles after the date on this service bulletin, whichever is later; and (2) before the accumulation of 35,000 total flight cycles, or within 1,800 flight cycles after the date on this service bulletin, whichever is later.
The repetitive inspection intervals range between 500 and 2,400 flight cycles, depending on the inspection option and configuration.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.
This proposed AD would retain certain requirements of AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008). This proposed AD would also require accomplishing the actions specified in Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, except as discussed under “Differences Between the AD and the Service Information.”
Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies contacting the manufacturer for instructions on how to repair a certain condition, but this AD requires repairing that condition in one of the following ways:
• Using a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings.
The post-repair inspection specified in Tables 4 and 6 of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, is not required by this proposed AD.
We consider this proposed AD interim action. If final action is identified later, we might consider further rulemaking then.
We estimate that this proposed AD affects 596 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing airworthiness directive (AD) 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), and adding the following new AD:
(a) The FAA must receive comments on this AD action by January 12, 2012.
(b) This AD supersedes AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008).
(c) This AD applies to Model 737-300, -400, and -500 series airplanes, certificated in any category; as identified in Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011.
(d) Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 53, Fuselage.
(e) This AD was prompted by reports of additional crack findings of the fuselage skin at the chem-mill steps. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin panels at the chem-mill steps, which could result in sudden fracture and failure of the fuselage skin panels, and consequent rapid decompression of the airplane.
(f) Comply with this AD within the compliance times specified, unless already done.
(g) At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, except as provided by paragraph (j) and (k) of this AD: Do both a detailed inspection and a nondestructive inspection (NDI) (medium frequency eddy current, magneto optical imaging, C-scan, or ultrasonic phased array) to detect cracks in the fuselage skin along the chem-mill steps at stringers S-1 and S-2R, between station (STA) 400 and STA 460, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011. Repeat the applicable inspections thereafter at intervals not to exceed those specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011.
(h) If any crack is found during any inspection required by paragraph (g) of this AD, before further flight, repair in accordance with the Accomplishment Instructions of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011; except as provided by paragraph (i) of this AD. Installation of a repair that meets the conditions specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, terminates the repetitive inspections required by paragraph (g) of this AD for the repaired area only.
(i) If any crack is found during any inspection required by paragraph (g) of this AD and Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies to contact Boeing for repair: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (n) of this AD.
(j) Where Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies a compliance time relative to the date on that service bulletin, this AD requires compliance within the specified compliance time after the effective date of this AD.
(k) Where the Condition column of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, dated August 10, 2011, specifies a condition based on whether an airplane has or has not been inspected, this AD bases the condition on whether an airplane has or has not been inspected as of the effective date of this AD.
(l) The post-repair inspection specified in Tables 4 and 6 of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, August 10, 2011, is not required by this AD.
The damage tolerance inspections specified in Tables 4 and 6 of paragraph 1.E., “Compliance,” of Boeing Service Bulletin 737-53A1293, Revision 2, August 10, 2011, may be used in support of compliance with section 121.1109(c)(2) or 129.109(c)(2) of the Federal Aviation Regulations (14 CFR 121.1109(c)(2) or 14 CFR 129.109(c)(2)).
(m) Actions done before the effective date of this AD in accordance with Boeing Alert Service Bulletin 737-53A1293, Revision 1, July 7, 2010, are acceptable for compliance with the corresponding actions required by this AD.
(n)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes ODA that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane.
(4) AMOCs approved for AD 2008-19-03, Amendment 39-15670 (73 FR 56958, October 1, 2008), are approved as AMOCs for the corresponding requirements in this AD.
(o) For more information about this AD, contact Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6447; fax: (425) 917-6590; email:
(p) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 190 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
It has been found the occurrence of damage on the rod end of the Main Landing Gear (MLG) retraction actuator. The ANAC [Agência Nacional de Aviação Civil] is issuing this AD to prevent breakage of the MLG retracting actuator rod, which may result in MLG extension with no hydraulic damping and consequent damage to the locking mechanism and collapse of the MLG.
The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
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For service information identified in this proposed AD, contact Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170-Putim-12227-901 São Jose dos Campos-SP-BRASIL; telephone +55 12 3927-5852 or +55 12 3309-0732; fax +55 12 3927-7546; email
You may examine the AD docket on the Internet at
Cindy Ashforth, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425) 227-2768; fax (425) 227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The Agencia Nacional De Aviacao Civil—Brazil (ANAC), which is the airworthiness authority for Brazil, has issued Brazilian Airworthiness Directive 2011-02-01, dated February 12, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
It has been found the occurrence of damage on the rod end of the Main Landing Gear (MLG) retraction actuator. The ANAC [Agência Nacional de Aviação Civil] is issuing this AD to prevent breakage of the MLG retracting actuator rod, which may result in MLG extension with no hydraulic damping and consequent damage to the locking mechanism and collapse of the MLG.
EMBRAER has issued Service Bulletin 190-32-0036, dated October 4, 2010; and Service Bulletin 190-32-0037, dated October 6, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the proposed AD.
Based on the service information, we estimate that this proposed AD would affect about 73 products of U.S. registry.
In addition, we estimate that any necessary follow-on actions would take about 6 work-hours and require parts costing $0, for a cost of $510 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. We have no way of determining the number of products that may need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments by January 12, 2012.
(b) None.
(c) This AD applies to Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 190-100 STD, -100 LR, -100 ECJ, and -100 IGW airplanes; and Model ERJ 190-200 STD, -200 LR, and -200 IGW airplanes; certificated in any category; all serial numbers.
(d) Air Transport Association (ATA) of America Code 32: Landing Gear.
(e) The mandatory continuing airworthiness information (MCAI) states:
It has been found the occurrence of damage on the rod end of the Main Landing Gear (MLG) retraction actuator. The ANAC [Agência Nacional de Aviação Civil] is issuing this AD to prevent breakage of the MLG retracting actuator rod, which may result in MLG extension with no hydraulic damping and consequent damage to the locking mechanism and collapse of the MLG.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Within 30 days after the effective date of this AD, do a one-time general visual inspection to determine if part number (P/N) 190-70980-403 is installed on the left-hand and right-hand MLG retraction actuator. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the MLG retraction actuator can be conclusively determined from that review.
For the purpose of this AD, a general visual inspection (GVI) is: “A visual examination of an interior or exterior area, installation or assembly to detect obvious damage, failure or irregularity. This level of inspection is made from within touching distance, unless otherwise specified. A mirror may be necessary to enhance visual access to all exposed surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight or droplight, and may require removal or opening of access panels or doors. Stands, ladders or platforms may be required to gain proximity to the area being checked.”
(1) No further action is required by paragraph (g) of this AD if no MLG retraction actuator having P/N 190-70980-403 is found.
(2) If any MLG retraction actuator having P/N 190-70980-403 is found, do a GVI of the actuator and bolt (P/N 2821-0028) for discrepancies (such as cracks, damage, and movement between the actuator rod end and shock strut lug of the MLG retraction actuator), in accordance with “Part I” of the Accomplishment Instructions of EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010, within the applicable compliance time specified in paragraphs (g)(2)(i) and (g)(2)(ii) of this AD. Repeat the inspection, thereafter, at intervals not to exceed 3,500 flight cycles, until the actions required by paragraph (j) of this AD are done.
(i) For any MLG retraction actuator that has accumulated fewer than 3,500 total flight cycles as of the effective date of this AD, do the GVI of the actuator before the accumulation of 4,500 total flight cycles on the MLG retraction actuator.
(ii) For any MLG retraction actuator that has accumulated 3,500 total flight cycles or more as of the effective date of this AD, do the GVI of the actuator within 1,000 flight cycles after the effective date of this AD.
(h) If any discrepancy is found during any inspection required by paragraph (g)(2) of this AD, including any movement between the actuator rod-end and shock strut lug, before further flight, replace the MLG retraction actuator, and as applicable the anti-rotation pin and the attachment bolt, in accordance with “Part II” and “Part III,” as applicable, of EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010; except where EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010, specifies to contact the manufacturer, before further flight repair in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, or Agência Nacional de Aviação Civil (or its delegated agent).
(i) Before any MLG retraction actuator having P/N 190-70980-403 accumulates
(j) For all actuators: Within 20,000 flight cycles or within 96 months after the effective date of this AD, whichever occurs first, do the replacement and modification, as applicable, in accordance with “Part III” of EMBRAER Service Bulletin 190-32-0037, dated October 6, 2010. Doing the actions in this paragraph is a terminating action for the requirements specified in paragraphs (g), (h), and (i) of this AD.
This AD differs from the MCAI and/or service information as follows: Brazilian Airworthiness Directive 2011-02-01, dated February 12, 2011, requires replacing the MLG retraction actuator, and as applicable, the anti-rotation pin and attachment bolt within the next 500 flight cycles if any discrepancy is found. However, if any discrepancy is found, this AD requires replacing the MLG retraction actuator, and as applicable, the anti-rotation pin and attachment bolt, before further flight.
(k) The following provisions also apply to this AD:
(1)
(2)
(l) Refer to MCAI Brazilian Airworthiness Directive 2011-02-01, dated February 12, 2011; EMBRAER Service Bulletin 190-32-0036, dated October 4, 2010; and EMBRAER Service Bulletin 190-32-0037, dated October 6, 2010; for related information.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede two existing airworthiness directives (AD) that apply to Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. The first existing AD currently requires, for certain airplanes, repetitive inspections of the Station (STA) 348.2 frame to detect cracking under the stop fittings and intercostal flanges at stringers S-14L, S-15L, and S-16L, and corrective action if necessary. The second existing AD currently requires repetitive inspections to detect cracking of the intercostal webs, attachment clips, and stringer splice channels, and corrective action if necessary. Since we issued those ADs, we have received reports of cracking of the STA 348.2 frame above the two outboard fasteners attaching the frame inner chord and door stop fittings, and in the outboard chord at stringer S-16L. We have also received reports of missing fasteners in the STA 348.2 frame inner chord. This proposed AD would require additional airplanes to do the inspection for cracking under the stop fittings; extend the repetitive interval for certain airplanes; add a one-time inspection to detect missing fasteners; and update or add certain inspection and repair instructions. This proposed AD would also require, for certain airplanes, repetitive inspections of the cargo barrier net fitting for cracking and repair if necessary. This proposed AD would also add, for certain airplanes, repetitive inspections for cracking of the S-15L aft intercostal, and repair if necessary. We are proposing this AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door cutout, which could result in loss of the forward entry door and rapid decompression of the airplane.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
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•
•
•
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
You may examine the AD docket on the Internet at
Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356;
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On April 20, 2004, we issued AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), for all Boeing Model 737-200C series airplanes. That AD requires repetitive inspections of the Station (STA) 348.2 frame to detect cracking under the stop fittings and intercostal flanges at Stringers S-14L, S-15L, and S-16L; and corrective action if necessary. That AD resulted from a report of cracks in the STA 348.2 frame on a Boeing Model 737-200C series airplane. We issued that AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door cutout, which could result in the loss of the forward entry door and rapid decompression of the airplane.
On July 23, 2009, we issued AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. That AD requires repetitive inspections of the intercostal webs, attachment clips, and stringer splice channels for cracks; and corrective action if necessary. That AD resulted from reports of fatigue cracks on several Boeing Model 737-200 series airplanes. We issued that AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door, which could result in loss of the forward entry door and rapid decompression of the airplane.
Since we issued AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), we have received reports of cracking above the two outboard fasteners attaching the frame inner chord and door stop fitting of the STA 348.2 frame at S-15L. The cracking was reported on seven airplanes that had accumulated between 19,185 and 64,800 flight cycles (AD 2004-09-09 applies only to Model 737-200C airplanes). Cracking has also been found in the outboard chord at S-16L. In addition, we have received reports of 10 airplanes with missing fasteners in the STA 348.2 frame inner chord at S-7L through S-15L.
In addition, the requirement to inspect the intercostal on the aft side at S-14L to S-16L is common to both AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009). Service history indicates that the repetitive inspection interval of 6,000 flight cycles for that area, as required by AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), is adequate to ensure continued operational safety. The repetitive interval required by AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), is 4,500 flight cycles.
Boeing Commercial Airplanes has received a Organization Designation Authorization (ODA). We have revised paragraph (h) of this proposed AD to delegate the authority to approve an alternative method of compliance for any repair required by this AD to the Boeing Commercial Airplanes ODA rather than a Designated Engineering Representative (DER).
We reviewed Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. The procedures in Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, differ from those in 737-53A1204, Revision 1, dated March 26, 2007 (the appropriate source of service information for AD 2009-16-14 (74 FR 38901, August 5, 2009)), as follows:
• Repetitive detailed and high frequency eddy current (HFEC) inspections for cracking of the S-15L aft intercostal between body station (BS) 348.2 and BS 360 and a detailed inspection of the cargo barrier net fitting at the intercostal are added for Model 737-200C airplanes.
• New repair instructions are added for cracking found at the S-14L, S-15L, and S-16L intercostals. The repair includes either doing actions specified in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010 (described below), or, if a crack is at the S-15L aft intercostal or the damage at other intercostal locations is outside certain parameters covered in Boeing Alert Service Bulletin 737-53A1240, Revision 1, Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, specifies contacting Boeing for repair instructions.
We also reviewed Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010. The procedures in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, differ from those in Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003 (the appropriate source of service information for AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004)), as follows:
• All Model 737-100, -200, -300, -400, and -500 series airplanes (i.e., line numbers 1 through 3132) are added to the effectivity. For these airplanes, the service bulletin specifies procedures for inspecting under the stop fitting by doing HFEC and surface eddy current inspections for cracking of the frame, HFEC inspections for cracking of the reinforcement angle and shear web, and doing a detailed inspection for cracking of the STA 348.2 frame outer chord, inner chord, and reinforcement angle, and corrective actions if necessary. The corrective actions include replacing certain cracked parts with new parts, and if a crack is found in the frame outer chord, contacting Boeing for repair instructions and doing the repair.
• For Model 737-200C airplanes, the repetitive interval for the HFEC inspection of the STA 348.2 frame is extended from 4,500 flight cycles to 6,000 flight cycles.
• For Model 737-100, -200, -300, -400, and -500 series airplanes, a one-time detailed inspection is added to detect missing fasteners of the STA 348.2 frame inner chord at S-7L through S-15L. If any fastener is missing, the service bulletin specifies to contact Boeing for repair instructions.
• For all airplanes, intercostal inspections for cracking between STA 348.2 and STA 360 are now specified in Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. Previously, for the intercostals at S-14 through S-16L, this inspection was common to both Boeing Alert Service Bulletin 737-53A1204 and Boeing Alert Service Bulletin 737-53A1240 for Model 737-200C airplanes.
• For Group 3 airplanes, instructions are added for repair of the STA 348.2 frame inner chord, reinforcement angle, and shear web; and of the door stop intercostals at S-14L through S16L.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain certain requirements of AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004) and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009). This proposed AD would add airplanes to the applicability for the HFEC inspection for cracking of the stop fittings at the shear web at STA 348.2 frame; extend the repetitive interval for the HFEC inspection of the STA 348.2 frame for Model 737-200C airplanes; add an inspection to detect missing fasteners of the STA 348.2 frame inner chord; and update or add certain inspection and repair instructions. This proposed AD would also require accomplishing the actions specified in the service information described previously.”
Since those ADs were issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following tables:
We estimate that this proposed AD affects 581 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary repairs that would be required based on the results of the proposed inspections. We have no way of determining the number of aircraft that might need these repairs:
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing airworthiness directive (AD) 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), and adding the following new AD:
(a) The FAA must receive comments on this AD action by January 12, 2012.
(b) This AD supersedes AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004); and AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009).
(c) This AD applies to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category.
(d) Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 53, Fuselage.
(e) This AD was prompted by reports of cracking of the STA 348.2 frame above the two outboard fasteners attaching the frame inner chord and door stop fittings, and in the outboard chord at stringer S-16L. We have also received reports of missing fasteners in the STA 348.2 frame inner chord. We are issuing this AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door cutout, which could result in loss of the forward entry door and rapid decompression of the airplane.
(f) Comply with this AD within the compliance times specified, unless already done.
(g) For Model 737-200C series airplanes: Except as provided by paragraph (h) of this AD, prior to the accumulation of 46,000 total flight cycles, or within 2,250 flight cycles after June 4, 2004 (the effective date of AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004)), whichever occurs later, do detailed and eddy current inspections of the STA 348.2 frame for cracking under the stop fittings and intercostal flanges at Stringers 14L, 15L, and 16L by accomplishing paragraphs 3.A. and 3.B.1. through 3.B.7. of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003, or by accomplishing Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010. Do the actions in accordance with Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003; or Revision 1, dated June 29, 2010. Any applicable repair must be accomplished prior to further flight. Repeat the inspections thereafter at intervals not to exceed 6,000 flight cycles. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, may be used.
(h) If any crack is found during any inspection required by paragraph (g) of this AD, and Boeing Alert Service Bulletin 737-53A1240, dated April 10, 2003; or Revision 1, dated June 29, 2010; specifies to contact Boeing for appropriate action: Before further flight, repair in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or using a method approved in accordance with the procedures specified in paragraph (t) of this AD.
(i) For all Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, as identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Before the accumulation of 15,000 total flight cycles, or within 4,500 flight cycles after November 1, 2005 (the effective date of AD 2005-20-03, Amendment 39-14296 (70 FR 56361, September 27, 2005)), whichever occurs later: Do the inspections required by paragraphs (k) and (l) of this AD.
(j) For all Model 737-200C series airplanes, as identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Before the accumulation of 15,000 total flight cycles, or within 4,500 flight cycles after September 9, 2009 (the effective date of AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009)), whichever occurs later, do the inspection required by paragraph (m) of this AD.
(k) For Group 1 airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Perform a detailed inspection for cracking of the intercostal web, attachment clips, and stringer splice channels; and a high frequency eddy current (HFEC) inspection for cracking of the stringer splice channels located forward and aft of the forward entry door; and do all applicable corrective actions before further flight; in accordance with Parts 1 and 2 of the Work Instructions of Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or in accordance with Parts 1, 2, 4, and 5 of the Work Instructions of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. After September 9, 2009 and until the effective date of this AD, Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Revision 2, dated June 24, 2010; may be used. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(l) For Group 2 cargo airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Perform a detailed inspection for cracking of the intercostal webs and attachment clips located forward of the forward entry door, and do all applicable corrective actions before further flight, in accordance with Part 3 of the Work Instructions of Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or in accordance with Part 3 of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. After September 9, 2009 and until the effective date of this AD, Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Revision 2, dated June 24, 2010; may be used. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(m) For Group 2 cargo airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007: Perform a detailed inspection for cracking of the intercostal webs and attachment clips located aft of the forward entry door, and do all applicable corrective actions before further flight, in accordance with Part 4 of the Work Instructions of Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or in accordance with Part 3 of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(n) Repeat the inspections required by paragraphs (k), (l), and (m) of this AD thereafter at intervals not to exceed 6,000 flight cycles after the previous inspection, or within 3,000 flight cycles after September 9, 2009, whichever occurs later.
(o) Do the actions required by paragraphs (i), (j), (k), (l), (m), and (n) of this AD by accomplishing all the applicable actions specified in the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010; except as provided by paragraphs (o)(1) and (o)(2) of this AD. After September 9, 2009, and until the effective date of this AD, Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Revision 2, dated June 24, 2010; may be used. As of the effective date of this AD, only Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010, may be used.
(1) Where Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; or Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010; specifies to contact Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD.
(2) Where Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; specifies a compliance time relative to the date of a service bulletin, this AD requires compliance relative to September 9, 2009. Where Boeing Special Attention Service Bulletin 737-53-1204, dated June 19, 2003; or Boeing Alert Service Bulletin 737-53A1204, Revision 1, dated March 26, 2007; specifies a compliance time relative to the date of the initial release of the service bulletin, this AD requires compliance relative to November 1, 2005 (the effective date of AD 2005-20-03, Amendment 39-14296 (70 FR 56361, September 27, 2005)).
(p) For Groups 2 and 3 airplanes identified in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010: Within 4,500 flight cycles after the effective date of this AD, do a detailed inspection to detect missing fasteners of the STA 348.2 frame, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, except as required by paragraph (r) of this AD. If any fastener is missing, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD.
(q) For Groups 2 and 3 airplanes identified in Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010: Before the accumulation of 15,000 total flight cycles or within 4,500 flight cycles after the effective date of this AD, do HFEC and surface eddy current inspections for cracking of the frame, HFEC inspections for cracking of the reinforcement angle and shear web, and a detailed inspection for cracking of the STA 348.2 frame outer chord, inner chord, and reinforcement angle, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, except as required by paragraph (r) of this AD. If any crack is found during any inspection required by this paragraph, before further flight, do all applicable corrective actions in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, except as required by paragraph (r) of this AD, and except where that service bulletin specifies to contact Boeing, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD. Repeat the inspections thereafter at intervals not to exceed 6,000 flight cycles.
(r) Where Boeing Alert Service Bulletin 737-53A1240, Revision 1, dated June 29, 2010, specifies that for the instructions identified in paragraph 3.B., Work Instructions, and the Figure(s) which give the recommended sequence of steps, the sequence of the steps to do the service bulletin can be changed; the requirements in this AD do not allow the sequence of the steps to be changed.
(s) For Group 2 airplanes identified in Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010: Before the accumulation of 15,000 total flight cycles, or within 4,500 flight cycles after the effective date of this AD, whichever occurs later, do initial detailed and HFEC inspections for cracking of the S-15L aft intercostal between BS 348.2 and BS 360, and do a detailed inspection of the cargo barrier net fitting at the intercostal, in accordance with Figure 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1204, Revision 2, dated June 24, 2010. If any cracking is found, before further flight repair using a method approved in accordance with the procedures specified in paragraph (t) of this AD. Repeat the inspections at intervals not to exceed 6,000 flight cycles.
(t)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, it may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) AMOCs approved for AD 2004-09-09, Amendment 39-13598 (69 FR 23646, April 30, 2004), are approved as AMOCs for the corresponding requirements of this AD.
(5) AMOCs approved for AD 2009-16-14, Amendment 39-15987 (74 FR 38901, August 5, 2009), are approved as AMOCs for the corresponding requirements of this AD.
(u) For more information about this AD, contact Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone (425) 917-6450; fax (425) 917-6590; email:
(v) For service information identified in this AD, contact Boeing Commercial Airplanes,
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 707-100 long body, -200, -100B long body, and -100B short body series airplanes; Model 707-300, -300B, -300C, and -400 series airplanes; and Model 720 and 720B series airplanes. For certain airplanes, this proposed AD would require using redefined flight cycle counts, determining the type of material of the horizontal stabilizer, rear spar, upper chords, and lower chords on the inboard and outboard ends of the rear spar; repetitively inspecting for cracking of the horizontal stabilizer components; and repairing or replacing the chord, or modification of chord segments made from 7079 aluminum, if necessary. For all airplanes, this proposed AD would require inspecting certain structurally significant items, and repairing discrepancies if necessary. This proposed AD was prompted by reports of stress corrosion cracking in the chord segments made from 7079 aluminum in the horizontal stabilizer rear spar, and fatigue cracking in the chord segments made from 7075 aluminum. We are proposing this AD to detect and correct stress corrosion and/or fatigue cracking in the horizontal stabilizer, which could compromise the structural integrity of the stabilizer.
We must receive comments on this proposed AD by January 12, 2012.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
You may examine the AD docket on the Internet at
Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6577; fax: (425) 917-6590, email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received numerous reports of stress corrosion cracking in the chord segments made from 7079 aluminum in the Model 707 horizontal stabilizer rear spar. 7079 aluminum is known to be susceptible to stress corrosion cracking. Development of stress corrosion cracking was slowed by the accomplishment of the actions specified in Boeing 707 Service Bulletin 3356, Revision 2, dated December 12, 1991; and Boeing 707 Service Bulletin 3381, Revision 2, dated January 31, 1991.
In addition, we have received three reports of fatigue cracking in the upper chords of the horizontal stabilizer rear spar near the side of the body. These chords are made from 7075 aluminum. In all three cases, the actions specified in Boeing 707/720 Service Bulletin A3313, Revision 1, dated May 27, 1977, had been incorporated. The fatigue cracking in either 7075 or 7079 material configuration has occurred early in the life of the modified structure. The fatigue cracks were generated by frequent training flights that included multiple touch-and-go cycles, which are most prevalent with military operators. These conditions, if not corrected, could result in stress corrosion and/or fatigue cracking in the horizontal stabilizer, which could compromise the structural integrity of the stabilizer.
Parts made from 7079 aluminum have also been discovered on airplanes that were not originally delivered with those parts. Therefore, to adequately address the stress corrosion cracking in the chord segments in the rear spar of the horizontal stabilizer, it is necessary to determine the chord configuration on the airplane. Furthermore, it is also necessary to carefully maintain a record of that configuration until all chord segments of the rear spar of the horizontal stabilizers that are made from 7079 aluminum have been removed from the fleet. Since horizontal stabilizers can be swapped, it is also necessary to implement the inspections for early fatigue cracking on all airplanes, regardless of their current usage.
We have reviewed Boeing 707 Alert Service Bulletin A3515, dated December
Boeing 707 Alert Service Bulletin A3515 describes procedures for the following actions:
• Counting flight-cycles to determine the compliance times.
• Determining the type of material of the horizontal stabilizer, rear spar, upper chords, and lower chords on the inboard and outboard ends of the rear spar.
• Repetitive special detailed inspections for cracking of the upper chord on the inboard end of the rear spar of the left and right side horizontal stabilizers.
• Repetitive high frequency eddy current inspections for cracking of the web flanges of the upper and lower chords of the rear spar of the left and right side horizontal stabilizers between stabilizer stations 92.55 and 272.55 for 7079 aluminum components.
• Repetitive low frequency eddy current inspections for cracking of the forward skin flanges of the upper and lower chords of the rear spar in the left and right side horizontal stabilizers from stabilizer stations -13.179 to 272.55 (for lower chords) and 92.55 to 272.55 (for upper chords) for 7079 aluminum components.
• Repetitive special detailed inspections for cracking of the upper chord of the inboard side of the rear spar in the left and right side horizontal stabilizers from stabilizer station -13.179 to 92.55 for 7079 aluminum components.
• Replacing certain chord components made from 7079 aluminum.
• Corrective actions, including replacing the chord(s) with a new chord and contacting Boeing for repair instructions and doing the repair.
Boeing 707 Alert Service Bulletin A3516 specifies one-time inspections of certain structurally significant items, and provides procedures for counting flight cycles for determining the compliance times for the inspections.
We issued AD 85-12-01, Amendment 39-5073 (50 FR 26690, June 28, 1985), for Model 707 and 720 airplanes, as revised (AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October 8, 1986). That AD requires structural inspections and repairs or replacement on certain high time airplanes that have exceeded their fatigue design life.
We are proposing this AD because we evaluated all relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs. This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed below. The requirements of this proposed AD do not affect the requirements of AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October 8, 1986).
Paragraph (i) of this proposed AD specifies determining the material of the structural components of the horizontal stabilizer in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. That service bulletin also specifies that this action be repeated. We have determined that accomplishing this action one time only will provide an adequate level of safety, provided that the component material is determined before further flight on any replaced horizontal stabilizer.
Paragraph (i) of this proposed AD specifies a special detailed inspection of the upper chords, in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. That service bulletin specifies a compliance time of 180 days or 500 flight cycles (after the date on the service bulletin). This proposed AD, however, would remove the 500-flight-cycle compliance time to ensure that no airplane is unintentionally grounded, because it is possible an operator might exceed the flight-cycle grace period specified in paragraph (i) of this proposed AD before completing the inspection for chord material specified in paragraph (h) of this proposed AD. Similarly, paragraph (k) of this proposed AD removes the 250- and 1000-flight-cycle compliance times (specified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007) for the initial inspection. This proposed AD would require these inspections within 180 days after the effective date of the AD.
Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:
• Using a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
We consider this proposed AD interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this proposed AD would affect 10 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this proposed AD.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866,
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
3. Will not affect intrastate aviation in Alaska, and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments by January 12, 2012.
(b) This AD affects AD 85-12-01, Amendment 39-5073 (50 FR 26690, June 28, 1985), as revised by AD 85-12-01 R1, Amendment 39-5439, (51 FR 36002, October 8, 1986).
(c) This AD applies to The Boeing Company Model 707-100 long body, -200, -100B long body, and -100B short body series airplanes; Model 707-300, -300B, -300C, and -400 series airplanes; and Model 720 and 720B series airplanes; certificated in any category; as identified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, and Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008.
(d) Air Transport Association (ATA) of America Code 55: Stabilizers.
(e) This AD was prompted by reports of stress corrosion cracking in the chord segments made from 7079 aluminum in the horizontal stabilizer rear spar, and fatigue cracking in the chord segments made from 7075 aluminum. The Federal Aviation Administration is issuing this AD to detect and correct stress corrosion and/or fatigue cracking in the horizontal stabilizer, which could compromise the structural integrity of the stabilizer.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Flight cycles, as used in this AD, must be counted as defined in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007 (for Model 707 airplanes); or Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008 (for Model 707 airplanes, and Model 720 and 720B series airplanes).
(h) For airplanes identified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007: At the earlier of the times specified in paragraphs (h)(1) and (h)(2) of this AD, determine the type of material of the horizontal stabilizer, rear spar, upper chords, and lower chords on the inboard and outboard ends of the rear spar, in accordance with Part 2 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(1) Within 180 days after the effective date of this AD.
(2) Before further flight after any horizontal stabilizer is replaced after the effective date of this AD.
(i) For airplanes with horizontal stabilizer components made from 7075 aluminum, as determined during the inspection required by paragraph (h) of this AD: Within 180 days after the effective date of this AD, and before further flight after any replacement of the horizontal stabilizer, do a special detailed inspection for cracking of the upper chord on the inboard end of the rear spar in the left and right side horizontal stabilizers, from stabilizer station −13.179 to 92.55, in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspections thereafter at intervals not to exceed 500 flight cycles, and before further flight after any replacement of the horizontal stabilizer, except as provided by paragraph (j) of this AD. If any cracking is found, before further flight, either repair the cracking in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD; or replace the chord with a new chord, in accordance with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
For the purposes of this AD, a special detailed inspection is “an intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. The examination is likely to make extensive use of specialized inspection techniques and/or equipment. Intricate cleaning and substantial access or disassembly procedure may be required.
(j) For airplanes on which the chord is replaced with a new chord in accordance with Part 6 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007: Within 4,000 flight cycles after the chord replacement, do the inspections required by paragraph (i) of this AD, and repeat the inspections thereafter at the times specified in paragraph (i) of this AD.
(k) For airplanes with horizontal stabilizers that have components of the chords of the rear spar made from 7079 aluminum, as determined during the inspection required by paragraph (h) of this AD: Within 180 days after the effective date of this AD, do the actions required by paragraphs (k)(1), (k)(2), and (k)(3) of this AD, and repeat those actions at the applicable intervals specified in paragraphs (k)(1), (k)(2), and (k)(3) of this AD.
(1) Do a special detailed inspection for cracking of the upper chord of the inboard side of the rear spar in the left and right side horizontal stabilizers from stabilizer station −13.179 to 92.55, in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspection thereafter at intervals not to exceed 250 flight cycles or 180 days, whichever occurs first. If any cracking is found during any inspection required by this paragraph, before further flight, either repair the cracking, in accordance with Part 3 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD; or replace the chord with a new chord, in accordance with Part
(2) Do a high frequency eddy current inspection for cracking of the web flanges of the upper and lower chords of the rear spar in the left and right side horizontal stabilizers from stabilizer stations 92.55 to 272.55, in accordance with Part 4 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspection thereafter at intervals not to exceed 1,000 flight cycles or 180 days, whichever occurs first. If any cracking is found during any inspection required by this paragraph, before further flight, do the actions specified in paragraph (k)(2)(i) or (k)(2)(ii) of this AD.
(i) Determine whether the cracking meets the limits specified in Part 4 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, and whether a previous repair has been done; determine if all 7079 upper and lower chord segments installed on the horizontal stabilizer have had the Part II, Group 1, Preventative Modification specified in Boeing 707 Service Bulletin 3356 done; and do all applicable repairs and modifications, in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Do the actions required by this paragraph in accordance with Part 4 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD. Do all applicable repairs and modifications before further flight.
(ii) Replace the chord with a new chord, in accordance with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(3) Do low frequency eddy current (LFEC) inspections for cracking of the forward skin flanges of the upper and lower chords of the rear spar in the left and right side horizontal stabilizers from stabilizer stations −13.179 to 272.55 (for lower chords) and 92.55 to 272.55 (for upper chords), in accordance with Part 5 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Repeat the inspections thereafter at intervals not to exceed 1,000 flight cycles or 180 days, whichever occurs first. If any cracking is found during any inspection required by this paragraph, before further flight, do the actions specified in either paragraph (k)(3)(i) or paragraph (k)(3)(ii) of this AD.
(i) Repair cracking, and determine whether all 7079 upper and lower chord segments installed on the horizontal stabilizer have had the Part II—Preventative Modification specified in Boeing 707 Service Bulletin 3381 done, and do all applicable modifications, in accordance with Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007. Do the actions required by this paragraph in accordance with Part 5 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, except as required by paragraph (n) of this AD. Do all applicable modifications before further flight.
(ii) Replace the chord with a new chord, in accordance with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(l) For airplanes identified in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, with horizontal stabilizers that have rear spar chord components made from 7079 aluminum and have not had embodied the modification of Part II of Boeing 707 Service Bulletin 3381, dated July 25, 1980; or Revision 1, dated July 31, 1981: Before further flight after determining the type of material in accordance with paragraph (h) of this AD, modify all 7079 chord segments still installed on the horizontal stabilizer, in accordance with Part 5 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007; or replace the chord, in accordance with Part 6 of the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
(m) For all airplanes: Within 180 days or 1,000 flight cycles after the effective date of this AD, whichever occurs first, do the inspections of the applicable structurally significant items specified in and in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008. If any cracking is found, before further flight, repair in accordance with the procedures specified in paragraph (q) of this AD. The inspections required by AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October 8, 1986), are still required, except, as of the effective date of this AD, the flight-cycle interval for the repetitive inspections specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008, must be counted in accordance with the requirements of paragraph (g) of this AD.
(n) If any cracking is found during any inspection required by this AD, and Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, specifies to contact Boeing for appropriate action: Before further flight, repair the cracking using a method approved in accordance with the procedures specified in paragraph (q) of this AD.
(o) Where Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, specifies that operators “refer to” NDT procedures, the procedures must be done in accordance with the service information identified in paragraphs (o)(1), (o)(2), and (o)(3) of this AD, as applicable.
(1) Subject 51-00-00, “Structures-General,” Figure 20, “Electrical Conductivity Measurement for Aluminum,” of Part 6-Eddy Current, of the Boeing 707/720 Nondestructive Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.
(2) Subject 55-10-07, “Horizontal Stabilizer,” of Part 6-Eddy Current, of the Boeing 707/720 Nondestructive Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.
(3) Subject 51-01-00, “Orientation and Preparation for Testing” of Part 1-General, of the Boeing 707/720 Nondestructive Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.
(p) As of the effective date of this AD, no person may install any horizontal stabilizer assembly with any chord segment having a part number other than that identified in paragraph 2.C.2. of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, on any airplane.
(q)(1) The Manager, Seattle Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(r) For more information about this AD, contact Berhane Alazar, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: (425) 917-6577; fax: (425) 917-6590; email:
(s) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone (206) 544-5000, extension 1; fax (206) 766-5680; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace at Hastings, NE. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Hastings Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Comments must be received on or before January 12, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2011-0499/Airspace Docket No. 11-ACE-10, at the beginning of your comments. You may also submit comments through the Internet at
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137;
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0499/Airspace Docket No. 11-ACE-10.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Hastings Municipal Airport, Hastings, NE. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9V, dated August 9, 2011 and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Hastings Municipal Airport, Hastings, NE.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, and effective September 15, 2011, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Hastings Municipal Airport, and within 2 miles each side of the 150° bearing from the airport extending from the 7.2-mile radius to 10.4 miles southeast of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Boyne City, MI. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Boyne City Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Comments must be received on or before January 12, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2011-0828/Airspace Docket No. 11-AGL-16, at the beginning of your comments. You may also submit comments through the Internet at
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137;
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0828/Airspace Docket No. 11-AGL-16.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by establishing Class E airspace extending upward from 700 feet above the surface for new standard instrument approach procedures at Boyne City Municipal Airport, Boyne City, MI. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9V, dated August 9, 2011 and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at Boyne City Municipal Airport, Boyne City, MI.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, and effective September 15, 2011, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 9.9-mile radius of Boyne City Municipal Airport, and within 2 miles each side of the 080 degree bearing from the airport extending from the 9.9-mile radius to 11.9 miles east of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish restricted area airspace within the Devils Lake Military Operations Area (MOA), overlying Camp Grafton Range, in the vicinity of Devils Lake, ND. The new restricted areas would permit realistic training in modern tactics to be conducted at Camp Grafton Range while ensuring the safe and efficient use of the National Airspace System (NAS) in the Devils Lake, ND, area. Unlike restricted areas which are designated under Title 14 Code of Federal Regulations (14 CFR) part 73, MOAs are not rulemaking airspace actions. However, since the proposed restricted areas overlap the Devils Lake East MOA, the FAA is including a description of the Devils Lake East MOA change in this NPRM. The MOA change described herein will also be published in the National Flight Data Digest (NFDD).
Comments must be received on or before January 12, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Colby Abbott, Airspace, Regulations and ATC Procedures Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591;
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2011-0117 and Airspace Docket No. 09-AGL-31) and be submitted in triplicate to the Docket Management System (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2011-0117 and Airspace DocketNo. 09-AGL-31.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
Resulting from the 2005 Base Realignment and Closure Commission decisions, Grand Forks AFB was selected for a mission change from its existing aerial refueling mission to an emerging unmanned aerial system (UAS) mission. To accommodate this mission change, the United States (U.S.) Air Force is establishing an operational MQ-1, Predator, squadron at Hector International Airport, ND, with eight Predator aircraft being located at Grand Forks AFB. The launch and recovery operations and maintenance support activities for these aircraft will be accomplished at Grand Forks AFB. Additionally, the U.S. Air Force is
The UAS aircraft programmed to arrive at Grand Forks AFB will have mission and training requirements that include employing Intelligence/Reconnaissance/Surveillance, Close Air Support, and Time Sensitive Targeting tactics. Predator laser training will be accomplished at Camp Grafton Range near Devils Lake, ND. Since the Predator onboard laser system is not eye-safe, its use during training must be contained within restricted area airspace. Restricted areas are regulatory airspace areas that are designated under 14 CFR part 73 rulemaking procedures to contain activities that may present a hazard to nonparticipating aircraft. No person may operate an aircraft within a restricted area without the advance permission of the using or controlling agency.
With the emerging UAS mission at Grand Forks AFB and associated laser training requirements at Camp Grafton Range, the existing R-5401 restricted area surrounding the range is inadequate to satisfy laser training requirements for realistic mission profiles above 5,000 feet mean sea level (MSL). In order to fully exploit the capabilities of today's UAS aircraft and provide the essential training that replicates the conditions that are encountered during wartime deployments today, it is necessary to expand the restricted airspace around Camp Grafton Range. The U.S. Air Force has proposed the FAA establish restricted areas surrounding Camp Grafton Range and R-5401 to enable realistic UAS mission profiles above 5,000 feet MSL to contain the hazardous non-eye safe laser training.
The proposed restricted areas would be established within the existing Devils Lake East MOA and would also extend beyond the MOA's southern boundary approximately 10 NM at the furthest point. Additionally, the Devils Lake East and Devils Lake West MOAs and the existing air traffic control assigned airspaces associated with the MOAs would be retained to support integrated training activities; thus, allowing Predator crews to train for real world mission scenarios with other manned aircraft. To prevent confusion and conflict of having the proposed restricted areas and the existing MOA active in the same airspace at the same time, the Devils Lake East MOA would be amended to exclude R-5401 and the proposed restricted areas when they are active.
MOAs are nonregulatory airspace areas that are established administratively and published in the NFDD. MOAs are established to separate or segregate non-hazardous military flight activities from aircraft operating in accordance with instrument flight rules (IFR), and to advise pilots flying under visual flight rules (VFR) where these activities are conducted. IFR aircraft may be routed through an active MOA only when air traffic control can provide approved separation from the MOA activity. VFR pilots are not restricted from flying in an active MOA, but are advised to exercise caution while doing so. Normally, MOA proposals are not published in an NPRM, but are advertised for public comment through a nonrule circular distributed by an FAA Service Center office to aviation interests in the affected area. When a nonrulemaking action is an integral part of a rulemaking action, FAA procedures allow for the nonrulemaking proposal to be included in the NPRM. Since R-5401 and the proposed restricted areas R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F all infringe on the Devils Lake East MOA, the FAA is including a description of the Devils Lake East MOA amendment in this NPRM. Comments on the proposed MOA change may also be submitted as indicated above in the “Comments Invited” section of this NPRM.
The FAA is proposing to amend the Devils Lake East MOA legal description to exclude that airspace within the proposed restricted areas R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F, which overlaps airspace within the MOA, when any of the restricted areas are active, respectively. The intent would be to exclude the restricted areas individually only as they are activated. Additionally, the Devils Lake East MOA amendment will retain and move the R-5401 exclusionary language contained in the altitude information of the legal description to the boundaries information. Except for moving the R-5401 exclusion information, the altitude and time of use descriptions for Devils Lake East MOA will remain unchanged. This proposed amendment will prevent airspace conflict with the overlapping existing and proposed restricted areas.
By removing the current boundaries and altitudes descriptions and substituting the following:
The FAA is proposing to amend 14 CFR part 73 to expand the vertical and lateral limits of restricted area airspace over Camp Grafton Range to contain hazardous non-eye safe laser training operations by an emerging UAS mission at Grand Forks Air Force Base (AFB), transforming the range into a viable non-eye safe laser training location. Camp Grafton Range currently is surrounded by R-5401; however, the lateral boundaries and altitude are insufficient to contain the laser training mission profiles and tactics flown today in combat operations. This proposal would supplement R-5401 and establish additional restricted areas, R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F, to provide the vertical and lateral tactical maneuver airspace needed for UAS target acquisition prior to attack, and to contain the non-eye safe laser during laser target designation training operations from medium to high altitudes.
The proposed restricted area R-5402 boundary, described in the regulatory text, would be defined by a 7 nautical mile (NM) radius around the center of R-5401, with the northern boundary adjusted to lie along the 47°45′00″ N latitude. The proposed restricted area altitude would be upward from 500 feet above ground level to, but not including 10,000 feet MSL. This new restricted area would provide a pathway for the non-eye safe laser beam to transit from the proposed R-5403A, R-5403B, or R-5403C (described below) through the existing R-5401 and onto Camp Grafton Range.
The proposed restricted areas R-5403A, R-5403B, and R-5403C would share the same lateral boundaries, overlying R-5402 and layered in ascending order. The northern boundary of these R-5403 areas, as described in the regulatory text, would share the same northern boundary as R-5402, the 47°45′00″ N latitude. The western boundary would lie approximately 14 NM west of R-5402 along the 99°15′00″ W longitude and the eastern boundary would lie approximately 7 NM east of
The proposed restricted areas R-5403D, R-5403E, and R-5403F would also share the same lateral boundaries, adjacent to and southeast of R-5403A, R-5403B, and R-5403C, and also layered in ascending order. The northern boundary of these R-5403 areas, as described in the regulatory text, would share the same southern boundary of R-5403A, R-5403B, and R-5403C. The western boundary point would reach to the 99°15′00″ W longitude and the eastern boundary would lie along the 98°15′00″ W longitude. Finally, the southern boundary would be established to lie along the 47°30′00″ N latitude. The proposed restricted area altitudes, in ascending order, would be defined upward from 10,000 feet MSL to, but not including 12,000 feet MSL for R-5403D; upward from 12,000 feet MSL to, but not including 14,000 feet MSL for R-5403E; and upward from 14,000 feet MSL to, but not including Flight Level (FL) 180 for R-5403F. The additional lateral and vertical limits provided by these proposed restricted areas, in conjunction with R-5401, R-5402, R-5403A, R-5403B, R-5403C, and Camp Grafton Range, would establish the maneuvering airspace, standoff target acquisition, and hazardous non-eye safe laser employment training completely within restricted airspace, as noted above.
Restricted areas R-5402, R-5403A, R-5403B, R-5403C, R-5403D, R-5403E, and R-5403F will all be designated as “joint-use” airspace. This means that, during periods when any of the restricted airspace areas are not needed by the using agency for its designated purposes, the airspace will be returned to the controlling agency for access by other NAS users. The Minneapolis Air Route Traffic Control Center is the controlling agency for the proposed restricted areas.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish restricted airspace at Camp Grafton Range near Devils Lake, ND, to enhance safety and accommodate essential military training.
This proposal will be subjected to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.
Airspace, Prohibited Areas, Restricted Areas.
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 73 as follows:
1. The authority citation for part 73 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. § 73.54 is amended as follows:
Federal Trade Commission (FTC or Commission).
Advance notice of proposed rulemaking and public meeting announcement.
The Commission seeks comment on disclosures to help consumers, distributors, contractors, and installers easily determine whether a specific furnace, central air conditioner, or heat pump meets the applicable new Department of Energy efficiency standard for the regions where it will be installed. The Commission seeks comment on the content, location, and format of such disclosures. As part of this effort, the Commission staff will hold a public meeting with the Department of Energy to discuss possible disclosures.
Comments must be received by January 10, 2012. The public meeting will be held on December 16, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Hampton Newsome, Attorney, (202) 326-2889, Division of Enforcement, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
The Commission seeks comment on new labeling requirements and other disclosures for residential furnaces, central air conditioners, and heat pumps (
To facilitate the development of such disclosures, the Commission seeks comment on their appropriate content, location, and format. After considering comments, the Commission will publish specific proposed requirements for comment and then publish final disclosure requirements as amendments to the Commission's Appliance Labeling Rule (16 CFR Part 305).
The Commission's Appliance Labeling Rule, issued pursuant to the Energy Policy and Conservation Act (EPCA),
The EnergyGuide labels for heating and cooling equipment contain two key disclosures: (1) The product's efficiency
The Rule also requires manufacturers to provide distributors and installers with energy information about their furnaces, central air conditioners, and heat pumps in paper or electronic form (including internet-based access).
On June 27, 2011,
To promote
To help consumers and businesses determine whether a product conforms with the regional standards promulgated by DOE, EISA directs the FTC to develop new disclosures for furnaces, central air conditioners, and heat pumps. Specifically, the law requires the Commission to “determine the appropriate 1 or more methods for disclosing information so that consumers, distributors, contractors, and installers can easily determine whether a specific piece of equipment that is installed in a specific building is in conformance with the regional standard that applies to the building.”
The content of the new disclosures must help consumers and industry members avoid installing equipment in violation of regional standards. The Commission seeks suggestions for the best disclosure content to meet this goal. For example, such disclosures could simply explain that a particular product may or may not be installed in certain regions:
•
Federal law prohibits installation of this unit in Alabama, Arizona, Arkansas, California, Delaware, Florida, Georgia, Hawaii, Kentucky, Louisiana, Maryland, Mississippi, New Mexico, Nevada, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or the District of Columbia.
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Federal law prohibits installation of this unit in Arizona, California, New Mexico, or Nevada.
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Federal law prohibits the installation of this unit in Alaska, Colorado, Connecticut, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oregon, Pennsylvania Rhode Island, South Dakota, Utah, Vermont, Washington, West Virginia, Wisconsin, or Wyoming.
•
Federal law allows installation of this unit in any U.S. state.
Comments should also address the location and format for the required disclosures. For instance, the EnergyGuide label could be revised to include information about whether a specific piece of equipment meets standards for installation in a specific region. Alternatively, the manufacturer could provide the required disclosures through other means such as product nameplates, product packaging, brochures, user manuals, Web sites, or online databases. Such alternative methods might provide more space than the EnergyGuide labels for the disclosure of detailed compliance information. The disclosure format could also involve a combination of these approaches. For example, the Energy Guide label could include a QR (Quick Response) scan code to provide mobile phone access to an online database containing detailed product information in addition to disclosures on the label or elsewhere. The EPA recently adopted such an approach for new fuel economy labels on automobiles.
The Commission seeks general comments on potential disclosure methods to help consumers, distributors, contractors, and installers easily determine whether residential heating and cooling equipment meets applicable regional efficiency standards. The Commission invites interested persons to submit written comments on any issue of fact, law or policy that may bear upon the FTC's current labeling requirements. Please provide details to support your comments. We encourage commenters to consider the questions below when preparing comments.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
The Commission invites interested persons to submit written comments on any issue of fact, law, or policy that may bear upon the proposals under consideration. Please include explanations for any answers provided, as well as supporting evidence where appropriate. After examining the comments, the Commission will determine whether to issue specific amendments.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before January 10, 2012. Write “Regional Labeling for Heating and Cooling Equipment, (16 CFR Part 305) (Project No. P114202)” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Regional Labeling for Heating and Cooling Equipment, (16 CFR Part 305) (Project No.114202)” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex H), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Commission and DOE staff have scheduled a public meeting to give interested parties an opportunity to provide their views on potential FTC disclosures and the DOE enforcement plan related to new regional standards for furnaces, central air conditioners, and heat pumps. The public meeting will be held on December 16, 2011 at DOE. DOE will provide details regarding time, location, attendance and participation at the meeting.
By direction of the Commission.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations regarding the definition of an “interest in a limited partnership as a limited partner” for purposes of determining whether a taxpayer materially participates in an activity under section 469 of the Internal Revenue Code (Code). These proposed regulations affect individuals who are partners in partnerships.
Written or electronic comments and requests for a public hearing must be received by February 27, 2012.
Send submissions to: CC:PA:LPD:PR (REG-109369-10), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-109369-10), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC, or sent electronically, via the Federal eRulemaking Portal at
Concerning the proposed regulations, Michala Irons, (202) 622-3050; concerning submissions of comments and requests for public hearing, Oluwafunmilayo Taylor, (202) 622-7180 (not toll free numbers).
Section 469(a)(1) limits the ability of certain taxpayers to deduct losses from passive activities. Section 469(b) permits passive losses disallowed in one year to be carried over to the next year. Section 469(c)(1) provides that a passive activity means any activity which involves the conduct of any trade or business, and in which the taxpayer does not materially participate. Section 469(h)(1) provides that a taxpayer shall be treated as materially participating in an activity only if the taxpayer is involved in the operations of the activity on a basis which is regular, continuous, and substantial. The Treasury Department and the IRS promulgated temporary regulations under section 469 in 1988. See TD 8175, 53 FR 5686 (February 25, 1988). Section 1.469-5T(a) provides that an individual taxpayer shall be treated as materially participating in an activity for the taxable year if and only if:
(1) The individual participates in the activity for more than 500 hours during such year;
(2) The individual's participation in the activity for the taxable year constitutes substantially all of the participation in such activity of all individuals (including individuals who are not owners of interests in the activity) for such year;
(3) The individual participates in the activity for more than 100 hours during the taxable year, and such individual's participation in the activity for the taxable year is not less than the participation in the activity of any other individual (including individuals who are not owners of interests in the activity) for such year;
(4) The activity is a significant participation activity (within the meaning of § 1.469-5T(c)) for the taxable year, and the individual's aggregate participation in all significant participation activities during such year exceeds 500 hours;
(5) The individual materially participated in the activity (determined without regard to § 1.469-5T(a)(5)) for any five taxable years (whether or not consecutive) during the ten taxable years that immediately precede the taxable year;
(6) The activity is a personal service activity (within the meaning of § 1.469-5T(d)), and the individual materially participated in the activity for any three taxable years (whether or not consecutive) preceding the taxable year; or
(7) Based on all of the facts and circumstances (taking into account the rules in § 1.469-5T(b)), the individual participates in the activity on a regular, continuous, and substantial basis during such year.
Section 469(h)(2) presumptively treats losses from interests in limited partnerships as passive. Section 469(h)(2) provides that, except as provided in regulations, no interest in a limited partnership as a limited partner shall be treated as an interest with respect to which a taxpayer materially participates. Section 1.469-5T(e)(2) permits an individual taxpayer to establish material participation in a limited partnership but constrains the individual taxpayer to only three of the seven regulatory tests in § 1.469-5T(a), (§ 1.469-5T(a)(1), (a)(5), or (a)(6)).
Section 1.469-5T(e)(3)(i) generally provides that a partnership interest shall be treated as a limited partnership interest if (A) such interest is either designated as a limited partnership interest in the limited partnership agreement or the certificate of limited partnership, without regard to whether the liability of the holder of such interest for obligations of the partnership is limited under applicable State law; or (B) the liability of the holder of such interest for obligations of the partnership is limited, under the law of the State in which the partnership is organized, to a determinable fixed amount (for example, the sum of the holder's capital contributions to the partnership and contractual obligations to make additional capital contributions to the partnership). However, even if the interest is characterized as a limited partnership interest under § 1.469-5T(e)(3)(i), an exception under § 1.469-5T(e)(3)(ii) applies if the individual is a general partner in the partnership at all times during the partnership's taxable year ending with or within the individual's taxable year (or portion of the partnership's taxable year during which the individual (directly or indirectly) owns such limited partnership interest) (the “general partner exception”). If the general partner exception applies, the limited partnership interest will not be treated as such for the year in which the individual taxpayer is a general partner in the partnership. This allows the individual taxpayer to demonstrate material participation through any of the seven regulatory tests in § 1.469-5T(a).
Courts have concluded, in certain instances, that the holder of a limited liability company (LLC) interest is not treated as holding an interest in a limited partnership as a limited partner for purposes of applying the section 469 material participation tests. In
The proposed regulations provide that an interest in an entity will be treated as an interest in a limited partnership under section 469(h)(2) if (A) the entity in which such interest is held is classified as a partnership for Federal income tax purposes under § 301.7701-3; and (B) the holder of such interest does not have rights to manage the entity at all times during the entity's taxable year under the law of the jurisdiction in which the entity was organized and under the governing agreement. Rights to manage include the power to bind the entity. The proposed regulations provide rules concerning an interest in a limited partnership based on the purposes for which section 469 was enacted, and the manner in which the provision is structured and operates within the Code. Accordingly, the rules concerning an interest in a limited partnership in the proposed regulations are provided solely for purposes of section 469 and no inference is intended that the same rules would apply for any other provisions of the Code requiring a distinction between a general partner and a limited partner.
In
The regulations are proposed to apply to taxable years beginning on or after the date of publication of the Treasury decision adopting these regulations as final regulations in the
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, these regulations will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. All comments will be available for public inspection and copying. A public hearing will be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the
The principal author of these proposed regulations is Michala Irons, Office of the Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
1. Revising the entries for § 1.469-5(a), (b), (c), (d), and (e).
2. Removing the entries for § 1.469-5T(e)(1), (e)(2), and (e)(3).
The revisions read as follows:
(a) through (d) [Reserved].
(e) Treatment of an interest in a limited partnership as a limited partner.
(1) In general.
(2) Exceptions.
(3) Interest in a limited partnership as a limited partner.
(i) In general.
(ii) Individual holding an interest other than an interest in a limited partnership as a limited partner.
(4) Effective/applicability date.
(a) through (d) [Reserved].
(e)
(i) The individual's share of any income, gain, loss, deduction, or credit from such activity that is attributable to an interest in a limited partnership as a limited partner; and
(ii) Any gain or loss from such activity recognized upon a sale or exchange of such an interest.
(2)
(3)
(A) The entity in which such interest is held is classified as a partnership for Federal income tax purposes under § 301.7701-3; and
(B) The holder of such interest does not have rights to manage the entity at all times during the entity's taxable year under the law of the jurisdiction in which the entity is organized and under the governing agreement.
(ii)
(4)
(e)
(f)
Financial Crimes Enforcement Network, Treasury (“FinCEN”), Treasury.
Notice of proposed rulemaking.
In a notice of finding published elsewhere in this issue of the
Written comments on the notice of proposed rulemaking must be submitted on or before January 27, 2012.
You may submit comments, identified by RIN 1506-AB16, by any of the following methods:
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•
The FinCEN regulatory helpline at (800) 949-2732 and select Option 6.
On October 26, 2001, the President signed into law the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (the “USA PATRIOT Act”), Public Law 107-56. Title III of the USA PATRIOT Act amends the anti-money laundering provisions of the Bank Secrecy Act (“BSA”), codified at 12 U.S.C. 1829b and 1951-1959, and 31 U.S.C. 5311-5314, and 5316-5332, to promote the prevention, detection, and prosecution of international money laundering and the financing of terrorism. Regulations implementing the BSA appear at 31 CFR Chapter X. The authority of the Secretary of the Treasury (the “Secretary”) to administer the BSA and its implementing regulations has been delegated to the Director of FinCEN.
Section 311 of the USA PATRIOT Act (“section 311”) added section 5318A to the BSA, granting the Secretary the authority, upon finding that reasonable grounds exist for concluding that a foreign jurisdiction, institution, class of transaction, or type of account is of “primary money laundering concern,” to require domestic financial institutions and financial agencies to take certain “special measures” against the primary money laundering concern. Section 311 identifies factors for the Secretary to consider and Federal agencies to consult before the Secretary may conclude that a jurisdiction, institution, class of transaction, or type of account is of primary money laundering concern. The statute also provides similar procedures,
Taken as a whole, section 311 provides the Secretary with a range of options that can be adapted to target specific money laundering and terrorist financing concerns most effectively. These options give the Secretary the authority to bring additional pressure on those jurisdictions and institutions that pose money laundering threats. Through the imposition of various special measures, the Secretary can gain more information about the jurisdictions, institutions, transactions, or accounts of concern; can more effectively monitor the respective jurisdictions, institutions,
Before making a finding that reasonable grounds exist for concluding that a jurisdiction is of primary money laundering concern, the Secretary is required to consult with both the Secretary of State and the Attorney General. The Secretary is also required by section 311, as amended,
• Evidence that organized criminal groups, international terrorists, or entities involved in the proliferation of weapons of mass destruction or missiles, have transacted business in that jurisdiction;
• The extent to which that jurisdiction or financial institutions operating in that jurisdiction offer bank secrecy or special regulatory advantages to nonresidents or nondomiciliaries of that jurisdiction;
• The substance and quality of administration of the bank supervisory and counter-money laundering laws of that jurisdiction;
• The relationship between the volume of financial transactions occurring in that jurisdiction and the size of the economy of the jurisdiction;
• The extent to which that jurisdiction is characterized as an offshore banking or secrecy haven by credible international organizations or multilateral expert groups;
• Whether the United States has a mutual legal assistance treaty with that jurisdiction, and the experience of United States law enforcement officials and regulatory officials in obtaining information about transactions originating in or routed through or to such jurisdiction; and
• The extent to which that jurisdiction is characterized by high levels of official or institutional corruption.
If the Secretary determines that reasonable grounds exist for concluding that a jurisdiction is of primary money laundering concern, the Secretary must determine the appropriate special measure(s) to address the specific money laundering risks. Section 311 provides a range of special measures that can be imposed individually, jointly, in any combination, and in any sequence.
• Whether similar action has been or is being taken by other nations or multilateral groups;
• Whether the imposition of any particular special measures would create a significant competitive disadvantage, including any undue cost or burden associated with compliance, for financial institutions organized or licensed in the United States;
• The extent to which the action or the timing of the action would have a significant adverse systemic impact on the international payment, clearance, and settlement system, or on legitimate business activities involving the particular jurisdiction; and
• The effect of the action on United States national security and foreign policy.
Today, as detailed elsewhere in this part,
As a result of that finding, and based upon the additional consultations and the consideration of all relevant factors discussed in the finding and in this notice of proposed rulemaking, the Director of FinCEN has determined that reasonable grounds exist for the imposition of the fifth special measure authorized by section 5318A(b)(5).
The United Nations Security Council has adopted multiple resolutions imposing sanctions on Iran for its refusal to comply with international nuclear obligations and proliferation sensitive activities, including United Nations Security Council resolutions (“UNSCRs”) 1696,
Iran's serious deficiencies with respect to anti-money laundering/countering the financing of terrorism (“AML/CFT”) controls have long been highlighted by numerous international bodies and government agencies. Starting in October 2007, the Financial Action Task Force (“FATF”) has issued a series of public statements expressing its concern that Iran's lack of a comprehensive AML/CFT regime represents a significant vulnerability within the international financial system. The statements further called upon Iran to address those deficiencies with urgency, and called upon FATF-member countries to advise their institutions to conduct enhanced due diligence with respect to the risks associated with Iran's deficiencies.
The FATF has been particularly concerned with Iran's failure to address the risk of terrorist financing, and starting in February 2009, the FATF called upon its members and urged all jurisdictions to apply effective counter-measures to protect their financial sectors from the terrorist financing risks emanating from Iran.
The FATF's most recent statement in October 2011 reiterated, with a renewed urgency, its concern regarding Iran's failure to address the risk of terrorist financing and the serious threat this poses to the integrity to the international financial system.
Although none of these actions to sanction Iran prohibit domestic financial institutions and agencies from opening or maintaining a correspondent account for or on behalf of any financial institution in Iran, or require the type of special due diligence outlined in this proposed rulemaking, FinCEN encourages other countries or multilateral groups to take similar action based on the findings contained in this rulemaking.
The fifth special measure sought to be imposed by this rulemaking would prohibit covered financial institutions from opening and maintaining correspondent accounts for, or on behalf of, Iranian banking institutions. As a corollary to this measure, covered financial institutions also would be required to take reasonable steps to apply special due diligence, as set forth below, to all of their correspondent accounts to help ensure that no such account is being used indirectly to provide services to an Iranian banking institution. FinCEN does not expect the burden associated with these requirements to be significant given that U.S. financial institutions have long been subject to sanctions regulations prohibiting the provision of correspondent account services for banking institutions in Iran. There is a minimal burden involved in transmitting a one-time notice to certain correspondent account holders concerning the prohibition on indirectly providing services to Iranian banking institutions. In addition, U.S. financial
Banking institutions in Iran generally are not major participants in the international payment system and are not relied upon by the international banking community for clearance or settlement services. Additionally, given the preexisting OFAC and international sanctions on Iran and certain Iranian banking institutions, it is unlikely that these new measures or the timing of the new measures will have a significant impact on the international payment, clearance, and settlement system. Financial transactions between the United States and Iran pertaining to licensed agricultural and medical exports to Iran, as well as other licensed transactions or transactions exempted or not prohibited from the scope of OFAC sanctions, may continue under the rule as proposed.
The exclusion from the U.S. financial system of jurisdictions that serve as conduits for significant money laundering activity, for the financing of terrorism or weapons of mass destruction or their delivery systems, and for other financial crimes enhances U.S. national security by making it more difficult for terrorists and money launderers to access the substantial resources of the U.S. financial system. To the extent that this action serves as an additional tool in preventing Iran from accessing the U.S. financial system, the proposed action supports and upholds U.S. national security and foreign policy goals. More generally, the imposition of the fifth special measure would complement the U.S. Government's worldwide efforts to expose and disrupt international money laundering and terrorist financing.
Therefore, pursuant to the finding of the Director of FinCEN that Iran is a jurisdiction of primary money laundering concern, and after conducting the required consultations and weighing the relevant factors, FinCEN has determined that reasonable grounds exist for imposing the fifth special measure authorized by 31 U.S.C. 5318A(b)(5) against Iran.
The proposed rule would prohibit covered financial institutions from establishing, maintaining, or managing in the United States any correspondent account for, or on behalf of, banking institutions in Iran. As a corollary to this prohibition, covered financial institutions would be required to apply special due diligence to their correspondent accounts to guard against their improper indirect use by Iranian banking institutions. At a minimum, that special due diligence must include two elements. First, a covered financial institution must notify those correspondent account holders that the covered financial institution knows or has reason to know provide services to Iranian banking institutions, that such correspondents may not provide Iranian banking institutions with access to the correspondent account maintained at the covered financial institution. Second, a covered financial institution must take reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions, to the extent that such indirect use can be determined from transactional records maintained by the covered financial institution in the normal course of business. A covered financial institution should take a risk-based approach when deciding what, if any, additional due diligence measures it should adopt to guard against the improper indirect use of its correspondent accounts by Iranian banking institutions, based on risk factors such as the type of services it offers and the geographic locations of its correspondents.
Section 1010.657(a)(1) defines the term “correspondent account” by reference to the definition contained in 31 CFR 1010.605(c)(1)(ii). Section 1010.605(c)(1)(ii) defines a correspondent account to mean:
• An account established to receive deposits from, or make payments or other disbursements on behalf of, a foreign bank, or handle other financial transactions related to the foreign bank.
In the case of a U.S. depository institution, this broad definition includes most types of banking relationships between a U.S. depository institution and a foreign bank that are established to provide regular services, dealings, and other financial transactions including demand deposit, savings deposit, or other transaction or asset accounts, and credit accounts or other extensions of credit.
In the case of securities broker-dealers, futures commission merchants, introducing brokers in commodities, and investment companies that are open-end companies (mutual funds), we are using the same definition of “account” for purposes of this rule as was established in the final rule implementing section 312 of the USA PATRIOT Act.
Section 1010.657(a)(2) of the proposed rule defines “covered financial institution” with the same definition used in the final rule implementing section 312 of the USA PATRIOT Act,
• An insured bank (as defined in section 3(h) of the Federal Deposit Insurance Act (12 U.S.C. 1813(h));
• A commercial bank;
• An agency or branch of a foreign bank in the United States;
• A federally insured credit union;
• A credit union;
• A savings association;
• A corporation acting under section 25A of the Federal Reserve Act (12 U.S.C. 611);
• A trust bank or trust company that is federally regulated and is subject to an anti-money laundering program requirements;
• A broker or dealer in securities registered, or required to be registered,
• A futures commission merchant or an introducing broker registered, or required to be registered, with the Commodity Futures Trading Commission under the Commodity Exchange Act (7 U.S.C. 1
• A private banker; and
• A mutual fund.
Section 1010.657(a)(3) of the proposed rule defines a foreign bank as that term is defined in 1010.100(u). An Iranian banking institution shall mean any foreign bank chartered by Iran, including any branches, offices, or subsidiaries of such bank operating in any jurisdiction, and any branch or office within Iran of any foreign bank licensed by Iran. In addition, the Central Bank of Iran (Bank Markazi Iran),
A covered financial institution should take commercially reasonable measures to determine whether it maintains a correspondent account for an Iranian banking institution, including a branch, office, or subsidiary of an Iranian banking institution.
For purposes of complying with the proposed rule's prohibition on the opening or maintaining of correspondent accounts for, or on behalf of, Iranian banking institutions, FinCEN expects that a covered financial institution will take such steps that a reasonable and prudent financial institution would take to protect itself from loan fraud or other fraud or loss based on misidentification of a person's status.
Section 1010.657(b)(1) of the proposed rule requires all covered financial institutions to terminate any correspondent account that is established, maintained, administered, or managed in the United States for, or on behalf of, Iranian banking institutions, provided that the account is not blocked under any Executive Order issued pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701
As a corollary to the prohibition on maintaining correspondent accounts directly for Iranian banking institutions, proposed section 1010.657(b)(2) requires a covered financial institution to apply special due diligence to its correspondent accounts
Notice: Pursuant to U.S. regulations issued under section 311 of the USA PATRIOT Act, 31 CFR 1010.657, we are prohibited from establishing, maintaining, administering or managing a correspondent account for, or on behalf of, an Iranian banking institution or any of its subsidiaries. The regulations also require us to notify you that you may not provide an Iranian banking institution or any of its subsidiaries with access to the correspondent account you hold at our financial institution other than for the purpose of processing transactions that are authorized, exempt, or not prohibited pursuant to any Executive Order issued under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) or 31 C.F.R. Chapter V. If we become aware that an Iranian banking institution or any of its subsidiaries is indirectly using the correspondent account you hold at our financial institution for transactions other than those specified above, we will be required to take appropriate steps to prevent such access, including terminating your account.
The purpose of the notice requirement is to help ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the U.S. financial system. However, FinCEN does not require or expect a covered financial institution to obtain a certification from any of its correspondent account holders that indirect access will not be provided in order to comply with this notice requirement. Instead, methods of compliance with the notice requirement could include, for example, transmitting a one-time notice by mail, fax, or email to certain of the covered financial institution's correspondent account customers, informing them that they may not provide Iranian banking institutions with access to the covered financial institution's correspondent account, or including such information in the next regularly occurring transmittal from the covered financial institution to those correspondent account holders. FinCEN specifically solicits comments on the form and scope of the notice that would be required under the rule. FinCEN also requests comment as to whether a one-time notice will be sufficient to ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the financial system, as well as the incremental costs that financial institutions would incur if this rule required an annual notice.
A covered financial institution also would be required under this rulemaking to take reasonable steps to identify any indirect use of its correspondent accounts by Iranian
Notifying certain correspondent account holders and taking reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions in the manner discussed above are the minimum due diligence requirements under the proposed rule. Beyond these minimum steps, a covered financial institution should adopt a risk-based approach for determining what, if any, additional due diligence measures it should implement to guard against the improper indirect use of its correspondent accounts by Iranian banking institutions, based on risk factors such as the type of services it offers and the geographic locations of its correspondent account holders.
A covered financial institution that obtains knowledge that a correspondent account is being used by a foreign bank to provide indirect access to an Iranian banking institution must take all appropriate steps to prevent such indirect access, including the notification of its correspondent account holder per section 1010.657(b)(2)(i)(A) and, where necessary, terminating the correspondent account. However, this provision does not require financial institutions to prevent indirect access to correspondent accounts when such access is necessary to conduct transactions involving Iranian banking institutions that are: (1) Authorized pursuant to Executive Orders issued under IEEPA or pursuant to 31 CFR Chapter V, including transactions authorized by the Office of Foreign Assets Control; (2), exempted from the prohibitions of such authority; or (3) not prohibited by such authority.
A covered financial institution may afford the foreign bank a reasonable opportunity to take corrective action prior to terminating the correspondent account. Should the foreign bank refuse to comply, or if the covered financial institution cannot obtain adequate assurances that Iranian banking institutions will no longer be able to improperly access the correspondent account, the covered financial institution must terminate the account within a commercially reasonable time. This means that the covered financial institution should not permit the foreign bank to establish any new positions or execute any transactions through the account, other than those necessary to close the account. A covered financial institution may reestablish an account closed under the proposed rule if it determines that the account will not be used to provide improper indirect access to an Iranian banking institution. FinCEN specifically solicits comments on the requirement under the proposed rule that covered financial institutions prevent improper indirect access to Iranian banking institutions, once such indirect access is identified.
Section 1010.657(b)(3) of the proposed rule clarifies that the rule does not impose any reporting requirement upon any covered financial institution that is not otherwise required by applicable law or regulation. A covered financial institution must, however, document its compliance with the requirement that it notify those correspondent account holders that the covered financial institution knows or has reason to know provide services to Iranian banking institutions, that such correspondents may not provide Iranian banking institutions with improper access to the correspondent account maintained at the covered financial institution.
FinCEN invites comments on all aspects of the proposal to prohibit the opening or maintaining of correspondent accounts for or on behalf of Iranian banking institutions, and specifically invites comments on the following matters:
1. The form and scope of the notice to certain correspondent account holders that would be required under the rule and whether a one-time notice will be sufficient to ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the financial system, and the incremental costs that financial institutions would incur if this rule required an annual notice;
2. The appropriate scope of the proposed requirement for a covered financial institution to take reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions;
3. The appropriate steps a covered financial institution should take once it identifies an indirect use of one of its correspondent accounts by an Iranian banking institution; and
4. The impact of the proposed special measure upon legitimate transactions with Iran involving, in particular, U.S. persons and entities; foreign persons, entities, and governments; and multilateral organizations doing legitimate business with persons or entities operating in Iran.
It is hereby certified that this proposed rule will not have a significant economic impact on a substantial number of small entities. Given that U.S. financial institutions have long been subject to sanctions regulations prohibiting the provision of correspondent account services for banking institutions in Iran, FinCEN assesses that the prohibition on maintaining such accounts will not have a significant impact on a substantial number of small entities. In addition, all U.S. persons, including U.S. financial institutions, currently must exercise some degree of due diligence in order to comply with various legal requirements. The tools used for such purposes, including commercially available software used to comply with the economic sanctions programs administered by OFAC, can easily be modified to monitor for the use of correspondent accounts by Iranian banking institutions. Thus, the special due diligence that would be required by this rulemaking—
The collection of information contained in this proposed rule is being submitted to the Office of Management
The collection of information in this proposed rule is in 1010.657(b)(2)(i) and 1010.657(b)(3)(i). The notification requirement in 1010.657(b)(2)(i) is intended to ensure cooperation from correspondent account holders in denying Iranian banking institutions access to the U.S. financial system. The information required to be maintained by 1010.657(b)(3)(i) will be used by federal agencies and certain self-regulatory organizations to verify compliance by covered financial institutions with the provisions of 31 CFR 1010.657. The class of financial institutions affected by the notification requirement is identical to the class of financial institutions affected by the recordkeeping requirement. The collection of information is mandatory.
FinCEN specifically invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the mission of FinCEN, including whether the information shall have practical utility; (b) the accuracy of FinCEN's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information required to be maintained; (d) ways to minimize the burden of the required collection of information, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to maintain the information.
The proposed rule is not a significant regulatory action for purposes of Executive Order 12866, “Regulatory Planning and Review.”
Administrative practice and procedure, Banks and banking, Brokers, Counter-money laundering, Counter-terrorism, Foreign banking, Iran.
For the reasons set forth in the preamble, chapter X of title 31 of the Code of Federal Regulations is proposed to be amended as follows:
1. The authority citation for chapter X is amended to read as follows:
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314, 5316-5332 Title III, secs. 311, 312, 313, 314, 319, 326, 352, Pub. L. 107-56, 115 Stat. 307.
2. Subpart F of Chapter X is amended by adding new § 1010.657 under the undesignated center heading “SPECIAL DUE DILIGENCE FOR CORRESPONDENT ACCOUNTS AND PRIVATE BANKING ACCOUNTS” to read as follows:
(a)
(1)
(2)
(3)
(4)
(i) Any foreign bank chartered by Iran, including any branches, offices, or subsidiaries of such bank operating in any jurisdiction, and any branch or office within Iran of any foreign bank licensed by Iran;
(ii) The Central Bank of Iran (Bank Markazi Iran); and
(iii) Any foreign bank of which more than 50 percent of the voting stock or analogous interest is owned by two or more foreign banks chartered by Iran.
(5)
(b)
(1)
(2)
(i) A covered financial institution shall apply special due diligence to its correspondent accounts that is reasonably designed to guard against their improper indirect use by Iranian banking institutions. At a minimum, that special due diligence must include:
(A) Notifying those correspondent account holders that the covered financial institution knows or has reason to know provide services to Iranian banking institutions, that such correspondents generally may not provide Iranian banking institutions with access to the correspondent account maintained at the covered financial institution; and
(B) Taking reasonable steps to identify any indirect use of its correspondent accounts by Iranian banking institutions, to the extent that such indirect use can be determined from transactional records maintained in the covered financial institution's normal course of business.
(ii) A covered financial institution shall take a risk-based approach when deciding what, if any, other due diligence measures it should adopt to guard against the improper indirect use of its correspondent accounts by Iranian banking institutions.
(iii) A covered financial institution that obtains knowledge that a correspondent account is being used by the foreign bank to provide indirect access to an Iranian banking institution, shall take all appropriate steps to prevent such indirect access, including the notification of its correspondent account holder under paragraph
(3)
(i) A covered financial institution is required to document its compliance with the notice requirement set forth in paragraph (b)(2)(i)(A) of this section.
(ii) Nothing in this section shall require a covered financial institution to report any information not otherwise required to be reported by law or regulation.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to approve several State Implementation Plan (SIP) revisions submitted by the South Carolina Department of Health and Environmental Control (SC DHEC). These revisions establish reasonably available control technology (RACT) requirements for the three major sources located in the portion of York County, South Carolina that is within the bi-state Charlotte-Gastonia-Rock Hill, North Carolina-South Carolina 1997 8-hour ozone nonattainment area that either emit volatile organic compounds, nitrogen oxides or both. The bi-state Charlotte-Gastonia-Rock Hill 1997 8-hour ozone nonattainment area is hereinafter referred to as the “bi-state Charlotte Area.” In addition, South Carolina's SIP revisions include negative declarations for certain source categories for which EPA has control technique guidelines, meaning that SC DHEC has concluded that no such sources are located in that portion of the nonattainment area. EPA has evaluated the proposed revisions to South Carolina's SIP, and has preliminarily concluded that they are consistent with statutory and regulatory requirements and EPA guidance.
Written comments must be received on or before December 28, 2011.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2010-0017 and EPA-R04-OAR-2010-0018 by one of the following methods:
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Please see the direct final rule which is located in the Rules section of this
Zuri Farngalo, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Zuri Farngalo may be reached by phone at (404) 562-9152 or by electronic mail address
On March 12, 2008, EPA issued a revised ozone NAAQS. See 73 FR 16436. EPA subsequently announced a reconsideration of the 2008 NAAQS, and proposed new 8-hour ozone NAAQS in January 2010. See 75 Fr 2938. In September 2011, EPA withdrew the proposed reconsidered NAAQS and began implementation of the 2008 NAAQS. The current action, however, is being taken to address requirements under the 1997 ozone NAAQS for a portion of York County, South Carolina. Requirements for the bi-state Charlotte Area under the 2008 NAAQS will be addressed in the future.
For additional information see the direct final rule which is published in the Rules Section of this
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission seeks comment on a request by certain private parties, identified below, that the Commission authorize voluntary asymmetric digital sideband power for
Comments for this proceeding may be filed on or before December 19, 2011 and reply comments may be filed on or before January 3, 2012.
You may submit comments, identified by MM Docket No. 99-325, by any of the following methods:
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Peter H. Doyle, Chief, Media Bureau, Audio Division, at (202) 418-2700; Susan Crawford, Ann Gallagher, or Charles Miller, Media Bureau, Audio Division, at (202) 418-2700.
This is a summary of a Public Notice released by the Media Bureau on November 1, 2011. The full text of this document is available for public inspection and copying during regular business hours in the Commission's Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone (202) 488-5300, facsimile (202) 488-5563 or via email
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• Copies of the reports and any subsequently filed documents in this matter may be obtained electronically at
• Alternate formats of this Public Notice (computer diskette, large print, audio recording or Braille) are available to persons with disabilities by contacting the Consumer and Governmental Affairs Bureau at (202) 418-0530 or (202) 418-7365 (TTY).
On October 4, 2011, representatives of iBiquity Digital Corporation (iBiquity) and National Public Radio, Inc. (NPR) met with Media Bureau staff to discuss the possibility of permitting FM stations to operate with unequal digital sideband power levels. Concurrently, iBiquity filed a technical report that discusses the field performance of asymmetric digital sideband operation by FM stations. On October 24, 2011, NPR filed a report describing the results of field testing of asymmetric FM digital sidebands used in conjunction with the testing of newly-developed technology for reducing the peak-to-average power ratio in digital transmitters. Based on these reports, iBiquity and NPR requested that the Commission authorize voluntary asymmetric digital sideband power for FM stations. On November 1, 2011, the Media Bureau released the “November 1, 2011,
The iBiquity and NPR request and the iBiquity and NPR technical studies are available electronically from the Commission's Electronic Comment Filing System under MM Docket No. 99-235 at
The Public Notice tentatively concludes that it would be expedient to modify Form 335-FM (OMB control number 3060-1034), currently used for Digital Notifications, to accommodate requests for increased digital power and/or operation with asymmetric digital sideband power. The Public Notice also seeks comment on the process by which FM stations engaging in such operations would notify the Commission and how such notifications would be maintained in the Commission's electronic databases. Thus, the proposal under consideration may result in a new or revised information collection requirement being adopted by the Commission when the final rules are adopted. If the Commission adopts any new or revised information collection requirement, the Commission will publish a separate notice in the
This proceeding will be treated as a “permit-but-disclose” proceeding subject to the “permit-but-disclose” requirements under § 1.1206(b) of the Commission's rules (47 CFR 1.1206(b)).
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 5 U.S.C. 603, the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the proposed rule as provided in the “Dates” paragraph of the item. The Commission will send a copy of the proposed rule, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the proposed rule and IRFA (or summaries thereof) will be published in the
This document seeks comment on the iBiquity and NPR request that the Commission authorize voluntary asymmetric digital sideband power for FM stations. Currently, FM stations may operate only with equal power levels on the upper and lower primary digital sidebands. In the
Early experience with FM IBOC operation showed the one-percent digital power level to be insufficient to replicate analog coverage areas. In response to a request from a group of broadcasters, the Media Bureau issued its January 29, 2010,
A significant number of FM stations are currently precluded from taking advantage of the full 10 dB digital power increase permitted by the
The authority for this proposed rulemaking is contained in sections 1, 2, 4(i), 301, 302, 303, 307, 308, and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 301, 302, 303, 307, 308, and 309(j).
The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules. The RFA generally defines the term “small entity” as encompassing the terms “small business,” “small organization,” and “small governmental entity.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
In the
Non-super-powered FM stations requesting authorization to operate with digital ERP between −14 dBc and −10 dBc, or super-powered FM stations requesting digital ERP in excess of −20 dBc are required to file an informal request using the Engineering STA Form prior to commencement of the increased power FM digital operation. Licensees submitting such a request must use the simplified method set forth in the January 29, 2010,
The proposed rule changes may, in some cases, impose different reporting or recordkeeping requirements on FM radio stations, insofar as they would allow certain licensees to voluntarily operate with asymmetric digital sideband power. However, the information that would be reported is already familiar to broadcasters, and is similar to the current IBOC digital operation notification or authorization reporting requirements, so any additional burdens would be minimal. The Public Notice tentatively concludes that it would be expedient to modify Form 335-FM, currently used for Digital Notifications, to accommodate requests for increased digital power and/or operation with asymmetric digital sideband power.
The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities (5 U.S.C. 603(b)).
Operation of hybrid digital facilities by Commission licensees and permittees is voluntary. Likewise, use of asymmetric FM digital sideband powers would be limited to those licensees and permittees expressly seeking authorization for such operation. The proposal to permit use of asymmetric FM digital sideband powers thus would not impose any additional burden on FM broadcasters. In fact, for those FM broadcasters that choose to operate hybrid FM facilities, the proposal would confer a benefit. Currently, a significant number of FM stations are precluded from operating maximum permissible hybrid FM digital facilities. This occurs in the case of an FM station operating hybrid digital facilities that has a nearby FM station on one, but not both, of its two first-adjacent channels, thus limiting allowable digital power in both sidebands to a level that protects the sole limiting station. By permitting asymmetric FM digital sideband operation, such a station could increase to maximum permissible digital power on the sideband opposite the limiting FM station, thus achieving improved digital facilities and signal coverage. Because operation under the proposed rule is voluntary, and would only be undertaken by licensees and permittees that would realize a benefit from such operation, consideration of alternatives was not required.
None.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of regulatory review; Request for comments.
NHTSA seeks comments on the economic impact of its regulations on small entities. As required by Section 610 of the Regulatory Flexibility Act, we are attempting to identify rules that may have a significant economic impact on a substantial number of small entities. We also request comments on ways to make these regulations easier to read and understand. The focus of this notice is rules that specifically relate to school buses and other buses.
You should submit comments early enough to ensure that Docket Management receives them not later than January 27, 2012.
You may submit comments [identified by DOT Docket ID Number NHTSA-2011-0160] by any of the following methods:
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Juanita Kavalauskas, Office of Regulatory Analysis, Office of Regulatory Analysis and Evaluation, National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590 (telephone (202) 366-2584, fax (202) 366-3189).
Section 610 of the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), requires agencies to conduct periodic reviews of final rules that have a significant economic impact on a substantial number of small business entities. The purpose of the reviews is to determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the objectives of applicable statutes, to minimize any significant economic impact of the rules on a substantial number of such small entities.
The Department of Transportation (DOT) published its Semiannual Regulatory Agenda on November 22, 1999, listing in Appendix D (64 FR 64684) those regulations that each operating administration will review under section 610 during the next 12 months. Appendix D contained DOT's 10-year review plan for all of its existing regulations. On November 24, 2008, NHTSA published in the
The National Highway Traffic Safety Administration (NHTSA, “we”) has divided its rules into 10 groups by subject area. Each group will be reviewed once every 10 years, undergoing a two-stage process—an Analysis Year and a Review Year. For purposes of these reviews, a year will coincide with the fall-to-fall publication schedule of the Semiannual Regulatory Agenda. The newly revised 10-year plan will assess years 9 and 10 of the old plan in years 1 and 2 of the new plan. Year 1 (2008) began in the fall of 2008 and will end in the fall of 2009; Year 2 (2009) will begin in the fall of 2009 and will end in the fall of 2010; and so on.
During the Analysis Year, we will request public comment on and analyze each of the rules in a given year's group to determine whether any rule has a significant impact on a substantial number of small entities and, thus, requires review in accordance with section 610 of the Regulatory Flexibility Act. In each fall's Regulatory Agenda, we will publish the results of the analyses we completed during the previous year. For rules that have subparts, or other discrete sections of rules that do have a significant impact on a substantial number of small entities, we will announce that we will be conducting a formal section 610 review during the following 12 months.
The section 610 review will determine whether a specific rule should be revised or revoked to lessen its impact on small entities. We will consider: (1) The continued need for the rule; (2) the nature of complaints or comments received from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other federal rules or with state or local government rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. At the end of the Review Year, we will publish the results of our review. The following table shows the 10-year analysis and review schedule:
During Year 4, we will continue to conduct a preliminary assessment of the following: 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222.
We are seeking comments on whether any requirements in 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. Business entities are generally defined as small businesses by Standard Industrial Classification (SIC) code, for the purposes of receiving Small Business Administration (SBA) assistance. Size standards established by SBA in 13 CFR 121.201 are expressed either in number of employees or annual receipts in millions of dollars, unless otherwise specified. The number of employees or annual receipts indicates the maximum allowed for a concern and its affiliates to be considered small. If your business or organization is a small entity and if any of the requirements in 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 have a significant economic impact on your business or organization, please submit a comment to explain how and to what degree these rules affect you, the extent of the economic impact on your business or organization, and why you believe the economic impact is significant.
If the agency determines that there is a significant economic impact on a substantial number of small entities, it will ask for comment in a subsequent notice during the Review Year on how these impacts could be reduced without reducing safety.
Executive Order 12866 and the President's memorandum of June 1, 1998, require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
• Have we organized the material to suit the public's needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that is not clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Would more (but shorter) sections be better?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
If you have any responses to these questions, please include them in your comments on this document.
In conjunction with our section 610 reviews, we will be performing plain language reviews over a ten-year period on a schedule consistent with the section 610 review schedule. We will review 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 to determine if these regulations can be reorganized and/or rewritten to make them easier to read, understand, and use. We encourage interested persons to submit draft regulatory language that clearly and simply communicates regulatory requirements, and other recommendations, such as for putting information in tables that may make the regulations easier to use.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.
Your comments must not be more than 15 pages long. (49 CFR 553.21.) We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.
Please submit two copies of your comments, including the attachments, to Docket Management at the address given above under
Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590. In addition, you should submit two copies, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under
We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:
(1) Go to the Federal Docket Management System (FDMS) at
(2) FDMS provides two basic methods of searching to retrieve dockets and docket materials that are available in the system: (a) “Quick Search” to search using a full-text search engine, or (b) “Advanced Search,” which displays various indexed fields such as the docket name, docket identification number, phase of the action, initiating office, date of issuance, document title, document identification number, type of document,
(3) You may download the comments. However, since the comments are
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
90-day petition finding, request for information, and initiation of status review.
We, NMFS, announce a 90-day finding on a petition to list the scalloped hammerhead shark (
Information and comments on the subject action must be received by January 27, 2012.
You may submit comments, information, or data, identified by “NOAA-NMFS-2011-0261” by any one of the following methods:
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•
Instructions: All comments received are a part of the public record and may be posted to
Maggie Miller, NMFS, Office of Protected Resources, (301) 427-8403.
On August 14, 2011, we received a petition from WildEarth Guardians and Friends of Animals to list the scalloped hammerhead shark (
Section 4(b)(3)(A) of the ESA of 1973, as amended (16 U.S.C. 1531
Under the ESA, a listing determination may address a species, which is defined to also include subspecies and, for any vertebrate species, any DPS that interbreeds when mature (16 U.S.C. 1532(16)). A joint NMFS-U.S. Fish and Wildlife Service (USFWS) (jointly, “the Services”) policy clarifies the agencies' interpretation of the phrase “distinct population segment” for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). A species, subspecies, or DPS is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, and “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively, 16 U.S.C. 1532(6) and (20)). Pursuant to the ESA and our implementing regulations, we determine whether species are threatened or endangered based on any one or a combination of the following five section 4(a)(1) factors: (1) The present or threatened destruction, modification, or curtailment of habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms; and (5) any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)).
ESA-implementing regulations issued jointly by NMFS and USFWS (50 CFR 424.14(b)) define “substantial information” in the context of reviewing
Judicial decisions have clarified the appropriate scope and limitations of the Services' review of petitions at the 90-day finding stage, in making a determination that a petitioned action “may be” warranted. As a general matter, these decisions hold that a petition need not establish a “strong likelihood” or a “high probability” that a species is either threatened or endangered to support a positive 90-day finding.
We evaluate the petitioners' request based upon the information in the petition including its references and the information readily available in our files. We do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We will accept the petitioners' sources and characterizations of the information presented if they appear to be based on accepted scientific principles, unless we have specific information in our files that indicates the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation or that is contradicted by other available information will not be dismissed at the 90-day finding stage, so long as it is reliable and a reasonable person would conclude it supports the petitioners' assertions. In other words, conclusive information indicating the species may meet the ESA's requirements for listing is not required to make a positive 90-day finding. We will not conclude that a lack of specific information alone negates a positive 90-day finding if a reasonable person would conclude that the unknown information itself suggests an extinction risk of concern for the species at issue.
To make a 90-day finding on a petition to list a species, we evaluate whether the petition presents substantial scientific or commercial information indicating the subject species may be either threatened or endangered, as defined by the ESA. First, we evaluate whether the information presented in the petition, along with the information readily available in our files, indicates that the petitioned entity constitutes a “species” eligible for listing under the ESA. Next, we evaluate whether the information indicates that the species faces an extinction risk that is cause for concern; this may be indicated in information expressly discussing the species' status and trends, or in information describing impacts and threats to the species. We evaluate any information on specific demographic factors pertinent to evaluating extinction risk for the species (
Information presented on impacts or threats should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act or have acted on the species to the point that it may warrant protection under the ESA. Broad statements about generalized threats to the species, or identification of factors that could negatively impact a species, do not constitute substantial information indicating that listing may be warranted. We look for information indicating that not only is the particular species exposed to a factor, but that the species may be responding in a negative fashion; then we assess the potential significance of that negative response.
Many petitions identify risk classifications made by non-governmental organizations, such as the International Union on the Conservation of Nature (IUCN), the American Fisheries Society, or NatureServe, as evidence of extinction risk for a species. Risk classifications by other organizations or made under other Federal or state statutes may be informative, but the classification alone may not provide the rationale for a positive 90-day finding under the ESA. For example, as explained by NatureServe, their assessments of a species' conservation status do “not constitute a recommendation by NatureServe for listing under the U.S. Endangered Species Act” because NatureServe assessments “have different criteria, evidence requirements, purposes and taxonomic coverage than government lists of endangered and threatened species, and therefore these two types of lists should not be expected to coincide” (
The scalloped hammerhead shark is a circumglobal species that lives in coastal warm temperate and tropical seas. It occurs over continental and insular shelves, as well as adjacent deep waters, but is seldom found in waters cooler than 22 °C (Compagno, 1984; Schulze-Haugen
In the western Atlantic Ocean, the scalloped hammerhead range extends from the Northeast coast of the United States (from New Jersey to Florida) to Brazil, including the Gulf of Mexico and Caribbean Sea. In the eastern Atlantic, it can be found from the Mediterranean Sea to Namibia. Populations in the Indian Ocean are found in the following locations: South Africa and the Red Sea to Pakistan, India, and Myanmar, and in the western Pacific the scalloped hammerhead can be found from Japan and China to New Caledonia, including throughout the Philippines, Indonesia, and off Australia. Distribution in the eastern Pacific Ocean extends from the coast of southern California (U.S.), including the Gulf of California, to Ecuador and possibly Peru (Compagno, 1984), and off waters of Hawaii (U.S.) and Tahiti.
The general life history pattern of the scalloped hammerhead shark is that of a long lived (oldest known sharks of both sexes aged at 30.5 years; Piercy
The oldest aged scalloped hammerhead sharks had lengths of 241 cm (females) and 234 cm (males) (Piercy
The scalloped hammerhead shark is viviparous (
The scalloped hammerhead shark is a high trophic level predator (Cortés, 1999) and opportunistic feeder, with a diet that includes a wide variety of teleosts, cephalopods, crustaceans, and rays (Compagno, 1984).
We evaluated the information provided in the petition and readily available in our files to determine if the petition presented substantial scientific or commercial information indicating that the petitioned action may be warranted. The petition contains information on the species, including the taxonomy, species description, geographic distribution, habitat, population status and trends, and factors contributing to the species' decline. The petition states that the primary threat to the scalloped hammerhead shark is exploitation by fishing, with the ongoing practice of “finning” of particular concern. The petitioners also assert that the lack of adequate regulatory protection programs worldwide, as well the species' biological constraints, increase the susceptibility of the scalloped hammerhead shark to exploitation and extinction. Although data are not available to determine the actual number or size of the global population of scalloped hammerhead sharks, the information from our files and from the petitioners' references suggest that the scalloped hammerhead underwent significant range-wide declines from historical abundance levels (Feretti
According to the petition, at least three of the five causal factors in section 4(a)(1) of the ESA are adversely affecting the continued existence of the scalloped hammerhead shark, specifically: (B) Overutilization for commercial, recreational, scientific, or educational purposes; (D) inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. In the following sections, we use the information presented in the petition and in our files to determine whether the petitioned action may be warranted. We consider the global population of scalloped hammerhead sharks and will revisit the question of DPSs during a status review, if necessary. We summarize our analysis and conclusions regarding the information presented by the petitioner and in our files on the specific ESA section 4(a)(1) factors affecting the species' risk of global extinction below.
Information from the petition and in our files suggests that the primary threat to the scalloped hammerhead shark is from fisheries. We refer to the U.S. and Palau CITES (2010) proposal to list
Scalloped hammerhead sharks are both targeted and taken as bycatch in many global fisheries (
In the United States, scalloped hammerhead sharks are mainly caught as bycatch in longline and coastal gillnet fisheries and are known to suffer high mortality from capture. In the northwest Atlantic, on-line mortalities (for all age groups) were estimated at 91.4 percent and 93.8 percent (Mejuto
According to the CITES proposal, overutilization of scalloped hammerheads has also been documented off the coast of Belize, leading to an observed decline in the abundance and size of hammerheads and prompting a halt in the Belize-based shark fishery. However, fishing pressure on hammerheads still continues as a result of Guatemalan fishermen entering Belizean waters (CITES, 2010). Further south, in Brazil, declines between 60 and 90 percent of adult female scalloped hammerheads have been reported from 1993 to 2001 using CPUE data, while the abundance of neonates has significantly decreased over the past 10 years (CITES, 2010). In inshore waters, neonates are heavily targeted by coastal gillnets and recreational fisheries, and are also caught as bycatch in shrimp and pair trawls (CITES, 2010). Further offshore, catches of scalloped hammerheads have been documented as incidental take in other directed fisheries, such as a tuna fishery based in Santos City, São Paulo State, Brazil, where data has revealed a decline in these incidental catch weights, from 290 t in 1990 to 59 t in 1996 (Amorim
In the Pacific Ocean, juvenile scalloped hammerheads are targeted mainly in directed fisheries but also taken as bycatch by shrimp trawlers and coastal teleost fisheries. Importance of scalloped hammerheads in fishery landings appears to vary by region, from 11.9 percent of the total catch from El Salvador (number of individuals (n)=412; 1991-1992) to 36 percent from the Gulf of Tehauntepec, Mexico (n=8,659; 1996-1998), and ranging from 6 percent (n=339) to 74 percent (n=800) of the total catch off different parts of Guatemala (1996-1999) (CITES, 2010). In Ecuador, landings of hammerhead sharks have decreased since 1996, with a 51 percent decline in artisanal fishery landings between 2004 and 2006 in the Port of Manta, an area where artisanal and drift-net fleets account for 80 percent of shark landings in Ecuador (CITES, 2010).
In the Indian Ocean, pelagic sharks, including the scalloped hammerhead, are targeted in various fisheries, including semi-industrial, artisanal, and recreational fisheries. Countries that fish for sharks include: Egypt, India, Iran, Oman, Saudi Arabia, Sudan, United Arab Emirates, and Yemen, where the probable or actual status of the shark populations is unknown, and Maldives, Kenya, Mauritius, Seychelles, South Africa, and United Republic of Tanzania, where the actual status of the shark population is presumed to be fully to over exploited (Young, 2006). We conclude that the information in the petition and in our files suggests that fisheries may be impacting the continued existence of the scalloped hammerhead.
The petition asserts that the inadequacy of existing Federal, state, or international regulatory mechanisms require that the scalloped hammerhead shark be listed under the ESA. The petition contends that the lack of specific regulations for the scalloped hammerhead has failed to prevent large population declines of the shark species. However, the latest stock assessment for the northwestern Atlantic scalloped hammerhead shark population estimated that a total allowable catch (TAC) of 2,853 scalloped hammerhead sharks per year (or 69 percent of the 2005 catch) would allow a 70 percent probability of rebuilding to MSY in 10 years (Hayes
In addition, the petition asserts that there is little international regulation of fishing or trading to protect scalloped hammerheads; however, in 2010, the International Commission for the Conservation of Atlantic Tunas (ICCAT) developed recommendations 10-07 and 10-08, which specifically prohibit the retention, transshipping, landing, sorting, or selling of hammerhead sharks, other than bonnethead sharks, caught in association with ICCAT fisheries. The ICCAT is responsible for the conservation of tuna and tuna-like species in the Atlantic Ocean and adjacent seas and its recommendations are binding to Contracting Parties (of which there are 48, including the United States), unless Parties object pursuant to the treaty. On April 29, 2011, NMFS proposed and on August 29, 2011, finalized the implementation of these recommendations, which affect the U.S. commercial HMS pelagic
The petition notes that finning bans are a common form of shark management regulation and have been adopted by 19 countries, including Mexico, Costa Rica, and Chile, but argues that many of these bans contain loopholes that allow for the continued removal of shark fins at sea. It is important to note that the petition does not provide information that some countries and management bodies are working to address these issues, including the United States and the European Union (EU). In fact, on January 4, 2011, the 2010 U.S. Shark Conservation Act was signed. This legislation requires that all sharks caught in U.S. waters, with an exemption for smooth dogfish, be landed with fins naturally attached, effectively ending the practice of removing fins at sea in the United States (Pub. L. 111-348). However, even with the increase and strengthening of finning bans, the lack of internationally enforced catch limits or trade regulations allows for the continued and unregulated fishing of scalloped hammerheads in international waters. In 2010, the United States and Palau proposed to list
The petition contends that “biological vulnerability” in the form of long gestation periods, late maturity, large size, and documented schooling behavior, is affecting the species' ability to recover from exploitation. However, a recent ecological risk assessment for pelagic sharks found that scalloped hammerheads ranked among the less vulnerable species in terms of its biological productivity and susceptibility to the pelagic longline fisheries in the Atlantic Ocean (Cortés
The petition also asserts that “human population growth” may pose a serious threat to the scalloped hammerhead population. However, broad statements about generalized threats to the species do not constitute substantial information indicating that listing may be warranted. Although the petition presents information that the human population may be expanding, it does not provide information indicating an increase in fishing pressure on scalloped hammerhead sharks due specifically to this human population growth, or information that scalloped hammerhead sharks are responding in a negative fashion to human population growth.
We conclude that the petition presents substantial scientific or commercial information indicating that a combination of two of the section 4(a)(1) factors: Overutilization for commercial, recreational, scientific, or educational purposes, and inadequate existing regulatory mechanisms, may be causing or contributing to an increased risk of extinction for the scalloped hammerhead shark.
After reviewing the information contained in the petition, as well as information readily available in our files, and based on the above analysis, we conclude the petition presents substantial scientific information indicating the petitioned action of listing the scalloped hammerhead shark as threatened or endangered may be warranted. Therefore, in accordance with section 4(b)(3)(B) of the ESA and NMFS' implementing regulations (50 CFR 424.14(b)(2)), we will commence a status review of the species. During our status review, we will first determine whether the species is in danger of extinction (endangered) or likely to become so (threatened) throughout all or a significant portion of its range. If it is not, then we will consider whether the populations identified by the petitioner meet the DPS policy criteria, and if so, whether any of these are threatened or endangered. We now initiate this review, and thus, the scalloped hammerhead shark is considered to be a candidate species (69 FR 19975; April 15, 2004). Within 12 months of the receipt of the petition (August 14, 2012), we will make a finding as to whether listing the species (or any identified DPSs) as endangered or threatened is warranted as required by section 4(b)(3)(B) of the ESA. If listing the species (or any identified DPSs) is found to be warranted, we will publish a proposed rule and solicit public comments before developing and publishing a final rule.
To ensure that the status review is based on the best available scientific and commercial data, we are soliciting information on whether the scalloped hammerhead shark is endangered or threatened. Specifically, we are soliciting information in the following areas: (1) Historical and current distribution and abundance of this species throughout its range; (2) historical and current population trends; (3) life history in marine environments; (4) shark fin trade data; (5) any current or planned activities that may adversely impact the species; (6) ongoing or planned efforts to protect and restore the species and their habitats; (7) population structure information, such as genetics data; and (8) management, regulatory, and enforcement information. We request that all information be accompanied by: (1) Supporting documentation such as
A complete list of references is available upon request from NMFS Protected Resources Headquarters Office (see
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Animal and Plant Health Inspection Service, USDA.
Notice of a proposed new system of records; request for comment.
The Animal and Plant Health Inspection Service proposes to add a system of records to its inventory of records systems subject to the Privacy Act of 1974, as amended. The system of records being proposed is the APHIS Animal Health Surveillance and Monitoring System, USDA-APHIS-15. This notice is necessary to meet the requirements of the Privacy Act to publish in the
Although the Privacy Act requires only that the portion of the system which describes the “routine uses” of the system be published for comment, we invite comment on all portions of this notice.
You may submit comments by either of the following methods:
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Dr. Diane Sutton, Senior Staff Veterinarian,
The Privacy Act of 1974, as amended (5 U.S.C. 552a), requires agencies to publish in the
The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) is proposing to add a new system of records, entitled APHIS Animal Health Surveillance and Monitoring System (AHSM), that will be used to maintain records of activities conducted by the agency pursuant to its mission and responsibilities authorized by the Animal Health Protection Act (7 U.S.C. 8301
APHIS' Veterinary Services (VS) program will use the AHSM to collect, manage, and evaluate animal health data for disease control and surveillance programs. The AHSM will assist APHIS in obtaining and analyzing relevant epidemiological information, identifying appropriate response tactics, and effectively responding to an animal disease event in the United States. It will also allow us to identify and notify the owners of animals that have been or may have been exposed in an animal disease event. The AHSM may also be used to document animal health program results to justify expenditures and compile statistical data about animal disease control or surveillance programs.
The AHSM contains modules for the Veterinary Services Laboratory Submissions (VSLS), the National Poultry Improvement Plan (NPIP), and the Mobile Information Management system (MIM).
The AHSM contains personally identifiable information about the individual listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained and the owner of animals involved with animal disease control or surveillance programs. Such information includes name; mailing and physical address, including city, county, State, postal code, and latitude/longitude coordinates; telephone number; email address; and any animal, sample, or location identification numbers associated with the person. The system also contains information about APHIS employees, cooperators, and contractors who are directly involved in animal disease control or surveillance program activities such as name, home and work address, home and work email addresses, telephone number(s), and any assigned identification numbers.
APHIS may routinely share data in the AHSM with certain Federal and State animal health officials or Federal or State wildlife agencies for assistance in conducting, managing, and analyzing animal disease or surveillance programs, and monitoring animal diseases including those related to wildlife, feral animals, or alternative livestock. Data may also be shared with Federal or State agencies involved with public health such as the Departments of Homeland Security and Health and Human Services for the purposes of zoonotic disease surveillance or control activities. APHIS may also share data in the AHSM with the public through a Web site that lists participants in voluntary animal disease certification or quality assurance programs, and lists individuals or entities not in compliance with animal disease regulations. APHIS may also use the Web site to notify individuals who may have acquired exposed or potentially exposed animals when other means of contact are unavailable.
Other routine uses of this information include releases related to investigations pertaining to violations of law or related to litigation. A complete listing of the routine uses for this system is included in the accompanying document that is published along with this notice.
The proposed information collection requests associated with this system have been approved by or submitted for approval by the Office of Management and Budget under the Paperwork Reduction Act.
Chief Information Officer, U.S. Department of Agriculture, 1400 Independence Ave. SW., Washington, DC 20250.
A report on the new system of records, required by 5 U.S.C. 552a(r), as implemented by Office of Management and Budget Circular A-130, was sent to the Chairman, Committee on Homeland Security and Governmental Affairs, United States Senate; the Chairman, Committee on Oversight and Government Reform, House of Representatives; and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget.
APHIS Animal Health Surveillance and Monitoring System, USDA-APHIS-15.
None.
The AHSM is a Web-based system hosted at secure and geographically dispersed locations. A backup copy of the data is maintained at a secure U.S. government facility.
Individuals who are listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained; owners of animals involved with animal disease control or surveillance programs; dealers, agents, and brokers of animals; owners or operators of animal product processing, slaughter, or rendering establishments; accredited veterinarians; contractors; cooperators; and certain APHIS employees.
For the individuals listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained; owners of animals involved with animal disease control or surveillance programs; dealers, agents, and brokers of animals; or owners or operators of animal product processing, slaughter, or rendering establishments; the following information will be retained: Name; address, including city, county, State, postal code, and latitude/longitude coordinates; e-mail address; telephone number; operation type; species and breed of animals maintained; and data necessary for managing and analyzing animal disease control or surveillance programs and monitoring diseases related to wildlife, feral animals, or alternative livestock. The information retained for APHIS employees, cooperators, and contractors
Animal Health Protection Act (7 U.S.C. 8301
APHIS Veterinary Services (VS) program uses the AHSM to collect, manage, and evaluate animal health data for disease management and surveillance programs.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, records maintained in the system may be disclosed outside USDA as follows:
(1) To certain Federal and State animal health officials to conduct, analyze, and report on the progress of animal disease control or surveillance programs;
(2) To Federal and State wildlife agencies for assistance in managing and analyzing animal disease control or surveillance programs and monitoring diseases related to wildlife, feral animals, or alternative livestock;
(3) To Federal or State agencies involved with public health such as the Departments of Homeland Security and Health and Human Services for the purposes of zoonotic disease surveillance or control activities;
(4) To the public through a public Web site which lists participants in voluntary animal disease certification or quality assurance programs and documents compliance with such programs; lists individuals not in compliance with animal disease regulations; and notifies individuals who may have acquired exposed or potentially exposed animals when other means of contact are unavailable;
(5) To the appropriate agency, whether Federal, State, local, or foreign, charged with responsibility of investigating or prosecuting a violation of law or of enforcing, implementing, or complying with a statute, rule, regulation, or order issued pursuant thereto, of any record within this system when information available indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and either arising by general statute or particular program statute, or by rule, regulation, or court order issued pursuant thereto;
(6) To the Department of Justice when the agency, or any component thereof, or any employee of the agency in his or her official capacity, or any employee of the agency in his or her individual capacity where the Department of Justice has agreed to represent the employee, or the United States, in litigation, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice is deemed by the agency to be relevant and necessary to the litigation; provided, however, that in each case, the agency determines that disclosure of the records to the Department of Justice is a use of the information contained in the records that is compatible with the purpose for which the records were collected;
(7) For use in a proceeding before a court or adjudicative body before which the agency is authorized to appear, when the agency, or any component thereof, or any employee of the agency in his or her official capacity, or any employee of the agency in his or her individual capacity where the agency has agreed to represent the employee, or the United States, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the agency determines that use of such records is relevant and necessary to the litigation; provided, however, that in each case, the agency determines that disclosure of the records to the court is a use of the information contained in the records that is compatible with the purpose for which the records were collected;
(8) To appropriate agencies, entities, and persons when the agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; the agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, a risk of identity theft or fraud, or a risk of harm to the security or integrity of this system or other systems or programs (whether maintained by the agency or another agency or entity) that rely upon the compromised information; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the agency's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm;
(9) To contractors and other parties engaged to assist in administering the program. Such contractors and other parties will be bound by the nondisclosure provisions of the Privacy Act. This routine use assists the agency in carrying out the program, and thus is compatible with the purpose for which the records are created and maintained;
(10) To USDA contractors, partner agency employees or contractors, or private industry employed to identify patterns, trends or anomalies indicative of fraud, waste, or abuse; and
(11) To the National Archives and Records Administration or to the General Services Administration for records management inspections conducted under 44 U.S.C. 2904 and 2906.
None.
Records are maintained on magnetic tape and optical disk. Backup media is taken weekly to an offsite storage facility and stored on tape.
Records are retrieved primarily by first or last name, address, or phone number of the individual listed as the contact person for the location where the animal(s) subject to animal disease control or surveillance programs are maintained or the owner of animals involved with animal disease control or surveillance programs; and by animal, flock, herd, or premises numbers. However, under this system records can be retrieved by any of the categories that have been recorded.
The AHSM security plan includes management, operational, and technical controls to prevent misuse of data by system users. These controls include the use of role-based security and access rights, network firewalls, and requiring all users to obtain a government-issued login. Access to the system is monitored by USDA officials to ensure authorized and appropriate use of the data.
Individual electronic records are retained within the system for 150 years from the last date of creation, edit, or access of the records. Incremental and full system tape backups are retained for 1 month.
Associate Deputy Administrator, National Animal Health Policy and
Any individual may request general information regarding this system of records or information as to whether the system contains records pertaining to him/her from the system manager at the address above. All inquiries pertaining to this system should be in writing, must name the system of records as set forth in the system notice, and must contain the individual's name, telephone number, address, and email address.
Any individual may obtain information from a record in the system that pertains to him or her. Requests for hard copies of records should be in writing, and the request must contain the requesting individual's name, address, name of the system of records, timeframe for the records in question, any other pertinent information to help identify the file, and a copy of his/her photo identification containing a current address for verification of identification. All inquiries should be addressed to the Freedom of Information and Privacy Act Staff, Legislative and Public Affairs, APHIS, 4700 River Road Unit 50, Riverdale, MD 20737-1232.
Any individual may contest information contained within a record in the system that pertains to him/her by submitting a written request to the system manager at the address above. Include the reason for contesting the record and the proposed amendment to the information with supporting documentation to show how the record is inaccurate.
Information in this system comes primarily from the customers, including the individuals listed as the contact person for the location where the animals subject to animal disease control or surveillance programs are maintained, and the owners of animals involved with animal disease control or surveillance programs. Such information may be supplemented by information from other USDA agencies such as the Food Safety and Inspection Service, Farm Service Agency, APHIS' Wildlife Services, or from State veterinary health officials and animal testing laboratories.
Employee, cooperator, and contractor information is obtained primarily from the employee, cooperator, or contractor.
None.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice of advisory committee meeting.
Pursuant to the Federal Advisory Committee Act, this constitutes notice of the upcoming meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets twice annually to advise the GIPSA Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards Act. Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.
December 6, 2011, 8 a.m. to 4:30 p.m.; and December 7, 2011, 8 a.m. to 3:30 p.m.
The Advisory Committee meeting will take place at the Embassy Suites Hotel-Portland Downtown,319 SW Pine Street, Portland, Oregon, 97204.
Requests to orally address the Advisory Committee during the meeting or written comments may be sent to: Administrator, GIPSA, U.S. Department of Agriculture, 1400 Independence Avenue SW., STOP 3601, Washington, DC 20250-3601. Requests and comments may also be faxed to (202) 690-2173.
Terri L. Henry by phone at (202) 205-8281 or by email at
The purpose of the Advisory Committee is to provide advice to the GIPSA Administrator with respect to the implementation of the U.S. Grain Standards Act (7 U.S.C. 71-87k). Information about the Advisory Committee is available on the GIPSA Web site at
The agenda will include an overview of Federal Grain Inspection Service operations, updated tonnage fee projections, international programs, sorghum odor, moisture measurement, and the quality management program.
For a copy of the agenda please contact Terri L. Henry by phone at (202) 205-8281 or by email at
Public participation will be limited to written statements unless permission is received from the Committee Chairperson to orally address the Advisory Committee. The meeting will be open to the public.
Persons with disabilities who require alternative means of communication of program information or related accommodations should contact Terri L. Henry at the telephone number listed above.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Connecticut Advisory Committee to the Commission will be held at the Legislative Building, Hearing Group Room 3C, 210 Capitol Avenue, Hartford, CT 06106, and will convene at 9:30 a.m. on Tuesday, December 6, 2011. The purpose of the briefing meeting is to discuss police practices and the changing demographics in Connecticut. The purpose of the planning meeting is to plan future activities.
Members of the public are entitled to submit written comments. The comments must be received in the regional office by Friday, January 6, 2012. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 624 9th Street NW., Suite 740, Washington, DC 20425, faxed to (202) 376-7548, or emailed to
Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.
Records generated from this meeting may be inspected and reproduced at the
The meeting will be conducted pursuant to the provisions of the rules and regulations of the Commission and FACA.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Economic Development Administration, Department of Commerce.
Notice and opportunity for public comment.
Pursuant to Section 251 of the Trade Act of 1974, as amended (19 U.S.C. 2341
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 7106, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
The Materials Processing Equipment Technical Advisory Committee (MPETAC) will meet on December 12, 2011, 9 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials processing equipment and related technology.
1. Opening remarks and introductions.
2. Presentation of papers and comments by the Public.
3. Discussion on proposals from last and for next Wassenaar Meeting.
4. Report on proposed and recently issued changes to the Export Administration Regulations.
5. Other business.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 21, 2011, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with matters the premature disclosure of which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public. For more information, call Yvette Springer at (202) 482-2813.
The Emerging Technology and Research Advisory Committee (ETRAC) will meet on December 14 and 15, 2011, 8:30 a.m., Room 3884, at the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on emerging technology and research activities, including those related to deemed exports.
1. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
1. ETRAC Member Discussion Emerging Technology Analysis; and Impact of Export Controls on the conduct of U.S. science and technology activities in the United States.
2. Public Comments.
The open sessions will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 21, 2011, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended, that the portion of the meeting dealing with matters which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 D.S.C. 552b(c) (9) (B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)1 and 10(a) (3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Import Administration, International Trade Administration, Department of Commerce.
Lilit Astvatsatrian or Trisha Tran, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230;
On October 25, 2011, the Department of Commerce (“Department”) published in the
However, pursuant to our
This correction is published in accordance with sections 751(h) and 777(i) of the Tariff Act of 1930, as amended.
Import Administration, International Trade Administration, Department ofCommerce.
Joshua Morris at (202) 482-1779; AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On September 2, 2011, the Department of Commerce (“the Department”) published a notice announcing the opportunity to request an administrative review of the countervailing duty order on narrow woven ribbons with woven selvedge (“ribbons”) from the People's Republic of China (“PRC”) covering the period of September 1, 2010, through December 31, 2010.
Pursuant to 19 CFR 351.213(d)(l), the Secretary will rescind an administrative review, in whole or in part, if the party that requested a review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. On November 2, 2011, Dongfang withdrew its request for review within the 90-day period. Therefore, in response to Dongfang's timely withdrawal request, and as no other party requested a review, the Department is rescinding this administrative review.
The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess countervailing duties on all appropriate entries. For Dongfang, countervailing duties shall be assessed at rates equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the date of publication of this notice of rescission of administrative review.
This notice serves as a final reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This notice of rescission is issued and published in accordance with sections 751(a)(l) and 777(i)(l) of the Tariff Act, as amended, and 19 CFR 351.213(d)(4).
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The National Construction Safety Team (NCST) Advisory Committee (Committee), will hold a meeting via teleconference on Wednesday, December 21, 2011 from 3 p.m. to 5 p.m. Eastern Time. The primary purpose of this meeting is to discuss the NCST Advisory Committee's draft annual report to Congress. A copy of the draft report will be posted on the NCST Advisory Committee's web site at
The NCST Advisory Committee will hold a meeting via teleconference on Wednesday, December 21, 2011, from 3 p.m. until 5 p.m. Eastern Time.
Questions regarding the meeting should be sent to the Disaster and Failure Studies Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8611, Gaithersburg, Maryland 20899-8611. For instructions on how to participate in the meeting, please see the
Mr. Eric Letvin, Disaster and Failure Studies Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8611, Gaithersburg, Maryland 20899-8611. Mr. Letvin's email address is
The NCST Advisory Committee was established pursuant to Section 11 of the National Construction Safety Team Act (15 U.S.C. 7301
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app., notice is hereby given that the NCST Advisory Committee will hold a meeting via teleconference on Wednesday, December 21, 2011, from 3 p.m. until 5 p.m. Eastern Time. There will be no central meeting location. Interested members of the public will be able to participate in the meeting from remote locations by calling into a central phone number. The primary purpose of this meeting is to discuss the NCST Advisory Committee's draft annual report to Congress. A copy of the draft report will be posted on the NCST Advisory Committee's web site at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the NCST Advisory Committee's affairs are invited to request detailed instructions by contacting Eric Letvin on how to dial in from a remote location to participate in the meeting. Eric Letvin's email address is
All participants in the meeting are required to pre-register. Anyone wishing to participate must register by 5 p.m. Eastern Time on Monday, December 19, 2011, in order to be included. Please submit your name, email address, and phone number to Eric Letvin. After registering, participants will be provided with detailed instructions on
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The Advisory Committee on Earthquake Hazards Reduction (ACEHR or Committee), will hold a meeting via teleconference on Tuesday, December 20, 2011 from 11 a.m. to 1 p.m. Eastern Time. The primary purpose of this meeting is to develop an outline for the Committee's draft annual report to the NIST Director. Any draft meeting materials will be posted on the NEHRP Web site at
The ACEHR will hold a meeting via teleconference on Tuesday, December 20, 2011, from 11 a.m. until 1 p.m. Eastern Time.
Questions regarding the meeting should be sent to National Earthquake Hazards Reduction Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8604, Gaithersburg, Maryland 20899-8604. For instructions on how to participate in the meeting, please see the
Dr. Jack Hayes, National Earthquake Hazards Reduction Program Director, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8604, Gaithersburg, Maryland 20899-8604. Dr. Hayes' email address is
The Committee was established in accordance with the requirements of Section 103 of the NEHRP Reauthorization Act of 2004 (Public Law 108-360). The Committee is composed of 12 members appointed by the Director of NIST, who were selected for their technical expertise and experience, established records of distinguished professional service, and their knowledge of issues affecting the National Earthquake Hazards Reduction Program. In addition, the Chairperson of the U.S. Geological Survey (USGS) Scientific Earthquake Studies Advisory Committee (SESAC) serves in an ex-officio capacity on the Committee. The Committee assesses:
• Trends and developments in the science and engineering of earthquake hazards reduction;
• The effectiveness of NEHRP in performing its statutory activities (improved design and construction methods and practices; land use controls and redevelopment; prediction techniques and early-warning systems; coordinated emergency preparedness plans; and public education and involvement programs);
• Any need to revise NEHRP; and
• The management, coordination, implementation, and activities of NEHRP.
Background information on NEHRP and the Advisory Committee is available at
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app., notice is hereby given that the ACEHR will hold a meeting via teleconference on Tuesday, December 20, 2011, from 11 a.m. until 1 p.m. Eastern Time. There will be no central meeting location. Interested members of the public will be able to participate in the meeting from remote locations by calling into a central phone number. The primary purpose of this meeting is to develop an outline for the Committee's draft annual report to the NIST Director. Any draft meeting materials will be posted on the NEHRP Web site at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the Committee's affairs are invited to request detailed instructions by contacting Michelle Harman on how to dial in from a remote location to participate in the meeting. Michelle Harman's email address is
All participants of the meeting are required to pre-register. Anyone wishing to participate must register by close of business Wednesday, December 14, 2011, in order to be included. Please submit your name, email address, and phone number to Michelle Harman. After registering, participants will be provided with detailed instructions on how to dial in from a remote location in order to participate. Michelle Harman's email address is
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before January 27, 2012.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection
This request is for extension of a currently approved information collection.
NOS Office of Coast Survey manages the Certification Requirements for Distributors of NOAA Electronic Navigational Charts (NOAA ENCs®). The certification allows entities to download, redistribute, repackage, or in some cases reformat, official NOAA ENCs and retain the NOAA ENC's official status. The regulations for implementing the Certification are at 15 CFR part 995.
The recordkeeping and reporting requirements of 15 CFR part 995 form the basis for this collection of information. This information allows the Office of Coast Survey to administer the regulation, and to better understand the marketplace resulting in products that meet the needs of the customer in a timely and efficient manner.
Responses from the Certified ENC Distributors are all electronic and sent via email. All distributors have an Excel spreadsheet which they submit for the twice-yearly report.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;
(c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Mid-Atlantic Fishery Management Council (Council) and its Mid-Atlantic Monkfish Subcommittee will hold public meetings.
The meetings will be held Tuesday, December 13 through Thursday, December 15, 2011. See
The meetings will be held at Kingsmill, 1010 Kingsmill Road, Williamsburg, VA 23185; telephone: (757) 253-1703.
Dr. Christopher Moore, Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 674-2331 ext. 255.
Agenda items by day for the Council's Committees and the Council itself are:
On Tuesday, December 13, the Mid-Atlantic Monkfish Subcommittee will discuss issues and concerns unique to the Mid-Atlantic Monkfish fishery and potential management solutions. The Council will receive presentation on the CIE Review of the June 2012 Excessive Shares Workshop and followed by Council discussion on next steps. Kris Ohleth will provide the Council with a presentation on the Atlantic Wind Connection Project. The Council will receive a presentation from Chris Boelke and Lou Chiarella of the NMFS Habitat Division. The Council will discuss and identify the next steps related to the
On Wednesday, December 14, the Council in conjunction with the ASMFC's Summer Flounder, Scup, and Black Sea Bass Boards will review the Scientific and Statistical Committee's (SSC) and the associated Monitoring Committee's and Advisory Panel's specification recommendations and adopt 2012 commercial and recreational harvest levels and commercial management measures for summer flounder and scup, and finalize recreational management measures for summer flounder, scup, and black sea bass. The Council will review alternatives to address spatial and regional management of the black sea bass recreational fishery and discuss potential complimentary action by the Council and ASMFC Board related to Amendment 17 to the Summer Flounder, Scup, and Black Sea Bass FMP.
On Thursday, December 15, the Council will present the Ricks E Savage Award. The Council will receive a presentation by Ingrid Biedron of Cornell University on Fishery Management Councils: Decision-making, Communication, and Social Factors Associated with Ecosystem-based Fisheries Management. The Council will hold its regular Business Session to approve the October 2011 minutes and address any outstanding actions from the October 2011 meeting, review and approve SOPPs, review and approve 5-year research plan, receive Organizational Reports, Liaison Reports, the Executive Director's Report, the Science Report, Committee Reports, and any continuing and/or new business.
Although non-emergency issues not contained in this agenda may come before these groups for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of U.S. fishing opportunity.
NMFS announces a U.S. fishing opportunity for 1,000 mt yellowtail flounder in Division 3LNO of the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area during 2011. This action is necessary to make available this U.S. fishing opportunity on an equitable basis.
Expressions of interest regarding NAFO Division 3LNO yellowtail flounder will be accepted through December 13, 2011. Fishing operations must take place during 2011.
Expressions of interest regarding NAFO Division 3LNO yellowtail flounder should be made in writing to Patrick E. Moran in the NMFS Office of International Affairs, at 1315 East-West Highway, Silver Spring, MD 20910 (
Information relating to NAFO fish quotas, NAFO Conservation and Enforcement Measures, and the High Seas Fishing Compliance Act (HSFCA) Permit is available from Douglas Christel, at the NMFS Northeast Regional Office at 55 Great Republic Drive, Gloucester, MA 01930 (
Patrick E. Moran, (301) 427-8370.
NAFO has established and maintains conservation measures in its Regulatory Area that include one effort limitation fishery as well as fisheries with total allowable catches (TACs) and member nation quota allocations. The principal species managed are cod, flounder, redfish, American plaice, halibut, hake, capelin, shrimp, skates and squid. The United States currently receives no yellowtail flounder allocation from NAFO. However, as the result of a bilateral arrangement with Canada, the United States may request a transfer of up to 1,000 mt of NAFO Division 3LNO yellowtail flounder from Canada's quota allocation for use by U.S. vessels during 2011, or any succeeding year through 2017. In January 2011, this fishing opportunity was announced in the
Expressions of interest to fish 1,000 mt of yellowtail flounder in NAFO Division 3LNO will once again be considered from U.S. vessels in possession of, or eligible for, a valid HSFCA permit, which is available from the NMFS Northeast Regional Office (see
Note that vessels issued valid HSFCA permits under 50 CFR part 300 are exempt from multispecies permit, mesh size, effort-control, and possession limit restrictions, specified in 50 CFR 648.4, 648.80, 648.82 and 648.86, respectively, while transiting the U.S. exclusive economic zone (EEZ) with multispecies on board the vessel, or landing multispecies in U.S. ports that were caught while fishing in the NAFO Regulatory Area, provided:
1. The vessel operator has a letter of authorization issued by the Regional Administrator on board the vessel;
2. For the duration of the trip, the vessel fishes, except for transiting purposes, exclusively in the NAFO Regulatory Area and does not harvest fish in, or possess fish harvested in, or from, the U.S. EEZ;
3. When transiting the U.S. EEZ, all gear is properly stowed in accordance with one of the applicable methods specified in § 648.23(b); and
4. The vessel operator complies with the HSFCA permit and all NAFO conservation and enforcement measures while fishing in the NAFO Regulatory Area.
Relevant NAFO Conservation and Enforcement Measures include, but are not limited to, maintenance of a fishing logbook with NAFO-designated entries; adherence to NAFO hail system requirements; presence of an on-board observer; deployment of a functioning, autonomous vessel monitoring system; and adherence to all relevant minimum size, gear, bycatch, and other requirements. Further details regarding these requirements are available from the NMFS Northeast Regional Office, and can also be found in the current NAFO Conservation and Enforcement Measures on the Internet (see
In the event that no adequate expressions of interest in harvesting NAFO Division 3LNO yellowtail flounder during 2011 are made on behalf of U.S. vessels, expressions of interest will be considered from U.S. processors and other fishing interests intending to make use of a Canadian vessel under a chartering arrangement. Under the bilateral arrangement with Canada, the United States may enter into a chartering (or other) arrangement with a Canadian vessel to harvest the transferred yellowtail flounder. Prior notification to the NAFO Executive Secretary is necessary in this case. Expressions of interest from U.S. processors and other fishing interests intending to make use of a Canadian vessel under chartering arrangements should provide the following information: the name and registration number of the intended vessel; a copy of the charter; a detailed fishing plan, and a written letter of consent from the Department of Fisheries and Oceans, Canada. In addition, expressions of interest using a Canadian vessel under charter should be accompanied by a detailed description of anticipated benefits to the United States. Such benefits might include, but are not limited to, the use of U.S. processing facilities/personnel; the use of U.S. fishing personnel; marketing of the product in the United States; other specific positive effects on U.S. employment; evidence that fishing by the Canadian vessel will actually take place; and any available documentation of the physical characteristics and economics of the fishery for future use by the U.S. fishing industry.
Any Canadian vessel wishing to enter into a chartering arrangement with the United States must be in full current compliance with the requirements outlined in the NAFO Convention and Conservation and Enforcement Measures including, but not limited to, submission of the following reports to the NAFO Executive Secretary: provisional monthly catches within 30 days following the calendar month in which the catches were made; observer reports within 30 days following the completion of a fishing trip; and an annual statement of actions taken in order to comply with the NAFO Convention; and notification to NMFS of the termination of the charter fishing activities. Furthermore, the United States may also consider the vessel's previous compliance with NAFO bycatch, reporting and other provisions, as outlined in the NAFO Conservation and Enforcement Measures, before entering into a chartering arrangement. More details on NAFO requirements are available from NMFS (see
In the event that multiple expressions of interest are made by U.S. fishing vessels, processors, or interests to fish for NAFO Division 3LNO yellowtail in 2011, the information submitted regarding benefits to the United States will be used in making a selection. After reviewing all requests for allocations submitted, NMFS may decide not to grant any allocations if it is determined that no requests meet the criteria described in this notice. Once a decision has been made regarding the disposition of the fishing opportunity, NMFS will immediately take appropriate steps to notify all applicants and will contact Canada and NAFO to take appropriate action. If the 3LNO yellowtail flounder transferred from Canada is awarded to a U.S. vessel or a specified chartering operation during 2011, it may not be transferred without the express, written consent of NMFS.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to the Procurement List.
The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia, 22202-3259.
Patricia Briscoe,
This notice is published pursuant to 41 U.S.C. 47(a) (2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and service listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and service proposed for addition to the Procurement List.
Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following products and service are proposed for addition to Procurement List for production by the nonprofit agencies listed:
Defense Logistics Agency, Department of Defense (DoD).
Notice to amend a system of records.
The Defense Logistics Agency is proposing to amend a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
The proposed action will be effective without further notice on December 28, 2011 unless comments are received which would result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Ms. Jody Sinkler, DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221, or by phone at (703) 767-5045.
The Defense Logistics Agency's system of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The specific changes to the record system being amended are set forth below followed by the notice, as amended, published in its entirety. The proposed amendment is not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of new or altered systems reports.
Government Telephone Use Records (August 7, 2009, 74 FR 39652).
Delete entry and replace with “Records are located at System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and at the telephone control offices of the DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.”
Add “BlackBerry devices” to entry.
Add “and wireless devices” to first paragraph.
Delete entry and replace with “Records are stored on paper.”
Delete second sentence from entry.
Delete entry and replace with “Staff Director, System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and the Telecommunications Control Officers of DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.”
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.”
Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.”
Delete entry and replace with “The DLA rules for accessing records, for contesting contents, and appealing initial agency determinations are contained in 32 CFR part 323, or may be obtained from the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.”
Government Telephone Use Records.
Records are located at System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and at the telephone control offices of the DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.
DLA employees, military members, contractors, and individuals authorized to use government telephone systems, including wireless devices such as cellular telephones, pagers, BlackBerry devices, and telecommunications devices for the deaf or speech impaired and wireless air cards. The records also cover individuals who have been issued telephone calling cards.
The records include individual's name and physical location; duty telephone, cell, and pager numbers; billing account codes; government issued telephone calling card account number; equipment and calling card receipts and turn-in documents; device serial numbers; and details of telephone use to include dates and times of telephone calls made or received, numbers called or called from, city and state, duration of calls, and assessed costs.
10 U.S.C. 133, Under Secretary of Defense for Acquisition, Technology, and Logistics; 44 U.S.C. 3501 et seq., Federal Information Policy; Committee on National Security Systems Directive No. 900, Governing Procedures of the Committee on National Security Systems promulgated pursuant to 47 U.S.C. 901
Records are maintained to verify that telephones and wireless devices are used for official business or authorized purposes; to identify inappropriate calls and the persons responsible, and to collect the costs of those calls from those responsible. These records may be used as a basis for disciplinary action against offenders.
Records are also maintained to ensure proper certification and payment of bills; to safeguard telecommunications assets; for internal management control; for reporting purposes; and to forecast future telecommunications requirements and costs. Statistical data, with all personal identifiers removed, may be used by management officials for purposes of conducting studies, evaluations, and assessments.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974 these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
Information may be released to telecommunications service providers to permit servicing the account.
The DoD “Blanket Routine Uses” also apply to this system of records.
Records are stored on paper.
Records are retrieved by individual's name, billing account code, or telephone number.
Access to the data is limited to those who require the records in the performance of their official duties. Physical entry is restricted by the use of locks, guards, and administrative procedures. Employees are periodically briefed on the consequences of improperly accessing restricted databases or records.
Records are destroyed when 3 years old. Initial telephone use reports may be destroyed earlier if the information needed to identify abuse has been captured in other records.
Staff Director, System Engineering and Network Services (J6FIS), Defense Logistics Agency Headquarters, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221, and the Telecommunications Control Officers of DLA Primary Level Field Activities. Official mailing addresses are published as an appendix to DLA's compilation of systems of records notices.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.
Individuals seeking access to information about themselves contained in this system should address written inquiries to the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Individuals need to provide their full name and the DLA facility or activity where employed at the time the records were created or processed.
The DLA rules for accessing records, for contesting contents, and appealing initial agency determinations are contained in 32 CFR part 323, or may be obtained from the DLA FOIA/Privacy Act Office, Headquarters, Defense Logistics Agency, ATTN: DGA, 8725 John J. Kingman Road, Suite 1644, Fort Belvoir, VA 22060-6221.
Data is supplied by the telephone user, telecommunications service providers, and DLA management.
None.
Office of the Secretary, Department of Defense.
Notice of updated mental health rates for Fiscal Year 2012.
This notice provides the updated regional per-diem rates for low-volume mental health providers; the update factor for hospital-specific per-diems; the updated cap per-diem for high-volume providers; the beneficiary per-diem cost-share amount for low-volume providers; and, the updated per-diem rates for both full-day and half-day TRICARE Partial Hospitalization Programs for Fiscal Year 2012.
TRICARE Management Activity (TMA), Medical Benefits and Reimbursement Branch, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
Elan Green, Medical Benefits and Reimbursement Branch, TMA, telephone (303) 676-3907.
The final rule published in the
Partial hospitalization rates for full-day and half-day programs also will be updated by 3.0 percent for Fiscal Year 2012.
The cap amount for high-volume hospitals and units also will be updated by the 3.0 percent for Fiscal Year 2012.
The beneficiary cost share for low-volume hospitals and units also will be updated by the 3.0 percent for Fiscal Year 2012.
Per 32 CFR 199.14, the same area wage indexes used for the CHAMPUS Diagnosis-Related Group (DRG)-based payment system shall be applied to the wage portion of the applicable regional per-diem for each day of the admission. The wage portion shall be the same as that used for the CHAMPUS DRG-based payment system. For wage index values greater than 1.0, the wage portion of the regional rate subject to the area wage adjustment is 68.8 percent for Fiscal Year 2012. For wage index values less than or equal to 1.0, the wage portion of the regional rate subject to the area wage adjustment is 62 percent.
Additionally, 32 CFR 199.14, requires that hospital specific and regional per-diems shall be updated by the Medicare update factor for hospitals and units exempt from the Medicare prospective payment system.
The following reflect an update of 3.0 percent for Fiscal Year 2012.
The following reflect an update of 3.0 percent for Fiscal Year 2012 for the partial hospitalization rates.
The above rates are effective for services rendered on or after October 1, 2011.
Department of Defense.
Office of the Secretary, Department of Defense (DoD).
Notice of DRG revised rates.
This notice describes the changes made to the TRICARE DRG-based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS).
It also provides the updated fixed loss cost outlier threshold, cost-to-charge ratios and the data necessary to update the FY 2012 rates.
TRICARE Management Activity (TMA), Medical Benefits and Reimbursement Systems, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
Mark A. Jacobs, Medical Benefits and Reimbursement Systems, TMA, telephone (303) 676-3802.
Questions regarding payment of specific claims under the TRICARE DRG-based payment system should be addressed to the appropriate contractor.
The final rule published on September 1, 1987 (52 FR 32992) set forth the basic procedures used under the CHAMPUS DRG-based payment system. This was subsequently amended by final rules published August 31, 1988 (53 FR 33461), October 21, 1988 (53 FR 41331), December 16, 1988 (53 FR 50515), May 30, 1990 (55 FR 21863), October 22, 1990 (55 FR 42560), and September 10, 1998 (63 FR 48439).
An explicit tenet of these final rules, and one based on the statute authorizing the use of DRGs by TRICARE, is that the TRICARE DRG-based payment system is modeled on the Medicare PPS, and that, whenever practicable, the TRICARE system will follow the same rules that apply to the Medicare PPS. The Centers for Medicare and Medicaid Services (CMS) publishes these changes annually in the
In addition, this notice updates the rates and weights in accordance with our previous final rules. The actual changes we are making, along with a description of their relationship to the Medicare PPS, are detailed below.
Following is a discussion of the changes CMS has made to the Medicare PPS that affect the TRICARE DRG-based payment system.
Under both the Medicare PPS and the TRICARE DRG-based payment system, cases are classified into the appropriate DRG by a Grouper program. The Grouper classifies each case into a DRG on the basis of the diagnosis and procedure codes and demographic information (that is, sex, age, and discharge status). The Grouper used for the TRICARE DRG-based payment system is the same as the current Medicare Grouper with two modifications. The TRICARE system has replaced Medicare DRG 435 with two age-based DRGs (900 and 901), and has implemented thirty-four (34) neonatal DRGs in place of Medicare DRGs 385 through 390. For admissions occurring on or after October 1, 2001, DRG 435 has been replaced by DRG 523. The TRICARE system has replaced DRG 523 with the two age-based DRGs (900 and 901). For admissions occurring on or after October 1, 1995, the CHAMPUS grouper hierarchy logic was changed so the age split (age <29 days) and assignments to MDC 15 occur before assignment of the PreMDC DRGs. This resulted in all neonate tracheostomies and organ transplants to be grouped to MDC 15 and not to DRGs 480-483 or 495. For admissions occurring on or after October 1, 1998, the CHAMPUS grouper hierarchy logic was changed to move DRG 103 to the PreMDC DRGs and to assign patients to PreMDC DRGs 480, 103 and 495 before assignment to MDC 15 DRGs and the neonatal DRGs. For admissions occurring on or after October 1, 2001, DRGs 512 and 513 were added to the PreMDC DRGs, between DRGs 480 and 103 in the TRICARE grouper hierarchy logic. For admissions occurring on or after October 1, 2004, DRG 483 was deleted and replaced with DRGs 541 and 542, splitting the assignment of cases on the basis of the performance of a major operating room procedure. The description for DRG 480 was changed to “Liver Transplant and/or Intestinal Transplant”, and the description for DRG 103 was changed to “Heart/Heart
The MS-DRG system consolidated the 43 pediatric CMS DRGs that were defined based on age less than or equal to 17 into the most clinically similar MS-DRGs. In the CMS Inpatient Prospective Payment System final rule for MS-DRGs, CMS stated for the Medicare population these pediatric CMS DRGs contained a very low volume of patients. At the same time, Medicare encouraged private insurers and other non-Medicare payers to make refinements to MS-DRGs to better suit the needs of the patients they serve. Consequently, TRICARE finds it appropriate to retain the pediatric CMS-DRGs for our population. TRICARE is also retaining the TRICARE-specific DRGs for neonates and substance use.
TRICARE retained the MS-DRG numbering system for FY09 and those TRICARE-specific DRGs were assigned available, blank DRG numbers unused in the MS-DRG system. We refer the reader to
For FY09, TRICARE used the MS-DRG v26.0 pre-MDC hierarchy, with the exception that MDC 15 is applied after DRG 011-012 and before MDC 24.
For FY 10, there were no additional or deleted DRGs.
For FY 11, DRG 009 was deleted; DRGs 014 and 015 were added.
For FY 12, the added DRGs and deleted DRGs are the same as those included in CMS' final rule published on August 18, 2011 (76 FR 51476-51846). That is, DRG 015 is deleted; DRGs 016 and 017 are being added.
TRICARE will continue to use the same wage index amounts used for the Medicare PPS. TRICARE will also duplicate all changes with regard to the wage index for specific hospitals that are re-designated by the Medicare Geographic Classification Review Board. In addition, TRICARE will continue to utilize the out commuting wage index adjustment.
TRICARE is adopting CMS' percentage of labor related share of the standardized amount. For wage index values greater than 1.0, the labor related portion of the Adjusted Standardized Amount (ASA) shall equal 68.8 percent. For wage index values less than or equal to 1.0 the labor related portion of the ASA shall continue to equal 62 percent.
TRICARE will update the adjusted standardized amounts according to the final updated hospital market basket used for the Medicare PPS for all hospitals subject to the TRICARE DRG-based payment system according to CMS's August 18, 2011, final rule. For FY 2012, the market basket is 3.0%. Medicare applied reductions to the market basket in FY 2012, with an adjustment of 1.0 percentage point for economy-wide productivity and less 0.1 percentage point for hospitals in all areas. However, these reductions do not apply to TRICARE.
Since TRICARE does not include capital payments in our DRG-based payments (TRICARE reimburses hospitals for their capital costs as reported annually to the contractor on a pass through basis), we will use the fixed loss cost outlier threshold calculated by CMS for paying cost outliers in the absence of capital prospective payments. For FY 2012, the TRICARE fixed loss cost outlier threshold is based on the sum of the applicable DRG-based payment rate plus any amounts payable for Indirect Medical Education (IDME) plus a fixed dollar amount. Thus, for FY 2012, in order for a case to qualify for cost outlier payments, the costs must exceed the TRICARE DRG base payment rate (wage adjusted) for the DRG plus the IDME payment plus $21,482 (wage adjusted). The marginal cost factor for cost outliers continues to be 80 percent.
The FY 2012 TRICARE National Operating Standard Cost as a Share of Total Costs (NOSCASTC) used in calculating the cost outlier threshold is 0.919. TRICARE uses the same methodology as CMS for calculating the NOSCASTC; however, the variables are different because TRICARE uses national cost to charge ratios while CMS uses hospital specific cost to charge ratios.
Passage of the MMA of 2003 modified the formula multipliers to be used in the calculation of the indirect medical education IDME adjustment factor. Since the IDME formula used by TRICARE does not include disproportionate share hospitals (DSHs), the variables in the formula are different than Medicare's, however; the percentage reductions that will be applied to Medicare's formula will also be applied to the TRICARE IDME formula. The multiplier for the IDME adjustment factor for TRICARE for FY 2012 is 1.02.
For FY 2012 TRICARE is adopting CMS' expanded post acute care transfer policy according to CMS' final rule published August 18, 2011.
While CMS uses hospital-specific cost to charge ratios, TRICARE uses a national cost to charge ratio. For FY 2012, the cost-to-charge ratio used for the TRICARE DRG-based payment system for acute care hospitals and neonates will be 0.3460. This shall be used to calculate the adjusted standardized amounts and to calculate cost outlier payments, except for children's hospitals. For children's hospital cost outliers, the cost-to-charge ratio used is 0.3757.
The updated rates and weights are accessible through the Internet at
Department of the Army, DoD.
Notice of open meeting.
Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the following meeting notice is announced:
Individuals submitting a written statement must submit their statement to the Designated Federal Officer at the following address:
The Designated Federal Officer will review all timely submissions with the U.S. Army War College Subcommittee Chairperson, and ensure they are provided to members of the U.S. Army War College Subcommittee before the meeting that is the subject of this notice. After reviewing the written comments, the Chairperson and the Designated Federal Officer may choose to invite the submitter of the comments to orally present their issue during an open portion of this meeting or at a future meeting.
The Designated Federal Officer, in consultation with the U.S. Army War College Subcommittee Chairperson, may, if desired, allot a specific amount of time for members of the public to present their issues for review and discussion by the U.S. Army War College Subcommittee.
Defense Acquisition Regulations System, Department of Defense (DoD).
Notice and request for comments.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through November 30, 2012. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD will consider all comments received by January 27, 2012.
You may submit comments, identified by OMB Control Number 0704-0246, using any of the following methods:
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•
Comments received generally will be posted without change to
Ms. Meredith Murphy, telephone (703) 602-1302; facsimile (703) 602-0350. The information collection requirements addressed in this notice are available on the World Wide Web at:
Paper copies are available from Ms. Meredith Murphy, OUSD(AT&L)DPAP(DARS), 3060 Defense Pentagon, Room 3B855, Washington, DC 20301-3060.
This requirement provides for the collection of information related to providing Government property to contractors; contractor use and management of Government property;
a. DFARS 245.302(1)(i) requires contractors to request and obtain contracting officer approval before using Government property on work for foreign governments and international organizations.
b. DFARS subpart 245.70, Plant Clearance Forms, prescribes the requirements for the use of the following forms:
(1)
(2)
(3)
(4)
(i) Downgrade useable property to scrap.
(ii) Abandonment or destruction.
(iii) Noncompetitive sale of surplus property.
(iv) Other disposal actions.
(5)
c. In addition, the following DD forms are prescribed in the clause at DFARS 252.245-7004, Reporting, Reutilization, and Disposal (AUG 2011):
(1)
(2)
Department of Defense (DoD).
Notice and request for comments.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through April 30, 2012. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD will consider all comments received by January 27, 2012.
You may submit comments, identified by OMB Control Number 0704-0187, using any of the following methods:
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•
•
•
Comments received generally will be posted without change to
Dr. Laura Welsh, Defense Acquisition Regulations System, OUSD(AT&L)DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060. Telephone 703-602-0326; facsimile 703-602-0350. The information collection requirements addressed in this notice are available on the World Wide Web at:
• Determine whether to provide precious metals as Government-furnished material;
• Determine an entity's eligibility for award of a contract due to ownership or control by the government of a terrorist country;
• Determine an entity's eligibility for award of a contract under a national
• Determine whether there is a compelling reason for a contractor to enter into a subcontract in excess of $30,000 with a firm, or subsidiary of a firm, that is identified in the List of Parties Excluded from Federal Procurement and Nonprocurement as being ineligible for award of Defense subcontracts because it is owned or controlled by the government of a terrorist country;
• Evaluate claims of indemnification for losses or damages occurring under a research and development contract; and
• Keep track of radio frequencies on electronic equipment under research and development contracts so that the user does not override or interfere with the use of that frequency by another user.
This information collection pertains to information, as required in DFARS parts 208, 209, 235, and associated clauses in part 252 that an offeror must submit to DoD in response to a request for proposals or an invitation for bids or a contract requirement. In particular, the information collection covers the following DFARS requirements:
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•
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Defense Acquisition Regulations System, Department of Defense (DoD).
Notice; request for comments.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof.
DoD will consider all comments received by January 27, 2012.
You may submit comments, identified by OMB Control Number 0704-0454, using any of the following methods:
•
•
•
Comments received generally will be posted without change to
Mr. Julian Thrash, at (703) 602-0310. The information collection requirements addressed in this notice are available electronically on the Internet at:
Under the U.S.-International Atomic Energy Agency (IAEA) Additional Protocol, the United States is required to declare a wide range of public and private nuclear-related activities to the IAEA and potentially provide access to IAEA inspectors for verification purposes. The U.S.-IAEA Additional Protocol permits the United States unilaterally to declare exclusions from inspection requirements for activities with direct national security significance.
The clause at 252.204-7010 is included in contracts for research and development or major defense acquisition programs involving fissionable materials (e.g., uranium, plutonium, neptunium, thorium, americium); other radiological source materials; or technologies directly related to nuclear power production, including nuclear or radiological waste materials.
The clause requires a contractor to provide written notification to the applicable DoD program manager and a copy of the notification to the contracting officer, if the contractor is required to report its activities under the U.S.-IAEA Additional Protocol. Upon such notification, DoD will determine if access may be granted to IAEA inspectors, or if a national security exclusion should be applied.
Department of Education (ED).
Notice of proposed information collection requests.
The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
An emergency review has been requested in accordance with the Act (44 U.S.C. Chapter 3507 (j)), since public harm is reasonably likely to result if normal clearance procedures are followed. Approval by the Office of Management and Budget (OMB) has been requested by December 9, 2011. A regular clearance process is also beginning. Interested persons are invited to submit comments on or before January 27, 2012.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street NW., Room 10222, New Executive Office Building, Washington, DC 20503, be faxed to (202) 395-5806 or emailed to
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Director of OMB provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The Office of Management and Budget (OMB) may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g., new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. ED invites public comment.
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on respondents, including through the use of information technology.
The purpose of the special consolidation initiative is to encourage borrowers who have both commercially-held FFEL Program loans and other loans that are held by the Department (either Direct Loan Program loans or FFEL Program loans previously sold to the Department by a FFEL Program lender) to consolidate their commercially-held FFEL Program loans into the Direct Loan Program. Currently, these borrowers have at least two loan servicers and are required to make at least two separate monthly payments on
The Department is requesting emergency clearance of the Special Direct Consolidation Loan LVC because the regular clearance process would prevent the Department from making Special Direct Consolidation Loans by the announced implementation date. Further, because the statutory authority under which the Department is providing the incentives will end on June 30, 2012, the use of normal clearance procedures would significantly shorten the already limited period during which Special Direct Consolidation Loans can be offered, with the result that fewer borrowers would be able to benefit from the reduced interest rates offered as part of the special initiative.
Copies of the proposed information collection request may be accessed from
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-(800) 877-8339.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Additional comments may be submitted on or before December 28, 2011.
Submit your comments, referencing Docket ID No. EPA-HQ-OW-2004-0015, to: (1) EPA online using
Clifford Yee, Office of Wastewater Management, Mail Code: 4204M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-0598; fax number: (202) 501-2403; email address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On July 11, 2011 (76 FR 40723), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments during the comment period. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.
EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2004-0015, which is available for online viewing at
Use EPA's electronic docket and comment system at
The 1987 Act declares that water pollution control revolving funds shall be administered by an instrumentality of the State subject to the requirements of the act. This means that each State has a general responsibility for administering its revolving fund and must take on certain specific responsibilities in carrying out its administrative duties. The information collection activities will occur primarily at the program level through the State IUP and Annual Report. The information is needed annually to implement section 606 of the Clean Water Act. The Act requires the information to ensure national accountability, adequate public comment and review, fiscal integrity and consistent management directed to achieve environmental benefits and results. The individual information collections are:
(1)
(2)
(3)
(4)
Environmental Protection Agency (EPA).
Notice of extension of public comment.
EPA is announcing an extension of the public comment period for the second external review draft of a document titled, “
The public comment period began on September 30, 2011, and ends December 30, 2011. Comments must be received by EPA by December 30, 2011.
The “
For technical information, contact Dr. James Brown, NCEA; telephone: (919) 541-0765; facsimile: (919) 541-1818; or email:
Comments may be submitted electronically via
For information on submitting comments to the docket, please contact the Office of Environmental Information Docket; telephone: (202) 566-1752; facsimile: (202) 566-1753; or email:
Environmental Protection Agency (EPA).
Notice.
The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the Chartered SAB on December 21, 2011 to conduct a quality review of a draft SAB report, a draft
The public teleconference will be held on December 21, 2011 from 2:30 p.m. to 5 p.m. (Eastern Time).
The public teleconference will be conducted by telephone only.
Any member of the public wishing to obtain general information concerning the public teleconference may contact Dr. Angela Nugent, Designated Federal Officer (DFO). Dr. Nugent may be contacted at the EPA Science Advisory Board (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; or by telephone/voice mail at (202) 564-2218; fax at (202) 565-2098; or email at
The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the EPA Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Pursuant to FACA and EPA policy, notice is hereby given that the SAB will hold a public teleconference to conduct a quality review of a draft SAB report, a draft
EPA's Office of Air and Radiation (OAR) has requested SAB advice related to EPA's review of its regulatory standards in 40 CFR Part 192—Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings in regard to underground In-Situ Leach Recovery (ISL/ISR) facilities.
EPA is authorized to develop standards for the protection of public health, safety, and the environment from radiological and non-radiological hazards associated with residual radioactive materials. The Agency is currently undertaking a review to determine if the existing standards, last revised by EPA in 1995, should be updated. The expectation is that ISL/ISR operations will be the most common type of new uranium extraction facility in the United States. These facilities can affect groundwater. Accordingly, EPA is seeking scientific advice and relevant technical criteria to establish standards and procedures, including the relevant period of monitoring for ISL/ISR facilities, once uranium extraction operations are completed, in order to provide reasonable assurances of aquifer stability and groundwater protection. Background information about this advisory activity can be found on the SAB Web site at
The agenda and other materials in support of the teleconference will be placed on the SAB Web site at
Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office.
Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for EPA. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for the SAB to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the Designated Federal Officer directly.
In general, individuals or groups requesting an oral presentation at a teleconference will be limited to three minutes. Those interested in being placed on the public speakers list for the December 21, 2011 teleconference should contact Dr. Nugent at the contact information provided above no later than December 14, 2011.
Written statements should be supplied to the DFO via email at the contact information noted above by December 14, 2011 for the teleconference so that the information may be made available to the Panel members for their consideration. Written statements should be supplied in one of the following electronic formats: Adobe Acrobat PDF, MS Word, MS PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format. It is the SAB Staff Office general policy to post written comments on the web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of
Copyrighted material will not be posted without explicit permission of the copyright holder.
For information on access or services for individuals with disabilities, please contact Dr. Nugent (202) 564-2218 or
Environmental Protection Agency.
Notice; request for public comment.
In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement for recovery of past and projected future response costs concerning the ICG Castings, Inc., Dowagiac site in Dowagiac, Michigan with the following settling party: The City Of Dowagiac Brownfield Redevelopment Authority. The settlement requires the settling party to pay $25,000 to the Hazardous Substance Superfund and requires the performance of specified response activities for the site. The settlement includes a covenant not to sue the settling party pursuant to Sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a). For 30 days following the date of publication of this notice, the United States will receive written comments relating to the settlement. The United States will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper or inadequate. The United States response to any comments received will be available for public inspection at the Dowagiac District Library, 211 Commercial Street, Dowagiac, Michigan 49047, Attn: Katherine Johnson and 77 West Jackson Boulevard, 7th floor Superfund File Room, Chicago, Illinois.
Comments must be submitted on or before December 28, 2011.
The proposed settlement is available for public inspection at 77 West Jackson Boulevard, 7th floor Superfund File Room, Chicago, Illinois. A copy of the proposed settlement may be obtained from Stuart P. Hersh, Associate Regional Counsel, C-14J, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone: (312) 886-6235. Comments should reference the ICG Castings, Inc., Dowagiac site in Dowagiac, Michigan and EPA Docket No. V-W-11-C-978 and should be addressed to Stuart P. Hersh, Associate Regional Counsel, C-14J, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Stuart P. Hersh, Associate Regional Counsel, C-14J, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone (312) 886-6235
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, 42 U.S.C. 9601,
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before January 27, 2012. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at (202) 395-5167 or via Internet at
Judith B. Herman, Office of Managing Director, (202) 418-0214.
Section 74.605 requires that licensees of TV pickup stations in the 6875-7125 MHz and 12700-13200 MHz bands shall register their stationary receive sites using the Commission's Universal Licensing System. TV Pickup licensees record their receive-only sites in the Universal Licensing System (ULS) database, including all fixed service locations. The TV Pickup stations, licensed under Part 74 of the Commission's rules, make it possible for television and radio stations and networks to transmit program material from the sites of breaking news stories or other live events to television studios for inclusion in broadcast programs, to transmit programming material from studios to broadcasting transmitters for delivery to consumers' televisions and radios, and to transmit programs between broadcast stations. Registering the receive sites will allow analysis to determine whether Fixed Service links will cause interference to TV Pickup stations.
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) third Communications Security, Reliability, and Interoperability Council (CSRIC III) will hold a meeting on December 16, 2011, from 9 a.m. to 1 p.m. in the Commission Meeting Room of the Federal Communications Commission, Room TW-C305, 445 12th Street SW., Washington, DC 20554.
December 16, 2011.
Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW., Washington, DC 20554.
Jeffery Goldthorp, CSRIC Designated Federal Officer, (202) 418-1096 (voice) or
The CSRIC is a Federal Advisory Committee that will provide recommendations to the FCC regarding best practices and actions the FCC can take to ensure the security, reliability, and interoperability of communications systems. On March 19, 2011, the FCC, pursuant to the Federal Advisory Committee Act, renewed the charter for the CSRIC for a period of two years through March 18, 2013.
Working Group 1 on Next Generation 9-1-1, will present a final report for vote at this meeting. Each of the remaining Working Groups from CSRIC III will present an update. Topics will include alerting systems, 9-1-1 location accuracy, and network security. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at
Federal Election Commission.
Thursday, December 1, 2011 at 10 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and the Board's Regulation LL (12 CFR part 238) to acquire shares of a savings and loan holding company. The factors that are considered in acting on the notices are
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 12, 2011.
1.
This notice corrects a notice (FR Doc. 11-30105) published on page 72206 of the issue for Tuesday, November 22, 2011.
Under the Federal Reserve Bank of San Francisco heading, the entry for American Start-Up Financial Institutions Investments, I, L.P., and CKH Capital, Inc., both in Monterey Park, California, is revised to read as follows:
A.
1.
In connection with this application, Applicants also have applied to retain 5.9 percent interest of the voting shares of First PacTrust Bancorp, Inc., and thereby indirectly retain Pacific Trust Bank, both in Chula Vista, California, and engage in operating as savings and loan association, pursuant to section 225.28(b)(4)(ii) of Regulation Y.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before December 22, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Linda Holleran (202) 326-2267, FTC, Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for November 21, 2011), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before December 22, 2011. Write “PoolCorp, File No. 101 0115” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “PoolCorp, File No. 101 0115” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission has accepted for public comment an Agreement Containing Consent Order to Cease and Desist (“Agreement”) with Pool Corporation (“PoolCorp”). PoolCorp is the world's largest distributor of products used in the construction, renovation, repair, service, and maintenance of residential and commercial swimming pools. The Agreement resolves charges that PoolCorp used exclusionary acts and practices to maintain its monopoly power in the pool product distribution market in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45.
The administrative complaint that accompanies the Agreement (“Complaint”) alleges that PoolCorp used its monopoly power in local geographic markets to prevent manufacturers from supplying pool products to new entrants since at least 2003. As a result, PoolCorp foreclosed rival distributors from obtaining pool products—a necessary input to compete—and significantly raised its rivals' costs, thereby lowering output, increasing prices, and diminishing consumer choice.
The Commission anticipates that the competitive issues described in the Complaint will be resolved by accepting the proposed Order, subject to final approval, contained in the Agreement. The Agreement has been placed on the public record for 30 days for receipt of comments from interested members of the public. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the Agreement and comments received, and will decide whether it should withdraw from the Agreement or make final the Order contained in the Agreement.
The purpose of this Analysis to Aid Public Comment is to invite and facilitate public comment concerning the proposed Order. It is not intended to constitute an official interpretation of the Agreement and proposed Order or in any way to modify their terms.
The Agreement is for settlement purposes only and does not constitute an admission by PoolCorp that the law has been violated as alleged in the Complaint or that the facts alleged in the Complaint, other than jurisdictional facts, are true.
The Complaint makes the following allegations.
This case involves wholesale distribution in the swimming pool industry. There are over nine million residential pools in the United States, and over 250,000 commercial pools operated by hotels, country clubs, apartment buildings, municipalities, and others. In 2010, the distribution of pool products was an estimated $3 billion industry in the United States. Manufacturers use distributors to sell the products used to build, repair, service, and maintain residential and commercial swimming pools (“pool products”). Pool products include, among others, pumps, filters, heaters, covers, cleaners, diving boards, steps, rails, pool liners, pool walls, and the parts necessary to maintain pool equipment. Distributors purchase pool products from manufacturers, warehouse them, and then resell the products to pool retail stores, pool service companies and pool builders (collectively, “pool dealers” or “dealers”). Dealers, in turn, sell the pool products to the ultimate consumer: owners of residential and commercial swimming pools. The swimming pool industry is very fragmented and wholesale distributors make it more efficient for manufacturers and dealers to sell their products. Distributors purchase most, if not all, brands of pool products that are produced by manufacturers so that they can provide convenient one-stop shopping for their dealer customers. Distributors also extend credit and provide quick delivery of pool products to thousands of dealers. The vast majority of dealers are mom-and-pop operations that are too small to buy directly from manufacturers; for these dealers, distributors are their only source of pool products. Distributors also allow manufacturers to operate their factories year-round by purchasing large quantities of pool products throughout the year, even though the pool industry is seasonal.
In general, manufacturers are willing to sell their products to any credit-worthy distributor that has a physical warehouse and personnel with knowledge of the pool industry. Manufacturers typically prefer to have two or more distributors selling their products in a local geographic market in order to ensure that the distributors compete and give competitive service and prices to their dealer customers.
To compete effectively as a distributor, a firm must be able to buy pool products directly from manufacturers. There are no cost-effective alternatives. While there are
The relevant market is no broader than the wholesale distribution of pool products in the United States and numerous local geographic markets. With the exception of large national retail chains that purchase pool products for their retail centers located throughout the United States, competition among distributors for sales to dealers occurs locally. PoolCorp has monopoly power in numerous local markets, as evidenced by a persistently high market share of 80 percent or more for the past five years. PoolCorp's conduct of foreclosing new distributor entrants from obtaining pool products directly from manufacturers represents a significant barrier to entry.
Beginning in 2003 and continuing to today, PoolCorp has implemented an exclusionary policy that effectively impeded entry by new distributors by preventing them from being able to purchase pool products directly from manufacturers. Specifically, when a new distributor attempted to enter a local geographic market, PoolCorp threatened manufacturers that it would not deal with them if they also supplied the new entrant. PoolCorp threatened to terminate the purchase and sale of the manufacturer's pool products for all 200+ PoolCorp distribution centers located throughout the United States. PoolCorp's policy did not exclude existing rivals from obtaining pool products from manufacturers.
PoolCorp's threat was significant. The loss of sales to PoolCorp could be “catastrophic” to the financial viability of even major manufacturers. No other distributor could replace the large volume of potential lost sales to PoolCorp, particularly in markets where PoolCorp is the only distributor. New entrants could not offer any economic incentive to manufacturers that would offset the risks imposed by PoolCorp's threats.
After receiving these threats, manufacturers, including the three “must-have” manufacturers, refused to sell pool products to the new distributors and canceled any pre-existing orders. PoolCorp thus effectively foreclosed new distributors from obtaining pool products from manufacturers that represented more than 70 percent of all pool product sales.
In some cases, the new distributors were able to purchase pool products from other distributors. This counterstrategy, however, did not mitigate the effects of PoolCorp's conduct. As a general rule, distributors do not sell pool products to other distributors. Even when possible, this alternative is not a viable long-term strategy because it substantially increases the entrant's costs and lessens its quality of service. For example, buying pool products from a distributor forces the new distributor entrant to pay transportation costs from the distributor's location rather than receiving free shipping under manufacturer programs. The purchases are also at a marked-up price and do not qualify for key manufacturer year-end rebates.
By effectively increasing its rivals' costs, PoolCorp's exclusionary policy prevented the new distributor entrants from being able to compete aggressively on price. Additionally, without full control of their inventory, the entrants' ability to provide quality service to their dealer customers was diminished. PoolCorp specifically targeted new entrants, rather than established rivals, because the new distributors represented a significant competitive threat due to their likelihood to compete aggressively on price in order to earn new business. PoolCorp's conduct, therefore, had the purpose and effect of maintaining and enhancing PoolCorp's monopoly power in numerous local markets where its dominance would otherwise be threatened by new entrants. PoolCorp's exclusionary policy, therefore, has likely resulted in higher prices and reduced output. There are no procompetitive efficiencies that justify PoolCorp's conduct.
The offense of monopolization under § 2 of the Sherman Act has two elements: (1) the possession of monopoly power in the relevant market; and (2) the willful acquisition, enhancement or maintenance of that power through exclusionary conduct.
The factual allegations in the complaint regarding market structure support a finding of monopoly power and competitive harm. PoolCorp's “all or nothing” threats acted as a powerful deterrent to manufacturers against dealing with new distributor entrants by jeopardizing a large and irreplaceable percentage of the manufacturer's sales. PoolCorp's conduct effectively foreclosed new entrants from manufacturers representing more than 70 percent of pool product sales. New entrants were unable to provide any economic incentive to manufacturers that could offset the risk posed by PoolCorp's threats. Raising rivals' costs by restraining their supply of inputs can be a “particularly effective method of anticompetitive exclusion.”
Additionally, the work-around strategy employed by some new entrants of purchasing pool products from other distributors significantly raised their costs and reduced their ability to provide quality service. PoolCorp's exclusionary policy therefore prevented these firms from providing a meaningful
Notably, PoolCorp's conduct targeted new entry and did not exclude existing rivals. The test for exclusionary conduct, however, is not total foreclosure, but “whether the challenged practices bar a substantial number of rivals or severely restrict the market's ambit.”
A monopolist may rebut a
There are no procompetitive efficiencies that justify PoolCorp's conduct. In some cases, for example, exclusive arrangements with suppliers could be necessary to prevent free-riding or to secure adequate supply. Here, however, PoolCorp did not offer any services upon which a new entrant could free-ride. Further, the pool industry is not subject to product shortfalls that could justify exclusive arrangements with suppliers. In short, PoolCorp's practice of foreclosing new entrants from supply did not help PoolCorp compete on the merits by improving its efficiency, quality or prices.
The proposed Consent Order remedies PoolCorp's anticompetitive conduct. Paragraph II of the Order addresses the core of PoolCorp's conduct. Specifically, Paragraph II of the proposed Consent Order prohibits PoolCorp from:
• Conditioning the sale or purchase of pool products, or membership in PoolCorp's preferred vendor programs, on the intended or actual sale of pool products by a manufacturer to any distributor other than PoolCorp;
• Pressuring, urging or otherwise coercing manufacturers to refrain from selling, or to limit their sales, to any distributors other than PoolCorp; and
• Discriminating or retaliating against a manufacturer for selling, or intending to sell, pool products to any distributor other than PoolCorp.
The definition of “distributor” includes any entity that buys pool products directly from manufacturers and resells those products to dealers or others. The Order explicitly allows PoolCorp to enter into exclusive agreements with manufacturers to purchase private-label pool products.
Paragraph III of the Proposed Order requires PoolCorp to implement an antitrust compliance program. Paragraph IV-VI impose reporting and other compliance requirements. The Order will expire in 20 years.
By direction of the Commission, Commissioner Rosch dissenting.
The Commission is today issuing for public comment a Complaint and Order that would resolve allegations that Pool Corporation (“PoolCorp”) used anticompetitive acts and practices to exclude rivals from, and to maintain its monopoly power in, several local pool product distribution markets, in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45.
On the basis of staff's investigation and as outlined in the Complaint, we have reason to believe that a violation of the antitrust laws has occurred—and that Commission action is in the public interest. 15 U.S.C. 45(b). Specifically, the Complaint alleges that PoolCorp, which possesses monopoly power in many local distribution markets, threatened its suppliers (
As alleged in the Complaint, PoolCorp's actions foreclosed new entrants from obtaining pool products from manufacturers representing more than 70 percent of sales. Significantly, there is no efficiency justification for PoolCorp's conduct. That is, without any legitimate justification, PoolCorp dictated whether new competitors could access the full range of merchandise needed to compete effectively in the market.
Although we recognize that PoolCorp's alleged conduct did not target incumbent distributors, we nevertheless have reason to believe that the conduct harmed competition and consumers. Separate from PoolCorp,
Because we have reason to believe that PoolCorp's conduct had the purpose and effect of maintaining PoolCorp's monopoly power in numerous local markets where its dominance was threatened by new distributor entrants, we support the attached Complaint and Order.
This case presents the novel situation of a company willing to enter into a consent decree notwithstanding a lack of evidence indicating that a violation has occurred. The FTC Act requires that the Commission find a “reason to believe” that a violation has occurred and determine that Commission action would be in the public interest any time it issues a complaint. 15 U.S.C. 45(b). In my view, the same standard applies regardless of whether the Commission is seeking a litigated decree or a consent decree for the charged violation. Accordingly, I would reject the proposed consent decree and close the investigation.
After a year and a half of investigation, we have not been able to identify any harm to consumers or competition as a result of actions by Pool Corporation, Inc. (“PoolCorp”), and further investigation appears unlikely to uncover such effects. As an initial matter, it is important to note that, even accepting the allegations in the complaint, PoolCorp did not engage in a general pattern of exclusionary conduct. Rather, the complaint alleges that PoolCorp threatened manufacturers not to supply an entering distributor in various local markets. There is no allegation that PoolCorp sought to restrict supply to (1) incumbents in any of these local markets, (2) established distributors seeking to expand into markets dominated by PoolCorp, or (3) established distributors in any of the dozens of other local markets across the country.
The limited scope of PoolCorp's alleged exclusionary conduct is, of course, no defense. PoolCorp's alleged threats to manufacturers, had they been successful, may well have violated the antitrust laws. But that is not what happened. The investigation revealed that PoolCorp's demands were not honored by manufacturers. Instead, the evidence showed that manufacturers made unilateral decisions not to supply the de novo entrants in the various local markets.
There were legitimate reasons for pool equipment manufacturers not to sell to these entrants. A manufacturer will typically accept a new distributor only if the distributor will add to the value of the distribution network by, for example, improving growth opportunities or increasing promotional activities. Manufacturers often require a de novo entrant to have adequate facilities, a history of successful operations, and a favorable credit history before supporting it. In this case, many of the allegedly excluded de novo entrants did not satisfy these requirements. The lack of evidence establishing causation between PoolCorp's requests and action by the manufacturers, combined with plausible justifications for the manufacturers' actions, should be fatal to this case.
Another problem with this case is that no entrants were actually excluded.
A third problem with this case is that there was no consumer injury. The investigation did not uncover price increases, service degradation, or other anticompetitive effects in any local markets.
The lack of consumer injury is also corroborated by the very low entry barriers in this industry. Opening a pool supply distributorship requires access to one or more of the major equipment suppliers, a few trucks, a medium-sized warehouse, access to credit, and no more than ten employees. There are hundreds of profitable pool supply distributors, and entry and expansion are frequent events. Thus, any effort to exclude a competitor would become a game of whack-a-mole: As soon as one competitor is driven from the market, another would pop up.
Accordingly, I cannot find that there is a “reason to believe” that a violation occurred or that accepting the proposed consent decree would be in the public
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Atomic Weapons Employees who worked at Vitro Manufacturing in Canonsburg, Pennsylvania, from January 1, 1960 through September 30, 1965, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from W.R. Grace and Company in Curtis Bay, Maryland, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Atomic Weapons Employees who worked at any building or area at the facility owned by W.R. Grace and Company in Curtis Bay, Maryland, for the operational period from May 1, 1956 through January 31, 1958, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 facility in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Y-12 facility in Oak Ridge, Tennessee, during the period from January 1, 1948 through December 31, 1957, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to DCAS@CDC.GOV.
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ames Laboratory at Iowa State University, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All Department of Energy (DOE) employees, its predecessor agencies, and its contractors and subcontractors who worked in any area of the Ames Laboratory at Iowa State University during the period from August 13, 1942 through December 31, 1970, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more classes of employees included in the Special Exposure Cohort.
This designation became effective on November 17, 2011, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on November 17, 2011, members of this class of employees, defined as reported in this notice, became members of the Special Exposure Cohort.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Titanium Alloys Manufacturing in Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone (877) 222-7570. Information requests can also be submitted by email to
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Medical Office Survey on Patient Safety Culture Comparative Database.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Comments on this notice must be received by January 27, 2012.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
Medical Office Survey on Patient Safety Culture Comparative Database.
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Medical Office Survey on Patient Safety Culture (Medical Office SOPS) Comparative Database. The Medical Office SOPS Comparative Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture. Medical offices in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Medical Office SOPS Database is modeled after the Hospital SOPS Database [OMB NO. 0935-0162; approved 05/04/2010] that was originally developed by AHRQ in 2006 in response to requests from hospitals interested in knowing how their patient safety culture survey results compare to those of other hospitals.
In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in outpatient ambulatory health care, AHRQ developed and pilot tested the Medical Office Survey on Patient Safety Culture with OMB approval (OMB NO.0935-0131; Approved July 5, 2007).
The survey is designed to enable medical offices to assess provider and staff opinions about patient safety issues, medical error, and error reporting and includes 52 items that measure 12 dimensions of patient safety culture. AHRQ released the survey to the public along with a Survey User's Guide and other toolkit materials in December 2008 on the AHRQ Web site (located at
The Medical Office SOPS and the Comparative Database are supported by AHRQ to meet its goals of promoting improvements in the quality and safety of health care in medical office settings. The survey, toolkit materials, and preliminary comparative database results are all made available to the public along with technical assistance provided by AHRQ through its contractor at no charge to medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.
The goal of this project is to create the Medical Office SOPS Comparative Database. This database will (1) Allow medical offices to compare their patient safety culture survey results with those of other medical offices; (2) provide data to medical offices to facilitate internal assessment and learning in the patient safety improvement process; and (3) provide supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture. De-identified data files will also be available to researchers conducting patient safety data analysis. The database will include 52 items that measure 12 areas, or composites, of patient safety culture.
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (a)(8).
To achieve the goal of this project the following activities and data collections will be implemented:
(1) Eligibility Form—The purpose of this form is to determine the eligibility status and initiate the registration process for medical offices seeking to voluntarily submit their MO SOPS data to the MO SOPS Comparative Database. The medical office point of contact (POC) will complete the form. The POC is either an office manager, nurse manager, or a survey vendor who contracts with a medical office to collect their data. The POC may submit data on behalf of multiple medical offices because many medical offices are part of a larger practice with multiple sites or part of a larger health system that includes many medical office sites.
(2) Data Use Agreement—The purpose of this form is to obtain authorization from medical offices to use their voluntarily submitted MO SOPS data for analysis and reporting according to the terms specified in the Data Use Agreement (DUA). The medical office POC will complete the form.
(3) Medical Office Information Form—The purpose of this form is to obtain basic information about the characteristics of the medical offices submitting their MO SOPS data to the MO SOPS Comparative Database (e.g., number of providers and staff, ownership, and type of specialty). The medical office POC will complete the form.
(4) Data Submission—After the medical office POC has completed the Medical Office Eligibility Form, the Data Use Agreement and the Medical Office Information Form, they will submit their data from the MO SOPS to the MO SOPS Comparative Database.
Data from the AHRQ Medical Office Survey on Patient Safety Culture are used to produce three types of products: 1) A Medical Office SOPS Comparative Database Report that is produced periodically and made available to the public on the AHRQ Web site (see
Medical offices are asked to voluntarily submit their Medical Office SOPS data to the comparative database. The data are then edited to detect and correct errors and aggregated and used to produce a Comparative Database Report that displays averages, standard deviations, and percentile scores on the survey's 52 items and 12 patient safety culture dimensions, as well as displaying these results by medical office characteristics (size of office, specialty, geographic region, etc.) and staff characteristics (staff position).
Exhibit 1 shows the estimated annualized burden hours for the medical office to participate in the Medical Office SOPS Comparative Database. The POC completes a number of data submission steps and forms, beginning with completion of the online Medical Office SOPS Database Eligibility Form and Data Use Agreement, which will be completed for 150 medical offices annually. The Medical Office Information Form will be completed for each medical office; since each POC represents an average of 10 medical offices, a total of 1,500 Information Forms will be completed annually, each requiring about 5 minutes to complete. The POC will submit data for all of the medical offices they represent which will take about 4 and
Medical offices administer the AHRQ Medical Office Survey on Patient Safety Culture on a periodic basis. Hospitals submitting to the Hospital SOPS Comparative Database administer the survey every 16 months on average. Similarly, the number of medical office submissions to the database is likely to vary each year because medical offices do not administer the survey and submit data every year. The 150 respondents/POCs shown in Exhibit 1 are based on an estimate.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $34,779 annually.
The estimated annualized cost to the government for developing, maintaining, and managing the database and analyzing the data and producing reports is shown below. The cost is estimated to be $310,000 annually for 3 years. The total cost is estimated to be $930,000.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project:
Comments on this notice must be received by January 27, 2012.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Consumer Assessment of Healthcare Providers and Systems (CAHPS) Database for Clinicians and Groups. The CAHPS Clinician and Group Database (CAHPS CG Database) consists of data from the AHRQ CAHPS Clinician and Group Survey (CAHPS CG Survey). Health systems administrators, medical groups and medical practitioners in the U.S. are asked to voluntarily submit data from the CAHPS CG Survey to AHRQ through its contractor.
Dating back to the first phase of the CAHPS program (1996-2000), the CAHPS Consortium recognized the need for a standardized, evidence-based instrument that would gather data on patients' experiences with physicians and staff in outpatient medical practices, enabling clinicians and administrators to assess and improve patients' experiences with medical care. In 1999, the Consortium began work on a survey that would assess patients' experiences with medical groups and clinicians. Working in collaboration with the Pacific Business Group on Health, whose Consumer Assessment Survey established a precedent for this type of instrument; the CAHPS Consortium developed a preliminary instrument known as the CAHPS Group Practices Survey (G-CAHPS).
In August 2004, AHRQ issued a notice in the
The current CAHPS Consortium includes AHRQ, the Centers for Medicare & Medicaid Services (CMS), RAND, Yale School of Public Health, and Westat.
AHRQ has developed the database for CAHPS CG Survey data following the CAHPS Health Plan Database as a model. The CAHPS Health Plan Database was developed in 1998 in response to requests from health plans, purchasers, and CMS for comparative data to support public reporting of health plan ratings, health plan accreditation and quality improvement (OMB Control Number 0935-0165, Expiration Date 7/31/2013). Demand for comparative results from the CG Survey has grown as well, and therefore AHRQ has developed a dedicated CG Database to support benchmarking, quality improvement, and research.
The CAHPS CG Database contains data from AHRQ's standardized CAHPS CG Survey, which provides comparative measures of quality to health care purchasers, consumers, regulators, and policy makers. The Database also provides data for AHRQ's annual National Healthcare Quality and National Healthcare Disparities Reports.
Health systems, medical groups and practices that administer the CAHPS CG Survey according to CAHPS specifications can participate in this project. A health system is a complex of facilities, organizations, and providers of health care in a specified geographic area. A medical group is defined as a medical group, Accountable Care Organization (ACO), state organization or some other grouping of practices. A practice is an outpatient facility in a specific location whose physicians and other providers share administrative and clinical support staff Each practice located in a building containing multiple medical offices is considered a separate practice.
The goal of this project is to continue to update the CAHPS CG Database, with the latest results of the CAHPS CG Survey. These results consist of 37 items that measure 5 areas or composites of patients' experiences with physicians and staff in outpatient medical practices. This database will 1) allow participating organizations to compare their survey results with those of other outpatient medical groups; 2) facilitate internal assessment and learning in the quality improvement process; and 3) provide information to help identify strengths and areas with potential for improvement in patient care. The five composite measures are:
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and health surveys and database development. 42 U.S.C. 299a(a)(1), (2), and (8).
To achieve the goal of this project, the following activities and data collections will be implemented:
(1) Registration Form—The purpose of this form is to determine the eligibility status and initiate the registration process for participating organizations seeking to voluntarily submit their CAHPS CG Survey data to the CAHPS CG Comparative Database. The point of contact (POC) at the participating organization (or parent organization) will complete the form. The POC is either a corporate-level health care manager or a survey vendor who contracts with a participating organization to collect the CAHPS CG Survey data.
(2) Data Use Agreement—The purpose of this form is to obtain authorization from participating organizations to use
(3) Data Submission—After the POC has completed the Registration Form and the Data Use Agreement, they will submit their patient-level data from the CAHPS CG Survey to the CAHPS CG Comparative Database. Data on the organizational characteristics such as ownership, number of patient visits per year and medical specialty, and information related to survey administration such as mode and dates of survey administration, sample size, and response rate, which are collected as part of CAHPS CG Survey operations, are also submitted. Each submission will consist of 3 data files: (1) A Group File that contains information about the group ownership and size of group, (2) a Practice File containing type of practice, the practice ownership and affiliation (
Survey data from the CAHPS CG Database is used to produce three types of products: (1) An online reporting of results available to the public on the CAHPS User Network web site; (2) comparative reports that are confidential and customized for each participating organization (
Information for the CAHPS CG Database is collected by AHRQ through its contractor Westat. Participating organizations are asked to voluntarily submit their data to the CARPS Database. The data is cleaned with standardized programs, then aggregated and used to produce comparative results. In addition, reports are produced that compare the participating organizations' results to the database in a password-protected section of the CAHPS Database online reporting system. Trend data will be available to participants when enough data is collected across consecutive years.
Exhibit 1 shows the estimated annualized burden hours for participating organizations. The burden hours and costs below are based on an estimated number of participants. It is estimated that about 30 health systems, medical groups and practices will participate in the CAHPS CG Database. The number of data submissions per participating organization will vary because some participants may submit data for multiple practices, while others may only submit data for one.
The total burden for completing the registration, DUA and data submission process is estimated to be 246 hours. The 30 participating organizations that complete the registration form and submit information to the CAHPS CG Database are a combination of an estimated 20 health systems, medical groups and practices and 10 estimated vendors. Information about survey administration and the survey data files are submitted together for each participating organization.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to complete the submission process. The cost burden is estimated to be $10,485 annually.
Exhibit 3 shows the estimated annualized cost to the government for developing, maintaining and managing the CAHPS CG Database, analyzing the data and reporting results. The cost is estimated to be $220,000 annually. Annualized costs for collecting and processing the CAHPS CG Database are based upon 10 years of historical CAHPS Health Plan Database project costs. AHRQ wishes to continue this data collection indefinitely and requests OMB approval for 3 years.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
The Office of Grants Management (OGM), in the Administration for Children and Families (ACF) is proposing the collection of program performance data for ACF's discretionary grantees. To collect this data OGM has developed a form from the basic template of the OMB-approved reporting format of the Program Performance Report. OGM will use this data to determine if grantees are proceeding in a satisfactory manner in meeting the approved goals and objectives of the project, and if funding should be continued for another budget period.
Estimated Total Annual Burden Hours: 6,000.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
The purpose of this Program Instruction is to streamline and simplify the application and reporting processes by consolidating the PIs into one single PI and requiring one single, consolidated application (App) package and program assessment report (PAR) per State court annually. These revisions will satisfy statutory programmatic requirements and reduce both the number of required responses and associated total burden hours for State courts.
This new PI also describes programmatic and fiscal provisions and reporting requirements for the grants, specifies the application submittal and approval procedures for the grants for fiscal years 2012 through 2015, and identifies technical resources for use by State courts during the course of the grants. The agency uses the information received to ensure compliance with the statute and provide training and technical assistance to the grantees.
Estimated Total Annual Burden Hours: 9,256.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, as amended on February 25, 2009, and on August 23, 2010, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). Following issuance of FDA's August 23, 2010, amended Authorization letter, on April 8, 2011, BARDA submitted a request on behalf of ASPR to further amend the Authorization to reflect certain programmatic changes, including by replacing references to the CRI with the National Postal Model (NPM). In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization in its entirety on October 14, 2011. The Authorization, as amended and reissued, includes explanations for its reissuance and is reprinted in this document.
The amended Authorization is effective as of October 14, 2011.
Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4121, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Luciana Borio, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4280, Silver Spring, MD 20993-0002, (301) 796-4637.
In 2004, the Secretary of the Department of Homeland Security (DHS) issued a material threat determination indicating that
On October 1, 2008, BARDA requested and on October 3, 2008, FDA issued an EUA for doxycycline hyclate tablet emergency kits for eligible USPS participants in the CRI and their household members, subject to the terms and conditions of the Authorization. As required under section 564(h)(1) of the FD&C Act, in the
An electronic version of this document and the full text of the Authorization are available on the Internet at
Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act were met, on October 3, 2008, FDA authorized the emergency use of doxycycline hyclate tablet emergency kits for eligible USPS participants in the CRI and their household members subject to the terms and conditions of the Authorization. The letter of Authorization in its entirety (not including the amended authorized versions of the fact sheets and other written materials), as amended on February 25, 2009, on August 23, 2010, and on October 14, 2011, follows and provides an explanation of the reasons for its amendment.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined that TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for docetaxel injection, 40 mg/mL, if all other legal and regulatory requirements are met.
Nam Kim, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, (301) 796-3472.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
TAXOTERE (docetaxel) Injection, 40 mg/mL is the subject of NDA 20-449, held by Sanofi-aventis U.S., and initially approved on May 14, 1996. TAXOTERE is indicated for breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer as described in detail on the drug product's labeling.
TAXOTERE (docetaxel) Injection, 40 mg/mL, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Sandoz, Inc. (Sandoz), submitted a citizen petition dated June 21, 2011 (Docket No. FDA-2011-P-0488), under 21 CFR 10.30, requesting that the Agency determine whether TAXOTERE (docetaxel) Injection, 40 mg/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that TAXOTERE (docetaxel) Injection, 40 mg/mL was not withdrawn for reasons of safety or effectiveness. The petitioner Sandoz has identified no data or other information suggesting that TAXOTERE (docetaxel) Injection, 40 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TAXOTERE (docetaxel) Injection, 40 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list TAXOTERE (docetaxel) Injection, 40 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to TAXOTERE (docetaxel) Injection, 40 mg/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,” dated November 2011. The draft guidance document provides recommendations on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, the draft guidance provides notification that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. The guidance is intended for blood establishments that
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 27, 2012.
Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-(800) 835-4709 or (301) 827-1800. See the
Submit electronic comments on the draft guidance to
Paul Levine, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, (301) 827-6210.
FDA is announcing the availability of a draft document entitled “Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,” dated November 2011. FDA is providing blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes; with recommendations concerning the use of FDA-licensed NAT to screen blood donors for HBV DNA. FDA is also providing these blood establishments with recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling.
In addition, FDA is notifying those blood establishments that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. FDA-licensed HBV NAT can detect evidence of infection at an earlier stage than is possible using previously approved HBsAg and anti-HBc tests. Therefore, FDA is recommending the use of an FDA-licensed HBV NAT, in accordance with the requirements under 610.40(a) and (b) (21 CFR 610.40(a) and (b)).
The draft guidance, when finalized, is intended to supplement previous memoranda and guidance from FDA to blood establishments concerning the testing of donations for HBsAg and anti-HBc, and the management of donors and units mentioned in those documents. Note that testing Whole Blood and blood components for transfusion and Source Leukocytes for further manufacture for HBsAg and anti-HBc, and Source Plasma for HBsAg should continue when a blood establishment implements HBV NAT. FDA may consider advancements in technology for testing blood donations, as well as data obtained following the implementation of HBV NAT, to make future recommendations on adequate and appropriate testing for HBV.
The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 606.121, 610.40 and 640.70 have been approved under OMB Control Numbers 0910-0537, 0910-0116, and 0910-0338, respectively.
The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.” This guidance document provides industry and Agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
Submit written requests for single copies of the guidance document entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to (301) 847-8149. See the
Submit electronic comments on the guidance to
Kate Simon, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5552, Silver Spring, MD 20993-0002, (301) 796-6210.
FDA is issuing this guidance to provide industry and Agency staff with recommendations for studies to establish the performance characteristics of IVDs intended for the detection, or detection and differentiation, of human papillomaviruses. These devices are used in conjunction with cervical cytology to aid in screening for cervical cancer. They include devices that detect a group of human papillomavirus (HPV) genotypes, particularly high risk human papillomaviruses, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype(s) of HPV is (are) present.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB control number. 0910-0231; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.
Interested persons may submit to the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.” The purpose of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Submit electronic comments on the guidance to
Adebayo Laniyonu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2350, Silver Spring, MD 20993-0002, (301) 796-2050; or Siham Biade, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2311, Silver Spring, MD 20993-0002, (301) 796-2050.
FDA is announcing the availability of a guidance for industry entitled “Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.” The objective of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects of therapeutic radiopharmaceutical agents. This guidance is not intended to address late radiation toxicity of radiobiologicals (e.g., radiolabeled monoclonal antibodies) or to apply to diagnostic radiopharmaceuticals whose low doses are not expected to elicit late radiation toxic effects.
This guidance focuses solely on late radiation safety concerns that are unique to therapeutic radiopharmaceuticals and provides recommendations for late radiation toxicity nonclinical study designs including issues regarding good laboratory practices, species selection, dose selection, timing of study, and study parameters.
Late radiation toxicity differs from early or acute radiation toxicity. Acute radiation toxicity (
Therapeutic radiopharmaceuticals are typically administered systemically to treat cancer. The radiation absorbed doses delivered by therapeutic radiopharmaceuticals may be comparable to those delivered with external beam radiotherapy (XRT). At therapeutic doses of radiation, the late radiation toxicities commonly associated with XRT (
Therefore, there is a need to gain additional knowledge in this area to support the safe administration of therapeutic radiopharmaceuticals to humans. Because studies in humans would be unethical, the best means to gain insight into this issue is by conducting nonclinical late radiation toxicity studies. These studies will aid in identifying organs at risk and establish a margin of safety for late radiation toxicity. As a result, these studies will help to minimize the risk of late-occurring radiation toxicities in clinical trials of therapeutic radiopharmaceuticals.
This guidance finalizes the draft guidance of the same name issued in June 2005 and includes edits based on public comments to improve clarity.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Ms. Martha Monser, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Science Board to the FDA (the Science Board).
FDA has special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Nominations received on or before December 28, 2011, will be given first consideration for membership on the Science Board. Nominations received after December 28, 2011, will be considered for nomination to the Science Board should nominees still be needed.
All nominations for membership should be sent electronically to
Regarding all nomination questions for membership, the primary contact is: Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4286, Silver Spring, MD 20993-0002, (301) 796-4627,
FDA is requesting nominations for voting members on the Science Board.
The Science Board shall provide advice primarily to the Commissioner of Food and Drugs (the Commissioner) and other appropriate officials on both general and specific scientific and technical issues as well as emerging issues within the scientific community. Additionally, the Science Board will
Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, and other scientific disciplines. Members shall represent academia and industry. The Science Board may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is either recommended by either a consortium of consumer oriented organizations or other interested persons. The Science Board may also include technically qualified federal members. FDA is currently specifically seeking persons knowledgeable in the fields of pharmacology, translational and clinical medicine, toxicology, clinical research and related biostatistics, public health and epidemiology, international public health and regulation, product safety, product manufacturing sciences and quality or other scientific areas relevant to FDA regulated products such as systems biology, advanced scientific informatics, nanotechnology, food sciences, medical devices and combination products.
Any interested person may nominate one or more qualified persons for membership on the Science Board. Self nominations are also accepted. Nominations shall include the name of the committee, complete curriculum vitae of each nominee, and their current business address and telephone number and email address if available. Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination, unless self nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Effective November 28, 2011.
David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, (301) 796-3601.
FDA approved MYLOTARG (gemtuzumab ozogamicin) for Injection on May 17, 2000, under the Agency's accelerated approval regulations, 21 CFR part 314, subpart H. MYLOTARG was indicated for the treatment of patients with CD33-positive acute myeloid leukemia in first relapse who were 60 years of age or older and who were not considered candidates for other cytotoxic chemotherapy. On May 21, 2010, FDA requested that Wyeth voluntarily withdraw MYLOTARG from the market, after results of a required postapproval clinical trial failed to verify clinical benefit to patients and raised new concerns about the drug's safety. In a letter dated October 25, 2010, Wyeth requested that FDA withdraw approval of NDA 21-174, MYLOTARG (gemtuzumab ozogamicin) for Injection, under § 314.150(d) (21 CFR 314.150(d)). In that letter, Wyeth also waived its opportunity for a hearing, provided under 21 CFR 314.150 and 314.530. In FDA's acknowledgment letter of November 2, 2010, the Agency stated that a large prospective trial that tested the addition of MYLOTARG to first-line chemotherapy for patients with newly diagnosed acute myelogenous leukemia failed to verify clinical benefit of MYLOTARG and raised safety concerns. FDA also acknowledged that Wyeth waived its opportunity for a hearing.
Therefore, under sections 505(e) and 506(b)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e) and 356(b)(3)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 21-174, and all amendments and supplements thereto, is withdrawn (see
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Department of Bioethics, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Marion Danis at Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156, Telephone: (301) 435-8727, Facsimile: (301) 496-0760, or email your request, including your address to:
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the functioning of the National Cancer Institute, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at
Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of the “4th Annual Trauma Spectrum Conference: Bridging the Gap Between Research and Clinical Practice of Psychological Health and Traumatic Brain Injury: Prevention, Diagnosis, Treatment and Recovery for the Iraq and Afghanistan Cohort” to be held December 8-9, 2011, at the National Institutes of Health (NIH), Bethesda, Maryland.
This year's event focuses on bridging the gap between research and clinical practices for psychological health and traumatic brain injury (TBI) health concerns for returning service members
Presented annually by three Federal partners—the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (part of the Department of Defense), the National Institutes of Health, and the Department of Veterans Affairs—the conference highlights research findings, resources, and best practices for Post-Traumatic Stress Disorder and TBI recovery. Additional topics include cognitive rehabilitation, sleep disorders, pain management, depression, implementation science, comparative effectiveness research, co-occurring disorders, and integrative telehealth/mobile technologies. Attendees are expected to include a wide array of researchers, clinicians, advocates, military service members, veterans, and their families.
The conference will be held on Thursday, December 8, and Friday, December 9, in the Natcher Conference Center on the NIH main campus, from 8:30 a.m. to 4:30 p.m. each day. The conference is free, but pre-registration is required. Registration is now open.
To view the agenda, information about continuing education units, and general conference information, visit the Trauma Spectrum Conference Web site at
Information on traveling to NIH and a visitor's map can be found at
For attendees who take Metrorail, the nearest station is Medical Center (on the Red Line). Pay parking is available at the NIH Gateway parking garage. Sign language interpreters will be available.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and thediscussions could disclose confidential trade secrets or commercial property such as patentablematerial, and personal information concerning individuals associated with the grant applications,the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding Information Collection Requests (ICRs), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of revisions to the following collections of information: 1625-0067, Claims under the Oil Pollution Act of 1990; and 1625-0068, State Access to the Oil Spill Liability Trust Fund for Removal costs under the Oil Pollution Act of 1990. Our ICRs describe the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before December 28, 2011.
You may submit comments identified by Coast Guard docket number [USCG-2011-0869] to the Docket Management Facility (DMF) at the U.S. Department of Transportation (DOT) and/or to OIRA. To avoid duplicate submissions, please use only one of the following means:
(1)
(2)
(3)
(4)
The DMF maintains the public docket for this Notice. Comments and material received from the public, as well as documents mentioned in this Notice as being available in the docket, will become part of the docket and will be available for inspection or copying at room W12-140 on the West Building Ground Floor, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find the docket on the Internet at
Copies of the ICRs are available through the docket on the Internet at
Ms. Kenlinishia Tyler, Office of Information Management, telephone (202) 475-3652 or fax (202) 475-3929, for questions on these documents. Contact Ms. Renee V. Wright, Program Manager, Docket Operations, (202) 366-9826, for questions on the docket.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collections. There is one ICR for each Collection.
The Coast Guard invites comments on whether these ICRs should be granted based on the Collections being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collections; (2) the accuracy of the estimated burden of the Collections; (3) ways to enhance the quality, utility, and clarity of information subject to the Collections; and (4) ways to minimize the burden of the Collections on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICRs referred to in this Notice.
We encourage you to respond to this request by submitting comments and
If you submit a comment, please include the docket number [USCG-2011-0869], indicate the specific section of the document to which each comment applies, providing a reason for each comment. If you submit a comment online via
You may submit comments and material by electronic means, mail, fax, or delivery to the DMF at the address under
To view comments, as well as documents mentioned in this Notice as being available in the docket, go to
OIRA posts its decisions on ICRs online at
Anyone can search the electronic form of comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (76 FR 58529, September 21, 2011) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.
1.
2.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of New Hampshire (FEMA-3344-EM), dated November 1, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 1, 2011, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the State of New Hampshire resulting from a severe storm during the period of October 29-30, 2011, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. This assistance excludes regular time costs for subgrantees' regular employees.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Albert Lewis, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of New Hampshire have been designated as adversely affected by this declared emergency:
All 10 counties in the State of New Hampshire for emergency practice measures (Category B) limited to direct Federal assistance, under the Public Assistance program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the Commonwealth of Massachusetts (FEMA-3343-EM), dated November 1, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 1, 2011, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the Commonwealth of Massachusetts resulting from a severe storm during the period of October 29-30, 2011, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. This assistance excludes regular time costs for subgrantees' regular employees.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Mark H. Landry, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the Commonwealth of Massachusetts have been designated as adversely affected by this declared emergency:
The counties of Berkshire, Essex, Franklin, Hampden, Hampshire, Middlesex, Norfolk, and Worcester for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
Pursuant to the Flood Disaster Protection Act of 1973, the Federal Emergency Management Agency (FEMA), via the Federal Insurance Administrator, must publish flood
The changes in procedure announced in this notice are effective December 1, 2011. The new procedure applies to all proposed flood hazard determinations including proposed flood elevation determinations published in the
The docket for this notice is available at
Lora Eskandary, Program Specialist, FEMA, 1800 South Bell Street, Mail Stop 3030, Arlington, VA 20598, at
The Federal Insurance Administrator must propose flood elevation determinations by publication of the proposed flood elevation determination for comment in the
Currently FEMA publishes base flood elevation (BFE) determinations for Flood Insurance Studies pursuant to 44 CFR 67.4 and 67.11 as proposed and final rules. However, there is no legal requirement to publish them as rules, and FEMA now plans to publish them as notices, which are administratively less burdensome. The background and legal authority for this change in procedure is explained below.
Sections 67.4 and 67.11 of Title 44 of the Code of Regulations (CFR) were initially promulgated in 1974, pursuant to section 110 of the Flood Disaster Protection Act of 1973, Public Law 93-234, which amended the National Flood Insurance Act of 1968. Section 110 states “In establishing projected flood elevations * * * [the agency] shall first propose such determinations by publication for comment in the
Sections 1917.4 and 1971.11 were finalized as proposed on July 24, 1974. The preamble to the final rule noted that one commenter had requested that the notification by newspaper could be more effective by increasing the number of days of publication. HUD did not alter the proposed regulatory text, however, because the publication standard had been set by the Flood Disaster Protection Act and could not be altered by regulation. Other commenters requested that communities who entered the flood insurance program prior to the passage of the Flood Disaster Protection Act of 1973 be allowed to appeal past flood elevation determinations. Again HUD declined to alter the proposed regulatory text because the Act did not apply retroactively. Further, HUD noted “an attempt to include such regular flood insurance program communities in this [sic] new appeals procedures could curtail the right of judicial review available to them under the National Flood Insurance Act of 1968 and Title 5 of the United States Code.”
The text of sections 1917.4 and 1917.11 has not changed since they were finalized in 1974.
The Federal Insurance Administrator shall propose flood elevation determinations in the following manner:
(a) Publication of the proposed flood elevation determination for comment in the
(b) Notification by certified mail, return receipt requested, of the proposed flood elevation determination to the CEO; and
(c) Publication of the proposed flood elevation determination in a prominent local newspaper at least twice during the ten day period immediately following the notification of the CEO.
The Federal Insurance Administrator's notice of the final flood elevation determination for a community shall be in written form and published in the
Since the applicable regulations were promulgated in 1974, base flood elevation determinations listed in feet or meters for specific localities have been published in the
Nowhere is it mentioned that the flood elevation determinations were to be published as rules. The extensive Congressional hearings from October 1973 regarding the proposed legislation focus on
The evidence indicates that publication in the
FEMA concludes that the statute does not require that the determinations must take the form of a regulation; rather, the requirement of publication in the
The information provided in the BFE notices will be less detailed than the information FEMA currently provides in the BFE rules. FEMA will no longer list in the
This new procedure will
This new procedure will also apply to certain Letters of Map Revision (LOMRs). A LOMR is a type of determination that FEMA issues under the authority of 44 CFR part 65. It may include changes to the technical content (
In addition to BFE determinations, FEMA also issues other types of flood hazard determinations including new and modified Special Flood Hazard Areas (SFHAs) and new and modified regulatory floodways. SFHAs are areas subject to inundation by the base flood and include the following flood insurance risk zone designations: A, AO, AH, A1-30, AE, A99, AR, AR/A1-30, AR/AE, AR/AO, AR/AH, AR/A, VO, V1-30, VE, and V. The various flood insurance risk zones represent different levels of risk and the type of flood hazard (
Under current practice, new or modified SFHAs or regulatory floodways not specifically related to changes in BFE determinations are not appealable under 44 CFR 67.8. For that reason, FEMA has not published notification of new and modified SFHAs and regulatory floodways in the
As of the effective date of this notice (December 1, 2011), FEMA will publish notification of new or modified SFHAs
As with appeals of BFE determinations, appeals of SFHA and regulatory floodway determinations must include supporting scientific and technical data certified by a registered professional engineer or licensed land surveyor pursuant to 44 CFR 67.6.
42 U.S.C. 4104; 44 CFR parts 65 and 67.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Vermont (FEMA-4043-DR), dated November 8, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 8, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Vermont resulting from severe storms and flooding on May 20, 2011, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, James N. Russo, of FEMA, is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Vermont have been designated as adversely affected by this major disaster:
Franklin, Washington, and Windham Counties for Public Assistance.
All counties within the State of Vermont are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 4, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the Commonwealth of Virginia resulting from an earthquake during the period of August 23 to October 25, 2011, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Donald L. Keldsen, of FEMA, is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of Virginia have been designated as adversely affected by this major disaster:
Louisa County for Individual Assistance.
All counties and independent cities in the Commonwealth of Virginia are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the District of Columbia (FEMA-4044-DR), dated November 8, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 8, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the District of Columbia resulting from an earthquake during the period of August 23-28, 2011, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation in the District of Columbia. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Kim R. Kadesch, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the District of Columbia have been designated as adversely affected by this major disaster:
The District of Columbia for Public Assistance.
The District of Columbia is eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Pennsylvania (FEMA-4030-DR), dated September 12, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The notice of a major disaster declaration for the Commonwealth of Pennsylvania is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 12, 2011.
Adams, Chester, and Northampton Counties for Public Assistance (already designated for Individual Assistance).
Lackawanna and Mifflin Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include the Public Assistance program for the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of November 4, 2011.
Louisa County for Public Assistance (already designated for Individual Assistance).
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for State of Missouri (FEMA-4012-DR), dated August 12, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Stephen R. Thompson, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Michael L. Karl as Federal Coordinating Officer for this disaster.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for State of Missouri (FEMA-1980-DR), datedMay 9, 2011, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Stephen R. Thompson, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Michael L. Karl as Federal Coordinating Officer for this disaster.
Transportation Security Administration, DHS.
Committee Management; Notice of Federal Advisory Committee Meeting.
The Transportation Security Administration (TSA) will hold a meeting of the Aviation Security Advisory Committee (ASAC) via telephone conference on December 15, 2011, to establish working groups and set the agenda for future activity. This meeting will be open to the public.
The Committee will meet on Thursday, December 15, 2011, from1-3:30 p.m. Eastern Standard Time (EST). This meeting may end early if all business is completed.
The Committee will meet via telephone conference, on December 15, 2011. There will be 100 teleconference lines to accommodate committee members, staff and public participation. To participate via telephone conference, please contact the person listed in the
Dean Walter, ASAC Designated Federal Officer, Transportation Security Administration (TSA-28), 601 12th St. South, Arlington, VA 20598-4028,
Notice of this meeting is given under section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). ASAC operates under the authority of 46 U.S.C. 70112 and provides advice, consults with, and makes recommendations to the Secretary of Homeland Security, via the Administrator of TSA on matters affecting civil aviation security.
This meeting is open to the public, but participation is limited to 100 telephone lines to accommodate all participants. Members of the public must make advance arrangements to present oral statements at the meeting. The public comment period will be held during the meeting on December 15, 2011, from approximately 3 to 3:30 p.m. EST, depending on the meeting progress. Speakers are requested to limit their comments to two minutes. Please note that the public comment period will end following the last call for comments. Written statements may also be presented to the Committee. Contact the person listed in the
The agenda for the meeting is as follows:
30-Day Notice of Information Collection Under Review; Form I-602, Application by Refugee for Waiver of Grounds of Excludability; OMB Control No. 1615-0069.
The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) will be submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until December 28, 2011. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), USCIS Desk Officer. Comments may be submitted to: Sunday Aigbe, Chief, Regulatory Products Division, Office of the Executive Secretariat, USCIS, 20 Massachusetts Avenue NW., Washington, DC 20529-2020. Comments may also be submitted to DHS via facsimile to (202) 272-8352 or via email at
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
If you need a copy of the information collection instrument, please visit the Web site at:
If additional information is required contact: USCIS, Regulatory Products Division, Office of the Executive Secretariat, 20 Massachusetts Avenue NW., Washington, DC 20529-2020, telephone (202) 272-8377.
Office of the Secretary, Interior.
Notice.
The Secretary of the Interior is publishing this notice as required by section 10(a) of the Soboba Band of Luiseño Indians Settlement Act of 2008, Public Law 110-297, 122 Stat. 2975, 2983 (Settlement Act). The publication of this notice causes certain waivers and releases of claims to become effective as required by the Settlement Act.
Address all comments and requests for additional information to Robert Laidlaw, Senior Policy Analyst, United States Department of the Interior, 1849 C Street NW., Room 3517, Washington, DC 20240.
The Settlement Act approves, ratifies, and confirms the Settlement Agreement entered into by the settlement parties, including the United States on behalf of the Tribe, the Tribe, the Metropolitan Water District of Southern California, Eastern Municipal Water District, and Lake Hemet Municipal Water District. The Settlement Act, which Congress enacted on July 31, 2008, determines the Tribe's water rights; resolves the Tribe's claims for interference with the water resources of, and damages to, the Tribe's Reservation; provides for construction of certain water projects to facilitate exercise of the Tribe's water rights secured by the Settlement Act; and resolves outstanding litigation.
Section 10(b) of the Settlement Act and article 3.3 of the Settlement Agreement provide that the Settlement Act and the Settlement Agreement shall be null and void if certain conditions are not fulfilled on or before March 1, 2012. The publication of this notice and the Statement of Findings below confirm that the conditions required by section 10(a) of the Settlement Act and article 3 of the Settlement Agreement have been fulfilled. Accordingly, the waivers and releases executed pursuant to section 8(a) of the Settlement Act and article 5 of the Settlement Agreement are effective as of November 28, 2011.
In accordance with section 10(a) of the Settlement Act and article 3.1 of the Settlement Agreement, I find as follows:
1. The Settlement Act was enacted on July 31, 2008.
2. To the extent that the Settlement Agreement conflicted with the Act, the Settlement Agreement has been revised to conform to the Act.
3. The Settlement Agreement, revised as necessary, and the waivers and releases described in article 5 of the Settlement Agreement and section 8(a) of the Settlement Act have been executed by the parties and by the Secretary.
4. Warranty deeds for the property to be conveyed to the Tribe described in article 4.6 of the Settlement Agreement have been placed in escrow and, in accordance with the Settlement Agreement, shall be delivered to the Tribe on the first business day following the Effective Date (
5. The Tribe and the Secretary have approved the Water Management Plan developed pursuant to article 4.8.A of the Settlement Agreement.
6. A judgment and decree substantially the same as Exhibit H to the Settlement Agreement has been approved by the United States District Court, Eastern Division of the Central District of California, and that judgment and decree has become final and non-appealable.
Fish and Wildlife Service, Interior.
Notice of issuance of permits.
We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).
Brenda Tapia, Division of Management Authority, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 212, Arlington, VA 22203; fax (703) 358-2280; or Email
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2280 (fax);
On the dates below, as authorized by the provisions of the ESA (16 U.S.C. 1531
Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents.
Bureau of Indian Affairs, Interior.
Notice of Reservation Proclamation.
This notice informs the public that the Assistant Secretary—Indian Affairs proclaimed approximately 30.00 acres, more or less, as the Fort Sill Apache Indian Reservation for the Fort Sill Apache Tribe of Indians.
Ben Burshia, Bureau of Indian Affairs, Division of Real Estate Services, Mail Stop-4639-MIB, 1849 C Street NW., Washington, DC 20240, telephone (202) 208-7737.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual.
A proclamation was issued according to the Act of June 18, 1934 (48 Stat. 986; 25 U.S.C. 467), for the land described below. The land was proclaimed to be an addition to and part of the reservation of the Fort Sill Apache Indian Reservation for the exclusive use of Indians entitled by enrollment or by tribal membership to residence at such reservation.
That part of the North half (N1/2) of Section Eleven (11), lying north of the Interstate 10 right-of-way, Township Twenty-four (24) south, Range Six (6) west, N.M.P.M., Luna County, New Mexico, being described as follows:
BEGINNING at a spike in the center of an abandoned asphalt roadway at the Northeast corner of said Section 11 and Northeast corner of this tract:
Thence S. 0°21′53″ W., along the east line of Section 11, a distance of 500.76 feet to a No. 5 steel rod at the Southeast corner of this tract and on the North boundary of the Interstate 10 right-of-way;
Thence adjoining the North boundary of said I-10 right-of-way through the following courses and distances; along a curve to the left from a tangent which bears N. 89°56′18″ W., having a radius of 789.30 feet, a delta angle of 32°47′40″, a chord which bears S. 73°39′52″ W., 445.63 feet through an arc length of 451.77 feet to I-10 P.C. marker 10+30.62;
Thence S. 57°12′44″ W., a distance of 231.01 feet to I-10 P.T. marker 8+00;
Thence along a curve to the right from a tangent which bears S. 57°16′8″ W., having a radius of 1096.00 feet, a delta angle of 39°58′50″, a chord which bears S. 77°15′43″ W., 749.36 feet, through an arc length of 764.78 feet to I-10 P.C. marker 45+11.53;
Thence N. 82°45′27″ W., a distance of 340.58 feet to a No. 5 steel rod at the Southwest corner of this tract;
Thence N. 0°21′53″ E., along a line parallel with the east line of Section 11, a distance of 871.49 feet to a No. 5 steel rod at the Northwest corner of this tract;
Thence N. 89°55′55″ E., along the North line of Section 11, a distance of 1688.27 feet to the point of beginning.
The above-described lands contain a total of 30.00 acres, more or less, which is subject to all valid rights, reservations, rights-of-way, and easements of record.
This proclamation does not affect title to the land described above, nor does it affect any valid existing easements for public roads and highways, public utilities and for railroads and pipelines and any other rights-of-way or reservations of record.
Bureau of Land Management, Interior.
Notice.
The purpose of this notice is to request public nominations to fill one position on the Utah Resource Advisory Council (RAC) in category three (representatives of state, county, or local elected office; employees of a state agency responsible for management of natural resources; representatives of Indian tribes within or adjacent to the area for which the council is organized; representatives of academia who are employed in natural sciences; or the public-at-large).
All nominations must be received no later than December 28, 2011.
Nominations should be sent to Sherry Foot, Special Programs Coordinator, Utah State Office, Bureau of Land Management, 440 West 200 South, Suite 500, Salt Lake City, UT 84101.
Sherry Foot, Special Programs Coordinator, Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, UT 84101; phone (801) 539-4195; or email
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-(800) 877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The Federal Land Policy and Management Act (FLPMA) directs the Secretary of the Interior to involve the public in planning and issues related to management of lands administered by the Bureau of Land Management (BLM). Section 309 of FLPMA directs the Secretary to establish 10- to 15-member citizen-based advisory councils that conform to the requirements of the Federal Advisory Committee Act (FACA). RAC membership must be balanced and representative of the various interests concerned with the land use planning and/or management of the public lands.
The BLM's Utah RAC is hosting a call for nominations for a position in category three (description addressed in the
Simultaneous with this notice, the BLM Utah State Office will issue a press release providing additional information for submitting nominations.
Bureau of Land Management, Interior.
Notice.
The plats of survey and supplemental plats of lands described below are scheduled to be officially filed in the Bureau of Land Management California State Office, Sacramento, California, thirty (30) calendar days from the date of this publication.
A copy of the plats may be obtained from the California State Office, Bureau of Land Management, 2800 Cottage Way, Sacramento, California 95825, upon required payment.
Chief, Branch of Geographic Services, Bureau of Land Management, California State Office, 2800 Cottage Way, Room W-1623, Sacramento, California 95825, (916) 978-4310.
These surveys and supplemental plats were executed to meet the administrative needs of various federal agencies; the Bureau of Land Management, Bureau of Indian Affairs, General Services Administration or U.S. Forest Service. The lands surveyed are:
43 U.S.C., Chapter 3.
Bureau of Land Management, Interior.
Notice of filing of plats of survey.
The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, on December 28, 2011.
Protests of the survey must be filed before December 28, 2011 to be considered.
Protests of the survey should be sent to the Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101-4669.
Marvin Montoya, Cadastral Surveyor, Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101-4669, telephone (406) 896-5124 or (406) 896-5009,
This survey was executed at the request of the Forest Supervisor, U.S. Forest Service, Flathead National Forest, Kalispell, Montana, and was necessary to determine federal interest lands.
The lands we surveyed are:
The plat, in one sheet, representing the corrective dependent resurvey of a portion of the section line between sections 2 and 11 and a portion of the subdivision of section 11, the dependent resurvey of a portion of the subdivision of section 11, and the survey of a portion of a warranty deed in Township 36
We will place a copy of the plat, in one sheet, and related field notes we described in the open files. They will be available to the public as a matter of information. If the BLM receives a protest against this survey, as shown on this plat, in one sheet, prior to the date of the official filing, we will stay the filing pending our consideration of the protest. We will not officially file this plat, in one sheet, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals.
43 U.S.C. Chap. 3.
Bureau of Land Management, Interior.
Notice of Intent.
Pursuant to applicable provisions of the Federal Lands Recreation Enhancement Act (REA), the Bureau of Land Management (BLM) La Jara Field Office is proposing to collect fees at the Zapata Falls Campground in Alamosa County, Colorado (Township 28S, Range 73W, Section 17). Under Section 2(2) of the REA, Zapata Falls Campground qualifies as a site wherein visitors can be charged an “Expanded Amenity Recreation Fee” authorized under section 3(g). In accordance with the REA, and the BLM's implementing regulations, the La Jara Field Office is proposing to charge $11 per night for individual sites and $20 per night for group-site fees for overnight camping within the developed campground.
This notice initiates the public comment period. Comments on issues may be submitted in writing by December 28, 2011. New fee implementation is contingent on a recommendation of the Colorado Front Range Resource Advisory Council (RAC) review. Per the REA, effective 6 months after the publication of this notice, and dependent on review and an affirmative recommendation by the Colorado Front Range RAC and modification approval from the BLM Colorado State Director. To meet the terms of a RAC recommendation, the La Jara Field Office will provide final public notice under REA and initiate fee collection at the Zapata Falls Campground.
You may submit comments related to the proposed fee collection at Zapata Falls Campground by any of the following methods:
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Sean Noonan, Outdoor Recreation Planner; telephone (719) 655-6136; see address above; email snoonan@blm.gov.
The Zapata Falls Campground was built in 2010 with American Recovery and Reinvestment Act funding. The campground has one camp host site, one group site, and 23 individual sites divided between a tent camping loop and an RV camping loop. The site includes water, restrooms, trails and signs. Pursuant to the REA and implementing regulations at 43 CFR subpart 2933, fees may be charged for overnight camping. Specific visitor fees will be identified and posted at the site and the La Jara Field Office. Fees must be paid at the self-service pay station located at the site. People holding the America The Beautiful—The National Parks and Federal Recreational Lands—Senior Pass (i.e., Interagency Senior Pass), a Golden Age Passport, the America the Beautiful—The National Parks and Federal Recreational Lands—Access Pass (i.e, Interagency Access Pass), or a Golden Access Passport will be entitled to a 50 percent reduction on all overnight camping fees. The BLM is committed to providing and receiving fair value for the use of developed recreation facilities and services in a manner that meets public-use demands, provides for quality experiences, and protects important resources. The BLM's policy is to collect fees at all specialized recreation sites, or where the BLM provides facilities, equipment or services, at Federal expense, in connection with outdoor use as authorized by the REA. Implementing a fee program for the campground will help ensure that funding is available to accomplish deferred maintenance, make future enhancements, maintain facilities and recreational opportunities, provide for law enforcement presence, develop additional services, and protect resources. Campground development is consistent with the 1991 San Luis Resource Area Resource Management Plan, the 2009 Zapata Falls Recreation Area Management Plan, and was analyzed in the Zapata Falls Campground Construction Project Environmental Assessment, CO-140-2009-017-EA. Proposed fees at the Zapata Falls Campground are consistent with other established fee sites in the area, including other BLM-administered sites and those managed by the United States Department of Agriculture Forest Service, United States Department of the Interior National Park Service, and Colorado Parks and Wildlife. The REA was signed into law in December 2004. The REA provides authority for the Secretaries of the Interior and Agriculture to establish, modify, charge and collect recreation fees for use of some Federal recreation lands and waters for 10 years, and contains specific provisions addressing public involvement in the establishment of recreation fees, including a requirement that Recreation Resource Advisory Committees or BLM RACs have the opportunity to make recommendations regarding establishment of such fees. The REA also directed the secretaries of the Interior and Agriculture to publish advance notice in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be advised that your entire comment—including your personal identifying information—may be made publicly available at any time.
16 U.S.C. 6803(b).
Bureau of Land Management, Interior.
Notice of Realty Action.
The Bureau of Land Management (BLM), Hollister Field Office, proposes to sell a parcel of public land totaling approximately 23.42 acres, more or less, in Santa Clara County, California. The public land would be sold for appraised fair market value. The appraised value of the public land is $135,000.
Comments regarding the proposed sale must be received by the BLM on or before January 12, 2012.
Written comments concerning the proposed sale should be sent to the Field Manager, BLM, Hollister Field Office, 20 Hamilton Court, Hollister, California 95023.
Christine Sloand, Realty Specialist, BLM, Hollister Field Office, 20 Hamilton Court, Hollister, California 95023, or phone (831) 630-5022.
The following public land is proposed for competitive sale in accordance with Sections 203 and 209 of the Federal Land Policy and Management Act of 1976 (FLPMA), as amended (43 U.S.C. 1713 and 1719).
The area described contains 23.42 acres, more or less, in Santa Clara County, California.
Appraised fair market value: $135,000.
The public land was first identified as suitable for disposal in the 1984 BLM Hollister Resource Management Plan (RMP) and remains available for sale under the 2007 Hollister RMP revision. The land is not needed for any other Federal purpose, and its disposal would be in the public interest. The land is difficult and uneconomic to manage as part of the public lands because it lacks legal access and is isolated from other public lands. The BLM has concluded the public interest would be best served by a competitive sale. The BLM has completed a mineral potential report which concluded there are no known mineral values in the land proposed for sale. The BLM proposes that conveyance of the Federal mineral interests would occur simultaneously with the sale of the land. The purchaser would be required to pay a $50 nonrefundable filing fee for the conveyance of the mineral interests.
On November 28, 2011, the above described land will be segregated from appropriation under the public land laws, including the mining laws, except for the sale provisions of FLPMA. Until completion of the sale, the BLM will no longer accept land use applications affecting the identified public land, except applications for the amendment of previously filed right-of-way applications or existing authorizations to increase the term of the grants in accordance with 43 CFR 2802.15 and 2886.15. The segregation will terminate upon issuance of a patent, publication in the
1. A reservation of a right-of-way to the United States for ditches and canals constructed by authority of the United States under the Act of August 30, 1890 (43 U.S.C 945);
2. A condition that the conveyance be subject to all valid existing rights of record;
3. An appropriate indemnification clause protecting the United States from claims arising out of the patentee's use, occupancy, or operations on the patented lands;
4. Additional terms and conditions that the authorized officer deems appropriate.
Public Comments regarding the proposed sale may be submitted in writing to the attention of the BLM Hollister Field Manager (see
43 CFR 2711.1-2(a) and (c)
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request renewed approval for the collection of information for surface and underground mining permit applications—minimum requirements for information on environmental resources.
Comments on the proposed information collection must be received by January 27, 2012, to be assured of consideration.
Comments may be mailed to John Trelease, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave. NW., Room 203—SIB, Washington, DC 20240. Comments may also be submitted electronically to
To receive a copy of the information collection request contact John Trelease, at (202) 208-2783, or by email at
The Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8 (d)]. This notice identifies an information collection that OSM will be submitting to OMB for renewed approval. This collection is contained in 30 CFR parts 779 and 783—Surface and Underground Mining Permit Applications—Minimum Requirements for Information on Environmental Resources. OSM will request a 3-year term of approval for this information collection activity.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control number for parts 779 and 783 is 1029-0035. Responses are required to obtain a benefit for this collection.
OSM has revised burden estimates, where appropriate, to reflect current reporting levels or adjustments based on Creestimates of burden on respondents and costs.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
This notice provides the public with 60 days in which to comment on the following information collection activity:
Notice is hereby given that on November 21, 2011, a proposed Consent Decree (“proposed Decree”) in
On September 21, 2009, the United States and the West Virginia Department of Environmental Protection and West Virginia Department of Health and Human Resources (collectively, “Plaintiffs”) filed a complaint against the Town of Fort Gay, West Virginia (“Defendant” or “Fort Gay”) for permanent injunctive relief and civil penalties under the Clean Water Act, 33 U.S.C. 1251-387; the Safe Drinking Water Act, 42 U.S.C. 300f-300j-26; the West Virginia Water Pollution Control Act, W.Va Code § 22-11-22; and Chapter 16, Article I, Section 9a of the West Virginia Code.
The proposed Decree requires Defendant to comply with certain permit requirements, to prepare and submit certain reports, to make capital improvements to the Fort Gay waste water collection and treatment system and drinking water treatment system (collectively, the “Facilities”), and to improve staffing at the Facilities. The proposed Decree appoints the County Commission of Wayne County, West Virginia as Receiver of the Facilities.
The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the proposed Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either emailed to
During the public comment period, the proposed Decree may be examined on the following Department of Justice Web site:
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 18, 2011, Aldrich Chemical Company Inc., DBA Isotec, 3858 Benner Road, Miamisburg, Ohio 45342-4304, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture small quantities of the listed controlled substances to produce isotope labeled standards for drug testing and analysis.
In reference to drug code 7370 the company plans to bulk manufacture a synthetic Tetrahydrocannabinol. No other activity for this drug code is authorized for this registration.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 9, 2011, Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for sale to its customers.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on September 15, 2011, Johnson Matthey Pharmaceutical Materials Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to utilize this facility to manufacture small quantities of the listed controlled substances in bulk and to conduct analytical testing in support of the company's primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to the company's customers.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 30, 2010, Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, Missouri 63042, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances as bulk controlled substances intermediates for distribution to its customers.
Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).
Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than January 27, 2012.
By Notice dated June 1, 2011 and published in the
The company plans to manufacture high purity drug standards used for analytical applications only in clinical, toxicological, and forensic laboratories.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Alltech Associates, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Alltech Associates Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.
By Notice dated June 14, 2011, and published in the
The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. Regarding (9640) the company plans to manufacture another controlled substance for sale to its customers.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Chattem Chemicals Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Chattem Chemicals Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.
By Notice dated June 13, 2011, and published in the
The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Boehringer Ingelheim Chemicals, Inc., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Boehringer Ingelheim Chemicals, Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.
By Notice dated June 22, 2011, and published in the
The company plans to manufacture the listed controlled substance for analytical research and clinical trials.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Pharmagra Labs, Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Pharmagra Labs, Inc. to ensure that the
60-day notice of information collection under review.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with established review procedures of the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted until January 27, 2012. This process is conducted in accordance with 5 CFR 1320.10.
All comments, suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Mr. Gregory E. Scarbro, Unit Chief, Federal Bureau of Investigation, CJIS Division, Module E-3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306, or facsimile to (304) 625-3566.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques of other forms of information technology,
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Veterans' Employment and Training Service, Labor.
Notice of open meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the Advisory Committee on Veterans' Employment, Training and Employer Outreach (ACVETEO). The ACVETEO will discuss Department of Labor's Veterans' Employment and Training Services' (VETS) core programs and new initiatives regarding efforts that assist veterans seeking employment and raise employer awareness as to the advantages of hiring veterans. There will be an opportunity for persons or organizations to address the committee. Any individual or organization that wishes to do so should contact Mr. Gregory Green (202) 693-4734. Time constraints may limit the number of outside participants/presentations. Individuals who will need accommodations for a disability in order to attend the meeting (i.e., interpreting services, assistive listening devices, and/or materials in alternative format) should notify the Advisory Committee no later than Wednesday, December 7, 2011 by contacting Mr. Gregory Green (202) 693-4734. Requests made after this date will be reviewed, but availability of the requested accommodations cannot be guaranteed. The meeting site is accessible to individuals with disabilities. This notice also describes the functions of the Advisory Committee. Notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act. This document is intended to notify the general public.
Veterans of Foreign Wars of the United States, 200 Maryland Avenue NE., Washington, DC 20002. ID is required to enter the building.
Ms. Nancy L. Hogan, Designated Federal Official, Advisory Committee on Veterans' Employment, Training and Employer Outreach, (202) 693-4700, or Mr. Gregory Green (202) 693-4734.
ACVETEO is a Congressionally mandated advisory committee authorized under Title 38, U.S. Code, Section 4110 and subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, as amended. The ACVETEO is responsible for: Assessing employment and training needs of veterans; determining the extent to which the programs and activities of the U.S. Department of Labor meet these needs; assisting to conduct outreach to employers seeking to hire veterans; making recommendations to the Secretary, through the Assistant Secretary of Labor for Veterans' Employment and Training (VETS), with respect to outreach activities and employment and training needs of veterans; and carrying out such other activities necessary to make required reports and recommendations. The ACVETEO meets at least quarterly.
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on October 6, 2010, applicable to workers of Whirlpool Corporation, including on-site leased workers from Career Solutions TEC Staffing, Fort Smith, Arkansas. The workers are engaged in the production of refrigerators and trash compactors. The notice was published in the
At the request of a company official, the Department reviewed the certification for workers of the subject firm. The company reports that workers leased from IBM Corporation, TEK Systems, Penske Logistics, Eurest, and Canteen were employed on-site at the Fort Smith, Arkansas location of Whirlpool Corporation. The Department has determined that these workers were sufficiently under the control of Whirlpool Corporation to be considered leased workers.
Based on these findings, the Department is amending this certification to include workers leased from IBM Corporation, TEK Systems, Penske Logistics, Eurest, and Canteen working on-site at the Fort Smith, Arkansas location of Whirlpool Corporation.
The amended notice applicable to TA-W-74,593 is hereby issued as follows:
All workers of Whirlpool Corporation, including on-site leased workers from Career Solutions TEC Staffing, Andrews International, IBM Corporation, TEK Systems, Penske Logistics, Eurest, and Canteen, Fort Smith, Arkansas, who became totally or partially separated from employment on or after October 2, 2010, through October 6, 2012, and all workers in the group threatened with total or partial separation from employment on the date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on June 25, 2010, applicable to workers of Premier Trim, LLC and Spectrum Trim, LLC, d/b/a Spectrum Grant De Mexico, Manufacturing Division, including on-site leased workers from Express Employment Professionals and Select Staff, Brownsville, Texas. The workers are engaged in activities related to the production of wood steering wheels. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm.
Information shows that as of January 29, 2010, Premier Trim, LLC, Spectrum Trim, LLC and Grant Products International, Inc. have merged and are officially one company under the name of Spectrum Grant de Mexico. Some workers separated from employment at the Brownsville, Texas location of Premier Trim, LLC and Spectrum Trim, LLC and Grant Products International, Inc. d/b/a Spectrum Grant de Mexico had their wages reported under a separate unemployment insurance (UI) tax account under the name Grant Products International, Inc.
Accordingly, the Department is amending this certification to properly reflect this matter.
The intent of the Department's certification is to include all workers of the subject firm who were adversely affected by a shift in the production of wood steering wheels to Mexico.
The amended notice applicable to TA-W-73,681 is hereby issued as follows:
All workers of Premier Trim, LLC, Spectrum Trim, LLC and Grant Products
Petitions have been filed with the Secretary of Labor under Section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221(a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than December 8, 2011.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than December 8, 2011.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue NW., Washington, DC 20210.
Employment and Training Administration, Labor.
Notice.
The Employment and Training Administration is issuing this notice to announce the receipt of a “Certification of Non-Relocation and Market and Capacity Information Report” (Form 4279-2) for the following:
All interested parties may submit comments in writing no later than December 12, 2011. Copies of adverse comments received will be forwarded to the applicant noted above.
Address all comments concerning this notice to Anthony D. Dais, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue NW., Room S-4231, Washington, DC 20210; or email
Anthony D. Dais, at telephone number (202) 693-2784 (this is not a toll-free number).
Section 188 of the Consolidated Farm and Rural Development Act of 1972, as established under 29 CFR part 75, authorizes the United States Department of Agriculture to make or guarantee loans or grants to finance industrial and business activities in rural areas. The Secretary of Labor must review the application for financial assistance for the purpose of certifying to the Secretary of Agriculture that the assistance is not calculated, or likely, to result in: (a) A transfer of any employment or business activity from one area to another by the loan applicant's business operation; or, (b) An increase in the production of goods, materials, services, or facilities in an area where there is not sufficient demand to employ the efficient capacity of existing competitive enterprises unless the financial assistance will not have an adverse impact on existing competitive enterprises in the area. The Employment and Training Administration within the Department of Labor is responsible for the review and certification process. Comments should address the two bases for certification and, if possible, provide data to assist in the analysis of these issues.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning its request for an extension of the Office of Management and Budget's (OMB) approval of the information collection requirements associated with its regulations and program regarding State Plans for the development and enforcement of state occupational safety and health standards (29 CFR Parts 1902, 1952, 1953, 1954, 1955, 1956).
Comments must be submitted (postmarked, sent, or received) by January 27, 2012.
Laura Seeman, Directorate of Cooperative and State Programs, Office of State Programs, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-3700, 200 Constitution Avenue NW, Washington, DC 20210; telephone: (202) 693-2244; email,
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., the 27 States with OSHA-approved State Plans) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in
• 29 CFR part 1902, State Plans for the Development and Enforcement of State Standards;
• 29 CFR part 1952, Approved State Plans for Enforcement of State Standards;
• 29 CFR part 1953, Changes to State Plans for the Development and Enforcement of State Standards;
• 29 CFR part 1954, Procedures for the Evaluation and Monitoring of Approved State Plans;
• 29 CFR part 1955, Procedures for Withdrawal of Approval of State Plans; and
• 29 CFR part 1956, State Plans for the Development and Enforcement of State Standards Applicable to State and Local Government Employees in States without Approved Private Employee Plans.
Section 18 of the Occupational Safety and Health Act (29 U.S.C. 667) offers an opportunity to the states to assume responsibility for the development and enforcement of state standards through the mechanism of an OSHA-approved State Plan. Absent an approved plan, states are precluded from enforcing occupational safety and health standards in the private sector with respect to any issue for which Federal OSHA has promulgated a standard. Once approved and operational, the state adopts standards and provides most occupational safety and health enforcement and compliance assistance in the state, under the authority of its plan, instead of Federal OSHA. States also must extend their jurisdiction to cover state and local government employees and may obtain approval of State Plans limited in scope to these workers. To obtain and maintain State Plan approval, a state must submit various documents to OSHA describing its program structure and operation, including any modifications thereto as they occur, in accordance with the identified regulations. OSHA funds 50 percent of the costs required to be incurred by an approved State Plan with the state at least matching and providing additional funding at its discretion.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on participating states who must comply; for example, by using automated or other technological information collection and transmission techniques.
OSHA is requesting that OMB extend its approval of the collection of information requirements associated with its State Plan regulations. In doing so, the Agency is proposing to increase the burden hours from 10,652 to 11,196 hours. The increase is a result of the approval of the Illinois Public Employee Only State Plan, increasing the number of approved State Plan respondents from 26 to 27, and an increase in the projected number of required State Plan responses and modifications as a result of changes in federal procedures. The total number of respondents increased to 28, including the 27 approved State Plans and one state developing a plan to seek State Plan approval. The Agency will summarize the comments submitted in response to this notice and will include this summary in its request to OMB.
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627).
Comments and submissions are posted without change at
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Copyright Office, Library of Congress.
Notice of objections and specialty station filings; correction.
Periodically, the Copyright Office (“Office”) seeks to update its list of specialty stations related to the use of the cable compulsory license. In response to the publication of an initial list of specialty stations for this purpose in April of this year, the Office received objections filed by the Motion Picture Association of America to the identification of certain stations as being entitled to specialty station status in accordance with the Federal Communications Commission's (“FCC”) definition of specialty station in effect on June 24, 1981. Corrections are being made to the specialty station list published on November 8, 2011.
Ben Golant, Assistant General Counsel, Copyright GC/I&R, P.O. Box 70400, Southwest Station, Washington, DC 20024.
The Office corrects the following errors in the Notice of Objections published in the
• On page 69289, WNYA-CA, Albany, NY was misidentified as WYNA-CA.
• On page 69289, W34DI, Port Jervis, NY was misidentified as W34d1.
• On page 69289, W46DQ, Port Jervis, NY was misidentified as W42DQ.
• On page 69289, W42CX, Port Jervis, NY was missing from the list as a station to which MPAA filed an objection (no evidence of construction or the type of programming broadcast should not be identified as specialty stations)
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation announces the following meeting.
If you plan to attend the meeting, please send an email with your name and affiliation to the individual listed above, by the day before the meeting, so that a visitor badge can be prepared.
Nuclear Regulatory Commission.
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the
Information pertaining to the requirement to be submitted:
1.
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3.
4.
5.
6.
7.
Submit, by January 27, 2012, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized,
The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:
Public comments and supporting materials related to this document can be found at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the
Information pertaining to the requirement to be submitted:
1.
2.
3.
4.
5.
6.
7.
Submit, by January 27, 2012, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:
The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2011-0263.
Public comments and supporting materials related to this document can be found at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is
Information pertaining to the requirement to be submitted:
1.
2.
3.
4.
5.
6.
7.
Submit, by January 27, 2012, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site:
Public comments and supporting materials related to this document can be found at
Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at (301) 415-6258, or by e-mail to
The application for a license to export high-enriched Uranium has been revised as noted below. Notice of this application was previously published in the
Pursuant to 10 CFR 110.70 (b) “Public Notice of Receipt of an Application,” please take notice that the Nuclear Regulatory Commission (NRC) has received the following request for an export license. Copies of the request are available electronically through ADAMS and can be accessed through the Public Electronic Reading Room (PERR) link
A request for a hearing or petition for leave to intervene may be filed within thirty (30) days after publication of this notice in the
A request for a hearing or petition for leave to intervene may be filed with the NRC electronically in accordance with NRC's E-Filing rule promulgated in August 2007, 72 FR 49139 (Aug. 28, 2007). Information about filing electronically is available on the NRC's public Web site at
In addition to a request for hearing or petition for leave to intervene, written comments, in accordance with 10 CFR 110.81, should be submitted within thirty (30) days after publication of this notice in the
The information concerning this application for an export license follows.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
This document informs the public that an appeal of the closing of the Witten, South Dakota post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioners, and others to take appropriate action.
November 21, 2011: Administrative record due (from Postal Service); December 13, 2011, 4:30 p.m., Eastern Time: Deadline for notices to intervene.
Submit comments electronically by accessing the “Filing Online” link in the banner at the top of the Commission's Web site (
Stephen L. Sharfman, General Counsel, at (202) 789-6820 (case-related information) or
Notice is hereby given that, pursuant to 39 U.S.C. 404(d), the Commission received two petitions for review of the Postal Service's determination to close the Witten post office in Witten, South Dakota. The first petition for review received November 4, 2011, was filed by Mr. & Mrs. Calvin W. Adel. The second petition for review received November 10, 2011, was filed by Cary Long. The earliest postmark date is October 26, 2011. The Commission hereby institutes a proceeding under 39 U.S.C. 404(d)(5) and establishes Docket No. A2012-53 to consider Petitioners' appeal. If Petitioners would like to further explain their position with supplemental information or facts, Petitioners may either file a Participant Statement on PRC Form 61 or file a brief with the Commission no later than December 9, 2011.
After the Postal Service files the administrative record and the Commission reviews it, the Commission may find that there are more legal issues than those set forth above, or that the Postal Service's determination disposes of one or more of those issues. The deadline for the Postal Service to file the applicable administrative record with the Commission is November 21, 2011.
The appeal and all related documents are also available for public inspection in the Commission's docket section. Docket section hours are 8 a.m. to 4:30 p.m., Eastern Time, Monday through Friday, except on Federal government holidays. Docket section personnel may be contacted via electronic mail at
Commission reserves the right to redact personal information which may infringe on an individual's privacy rights from documents filed in this proceeding.
It is ordered:
1. The Postal Service shall file the applicable administrative record regarding this appeal no later than November 21, 2011.
2. Any responsive pleading by the Postal Service to this notice is due no later than November 21, 2011.
3. The procedural schedule listed below is hereby adopted.
4. Pursuant to 39 U.S.C. 505, Tracy Ferguson is designated officer of the Commission (Public Representative) to represent the interests of the general public.
5. The Secretary shall arrange for publication of this notice and order and Procedural Schedule in the
By the Commission.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan provides for the collection and dissemination of last sale and quotation information on options that are traded on the participant exchanges. The nine participants to the OPRA Plan are BATS Exchange, Inc., Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, International Securities Exchange, LLC, NASDAQ OMX BX Inc., NASDAQ OMX PHLX, Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
The purpose of OPRA's Datafeed Policy is to summarize, in one document, OPRA's definition of the term “datafeed” and a summary of information of interest to any prospective Vendor or Professional Subscriber that will receive a datafeed. OPRA requires that Professional Subscribers that receive OPRA datafeeds pay one of two fees, and requires that certain Vendors that receive OPRA datafeeds also pay a fee. OPRA is not proposing to change the amount of these fees in this filing, but rather to clarify the terms that describe when each of them is payable.
As stated in the Policy, OPRA defines a “datafeed” or “bulk datafeed”
OPRA classifies a datafeed recipient as either a “Vendor” or a “Professional Subscriber.” In either case, the datafeed recipient must enter into a contract directly with OPRA. OPRA classifies a datafeed recipient as a “Vendor” if the datafeed recipient intends to further retransmit the datafeed on an “external” basis, that is, to persons not employed by the datafeed recipient. In this case, the datafeed recipient must sign a “Vendor Agreement” with OPRA. A Vendor that receives an uncontrolled retransmission from another OPRA Vendor is sometimes referred to as a “downstream Vendor,” since it is “downstream” in the dissemination of the OPRA market data from the “upstream” Vendor that is sending the data to it. A Vendor that receives a datafeed directly from OPRA's data processor Securities Industry Automation Corporation (“SIAC”) must pay a monthly “Direct Access Fee” to OPRA.
OPRA classifies a datafeed recipient as a “Professional Subscriber” if the
The Policy describes the steps in the process by which OPRA approves a datafeed and the documentation that OPRA requires for each type of datafeed. For a prospective Vendor, the documentation consists of the Vendor Agreement and OPRA's form “Exhibit A” to the Vendor Agreement that has been completed by the entity. For a prospective Professional Subscriber, the documentation consists of the Professional Subscriber Agreement, one of the Riders described above, and OPRA's form “Exhibit A” to the applicable Rider that has been completed by the entity.
The Policy also describes OPRA' s reporting requirements for datafeed distributors and datafeed recipients. Datafeed distributors are required to report any changes in the datafeeds that they distribute on a monthly basis, and datafeed recipients are required to report with respect to their further distribution and use of OPRA data on a monthly basis.
The text of the proposed amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
OPRA designated this amendment as qualified to be put into effect upon filing with the Commission in accordance with clause (i) of paragraph (b)(3) of Rule 608 under the Act.
The Commission may summarily abrogate the amendment within sixty days of its filing and require refiling and approval of the amendment by Commission order pursuant to Rule 608(b)(2) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed OPRA Plan amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend the NYSE Arca Options Fee Schedule (“Fee Schedule”) to more clearly describe the fees and rebates relating to executed Qualified Contingent Cross (“QCC”) orders. The text of the proposed rule change is available at the Exchange, the Commission's Public Reference Room, and
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Fee Schedule to more clearly describe the fees and rebates relating to executed QCC orders. Specifically, the Exchange proposes to memorialize the intent set forth in its rule filing adopting the fee for executed QCC orders, which states that the fees relating to executed QCC orders “will apply to each side of the transaction.”
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan provides for the collection and dissemination of last sale and quotation information on options that are traded on the participant exchanges. The nine participants to the OPRA Plan are BATS Exchange, Inc., Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
OPRA's proposed “Policies with respect to Reporting and Usage-based Vendor Fees” (the “Policies”) are comprised of three sections. The first section describes OPRA policies relating to the reports that OPRA requires in order to determine the fees that are payable to OPRA by Vendors' and Professional Subscribers. The second and third sections describe OPRA policies pertaining to “Usage-based Vendor Fees.”
(1)
• The Professional Subscribers to which the Vendor is providing bulk data feeds of OPRA Data (enabling these Professional Subscribers to act as internal distributors).
• The Professional Subscribers that have entered into Professional Subscriber Agreements directly with OPRA and that have devices and/or User IDs entitled by the Vendors.
• The Professional Subscribers to which the Vendor distributes OPRA data and for whose access it pays OPRA usage-based fees (
• The Non-Professional Subscribers to whom the Vendor distributes OPRA data on a “Per Query” or “meter-based” basis and for whose access it pays OPRA usage-based fees.
• The Non-Professional Subscribers to whom the Vendor distributes OPRA data and for whose access it pays OPRA Nonprofessional Subscriber Fees.
• Any voice-synthesized market data service provided by the Vendor.
Also as described in Section 1, OPRA requires that a Professional Subscriber that is an internal distributor report to OPRA with respect to the devices and User IDs that have .been entitled by the Professional Subscriber to have access to OPRA data.
(2)
Paragraph 2(a) states OPRA's policy with respect to a Vendor that wishes to have access to OPRA data other than in connection with its activities as a Vendor—that is, to have access to OPRA
Paragraph 2(b) states OPRA's policy that a Vendor must report with respect to its dissemination of OPRA data to a Professional Subscriber entirely on either a “meter-based” basis (in which case, the Vendor is responsible for paying Usage-based Vendor Fees for its dissemination of OPRA data to the Professional Subscriber) or on a “device-based” basis (in which case, the Professional Subscriber is responsible for paying device-based fees with respect to the Vendor's dissemination of OPRA data to the Professional Subscriber).
The policy described in paragraph 2(c) states that, if a device or User ID is capable of receiving OPRA information from one Vendor for which a Professional Subscriber pays device-based fees and from a second Vendor for which the second Vendor pays usage-based fees, both types of fees must be paid by the respective payors. OPRA has had a longstanding policy—stated in OPRA's “Policies with respect to Device-Based Fees,”
(3)
• The quote meter must be able to recognize and count “quote packets” and/or “options chains”
○ If the Vendor is “capping” the fee payable by the Vendor for any Nonprofessional Subscriber at the monthly maximum amount stated in OPRA's Fee Schedule, the quote meter needs to be able to count usage only up to the maximum amount.
○ If the Vendor is “capping” the fee payable by the Vendor for any Professional Subscriber at the monthly maximum amount stated in OPRA's Fee Schedule, the quote meter needs to be able to count usage only up to the maximum amount.
• The quote meter must not count usage for any Nonprofessional Subscriber for which the Vendor is paying the Nonprofessional Subscriber Fee. (The service to these Nonprofessional Subscribers is not on a usage basis.)
• The quote meter must count usage separately for each option listed in a portfolio format or a market minder service. (For example, quote packets for a portfolio with five options series would constitute five quote packets.)
• The quote meter must count all “current” OPRA market data (
A Vendor's quote counting system must be able to comply with these requirements if the system is to be able to count quotes in a manner that results in an accurate determination of the Usage-based Vendor Fees that the Vendor owes to OPRA. Section 3 of the Policies provides a more accurate description of these requirements than OPRA's current policy entitled “Auditing” does.
The text of the proposed amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
OPRA designated this amendment as qualified to be put into effect upon filing with the Commission in accordance with clause (i) of paragraph (b)(3) of Rule 608 under the Act.
The Commission may summarily abrogate the amendment within sixty days of its filing and require refiling and approval of the amendment by Commission order pursuant to Rule 608(b)(2) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed OPRA Plan amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to adopt Rule 8.12A
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
On November 7, 2011, the Exchange filed to adopt a Quote Risk Monitor (QRM) rule.
C2 Rules require Market-Makers to maintain continuous electronic quotes.
A Market-Maker's risk in an options class is not limited to the risk in a single series of that class. Rather, a Market-Maker typically is active in quoting in multiple option classes, and each such option class can comprise dozens of individual option series. On C2, trades are automatically effected against a Market-Maker's then current quote. As a result, a Market-Maker faces exposure in all series of a class, requiring that the Market-Maker off-set or otherwise hedge its overall position in a class. The QRM functionality helps Market-Makers limit this overall exposure and risk. Specifically, the functionality permits a Market-Maker to establish parameters in the system to cancel its electronic quotes in all series of an option class until the Market-Maker refreshes those electronic quotes.
Under proposed Rule 8.12A, each Market-Maker that elects to use the functionality would be required to specify two parameters that the QRM Mechanism would use to determine when that Market-Maker's quotes should be cancelled. In particular, each Market-Maker is required to specify a maximum number of contracts for each option class (the “Contract Limit”) and a rolling time period in seconds during which such Contract Limit is to be measured (the “Measurement Interval”).
When the QRM Mechanism determines that the Market-Maker has traded more than the Contract Limit for any option class during any rolling Measurement Interval, the QRM Mechanism automatically cancels all of the Market-Maker's quotes in any series of that option class. By limiting its exposure across series, a Market-Maker is better able to quote aggressively in an option, knowing that the QRM
The Exchange notes that the proposed rule would not relieve a Market-Maker of its obligations to provide continuous electronic quotes under the Exchange rules
The basis under the Securities Exchange Act of 1934 (the “Act”) for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange neither solicited nor received comments on the proposal.
Because the proposed rule change: (i) Does not significantly affect the protection of investors or the public interest; (ii) does not impose any significant burden on competition; and (iii) does not become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Waiver of the operative delay will allow market makers to continue to use the QRM to manage risk associated with providing continuous quotes across a multitude of series and classes and thereby avoid a potentially adverse effect on the C2 market. For these reasons, the Commission designates that the proposed rule change become operative immediately upon filing.
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan provides for the collection and dissemination of last sale and quotation information on options that are traded on the participant exchanges. The nine participants to the OPRA Plan are BATS Exchange, Inc., Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc., NASDAQ Stock Market LLC, NYSE Amex, Inc., and NYSE Arca, Inc.
The purpose of OPRA's Policy with respect to Disaster Recovery Facilities is to address the fees that are payable to OPRA for a disaster recovery facility (a “DR facility”) maintained by an OPRA Vendor or Professional Subscriber.
The Policy states that a Vendor or Professional Subscriber that operates a DR facility at which it needs to have access to OPRA data should be certain that its agreements with OPRA accommodate the DR facility. The Policy states that, if a Vendor or Professional Subscriber operates multiple sites that act as “hot” back-up sites for each other, OPRA will consider the sites not to be DR facilities.
The Policy states that, if a Vendor is operating a DR facility and uses OPRA data at the site for purposes solely associated with operating the DR facility in furtherance of the Vendor's activities as a Vendor, OPRA does not charge fees specifically for the DR facility, with one exception: If the Vendor has a live direct circuit connection to receive OPRA data from OPRA's processor at the DR facility, OPRA's Direct Access Fee is applicable.
With respect to a Professional Subscriber, the Policy states that OPRA's standard Device-Based Fees will be applicable if a Professional Subscriber is operating a DR facility and has devices that are enabled to receive current OPRA data at the facility even when the site is not in actual use, but that these fees will not be applicable if devices at the site are not enabled to receive current OPRA data when the site is inactive. The Policy states that OPRA would not consider a device to be subject to fees if the device is temporarily enabled for current OPRA data solely for testing purposes. The Policy states that, as is the case for a Vendor that has a live direct circuit connection at its DR facility, if a Professional Subscriber has a live direct circuit connection at its DR facility, OPRA's Direct Access Fee will be applicable. Finally, the Policy states that, if devices at a DR facility are enabled to receive current OPRA data during an emergency, those devices will become fee-liable, but that OPRA will provide offsetting credits for devices that are unable to receive current OPRA data at the affected primary site as reasonably demonstrated by the Professional Subscriber to be appropriate in the circumstances.
The text of the proposed amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
OPRA designated this amendment as qualified to be put into effect upon filing with the Commission in accordance with clause (i) of paragraph (b)(3) of Rule 608 under the Act.
The Commission may summarily abrogate the amendment within sixty days of its filing and require refiling and approval of the amendment by Commission order pursuant to Rule 608(b)(2) under the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed OPRA Plan amendment is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Virginia (FEMA-4045-DR), dated 11/17/2011.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 11/17/2011, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 12934B and for economic injury is 12935B.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State ofPennsylvania (FEMA—4030—DR), dated 10/07/2011.
Submit completed loan applications to:U.S. Small Business Administration,Processing and Disbursement Center,14925 Kingsport Road,Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Pennsylvania, dated 10/07/2011, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law (Pub. L.) 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections and new information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Office of Management and Budget,
Social Security Administration, DCRDP,
I. The information collection below is pending at SSA. SSA will submit it to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than January 27, 2012. Individuals can obtain copies of the collection instrument by calling the SSA Reports Clearance Officer at (410) 965-8783 or by writing to the above email address.
II. SSA submitted the information collections below to OMB for clearance. Your comments regarding the information collections would be most useful if OMB and SSA receive them within 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than December 28, 2011. Individuals can obtain copies of the OMB clearance packages by calling the SSA Reports Clearance Officer at (410) 965-8783 or by writing to the above email address.
1.
Because SSA employees are Federal workers exempt from the requirements of the PRA, the burden below is only for SSA contractors.
2.
3.
Notice of request for public comments.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. The purpose of this notice is to allow 60 days for public comment in the
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The Department will accept comments from the public up to 60 days from November 28, 2011.
You may submit comments identified by any of the following methods:
• Persons with access to the Internet may view and comment on this notice by going to the regulations.gov Web site at
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You must include the DS form number (if applicable), information collection title, and OMB control number in any correspondence.
Rick A. Ruth, Deputy Assistant Secretary, Acting, for Private Sector Exchange, U.S. Department of State, SA-5, Floor 5, 2200 C Street NW., Washington, DC 20522-0505; or email at
We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the effective administration of the Summer Work Travel category of the Exchange Visitor Program.
• Evaluate the accuracy of our estimate of the burden of the proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of technology.
This collection of information is needed by the Bureau of Educational and Cultural Affairs in administering the Exchange Visitor Program (J-Visa) under the provisions of the Mutual Educational and Cultural Exchange Act, as amended. Summer Work Travel Job Placement Verification Forms are to be completed by designated program sponsors. A Job Placement Verification Form is required for each Summer Work Travel participant. It will set forth the employer, address of employment site, duties required by the job, whether the Summer Work Travel participant will receive any remuneration for housing and living expenses (and if so, the amount), and estimates of the living expenses and other costs the participants are likely to incur while in the United States. The Form must be signed by the participant, the sponsor, and the third party employer, if a third party organization is used in the conduct of the Summer Work Travel program.
Upon request, Summer Work Travel applicants must present fully executed Job Placement Verification Forms (Form DS-7007) to any Consular Official interviewing them in connection with the issuance of J-1 visas.
The collection will be submitted to the Department by mail or fax as requested by the Department of State during the review of program sponsor files, re-designations, incidents, etc.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of RTCA Special Committee 223 Airport Surface Wireless Communications Eleventh Meeting.
The FAA is issuing this notice to advise the public of a meeting of
The meeting will be held December 6-7th, 2011, from 9 a.m.-5 p.m.
The meeting will be held at Booz Allen Hamilton, 1201 Maryland AvenueSW., Suite 5121B, Washington, DC 20024
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a Special Committee 223, Airport Surface Wireless Communications Meeting. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Announcement of Railroad Safety Advisory Committee (RSAC) Working Group activities.
The FRA is updating its announcement of RSAC's Working Group activities to reflect its current status.
Larry Woolverton, RSAC Designated Federal Officer/Administrative Officer, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6212; or Robert Lauby, Deputy Associate Administrator for Regulatory and Legislative Operations, FRA, 1200 New Jersey Avenue SE., Mailstop 25, Washington, DC 20590, (202) 493-6474.
This notice serves to update FRA's last announcement of working group activities and status reports of December 7, 2010 (75 FR 76070). The 44th full RSAC meeting was held May 20, 2011, and the 45th meeting is scheduled for December 8, 2011, at the National Association of Home Builders, National Housing Center, located at 1201 15th Street NW., Washington, DC 20005.
Since its first meeting in April of 1996, the RSAC has accepted 36 tasks. Status for each of the open tasks (neither completed nor terminated) is provided below:
Engineering Task Force. The Passenger Safety Working Group approved a request from FRA to establish an ETF under the Passenger Safety Working Group in August 2009. The mission of the task force is to produce a set of technical evaluation criteria and procedures for passenger rail equipment built to alternative designs. The technical evaluation criteria and procedures would provide a means of establishing whether an alternative design would result in performance at least equal to the structural design standards set forth in the Passenger Equipment Safety Standards (Title 49 Code of Federal Regulations (CFR) part 238). The initial focus of this effort will be on Tier I standards. When completed, the criteria and procedures would form a technical basis for making determinations concerning equivalent safety pursuant to 49 CFR Section 238.201, and provide a technical framework for presenting evidence to FRA in support of any request for waiver of the compressive (buff) strength requirement, as set forth in 49 CFR 238.203.
Engineering Task Force II. To build on the success of the ETF in developing a set of alternative technical criteria and procedures for evaluating the crashworthiness and occupant protection performance of passenger rail equipment in service at conventional operating speeds, the FRA requested that the Passenger Safety Working Group re-task the group to concentrate on developing crashworthiness and occupant protection safety recommendations for high-speed passenger trains. The Passenger Safety Working Group accepted the task on July 28, 2010, by electronic vote. Under the new task, the task force may address any safety features of the equipment, including but not limited to crashworthiness, interior occupant protection, glazing, emergency egress, and fire safety features. Any type of equipment may be addressed, including conventional locomotives, high-speed power cars, cab cars, multiple-unit (MU) locomotives, and coach cars. The equipment addressed may be used in any type of passenger service, from conventional-speed to high-speed. Recommendations may take the form of criteria and procedures, revisions to existing regulations, or adoption of new regulations, including rules of particular applicability. The work of the re-tasked ETF is intended to assist FRA in developing appropriate safety standards for the high-speed rail projects planned for California. The Engineering Task Force II held a kickoff meeting on October 21-22, 2010, to begin work on the new high-speed task, and had follow-on meetings on January 11-12, 2011, February 14-15 2011, March 30-31, 2011, and June 16-17, 2011. Consensus Tier III recommendations of the ETF have been developed and were accepted by vote during a scheduled meeting on October 6-7, 2011. The ETF II has formed two additional Task Groups to work in the areas of track worthiness and brakes. The Track worthiness Task Group is tasked to identify potential safety issues related to operation of high-speed train sets on conventional track and to make recommendations on how best to mitigate any consequences. The Task Group includes experts and key stakeholders such as international operators of high-speed equipment, car builders, wheel/rail interaction dynamics specialists, and other RSAC working group members involved in vehicle/track interaction. The Brakes Task Group is tasked to review braking system requirements and international braking system requirements verses existing U.S. requirements including inspection and maintenance and identify common features, determine basic parameters and consider use of service proven braking systems. The Task Group will also consider performance based provisions/requirements with consideration for operator's to develop maintenance, inspection, and service plans and make recommendations regarding brakes to the ETF II as related to Tier III. Contact: Robert Lauby, (202) 493-6474.
Emergency Preparedness Task Force. At the working group meeting on March 9-10, 2005, the working group received and approved the consensus report of the Emergency Preparedness Task Force related to emergency communication, emergency egress, and rescue access. These recommendations were presented to and approved by the full RSAC on May 18, 2005. The working group met on September 7-8, 2005, and additional, supplementary recommendations were presented to and accepted by the full RSAC on October 11, 2005. The Notice of Proposed Rulemaking (NPRM) was published on August 24, 2006 (71 FR 50275), and was open for comment until October 23, 2006. The working group agreed upon recommendations for the final rule, including resolution of final comments received, during the April 17-18, 2007, meeting. The recommendations were presented to and approved by the full RSAC on June 26, 2007. The Passenger Train Emergency Systems final rule, focusing on emergency communication, emergency egress, and rescue access, was published on February 1, 2008 (73 FR 6370). The task force met on October 17-18, 2007, and reached consensus on the draft rule text for a followup NPRM on Passenger Train Emergency Systems, focusing on low location emergency exit path marking, emergency lighting, and emergency signage. The task force presented the draft rule text to the Passenger Safety Working Group on December 11-12, 2007, and the consensus draft rule text was presented to, and approved by full RSAC vote during the February 20, 2008, meeting. During the May 13-14, 2008, meeting, the task force recommended clarifying the applicability of back-up emergency communication system requirements in the February 1, 2008, final rule, and FRA announced its intention to exercise limited enforcement discretion for a new provision amending instruction requirements for emergency window exit removal. The working group ratified these recommendations on June 19, 2008. The task force met again on March 31, 2009, to clarify issues related to the followup NPRM raised by members. The modified rule text was presented to and approved by the Passenger Safety Working Group on June 8, 2009. The working group requested that FRA draft
Mechanical Task Force—Completed. Initial recommendations on mechanical issues (revisions to 49 CFR Part 238) were approved by the full RSAC on January 26, 2005. At the working group meeting of September 7-8, 2005, the task force presented additional perfecting amendments and the full RSAC approved them on October 11, 2005. An NPRM was published in the
Crashworthiness Task Force—Completed. Among its efforts, the Crashworthiness Task Force provided consensus recommendations on static-end strength that were adopted by the working group on September 7-8, 2005. The full RSAC accepted the recommendations on October 11, 2005. The front-end strength of cab cars and MU locomotives NPRM was published in the
Vehicle/Track Interaction Task Force. The task force is developing proposed revisions to 49 CFR Parts 213 and 238, principally regarding high-speed passenger service. The task force met on October 9-11, 2007, and again on November 19-20, 2007, in Washington, DC, and presented the final task force report and final recommendations and proposed rule text for approval by the Passenger Safety Working Group at the December 11-12, 2007, meeting. The final report and the proposed rule text were approved by the working group and were presented to and approved by full RSAC vote during the February 20, 2008, meeting. The group met on February 27-28, 2008, and by teleconference on March 18, 2010, to address unresolved issues, and the NPRM was published on May 10, 2010 (75 FR 25928). The task force was called back into session on August 5-6, 2010, to review and consider NPRM comments. The final rule will amend the Track Safety Standards and Passenger Equipment Safety Standards for high-speed train operations and train operations at high cant deficiencies to promote the safe interaction of rail vehicles with the track over which they operate. It will revise both the safety limits for these operations and the process to qualify them. It accounts for a range of vehicle types that are currently used and may likely be used on future high-speed or high cant deficiency rail operations, and would provide safety assurance for train operations in all classes of track. It is based on the results of simulation studies designed to identify track geometry irregularities associated with unsafe wheel forces and acceleration, thorough reviews of vehicle qualification and revenue service test data, and consideration of international practices. The draft final rule was sent to the task force for final consensus on November 11, 2011. The target date set for the final rule is April 2012. Contact: John Mardente, (202) 493-1335.
General Passenger Safety Task Force. At the Passenger Safety Working Group meeting on April 17-18, 2007, the task force presented a progress report to the working group. The task force met on July 18-19, 2007, and afterwards it reported proposed reporting cause codes for injuries involving the platform gap, which were approved by the Working Group by mail ballot in September 2007. The full RSAC approved the recommendations for changes to 49 CFR Part 225 accident/incident cause codes on October 25, 2007. The General Passenger Safety Task Force presented draft guidance material for management of the gap that was considered and approved by the Working Group during the December 11-12, 2007, meeting and was presented to and approved by full RSAC vote during the February 20, 2008, meeting. The group met April 23-24, 2008, December 3-4, 2008, April 21-23, 2009, October 7-8, 2009, and July 30, 2010 by GoTo/Webinar teleconference. The task force continues work on passenger train door securement, “second train in station,” trespasser incidents, and System Safety-based solutions by developing a regulatory approach to System Safety. The task force has created two task groups to focus on these issues.
The Door Safety Task Group has reached consensus on 47 out of 48 safety issues and had five items that have been remanded to the task force for vote. The issues are addressed in the area of passenger train door mechanical and operational requirements and presented draft regulatory language to the Passenger Safety Working Group at the September 16, 2010, meeting. More work remains to ensure the 49 CFR Part 238 door rule consensus document and the proposed American Public Transit Association (APTA) door standard (APTA SS-M-18-10) use uniform language. The document was approved by the Passenger Safety Working Group by electronic vote on March 31, 2011, and approved by the RSAC on May 20, 2011. This rulemaking would amend the passenger equipment safety standards to enhance safety standards as they relate to passenger door securement while a passenger train is in service based on research and experiences of FRA safety inspectors. Specifically, FRA would incorporate by reference APTA standard: “APTA SS-M-18-10 Standard for Powered Exterior Side Door System Design for New Passenger Cars.” A draft NPRM is currently under development with a target publication date of May 2012. No additional Door Task Group meetings are currently scheduled. Contact: Brian Hontz, (610) 521-8220.
The System Safety Task Group has produced draft regulatory language for a System Safety Rule, but further work on this rulemaking is delayed until a study of legal protections for Risk Reduction Program (RRP) and System Safety Program (SSP) risk analysis data that is required by the RSIA is complete. The legal study is expected to be complete by December 2012. The System Safety rulemaking would improve passenger railroad safety through structured, proactive processes and procedures developed by passenger railroad operators. It would require passenger railroads to establish an SSP that would systematically evaluate and manage risks in order to reduce the number and rates of railroad accidents, incidents, injuries, and fatalities. The target date
Physicians Task Force. A Physicians Task Force was established by the working group in May 2007, and tasked to draft recommended medical qualification criteria and protocols for locomotive engineers and conductors. The Physicians Task Force has had meetings or conference calls on July 24, 2007; August 20, 2007; October 15, 2007; October 31, 2007; June 23-24, 2008; September 8-10, 2008; October 8, 2008; November 12-13, 2008; December 8-10, 2008; January 27-28, 2009; February 24-25, 2009; March 11-12, 2009; March 31-April 1, 2009; April 15, 2009; April 22, 2009; May 13, 2009; May 20, 2009; June 17, 2009; January 21-22, 2010; March 3, 2010; August 16-17, 2010; and October 25-26, 2010; December 17, 2010; January 11, 2011; March 3-4, 2011; May 16-17, 2011; August 18, 2011; August 25, 2011; August 31, 2011. On September 1, 2011, the task force notified working group members that it had made significant progress in completing its task and requested that the working group participate in clarifying a limited number of remaining operational issues relevant to the task that merited review by industry management, labor, and other stakeholders. No further meetings of the Physicians Task Force are currently scheduled. Contact: Dr. Bernard Arseneau, (202) 493-6002.
Critical Incident Task Force. The Medical Standards Working Group accepted RSAC Task 2009-02, Critical Incident Response, during the December 8-9, 2010, meeting. The working group has been tasked to provide advice regarding development of implementing regulations for critical incident stress plans as required by the RSIA. A Critical Incident Task Force was established by the working group during the May 24-26, 2010, Medical Standards Working Group meeting. The scheduled kickoff meeting for the Critical Incident Task Force scheduled for September 2, 2010, was postponed at the request of industry participants. In late March 2011, FRA leadership decided to request that the RSAC be asked to amend the Critical Incident task statement to remove reference to the Medical Standards Working Group and to allow the group to assume full working group status to expedite the work. The Committee approved the revised task statement with a target date for recommendations to the Committee of December 2011 and the task force transitioned to the Critical Incident Working Group. (See Critical Incident Working Group entry.) Contact: Dr. Bernard Arseneau, (202) 493-6002.
PTC Implementation Plan Task Force. A task force was formed to assist FRA in developing a model template for a successful PTC Implementation Plan (PTCIP), and in development of an example associated Risk Prioritization Methodology. PTCIPs are required to be submitted by April 16, 2010, under the mandate of the RSIA. FRA posted a final version of a PTCIP template and an example risk prioritization methodology model for prioritization of line segment implementation to the FRA public Web site on January 12, 2010, the same day the final rule was made available for public review. No further meetings of this task force are currently scheduled. Contact: Tom McFarlin, (202) 493-6203.
PTC Risk Evaluation Task Force. The creation of the PTC Risk Evaluation Task Force was approved by the PTC Working Group on April 1, 2010, to develop a computer model to estimate the risk of PTC-preventable accidents on a line segment basis. The group was formed by nominations from members of the PTC Working Group and the kickoff meeting was held via GoTo/Webinar on June 17, 2010. A followup meeting was held on August 3, 2010, and an additional followup GoTo/Webinar meeting was held on September 7, 2010. No additional meetings are scheduled at this time. Contact: Mark Hartong, (202) 493-1332.
Please refer to the notice published in the
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before December 28, 2011.
Comments should refer to docket number MARAD-2011-0152. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W21-203, Washington, DC 20590. Telephone (202) 366-5979, Email
As described by the applicant the intended service of the vessel DAUNTLESS is:
The complete application is given in DOT docket MARAD-2011-0152 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
National Highway Traffic Safety Administration, DOT.
Notice of Petition Grant.
JCA Corporation (JCA)
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), JCA has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of JCA's petition was published, with a 30-day public comment period, on November 9, 2010, in the
For further information on this decision, contact Mr. George Gillespie, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5299, facsimile (202) 366-7002.
JCA estimates that approximately 899,804 Trail America brand Special Trailer “ST” tires that were
JCA states that the noncompliance is that the maximum single load labeling and maximum inflation pressures on the sidewalls of the tires are in English units of “lb” and “psi” only; no Metric units are included as required by paragraph S6.5(d) of FMVSS No. 119.
JCA explained that no property damage or accidents have been reported to it or its customers as a result of the subject noncompliance.
JCA further explains that it has taken steps to correct the noncompliance in future production.
JCA also states that it believes the noncompliance is inconsequential to motor vehicle safety because the affected tires fulfill all other relevant requirements of FMVSS No. 119.
In summation, JCA believes that the described noncompliance is inconsequential to motor vehicle safety, and that its petition, to exempt it from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, should be granted.
While the correct tire inflation pressure is included on the subject tire sidewalls, it is not marked in both English and Metric unit systems on each sidewall as required by S6.5(d). However, because the tire inflation pressure is available and stated correctly on each tire in English units, it is unlikely that a consumer will not find or will misread pressure units due to the noncompliance. Therefore, the tires, as labeled, are likely to achieve the safety purpose of the standard. In the agency's judgment, the subject incorrect labeling of the tire inflation pressure information will have an inconsequential effect on motor vehicle safety.
NHTSA notes that the statutory provisions (49 U.S.C. 30118 (d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the 899,804
In consideration of the foregoing, NHTSA has decided that JCA has met its burden of persuasion that the subject FMVSS No. 119 labeling noncompliances are inconsequential to motor vehicle safety. Accordingly, JCA's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the subject noncompliance under 49 U.S.C. 30118 and 30120.
(49 U.S.C. 30118, 30120: delegations of authority at CFR 1.50 and 501.8)
National Highway Traffic Safety Administration, DOT.
Notice of Petition Grant.
General Motors, LLC (GM),
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), GM has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of GM's petition was published, with a 30-day public comment period, on October 21, 2010, in the
GM described the noncompliance as the absence of the required transmission shift position display for a certain ignition key cylinder position. GM explained that while the key is in the ignition there is a narrow ignition key cylinder position between the “ACC” and “OFF” positions within which the transmission shift lever can be moved and the indicator light that illuminates the transmission shift position display is inoperative. The Company added that this noncompliance only occurs when the engine is not running.
GM additionally stated that in all other ignition activation and operation positions, all of the subject vehicles comply with paragraph S3.1.4.1 of FMVSS No. 102.
GM argued its belief that the subject noncompliance is inconsequential to motor vehicle safety because:
As NHTSA recognized in proposing the standard (53 FR 32409-32411 (August 25, 1988)), the purpose of the display requirement for PRNDM information is to “provide the driver with transmission position information for the vehicle conditions where such information can reduce the likelihood of shifting errors.” Thus, in all but the rarest circumstances, the primary function of the PRNDM display is to inform the driver of gear selection and
With the exception of the absence of the required transmission shift position display for one narrow ignition key cylinder position, the system meets all other applicable requirements of FMVSS No. 102.
GM has no record of any incidents, injuries, owner complaints or field reports related to this noncompliance. GM added that if a customer reports this problem to them and requests a remedy, the Company will replace the ignition switch with a conforming component.
Since this noncompliance only occurs during an atypical operation, the noncompliance is not likely to occur under normal driving conditions. The only circumstance where the noncompliance would appear is if the ignition switch is in the intermediary position between the “OFF” and “ACC” detent positions prior to the interlock. In order for this condition to be present, a driver would have to first move the transmission control to “PARK.” In such a case, there are two possible scenarios for the driver: 1) leaving the vehicle with the key in the ignition or 2) remaining in the vehicle. GM provides the following analysis for both scenarios:
1. The driver exits the vehicle while leaving the key in the ignition:
If the driver attempted to remove the key before exiting the vehicle, the key would not be capable of removal. The doors may also still be locked if they are in the factory default setting to unlock in the “PARK” position.
As required by S5.1.3 of FMVSS No. 114, GM provides an audible warning to the driver that activates whenever the key has been left in the ignition locking system and the driver's door is opened.
The Owner's Manual supplied with the vehicle provides specific warnings and instructions on ensuring the vehicle is in “PARK” and the key is removed before exiting the vehicle.
2. The driver remains in the vehicle:
If the driver remains in the vehicle, he or she would likely either restart the vehicle's engine or attempt to remove the key to exit the vehicle.
If the driver attempts to restart the engine, paragraph S3.1.3 of FMVSS No. 102 requires that the starter be inoperative whenever the vehicle's transmission shift position is in a forward or reverse drive position. The driver rotating the ignition switch forward attempting to start the engine will definitely activate the PRNDM display. Therefore, the PRNDM information will be available to the driver who can see that the vehicle did not start because the transmission was not in “Park” or “Neutral.”
GM says that because both of these situations are addressed by FMVSS requirements, a lack of a transmission shift position display in either of these cases may constitute a minor inconvenience, but will have no consequence to safety. In addition, GM stated that NHTSA has previously granted similar petitions on 3 occasions.
Furthermore, GM also stated the following:
GM recognizes that there may be isolated non-driving situations in which a person may desire to know gear selection or the relative position of the gears with the engine off, such as when placing the vehicle in tow. However, these cases occur infrequently and do not occur during normal ignition activation and vehicle operation. If the subject condition [noncompliance] is present during these infrequent non-driving situations when PRNDM information may be desired, gear selection and relative positioning can easily be determined by rotating the ignition switch slightly clockwise past the accessory “ACC” detent to activate the shift indicator display without starting the vehicle's engine. Given the nature of these non-driving situations and since the information can be readily obtained with a slight key rotation, GM believes that the subject condition [noncompliance] will have no real or implied degradation of motor vehicle safety.
GM also indicated that it has corrected the problem that caused the subject noncompliance so that it cannot reoccur in future production.
In view of the above, GM believes that the described noncompliance is inconsequential and does not present a risk to motor vehicle safety. Thus, GM requests that its petition, to exempt it from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the 462,227
In consideration of the foregoing, NHTSA has decided that GM has met its burden of persuasion that the subject FMVSS No. 102 noncompliance is inconsequential to motor vehicle safety. Accordingly, GM's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the subject noncompliance under 49 U.S.C. 30118 and 30120.
(49 U.S.C. 30118, 30120: delegations of authority at CFR 1.50 and 501.8)
National Highway Traffic Safety Administration, DOT.
Grant of Petition for Decision of Inconsequential Noncompliance.
Goodyear Tire and Rubber Company, (Goodyear),
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Goodyear has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of Goodyear's petition was published, with a 30-day public comment period, on June 25, 2010, in the
For further information on this decision, contact Mr. George Gillespie, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5299, facsimile (202) 366-7002.
Affected are approximately 14,826 sizes P195/55R15 84V and P225/60R16 97H Goodyear brand Arizonian Silver Edition Plus model passenger car tires manufactured between August of 2007 and May of 2009 at Goodyear's plant located in Otrokovice, Czech Republic.
Goodyear explains that the noncompliance is that, due to a mold labeling error, the sidewall marking on the reference side of the tires incorrectly describes the actual number of plies in the tread area of the tires as required by paragraph S5.5(f). Specifically, the tires in question were inadvertently manufactured with “Tread Plies: 2 Polyester + 2 steel.” The labeling should have been “Tread Plies: 2 Polyester + 1 polyamide + 2 steel.
Goodyear also explains that while the non-compliant tires are mislabeled “the tires meet or exceed all applicable Federal Motor Vehicle Safety Standards.”
Goodyear argues that this noncompliance is inconsequential to motor vehicle safety because the noncompliant sidewall marking does not create an unsafe condition and all other labeling requirements have been met.
Goodyear points out that NHTSA has previously granted similar petitions for noncompliances in sidewall marking.
Goodyear additionally states that it has corrected the affected tire molds and all future production will have the correct material shown on the sidewall.
In summation, Goodyear believes that the described noncompliance of its tires to meet the requirements of FMVSS No. 139 is inconsequential to motor vehicle safety, and that its petition, to exempt from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, and should be granted.
The agency also believes the noncompliance will have no measurable effect on the safety of the tire retread, repair, and recycling industries. The use of steel cord construction in the sidewall and tread is the primary safety concern of these industries. In this case, since the tire sidewalls do not contain steel plies, this potential safety concern does not exist.
NHTSA notes that the statutory provisions (49 U.S.C. 30118 (d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the 14,826
In consideration of the foregoing, NHTSA has decided that Goodyear has met its burden of persuasion that the subject FMVSS No. 139 labeling noncompliances are inconsequential to motor vehicle safety. Accordingly, Goodyear's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the subject noncompliance under 49 U.S.C. 30118 and 30120.
(49 U.S.C. 30118, 30120: Delegations of authority at CFR 1.50 and 501.8).
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Request for comments on technical report.
This notice announces NHTSA's publication of a technical report describing relationships between a vehicle's mass, footprint (size), and body type and its rate of involvement in fatal crashes. The report's title is:
Comments must be received no later than January 27, 2012.
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You may call Docket Management at (202) 366-9826.
Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Center for Statistics and Analysis, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590.
Mass reduction while holding a vehicle's footprint (size) constant is a potential strategy for meeting footprint-based CAFE and GHG standards. An important corollary issue is the possible effect of mass reduction that maintains footprint on fatal crashes. One way to estimate these effects is statistical analyses of societal fatality rates per VMT, by vehicles' mass and footprint, for the current on-road vehicle fleet. Societal fatality rates include occupants of all vehicles in the crash as well as pedestrians. The analyses comprised MY 2000-2007 cars and LTVs in CY 2002-2008 crashes. Fatality rates were derived from FARS data, 13 State crash files, and registration and mileage data from R.L. Polk. The table presents the estimated percent increase in societal fatality rates per 100-pound mass reduction while holding footprint constant for five classes of vehicles:
Only the 1.44 percent risk increase in the lighter cars is statistically significant. There are non-significant increases in the heavier cars and the lighter truck-based LTVs and non-significant societal benefits for mass reduction in CUVs, minivans, and the heavier truck-based LTVs. Based on these results, potential combinations of mass reductions that maintain footprint and are proportionately somewhat higher for the heavier vehicles may be safety-neutral or better as point estimates and, in any case, unlikely to significantly increase fatalities. The primarily non-significant results are not due to a paucity of data, but because the societal effect of mass reduction while maintaining footprint, if any, is small.
This preliminary report is currently undergoing peer review. Information about the review is available in Docket No. NHTSA-2010-0152, including the peer-review charge at NHTSA-2010-0152-0024 and the names of the reviewers at NHTSA-2010-0152-0025.
This report updates and supersedes earlier NHTSA reports on vehicle mass, size and fatality risk issued in 2010 (75 FR 25324, Docket No. NHTSA-2010-0152, report available at
NHTSA welcomes public review of the evaluation plan and invites the reviewers to comment about the selection, priority, and schedule of the regulations to be evaluated. The agency is interested in learning of any additional data that may be useful in the evaluations. NHTSA will submit to the Docket a response to the comments and, if appropriate, will supplement or revise the evaluation plan.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the Docket number of this document (NHTSA-2010-0152) in your comments.
Your primary comments must not be more than 15 pages long (49 CFR 553.21). However, you may attach additional documents to your primary comments. There is no limit on the length of the attachments.
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Please send two paper copies of your comments to Docket Management, fax
We also request, but do not require you to send a copy to Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590 (or email them to
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, send three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Include a cover letter supplying the information specified in our confidential business information regulation (49 CFR Part 512).
In addition, send two copies from which you have deleted the claimed confidential business information to U.S. Department of Transportation, Docket Management Facility, M-30, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, or submit them via the Federal eRulemaking Portal.
In our response, we will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
You may read the materials placed in the docket for this document (e.g., the comments submitted in response to this document by other interested persons) at any time by going to
49 U.S.C. 30111, 30168; delegation of authority at 49 CFR 1.50 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Request for comments on technical report.
This notice announces NHTSA's publication of a Technical Report reviewing and evaluating its existing Safety Standard 201,
Comments must be received no later than March 27, 2012.
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You may call Docket Management at (202) 366-9826.
Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Center for Statistics and Analysis, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590.
Federal Motor Vehicle Safety Standard (FMVSS) No. 201—Occupant Protection in Interior Impact—was upgraded in 1995, with a 1998-2003 phase-in, to reduce occupants' risk of head injury from contact with a vehicle's upper interior, including its pillars, roof headers and side rails, and the upper roof. Initially, energy-absorbing materials alone were used to meet the standard. NHTSA
NHTSA issued previous evaluation reports on FMVSS No. 201 in 2006 (72 FR 9074, Docket No. NHTSA-2007-27371, report available at
NHTSA welcomes public review of the technical report. NHTSA will submit to the Docket a response to the comments and, if appropriate, will supplement or revise the report.
Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the Docket number of this document (NHTSA-2011-0168) in your comments.
Your primary comments must not be more than 15 pages long (49 CFR 553.21). However, you may attach additional documents to your primary comments. There is no limit on the length of the attachments.
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Please send two paper copies of your comments to Docket Management, fax them, or use the Federal eRulemaking Portal. The mailing address is U.S. Department of Transportation, Docket Management Facility, M-30, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The fax number is 1-(202) 493-2251. To use the Federal eRulemaking Portal, go to
We also request, but do not require you to send a copy to Charles J. Kahane, Chief, Evaluation Division, NVS-431, National Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington, DC 20590 (or email them to
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, send three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Include a cover letter supplying the information specified in our confidential business information regulation (49 CFR Part 512).
In addition, send two copies from which you have deleted the claimed confidential business information to U.S. Department of Transportation, Docket Management Facility, M-30, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, or submit them via the Federal eRulemaking Portal.
In our response, we will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
You may read the materials placed in the docket for this document (e.g., the comments submitted in response to this document by other interested persons) at any time by going to
49 U.S.C. 30111, 30168; delegation of authority at 49 CFR 1.50 and 501.8.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on Special Permit Applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given of the actions on special permits applications in (January to November 2011). The mode
Issued in Washington, DC, on November 17, 2011.
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before December 28, 2011, to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestion for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or e-mail at
Copies of the submission(s) may be obtained by calling (202) 927-5331, email at
Notice.
Pursuant to United States Code, Title 31, section 5135(b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for November 29, 2011.
Interested persons should call the CCAC HOTLINE at (202) 354-7502 for the latest update on meeting time and room location.
In accordance with 31 U.S.C. § 5135, the CCAC:
• Advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals.
• Advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made.
• Makes recommendations with respect to the mintage level for any commemorative coin recommended.
Andy Fishburn, United States Mint Liaison to the CCAC; 801 9th Street NW., Washington, DC 20220; or call (202) 354-6700.
Any member of the public interested in submitting matters for the CCAC's consideration is invited to submit them by fax to the following number: (202) 756-6525.
31 U.S.C. 5135(b)(8)(C).
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 27, 2012.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 461-9769 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501—3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 27, 2012.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 461-9769 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 28, 2011.
Submit written comments on the collection of information through
Denise McLamb, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461-7485, FAX (202) 461-0966 or email
An agency may not conduct or sponsor, and a person is not required to
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also addresses, implements or discusses certain statutory provisions including provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. In addition, this final rule with comment period discusses payments for Part B drugs; Clinical Laboratory Fee Schedule: Signature on Requisition; Physician Quality Reporting System; the Electronic Prescribing (eRx) Incentive Program; the Physician Resource-Use Feedback Program and the value modifier; productivity adjustment for ambulatory surgical center payment system and the ambulance, clinical laboratory, and durable medical equipment prosthetics orthotics and supplies (DMEPOS) fee schedules; and other Part B related issues.
In commenting, please refer to file code CMS-1524-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-1066 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
Ryan Howe, (410) 786-3355 or Chava Sheffield, (410) 786-2298, for issues related to the physician fee schedule practice expense methodology and direct practice expense inputs.
Elizabeth Truong, (410) 786-6005, or Sara Vitolo, (410) 786-5714, for issues related to potentially misvalued services and interim final work RVUs.
Ken Marsalek, (410) 786-4502, for issues related the multiple procedure payment reduction and pathology services.
Sara Vitolo, (410) 786-5714, for issues related to malpractice RVUs.
Michael Moore, (410) 786-6830, for issues related to geographic practice cost indices.
Ryan Howe, (410) 786-3355, for issues related to telehealth services.
Elizabeth Truong, (410) 786-6005, for issues related to the sustainable growth rate, or the anesthesia or physician fee schedule conversion factors.
Bonny Dahm, (410) 786-4006, for issues related to payment for covered outpatient drugs and biologicals.
Glenn McGuirk, (410) 786-5723, for issues related to the Clinical Laboratory Fee Schedule (CLFS) signature on requisition policy.
Claudia Lamm, (410) 786-3421, for issues related to the chiropractic services demonstration budget neutrality issue.
Jamie Hermansen, (410) 786-2064, or Stephanie Frilling, (410) 786-4507 for issues related to the annual wellness visit.
Christine Estella, (410) 786-0485, for issues related to the Physician Quality Reporting System, incentives for Electronic Prescribing (eRx) and Physician Compare.
Gift Tee, (410) 786-9316, for issues related to the Physician Resource Use Feedback Program and physician value modifier.
Stephanie Frilling, (410) 786-4507 for issues related to the 3-day payment window.
Pam West, (410) 786-2302, for issues related to the technical corrections or the therapy cap.
Rebecca Cole or Erin Smith, (410) 786-4497, for issues related to physician payment not previously identified.
(1) The interim final work, practice expense, and malpractice RVUs (including the physician time, direct practice expense (PE) inputs, and the equipment utilization rate assumption) for new, revised, potentially misvalued, and certain other CY 2012 HCPCS codes. These codes and their CY 2012 interim final RVUs are listed in Addendum C to this final rule with comment period.
(2) The physician self-referral designated health services codes listed in Tables 83 and 84.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-(800) 743-3951.
To assist readers in referencing sections contained in this preamble, we are providing a table of contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations (CFR). Information on the regulations' impact appears throughout the preamble and, therefore, is not discussed exclusively in section IX. of this final rule with comment period.
In addition, because of the many organizations and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order as follows:
In the past, the Addenda referred to throughout the preamble of our annual PFS proposed and final rules with comment period were included in the printed
Throughout this final rule with comment period, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2010 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The Act requires that payments under the physician fee schedule (PFS) are based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians' services was based on reasonable charges. We note that throughout this final rule with comment period, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (such as physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives, psychologists, or clinical social workers) that are permitted to furnish and bill Medicare under the PFS for their services.
The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101-239), and OBRA 1990, (Pub. L. 101-508). The final rule, published on November 25, 1991 (56 FR 59502), set forth the fee schedule for payment for physicians' services beginning January 1, 1992. Initially, only the physician work RVUs were resource-based, and the PE and malpractice RVUs were based on average allowable charges.
The physician work RVUs established for the implementation of the fee schedule in January 1992 was developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original physician work RVUs for most codes in a cooperative agreement with the Department of Health and Human Services (DHHS). In constructing the code-specific vignettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the Federal government, and obtained input from numerous physician specialty groups.
Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value guide, with appropriate adjustment of the conversion factor (CF), in a manner to assure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. We established a separate CF for anesthesia services, and we continue to utilize time units as a factor in determining payment for these services. As a result, there is a separate payment methodology for anesthesia services.
We establish physician work RVUs for new and revised codes based, in part, on our review of recommendations received from the American Medical Association's (AMA's) Specialty Society Relative Value Update Committee (RUC).
Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians service beginning in 1998. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based PE RVUs to resource-based RVUs.
We established the resource-based PE RVUs for each physician's service in a final rule with comment period, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, resource-based PE RVUs did not become fully effective until 2002.
This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data and the AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysician health professionals (for example, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician's service in both the office setting and out-of-office setting. We have since refined and revised these inputs based on recommendations from the AMA RUC. The AMA's SMS data provided aggregate specialty-specific information on hours worked and PEs.
Separate PE RVUs are established for procedures that can be performed in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department (HOPD). The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of providing the service, apart from payment under the PFS. The nonfacility RVUs reflect all
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the
In the calendar year (CY) 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007 and provided for a 4-year transition for the new PE RVUs under this new methodology. This transition ended in CY 2010 and direct PE RVUs are calculated in CY 2012 using this methodology, unless otherwise noted.
In the CY 2010 PFS final rule with comment period (74 FR 61749), we updated the PE/hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties. For this update, we used the Physician Practice Information Survey (PPIS) conducted by the AMA. The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) using a survey instrument and methods highly consistent with those of the SMS and the supplemental surveys used prior to CY 2010. We note that in CY 2010, for oncology, clinical laboratories, and independent diagnostic testing facilities (IDTFs), we continued to use the supplemental survey data to determine practice expense per hour (PE/HR) values (74 FR 61752). Beginning in CY 2010, we provided for a 4-year transition for the new PE RVUs using the updated PE/HR data. In CY 2012, the third year of the transition, PE RVUs are calculated based on a 75/25 blend of the new PE RVUs developed using the PPIS data and the previous PE RVUs based on the SMS and supplemental survey data.
Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based malpractice RVUs for services furnished on or after CY 2000. The resource-based malpractice RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice insurance premium data collected from commercial and physician-owned insurers from all the States, the District of Columbia, and Puerto Rico. In the CY 2010 PFS final rule with comment period (74 FR 61758), we implemented the Second Five-Year Review and update of the malpractice RVUs. In the CY 2011 PFS final rule with comment period, we described our approach for determining malpractice RVUs for new or revised codes that become effective before the next Five-Year Review and update (75 FR 73208). Accordingly, to develop the CY 2012 malpractice RVUs for new or revised codes we crosswalked the new or revised code to the malpractice RVUs of a similar source code and adjusted for differences in work (or, if greater, the clinical labor portion of the fully implemented PE RVUs) between the source code and the new or revised code.
Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less often than every 5-years. The First Five-Year Review of Work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The Second Five-Year Review of Work RVUs was published in the CY 2002 PFS final rule with comment period (66 FR 55246) and was effective in 2002. The Third Five-Year Review of Work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. The Fourth Five-Year Review of Work RVUs was initiated in the CY 2010 PFS final rule with comment period where we solicited candidate codes from the public for this review (74 FR 61941). Proposed revisions to work RVUs and corresponding changes to PE and malpractice RVUs affecting payment for physicians' services for the Fourth Five-Year Review of Work RVUs were published in a separate
In 1999, the AMA RUC established the Practice Expense Advisory Committee (PEAC) for the purpose of refining the direct PE inputs. Through March 2004, the PEAC provided recommendations to CMS for over 7,600 codes (all but a few hundred of the codes currently listed in the AMA's Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new bottom-up methodology for determining resource-based PE RVUs and transitioned the new methodology over a 4-year period. A comprehensive review of PE was undertaken prior to the 4-year transition period for the new PE methodology from the top-down to the bottom-up methodology, and this transition was completed in CY 2010. In CY 2010, we also incorporated the new PPIS data to update the specialty-specific PE/HR data used to develop PE RVUs, adopting a 4-year transition to PE RVUs developed using the PPIS data.
In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the First Five-Year Review of the malpractice RVUs (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). The Second Five-Year Review and update of resource-based malpractice RVUs was published in the CY 2010 PFS final rule with comment period (74 FR 61758) and was effective in CY 2010.
In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by section 3134 of the Affordable Care Act, which requires the agency to periodically identify, review and adjust values for potentially misvalued codes with an emphasis on the following categories: (1) Codes and families of codes for which there has been the fastest growth; (2) codes or families of codes that have experienced substantial changes in practice expenses; (3) codes that are recently established for new technologies or services; (4) multiple codes that are frequently billed in conjunction with furnishing a single service; (5) codes with low relative values, particularly those that are often billed multiple times for a single treatment; (6) codes which have not been subject to review
Budget neutrality typically requires that expenditures not increase or decrease as a result of changes or revisions to policy. However, section 1848(c)(2)(B)(ii)(II) of the Act requires adjustment only if the change in expenditures resulting from the annual revisions to the PFS exceeds a threshold amount. Specifically, adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.
To calculate the payment for every physician's service, the components of the fee schedule (physician work, PE, and malpractice RVUs) are adjusted by geographic practice cost indices (GPCIs). The GPCIs reflect the relative costs of physician work, PE, and malpractice in an area compared to the national average costs for each component.
RVUs are converted to dollar amounts through the application of a CF, which is calculated by CMS' Office of the Actuary (OACT).
The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:
The CY 2011 PFS final rule with comment period (75 FR 73170) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized many of the CY 2010 interim RVUs and implemented interim RVUs for new and revised codes for CY 2011 to ensure that our payment systems are updated to reflect changes in medical practice and the relative values of services. The CY 2011 PFS final rule with comment period also addressed other policies, as well as certain provisions of the Affordable Care Act and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
In the CY 2011 PFS final rule with comment period, we announced the following for CY 2011: the total PFS update of −10.1 percent; the initial estimate for the sustainable growth rate of −13.4 percent; and the conversion factor (CF) of $25.5217. These figures were calculated based on the statutory provisions in effect on November 2, 2010, when the CY 2011 PFS final rule with comment period was issued.
On December 30, 2010, we published a correction notice (76 FR 1670) to correct several technical and typographical errors that occurred in the CY 2011 PFS final rule with comment period. This correction notice announced a revised CF for CY 2011 of $25.4999, which was in accordance with the statutory provisions in effect as of November 2, 2010, the date the CY 2011 PFS final rule with comment period was issued.
On November 30, 2010, the Physician Payment and Therapy Relief Act of 2010 (PPATRA) (Pub. L. 111-286) was signed into law. Section 3 of Pub. L. 111-286 modified the policy finalized in the CY 2011 PFS final rule with comment period (75 FR 73241), effective January 1, 2011, regarding the payment reduction applied to multiple therapy services provided to the same patient on the same day in the office setting by one provider and paid for under the PFS (hereinafter, the therapy multiple procedure payment reduction (MPPR)). The PPATRA provision changed the therapy MPPR percentage from 25 to 20 percent of the PE component of payment for the second and subsequent “always” therapy services furnished in the office setting on the same day to the same patient by one provider, and excepted the payment reductions associated with the therapy MPPR from budget neutrality under the PFS.
On December 15, 2010, the Medicare and Medicaid Extenders Act of 2010 (MMEA) (Pub. L. 111-309) was signed into law. Section 101 of the MMEA provided for a 1-year zero percent update for the CY 2011 PFS. As a result of the MMEA, the CY 2011 PFS conversion factor was revised to $33.9764.
Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, required us to develop a methodology for a resource-based system for determining PE RVUs for each physician's service. We develop PE RVUs by looking at the direct and indirect physician practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. In addition, we note that section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. Therefore, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed history of the PE methodology.
We use a bottom-up approach to determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide each service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the AMA RUC. For a detailed explanation of the bottom-up direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
We use survey data on indirect practice expenses incurred per hour worked in developing the indirect
The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and healthcare professional groups. We believe the PPIS is the most comprehensive source of PE survey information available to date. Therefore, we used the PPIS data to update the PE/HR data for almost all of the Medicare-recognized specialties that participated in the survey for the CY 2010 PFS.
When we changed over to the PPIS data beginning in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we finalized a 4-year transition (75 percent old/25 percent new for CY 2010, 50 percent old/50 percent new for CY 2011, 25 percent old/75 percent new for CY 2012, and 100 percent new for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data.
Section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1848(c)(2)(H)(i) of the Act, which requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.
We do not use the PPIS data for reproductive endocrinology, sleep medicine, and spine surgery since these specialties are not separately recognized by Medicare, nor do we have a method to blend these data with Medicare-recognized specialty data.
Supplemental survey data on independent labs, from the College of American Pathologists, were implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for medical oncology, independent laboratories, and IDTFs were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data.
Previously, we have established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other with respect to physician time.
For registered dietician services, the resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).
There are four specialties whose utilization data will be newly incorporated into ratesetting for CY 2012. We proposed to use proxy PE/HR values for these specialties by crosswalking values from other, similar specialties as follows: Speech Language Pathology from Physical Therapy; Hospice and Palliative Care from All Physicians; Geriatric Psychiatry from Psychiatry; and Intensive Cardiac Rehabilitation from Cardiology. Additionally, since section 1833(a)(1)(K) of the Act (as amended by section 3114 of the Affordable Care Act) requires that payment for services provided by a certified nurse midwife be paid at 100 percent of the PFS amount, this specialty will no longer be excluded from the ratesetting calculation. We proposed to crosswalk the PE\HR data from Obstetrics/gynecology to Certified Nurse Midwife. These proposed changes were reflected in the “PE HR” file available on the CMS Web site under the supporting data files for the CY 2012 PFS proposed rule at
After consideration of the public comments we received, we are finalizing our CY 2012 proposals to update the PE/HR data as reflected in the “PE HR” file available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2012 is the third year of the 4-year transition to the PE RVUs calculated using the PPIS data.
To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplies) typically required to provide the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.
Section II.A.2.b. of this final rule with comment period describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the physician work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is described as follows:
• For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that perform the service to determine an initial indirect allocator. For example, if the direct portion of the PE RVUs for a given service were 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that performed the service, the initial indirect allocator would be 6.00 since 2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00.
• We then add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 6.00 plus 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
• We next incorporate the specialty-specific indirect PE/HR data into the calculation. As a relatively extreme example for the sake of simplicity, assume in our previous example that, based on the survey data, the average indirect cost of the specialties performing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties performing the second service with an indirect allocator of 5.00. In this case, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.
For procedures that can be furnished in a physician's office, as well as in a hospital or facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because Medicare makes a separate payment to the facility for its costs of furnishing a service, the facility PE RVUs are generally lower than the nonfacility PE RVUs.
Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), each of which may be performed independently or by different providers, or they may be performed together as a “global” service. When services have PC and TC components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)
For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).
First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data from the surveys.
Sum the costs of each direct input.
Apply a scaling adjustment to the direct inputs.
Create indirect allocators.
There are two situations where this formula is modified:
• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.
• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs.
For presentation purposes in the examples in Table 2, the formulas were divided into two parts for each service.
• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
• The second part is either the work RVUs, clinical PE RVUs, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).
Apply a scaling adjustment to the indirect allocators.
Calculate the indirect practice cost index.
The final PE BN adjustment is calculated by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” later in this section.)
• Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1. We note that since specialty code 97 (physician assistant) is paid at a percentage of the PFS and therefore excluded from the ratesetting calculation, this specialty has been added to the table for CY 2012.
• Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
• Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
• Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
• Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.
• Work RVUs: The setup file contains the work RVUs from this final rule with comment period.
The equipment cost per minute is calculated as:
In addition to examining the interest rate assumption, the RUC requested that CMS review the assumptions regarding useful life of equipment and yearly maintenance costs associated with maintaining high cost equipment and allow for comment on the methodologies used in developing these assumptions.
In this section, we discuss other specific CY 2012 proposals and changes related to direct PE inputs. The changes we proposed and are finalizing are included in the proposed CY 2012 direct PE database, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
It came to our attention that the minutes allocated for two particular equipment items have been inverted. This inversion affected three codes: 37232 (Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal angioplasty (List separately in addition to code for primary procedure)), 37233 (Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with atherectomy, includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)), and 37234 (Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)). In each case, the number of minutes allocated to the “printer, dye sublimation (photo, color)” (ED031) should have been appropriately allocated to the “stretcher” (EF018). The number of minutes allocated to the stretcher should have been appropriately allocated to the printer. Therefore, we proposed input corrections to the times associated with the two equipment items in the three codes.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to modify the direct PE database by correcting the input errors associated with the two equipment items in the three codes. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
We recently identified a number of CPT codes with inadvertently duplicated labor and supply inputs in the PE database. We proposed to remove the duplicate labor and supply inputs in the CY 2012 database as detailed in Table 3.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to remove the duplicate labor and supply inputs in the CY 2012 database as detailed in Table 3. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
For services described by certain codes, the direct PE database includes nonfacility inputs that reflect the assumption that moderate sedation is inherent in the procedure. These codes
• Clinical Labor Inputs: Registered Nurse (L051A) time that includes two minutes of time to initiate sedation, the number of minutes associated with the physician intra-service work time, and 15 minutes for every hour of patient recovery time for post-service patient monitoring. Supply Inputs: “Pack, conscious sedation” (SA044) that includes: an angiocatheter 14g-24g, bandage, strip 0.75in × 3in, catheter, suction, dressing, 4in × 4.75in (Tegaderm), electrode, ECG (single), electrode, ground, gas, oxygen, gauze, sterile 4in × 4in, gloves, sterile, gown, surgical, sterile, iv infusion set, kit, iv starter, oxygen mask (1) and tubing (7ft), pulse oximeter sensor probe wrap, stop cock, 3-way, swab-pad, alcohol, syringe 1ml, syringe-needle 3ml 22-26g, tape, surgical paper 1in (Micropore), tourniquet, and non-latex 1in × 18in.
• Equipment Inputs: “Table, instrument, mobile” (EF027), “ECG, 3-channel (with SpO2, NIBP, temp, resp)” (EQ011), “IV infusion pump” (EQ032), “pulse oxymetry recording software (prolonged monitoring)” (EQ212), and “blood pressure monitor, ambulatory, w-battery charger” (EQ269).
We have reviewed this recommendation and generally agree with these inputs. However, we note that the equipment item “ECG, 3-channel (with SpO2, NIBP, temp, resp)” (EQ011) incorporates the functionality of the equipment items “pulse oxymetry recording software (prolonged monitoring)” (EQ212), and “blood pressure monitor, ambulatory, w-battery charger” (EQ269). Therefore, we did not include these two items as standard nonfacility inputs for moderate sedation in our proposal to accept the AMA RUC recommendation with the refinement as stated.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to accept the AMA RUC recommendation with the refinement as stated. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking beginning with the CY 2012 PFS final rule with comment period.
During 2010, we received a request to update the price of “tray, bone marrow biopsy-aspiration” (SA062) from $24.27 to $34.47. The request included multiple invoices that documented updated prices for the supply item. We also received a request to update the useful life of “holter monitor” (EQ127) from 7 years to 5 years, based on its entry in the AHA's publication, ”Estimated Useful Lives of Depreciable Hospital Assets,” which we use as a standard reference. In each of these cases, we proposed to accept the updated inputs, as requested. The CY 2012 direct PE database reflects these proposed changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to accept the updated inputs, as requested. The CY 2012 direct PE database reflects these changes and is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
When creating G codes, we often develop work, PE, and malpractice RVUs by crosswalking the RVUs from similar (reference) codes. In most of these cases, the PE RVUs are directly crosswalked pending the availability of utilization data. Once that data is available, we crosswalk the direct PE inputs and develop PE RVUs using the regular practice expense methodology, including allocators that are derived from utilization data. For CY 2012, we are using this process to develop PE RVUs for the following services: G0245 (Initial physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) which must include: (1) The diagnosis of LOPS, (2) a patient history, (3) a physical examination that consists of at least the following elements: (a) Visual inspection of the forefoot, hindfoot and toe web spaces, (b) evaluation of a protective sensation, (c) evaluation of foot structure and biomechanics, (d) evaluation of vascular status and skin integrity, and (e) evaluation and recommendation of footwear and (4) patient education); G0246 (Follow-up physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) to include at least the following: (1) A patient history, (2) a physical examination that includes: (a) Visual inspection of the forefoot, hindfoot and toe web spaces, (b) evaluation of protective sensation, (c) evaluation of foot structure and biomechanics, (d) evaluation of vascular status and skin integrity, and (e) evaluation and recommendation of footwear, and (3) patient education); G0247 (Routine foot care by a physician of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) to include, the local care of superficial wounds (for example, superficial to muscle and fascia) and at least the following if present: (1) Local care of superficial wounds, (2) debridement of corns and calluses, and (3) trimming and debridement of nails); G0341 (Percutaneous islet cell transplant, includes portal vein catheterization and infusion); G0342 (Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion); G0343 (Laparotomy for islet cell transplant, includes portal vein catheterization and infusion); and G0365 (Vessel mapping of vessels for hemodialysis access (services for preoperative vessel mapping prior to creation of hemodialysis access using an autogenous hemodialysis conduit, including arterial inflow and venous outflow)). The values in Addendum B reflect the updated PE RVUs.
In addition, there is a series of G-codes describing surgical pathology services with PE RVUs historically valued outside of the regular PE methodology. These codes are: G0416 (Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 1-20 specimens); G0417 (Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to develop PE RVUs through the methodologies explained in the proposal. The final CY 2012 RVUs for these codes are displayed in Addendum B to this final rule with comment period.
As we describe in section II.A.2.f. of this final rule with comment period, in creating the indirect practice cost index, we calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service across all services performed by the specialty.
During a review of the physician time data for the CY 2012 PFS rulemaking, we noted an anomaly regarding the physician time allotted to a series of group service codes that are listed in Table 5. We believe that the time associated with these codes reflects the typical amount of time spent by the practitioner in furnishing the group service. However, because the services are billed per patient receiving the service, the time for these codes should be divided by the typical number of patients per session. In reviewing the data used in the valuation of work RVUs for these services, we noted that in one vignette for these services, the typical group session consisted of 6 patients. Therefore we proposed adjusted times for these services based on 6 patients. However, we sought comment on the typical number of patients seen per session for each of these services.
We appreciate all of the comments regarding this proposal. In the following paragraphs, we address how we will use this submitted information in order to set final time values for these codes—
• 90849 (Multiple-family group psychotherapy);
• 90853 (Group psychotherapy (other than of a multiple-family group); and
• 90857 (Interactive group psychotherapy).
We believe that the typical group session may be similar for 90857 based on similar code descriptors, work RVUs, and clinical vignettes. Therefore, pending new recommendations from the AMA RUC, we believe it would be appropriate to establish physician time for this code as 3 pre-service minutes, 9 intra-service minutes, and 10 post-service minutes with the understanding that the total resulting minutes is the product of these and the number of patients in the group.
For 90849, we believe that it would be most appropriate to wait for the new recommendations prior to adjusting the physician time because the typical group size and typical patient size is different, and we received no information regarding the typical group size.
• 92508 (Treatment of speech, language, voice, communication, and/or auditory processing disorder; group, 2 or more individuals)
• 96153 (Health and behavior intervention, each 15 minutes, face-to-face; group (2 or more patients))
• 97150 (Therapeutic procedure(s), group (2 or more individuals))
• 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes)
• G0109 (Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes)
• G0271 (Medical nutrition therapy, reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition, or treatment regimen (including additional hours needed for renal disease), group (2 or more individuals), each 30 minutes), and G0421 (Face-to-face educational services related to the care of chronic kidney disease; group, per session, per one hour)
We received no comments regarding the typical group time for these services. However, given the similarities of these services to CPT code 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes), we believe it would be appropriate to use the times for that code as a reasonable crosswalk and establish physician time for these codes as 2 pre-service minutes, 6 intra-service minutes, and 2 post-service minutes with the understanding that the total resulting minutes is the product of these and the number of patients in the group.
After consideration of the public comments and related information, we are finalizing our proposed updates to the physician time file, as amended for certain codes as explicitly addressed in this section. The final time values for these codes can be found in the final CY 2012 Physician Time file, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS proposed rule at
As a result of our review, we also proposed to update our physician time file to reflect the physician time associated with certain G-codes that had previously been missing from the file.
We received no comments regarding our proposal to update the physician time file to reflect the physician time associated with the G-codes that were previously missing from the file. Therefore, we are finalizing our updates to the physician time file. The final time values can be found in the final CY 2012 Physician Time file, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS proposed rule at
As discussed in section I. of this final rule with comment period, in order to value services under the PFS, section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: work, practice expense (PE), and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to include “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” Additionally, the statute provides that the work component shall include activities that occur before and after direct patient contact. Furthermore, the statute specifies that with respect to surgical procedures, the valuation of the work component for the code must reflect a “global” concept in which pre-operative and post-operative physicians' services related to the procedure are also included.
In addition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.” As discussed in detail in sections I.A.2. and I.A.3. of this final rule with comment period, the statute also defines the PE and malpractice components and provides specific guidance in the calculation of the RVUs for each of these components. Section 1848(c)(1)(B) of the Act defines the PE component as “the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.”
Section 1848(c)(2)(C)(ii) of the Act specifies that the “Secretary shall determine a number of practice expense relative value units for the services for years beginning with 1999 based on the relative practice expense resources involved in furnishing the service.” Furthermore, section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. On March 23, 2010, the Affordable Care Act was enacted, further requiring the Secretary to periodically identify and review potentially misvalued codes, and make appropriate adjustments to the relative values of those services identified as being potentially misvalued. Section 3134(a) of the Affordable Care Act added a new section 1848(c)(2)(K) to the Act which requires the Secretary to periodically identify potentially misvalued services using certain criteria, and to review and make appropriate adjustments to the relative values for those services. Section 3134(a) of the Affordable Care Act also added a new section 1848(c)(2)(L) to the Act which requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, identified using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.
As discussed in section I.A.1. of this final rule with comment period, we generally establish physician work RVUs for new and revised codes based on our review of recommendations received from the American Medical Association Specialty Society Relative Value Scale Update Committee (AMA RUC). We also receive recommendations from the AMA RUC regarding direct PE inputs for services, which we evaluate in order to develop the PE RVUs under the PFS. The AMA RUC also provides recommendations to us on the values for codes that have been identified as potentially misvalued. To respond to concerns expressed by MedPAC, the Congress, and other stakeholders regarding accurate valuation of services under the PFS, the AMA RUC created the Five-Year Review Identification Workgroup in 2006. In addition to providing recommendations to us for work RVUs and physician times, the AMA RUC's Practice Expense Subcommittee reviews direct PE inputs (clinical labor, medical supplies, and medical equipment) for individual services.
In accordance with section 1848(c) of the Act, we determine appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC and MedPAC, explain the basis of these adjustments, and respond to public comments in the PFS proposed and final rules. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available, in addition to taking into account the results of consultations with organizations representing physicians.
In its March 2006 Report to the Congress, MedPAC noted that “misvalued services can distort the price signals for physicians' services as well as for other health care services that physicians order, such as hospital services.” In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time for a number of reasons: For example, MedPAC stated, “when a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” That is, the amount of physician work needed to furnish an existing service may decrease when new technologies are incorporated. Services can also become overvalued when practice expenses decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently, reducing its cost per use. Likewise, services can become undervalued when physician work increases or practice expenses rise. In the ensuing years since MedPAC's 2006 report, additional groups of potentially misvalued services have been identified by the Congress, CMS, MedPAC, the AMA RUC, and other stakeholders.
In recent years CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. As MedPAC noted in its March 2009 Report to the Congress, in the intervening years since MedPAC made the initial recommendations, “CMS and the AMA RUC have taken several steps to improve the review process.” Most recently, section 1848(c)(2)(K)(ii) of the Act (as added by section 3134(a) of the Affordable Care Act) directed the Secretary to specifically examine, as determined appropriate, potentially misvalued services in seven categories as follows:
• Codes and families of codes for which there has been the fastest growth.
• Codes and families of codes that have experienced substantial changes in practice expenses.
• Codes that are recently established for new technologies or services.
• Multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes which have not been subject to review since the implementation of the RBRVS (the so-called `Harvard-valued codes').
• Other codes determined to be appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of the RVUs with the periodic review described in section 1848(c)(2)(B) of the Act. Finally, section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) which may include consolidation of individual services into bundled codes for payment under the physician fee schedule.
Over the last several years, CMS, in conjunction with the AMA RUC, has identified and reviewed numerous potentially misvalued codes in all seven of the categories specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years, consistent with the new legislative requirements on this issue. In the current process, we request the AMA RUC to review potentially misvalued codes that we identify and to make recommendations on revised work RVUs and/or direct PE inputs for those codes to us. The AMA RUC, through its own processes, also might identify and review potentially misvalued procedures. We then assess the recommended revised work RVUs and/or direct PE inputs and, in accordance with section 1848(c) of the Act, we determine if the recommendations constitute appropriate adjustments to the RVUs under the PFS.
Since CY 2009, as a part of the annual potentially misvalued code review, we have reviewed over 700 potentially misvalued codes to refine work RVUs and direct PE inputs in addition to continuing the comprehensive Five-Year Review process. We have adopted appropriate work RVUs and direct PE inputs for these services as a result of these reviews.
Our prior reviews of codes under the potentially misvalued codes initiative have included codes in all seven categories specified in section 1848(c)(2)(K)(ii) of the Act. That is, we have reviewed and assigned more appropriate values to certain—
• Codes and families of codes for which there has been the fastest growth;
• Codes and families of codes that have experienced substantial changes in practice expenses;
• Codes that were recently established for new technologies or services;
• Multiple codes that are frequently billed in conjunction with furnishing a single service;
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment;
• Codes which had not been subject to review since the implementation of the RBRVS (`Harvard valued'); and
• Codes potentially misvalued as determined by the Secretary.
In this last category, we have previously proposed policies in CYs 2009, 2010, and 2011, and requested that the AMA RUC review codes for which there have been shifts in the site-of-service (that is, codes that were originally valued as being furnished in the inpatient setting, but that are now predominantly furnished on an outpatient basis), as well as codes that qualify as “23-hour stay” outpatient services (these services typically have lengthy hospital outpatient recovery periods). We note that a more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2011 PFS final rule with comment period (75 FR 73215 through 73216).
In CY 2011, we identified additional codes under section 1848(c)(2)(K)(ii) of the Act that we believe are ripe for review and referred them to the AMA RUC (75 FR 73215 through 73216). Specifically, we identified potentially misvalued codes in the category of “Other codes determined to be appropriate by the Secretary,” referring lists of codes that have low work RVUs but that are high volume based on claims data, as well as targeted key
Since the publication of the CY 2011 PFS final rule with comment period, we released the Fourth Five-Year Review of Work (76 FR 32410), which discussed the identification and review of an additional 173 potentially misvalued codes. We initiated the Fourth Five-Year Review of work RVUs by soliciting public comments on potentially misvalued codes for all services included in the CY 2010 PFS final rule with comment period that was published in the
In summary, since CY 2009, CMS and the AMA RUC have addressed a number of potentially misvalued codes. For CY 2009, the AMA RUC recommended revised work values and/or PE inputs for 204 misvalued services (73 FR 69883). For CY 2010, an additional 113 codes were identified as misvalued and the AMA RUC provided us new recommendations for revised work RVUs and/or PE inputs for these codes to us as discussed in the CY 2010 PFS final rule with comment period (74 FR 61778). For CY 2011, CMS reviewed and adopted more appropriate values for 209 codes under the annual review of potentially misvalued codes. For CY 2012, we recently released the Fourth Five-Year Review of Work, which discussed the review of 173 potentially misvalued codes and proposed appropriate adjustments to RVUs. In section II.B.5.of this final rule with comment period, we also provide a list of codes identified for future consideration as part of the potentially misvalued codes initiative, that is, in addition to the codes that are part of the Fourth Five-Year Review of Work, as discussed in that section, we are requesting the AMA RUC review these codes and submit recommendations to us.
In addition to identifying and reviewing potentially misvalued codes, section 3134(a) of the Affordable Care Act added a new section 1848(c)(2)(L) of the Act, which specifies that the Secretary shall establish a formal process to validate RVUs under the PFS. The validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-, and intra-service components of work. The Secretary is directed to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848(c)(2)(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068), we solicited public comments on possible approaches and methodologies that we should consider for a validation process. We received a number of comments regarding possible approaches and methodologies for a validation process. As discussed in the CY 2011 PFS final rule with comment period (75 FR 73217), some commenters were skeptical that there could be viable alternative methods to the existing AMA RUC code review process for validating physician time and intensity that would preserve the appropriate relativity of specific physician's services under the current payment system. These commenters generally urged us to rely solely on the AMA RUC to provide valuations for services under the PFS.
While a number of commenters strongly opposed our plans to develop a formal validation process, many other commenters expressed support for the development and establishment of a system-wide validation process of the work RVUs under the PFS. As noted in the CY 2011 PFS final rule with comment period (75 FR 73217 through 73218), these commenters commended us for seeking new approaches to validation, as well as being open to suggestions from the public on this process. A number of commenters submitted technical advice and offered their time and expertise as resources for us to draw upon in any examination of possible approaches to developing a formal validation process.
However, in response to our solicitation of comments regarding time and motion studies, a number of commenters opposed the approach of using time and motion studies to validate estimates of physician time and intensity, stating that properly conducted time and motion studies are extraordinarily expensive and, given the thousands of codes paid under the PFS, it would be unlikely that all codes could be studied. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73218), we understand that these studies would require significant resources and we remain open to suggestions for other approaches to developing a formal validation process. We noted that MedPAC suggested in its comment letter that we should consider “collecting data on a recurring basis from a cohort of practices and other facilities where physicians and nonphysician clinical practitioners
While we received a modest number of comments specifically addressing technical and methodological aspects of developing a validation system, we believe it would be beneficial to provide an additional opportunity for stakeholders to submit comments on data sources and possible methodologies for developing a system-wide validation system. In the proposed rule, we solicited comments on data sources and studies which may be used to validate estimates of physician time and intensity that could be factored into the work RVUs, especially for services with rapid growth in Medicare expenditures, which is one of the Affordable Care Act categories that the statute specifically directs us to examine. We also solicited comments regarding MedPAC's suggestion of “collecting data on a recurring basis from a cohort of practices and other facilities where physicians and nonphysician clinical practitioners work.” We note that after our proposed rule was released, MedPAC further discussed its continuing concerns regarding accurate data. “In our June 2011 Report to the Congress, we expressed deep concern in particular about the accuracy of the fee schedule's time estimates--estimates of the time that physicians and other health professionals spend furnishing services. These estimates are an important factor in determining the RVUs for practitioner work. However, research for CMS and for the Assistant Secretary for Planning and Evaluation has shown that the time estimates are likely too high for some services. In addition, anecdotal evidence and the experience of clinicians on the Commission raises questions about the time estimates” (MedPAC Report to the Congress “Medicare and the Health Care Delivery System, June 2011”).
We plan to discuss the validation process in more detail in a future PFS rule once we have considered the matter further in conjunction with the public comments received on the CY 2011 rulemaking, as well as comments received on this final rule with comment period. We note that any proposals we would make on the formal validation process would be subject to public comment, and we would consider those comments before finalizing the policies.
As previously discussed, we are statutorily required under section 1848(c)(2)(B) of the Act to review the RVUs of services paid under the PFS no less often than every 5 years. In the past, we have satisfied this requirement by conducting separate periodic reviews of work, PE, and malpractice RVUs for established services every 5-years in what is commonly known as CMS' Five-Year Reviews of Work, PE, and Malpractice RVUs. On May 24, 2011, we released the proposed notice regarding the Fourth Five-Year Review of Work RVUs. The most recent comprehensive Five-Year Review of PE RVUs occurred for CY 2010; the same year we began using the Physician Practice Information Survey (PPIS) data to update the PE RVUs. The last Five-Year Review of Malpractice RVUs also occurred for CY 2010. These Five-Year Reviews have historically included codes identified and nominated by the public for review, as well as those identified by CMS and the AMA RUC.
In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis using various identification screens, such as codes with high growth rates, codes that are frequently billed together in one encounter, and codes that are valued as inpatient services but that are now predominately furnished as outpatient services. These annual reviews have not included codes identified by the public as potentially misvalued since, historically, the public has the opportunity to submit potentially misvalued codes during the Five-Year Review process.
With the enactment of the Affordable Care Act in 2010, which endorsed our initiative to identify and review potentially misvalued codes and emphasized the importance of our ongoing work in this area to improve accuracy and appropriateness of payments under the PFS, we believe that continuing the annual identification and review of potentially misvalued codes is necessary. Given that we are engaging in extensive reviews of work RVUs and direct PE inputs of potentially misvalued codes on an annual basis, we believe that separate and “freestanding” Five-Year Reviews of Work and PE may have become redundant with our annual efforts. Therefore, for CY 2012 and forward, we proposed to consolidate the formal Five-Year Review of Work and PE with the annual review of potentially misvalued codes. That is, we would begin meeting the statutory requirement to review work and PE RVUs for potentially misvalued codes at least once every 5-years through an annual process, rather than once every 5-years. Furthermore, to allow for public input and to preserve the public's ability to identify and nominate potentially misvalued codes for review, we proposed a process by which the public could submit codes for our potential review, along with supporting documentation, on an annual basis. Our review of these codes would be incorporated into our potentially misvalued codes initiative. This proposed public process is further discussed in section II.B.4. of this final rule with comment period. In the CY 2012 proposed rule, we solicited comments on our proposal to consolidate the formal Five-Year Reviews of Work and PE with the annual review of potentially misvalued codes.
To alleviate concerns that the consolidation could result in requiring specialty societies to survey a large
Commenters also expressed concern that CMS is proposing to review potentially misvalued codes on the same time frame as the review of new and revised codes where CMS has historically issued interim final values for these codes in the final rule with comment period. The commenters asserted they need to have the opportunity to review CMS' response to AMA RUC recommendations, comment on CMS' proposed values, and receive a response from CMS to these comments prior to January 1 of the year the revised RVUs will be used to pay physician claims. A commenter noted “physicians should not be penalized by having to receive potentially incorrect reimbursement for a procedure for as much as 12 months because of the government's timing of its notice and comment processes.” Other commenters, while supportive of CMS' proposal to consolidate reviews, stressed that the process should not be condensed so much that there is not time for thoughtful comment and consideration. Consequently, commenters urged CMS to work with the AMA RUC so that all recommendations for a given year are received by an earlier deadline, allowing for publication in that year's proposed rule and for comments to be addressed by CMS in that year's final rule before changes that affect payment are implemented.
To respond to the commenters who were worried that codes identified through the potentially misvalued codes process may not be equitably or “fairly” distributed among specialty societies and have suggested that CMS review a comparable proportion of codes for each specialty each year, we note that, based on our previous experience, the objective screens we have used to identify potentially misvalued codes do not produce lists of codes that are evenly distributed among the specialties that furnish them. Rather, the screens have tended to identify certain types of services more frequently than others (for example, due to rapidly changing technology) and therefore yield disproportionate numbers of potentially misvalued codes to be reviewed by the various specialty societies. However, we have received similar comments in previous rules regarding distribution among specialty societies. Consequently, in the CY 2012 proposed rule, we explicitly identified a list of potentially misvalued high expenditure codes that spans most specialties discussed in II.B.5.a. of this final rule with comment period.
Finally, to respond to the comments regarding the code review cycle, we note that the timing of CMS' current review process is constrained by the CPT Editorial Panel's scheduled release of new and revised codes by October 1 and the receipt of the complete AMA RUC's recommendations later in the year, which are at odds with the PFS rulemaking cycle. As we have indicated for many years in our PFS final rules with comment period, most recently in the CY 2011 rule (75 FR 73170), before adopting interim RVUs for new and revised codes, we have the opportunity to review and consider AMA RUC recommendations which are based on input from the medical community. If we did not adopt RVUs for new and revised codes in the initial year on an interim final basis, we would either have to delay using the codes for a year or permit each Medicare contractor to establish their own payment rate for the codes. We believe it would be contrary to the public interest to delay adopting values for new and revised codes for the initial year, especially since we have an opportunity to receive significant input from the medical community before adopting the values, and the alternatives could produce undesirable levels of uncertainty and inconsistency in payment for a year. We understand the preference of some commenters for the review of potentially misvalued codes to be conducted within a single rulemaking year in order to avoid payment under interim values for the coming year. However, we continue to believe that it is important to consolidate the work and PE reviews for all codes (new, revised, and potentially misvalued) into one cycle. As we have explained in several previous PFS final rules with comment period, most recently in the CY 2011 PFS final rule with comment period (75 FR 73170), we believe it is in the public interest to adopt interim final revised RVUs for codes that have been identified as misvalued. Similar to the new and revised codes, before making any changes to RVUs for potentially misvalued codes, we have an opportunity to review input from the medical community in the form of the AMA RUC recommendations for the codes. We believe a delay in implementing revised values for codes that have been identified as misvalued would perpetuate payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service and would continue unwarranted distortion in the payment for other services across the PFS.
We note that it is often difficult to draw definitive lines between the codes that are being reviewed as new, revised, or potentially misvalued. For example, CMS may identify a code as potentially misvalued in a given year and refer the family of codes to the AMA RUC for review. Subsequently, the AMA RUC may send the family of codes to the CPT Editorial Panel for revision because upon an initial review, the AMA RUC may have concluded that the family of services has evolved to the point that the code descriptors are no longer appropriate. The CPT Editorial Panel may revise the code(s) descriptors or may create entirely new codes to better define the service. In this final rule with comment period, we reviewed several new codes initially referred to the AMA RUC for review through our potentially misvalued codes initiative, and we believe that this trend likely will increase in the near future. Additionally, since CMS reviews and assigns interim values to new and revised codes in the PFS final rule with comment period for the coming year, consolidating the review of potentially misvalued codes with the new and revised codes is a more efficient and transparent process, and reduces the burden on both specialty societies and other stakeholders who would otherwise be called upon to consider, review and comment on the same family of codes in multiple rules. Moreover, consolidation of our review of new, revised, and potentially misvalued codes in one cycle allows for codes in a family to be reviewed together, resulting in more consistent valuation within code families and a better opportunity to maintain appropriate relativity within code families which, as we discuss in this section of this final rule with comment period, is a high priority.
Therefore, given the considerable overall support commenters expressed, we are finalizing our proposal without modification to consolidate periodic reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.
We note that while we proposed to review the physician work RVUs and direct PE inputs of potentially misvalued codes on an annual basis, we did not propose at this time to review malpractice RVUs on an annual basis. As discussed in section II.C. of this final rule with comment period, in general, malpractice RVUs are based on malpractice insurance premium data on a specialty level. The last comprehensive review and update of the malpractice RVUs occurred for CY 2010 using data obtained from the PPIS data. Since it is not feasible to conduct such extensive physician surveys to obtain updated specialty level malpractice insurance premium data on an annual basis, we believe the comprehensive review of malpractice RVUs should continue to occur at 5-year intervals.
Furthermore, in identifying and reviewing potentially misvalued codes on an annual basis, we note that this new proposed process presents us with the opportunity to review simultaneously both the work RVUs and the direct PE inputs for each code. Heretofore, the work RVUs and direct PE inputs of potentially misvalued codes were commonly reviewed separately and at different times. For example, a code may have been identified as potentially misvalued based solely on its work RVUs so the AMA RUC would have reviewed the code and provided us with recommendations on the physician times and work RVUs. However, the direct PE inputs of the code would not necessarily have been reviewed concurrently and therefore, the AMA RUC would not necessarily have provided us with recommendations for any changes in the direct PE inputs of the code that would have been warranted to ensure that the PE RVUs of the code are determined more appropriately. Therefore, while this code may have been recently reviewed and revised under the potentially misvalued codes initiative for physician work, the PE component of the code could still be potentially misvalued. Going forward, we believe combining the reviews of both physician work and PE for each code under our potentially misvalued codes initiative will align the review of these codes and lead to more accurate and appropriate payments under the PFS.
Finally, it is important to note that the code-specific resource based relative value framework under the PFS system is one in which services are ranked relative to each other. That is, the work RVUs assigned to a code are based on the physician time and intensity expended on that particular service as compared to the physician time and intensity of the other services paid under the PFS. This concept of relativity to other services also applies to the PE RVUs, particularly when it comes to reviewing and assigning correct direct PE inputs that are relative to other similar services. Consequently, we are emphasizing the need to review both the work and PE components of codes that are identified as part of the potentially misvalued initiative to ensure that appropriate relativity is constructed and maintained in several key relationships:
• The work and PE RVUs of codes are ranked appropriately within the code family. That is, the RVUs of services within a family should be ranked progressively so that less intensive services and/or services that require less physician time and/or require fewer or less expensive direct PE inputs should be assigned lower work or PE RVUs relative to other codes within the family. For example, if a code for treatment of elbow fracture is under review under the potentially misvalued codes initiative, we would expect the work and PE RVUs for all the codes in the family also be reviewed in order to ensure that relativity is appropriately constructed and maintained within this family. Furthermore, as we noted in the CY 2010 PFS final rule with comment period (74 FR 61941), when we submit codes to the AMA RUC and request its review, in order to maintain relativity, we emphasized the importance of reviewing the base code of a family. The base code is the most important code to review because it is the basis for the valuation of other codes within the family and allows for all related codes to be reviewed at the same time (74 FR 61941).
• The work and PE RVUs of codes are appropriately relative based on a comparison of physician time and/or intensity and/or direct inputs to other services furnished by physicians in the same specialty. To continue the example discussed previously, if a code for treatment of elbow fracture is under review, we would expect this code to be compared to other codes, such as codes for treatment of humerus fracture, or other codes furnished by physicians in the same specialty, in order to ensure that the work and PE RVUs are appropriately relative within the specialty.
• The work and PE RVUs of codes are appropriately relative when compared to services across specialties. While it may be challenging to compare codes that describe completely unrelated services, since the entire PFS is a budget neutral system where payment differentials are dependent on the relative differences between services, it is essential that services across specialties are appropriately valued relative to each other. To illustrate the point, if a service furnished primarily by dermatology is analogous in physician time and intensity to another service furnished primarily by allergy/immunology, then we would expect the work RVUs for the two services to be
Under the previous Five-Year Reviews, the public was provided with the opportunity to nominate potentially misvalued codes for review. To allow for public input and to preserve the public's ability to identify and nominate potentially misvalued codes for review under our annual potentially misvalued codes initiative, we proposed a process by which on an annual basis the public could submit codes, along with documentation supporting the need for review. We proposed that stakeholders may nominate potentially misvalued codes by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. We would evaluate the supporting documentation and decide whether the nominated code should be reviewed as potentially misvalued during the following year. If we were to receive an overwhelming number of nominated codes that qualified as potentially misvalued in any given year, we would prioritize the codes for review and could decide to hold our review of some of the potentially misvalued codes for a future year. We noted that we may identify additional potentially misvalued codes for review by the AMA RUC based on the seven statutory categories under section 1848(c)(2)(K)(ii) of the Act.
We encouraged stakeholders who believe they have identified a potentially misvalued code, supported by documentation, to nominate codes through the public process. We emphasized that in order to ensure that a nominated code will be fully considered to qualify as a potentially misvalued code to be reviewed under our annual process, accompanying documentation must be provided to show evidence of the code's inappropriate valuation, either in terms of inappropriate physician times, work RVUs, and/or direct PE inputs. The AMA RUC developed certain “Guidelines for Compelling Evidence” for the Third Five-Year Review which we believe could be applicable for members of the public as they gather supporting documentation for codes they wish to nominate for the annual review of potentially misvalued codes. The specific documentation that we would seek under this proposal includes the following:
• Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following:
++ Technique.
++ Knowledge and technology.
++ Patient population.
++ Site-of-service.
++ Length of hospital stay.
++ Physician time.
• An anomalous relationship between the code being proposed for review and other codes. For example, if code “A” describes a service that requires more work than codes “B,” “C,” and “D,” but is nevertheless valued lower. The commenter would need to assemble evidence on service time, technical skill, patient severity, complexity, length of stay and other factors for the code being considered and the codes to which it is compared. These reference services may be both inter- and intra-specialty.
• Evidence that technology has changed physician work, that is, diffusion of technology.
• Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
• Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation;
• Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
• Analyses of physician time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting System (PQRS) databases).
• National surveys of physician time and intensity from professional and management societies and organizations, such as hospital associations.
We noted that when a code is nominated, and supporting documentation is provided, we would expect to receive a description of the reasons for the code's misvaluation with the submitted materials. That is, we would require a description and summary of the evidence is required that shows how the service may have changed since the original valuation or may have been inappropriately valued due to an incorrect assumption. We would also appreciate specific
As proposed in the CY 2012 proposed rule, after we receive the nominated codes during the 60-day comment period following the release of the annual PFS final rule with comment period, we would review the supporting documentation and assess whether they appear to be potentially misvalued codes appropriate for review under the annual process. We proposed that, in the following PFS proposed rule, we would publish a list of the codes received under the public nomination process during the previous year and indicate whether the codes would be included in the current review of potentially misvalued codes. We would also indicate the publicly nominated codes that we would not be including in the current review (whether due to insufficient documentation or for other reasons). Under this proposed process, the first opportunity for the public to nominate codes would be during the public comment period for this CY 2012 PFS final rule with comment period. We would publish in the CY 2013 PFS proposed rule, the list of nominated codes, and indicate whether they will be reviewed as potentially misvalued codes. We would request that the AMA RUC review these potentially misvalued codes along with any other codes identified by CMS as potentially misvalued, and provide to us recommendations for appropriate physician times, work RVUs, and direct PE inputs. We requested public comments on this proposed code nomination process and indicated that we would consider any suggestions to modify and improve the proposed process.
A number of commenters stated that they believe the supporting documentation criteria would ensure that all requests are considered fairly and urged CMS to conduct a rigorous review of public comments and supporting documentation when determining whether a publicly nominated code should be reviewed as a potentially misvalued code, especially when a code is nominated by only a few commenters or even a single commenter. Other commenters thought CMS should provide “guidelines” to justify bringing a code(s) forward for review in order to prevent a member of the public from asking that every single code paid under the Medicare PFS be reviewed. Some commenters noted that “professional associations participating on the RUC frequently struggle with the concept and documentation of ‘Compelling Evidence.' ” Consequently, the commenters believed that the public will likewise struggle with the concept of submitting evidence to substantiate potentially misvalued codes. Other commenters noted that the public nomination process proposed by CMS requires that commenters nominating codes include supportive evidence to show that the resource use related to the delivery of a service has changed in a way to suggest a code's RVUs may be misvalued, whereas CMS is not obligated to follow this same standard. The commenters suggested that CMS should be required to adhere to the supporting documentation that the public would need to provide when nominating a potentially misvalued code for review through the proposed public nomination process.
Several commenters believed that CMS should not restrict which codes could be nominated or referred. A number of commenters objected to CMS' proposal to consider only nominations of active codes that are covered by Medicare at the time of the nomination. The commenters believed this proposal was unfair to those specialties that do not serve a predominantly Medicare-aged population but who must also rely on the the resource based relative value scale. The commenters asserted that CMS has historically published the relative value recommendations from the AMA RUC for preventive services and other non-covered services. Commenters recommended that all valid CPT codes should remain open to comment and review. Commenters also believed as long as a stakeholder could provide adequate supporting documentation to support the nomination of the code, CMS should allow for the review of any code, including any codes that went through refinement in the past.
Commenters also expressed appreciation that CMS proposed to disclose in the PFS proposed rule the list of codes identified as potentially misvalued (including those that originated from the public nomination process) for future review because publishing the misvalued codes list provides some notice to affected parties who may wish to provide input during the review process. Some commenters suggested that following the nomination process, specialty societies should have another opportunity to review and comment on any relevant nominations before CMS decides to include the codes on the list of potentially misvalued codes in the proposed rule.
However, to respond to the commenters who suggested we should be required to follow the same process as the public for nominating potentially misvalued codes, we note that we have longstanding statutory authority to identify and review the RVUs of services no less often than every 5-years and that we frequently have exercised our discretion to prioritize codes for review.
We understand commenters' concerns about the burden that reviewing codes entails. We believe that by ranking codes in order of interest to CMS for review over a reasonable timeframe, we can help to reduce some of that burden. For this year, we have prioritized the review of codes to those that have some degree of significant financial impact on the PFS. Specifically, we have proposed a list of high expenditure codes for review in CY 2012. We also are limiting the review of RVUs to codes that are active, covered by Medicare, and for which the RVUs are used for payment purposes under the PFS so that resources are not expended on the review of codes with RVUs that have no financial impact on the PFS. We note that while we have published the AMA RUC relative value recommendations for non-covered services as a courtesy, these codes historically have not been reviewed by CMS and the RVUs are not valid for Medicare payment purposes. Therefore, while we will continue our historical practice of publishing the AMA RUC relative value recommendations for non-covered services, we will not be accepting for review either inactive or non-covered codes (for which the RVUs will have no financial impact on the PFS) through the public nomination process. We will consider any other active and Medicare covered services that are nominated by the public and supported by documentation of the nature described previously in this section.
Finally, we note that all timely comments received on the final rule with comment period can be accessed and reviewed by the public through
While we anticipate receiving nominations from the public for potentially misvalued codes in conjunction with rulemaking, we believe it is imperative that we continue
In the CY 2011 PFS proposed rule (75 FR 40068 through 40069), we identified and referred to the AMA RUC a list of potentially misvalued codes in three areas:
• Codes on the AMA RUC's multi-specialty points of comparison (MPC) list (used as reference codes in the valuation of other codes),
• Services with low work RVUs that are billed in multiples (a statutory category); and
• Codes that have low work RVUs for which CMS claims data show high volume (that is, high utilization of these codes represents a significant dollar impact in the payment system).
Our understanding is that the AMA RUC is currently working towards reviewing these codes at our request. We intend to provide an update and discuss any RVU adjustments to codes that have been identified as potentially misvalued in the CY 2012 PFS final rule, as they move through the review process.
Meanwhile, for CY 2012, we are continuing with our work to identify and review additional services under the potentially misvalued codes initiative. Stakeholders have noted that many of the services previously identified under the potentially misvalued codes initiative were concentrated in certain specialties. To develop a robust and representative list of codes for review under the potentially misvalued codes initiative, we examined the highest PFS expenditure services by specialty (based on our most recently available claims data and using the specialty categories listed in the PFS specialty impact table, see Table 84 in section IX.B. of this final rule with comment period) and identified those that have not been reviewed since CY 2006 (which was the year we completed the Third Five-Year Review of Work and before we began our potentially misvalued codes initiative).
In our examination of the highest PFS expenditure codes for each specialty (we used the specialty categories listed in the PFS specialty impact table, see Table 84 in section IX.B. of this final rule with comment period), we noted that Evaluation and Management (E/M) services consistently appeared in the top 20 high PFS expenditure services. We noted as well that most of the E/M services have not been reviewed since the comprehensive review of services for the Third Five-Year Review of Work in CY 2006. Therefore, after an examination of the highest PFS expenditure codes for each specialty, we have developed two code lists of potentially misvalued codes which we proposed to refer to the AMA RUC for review.
First, we proposed to request that the AMA RUC conduct a comprehensive review of all E/M codes, including the codes listed in Table 6. As shown previously, E/M services are commonly among the highest PFS expenditure services. Additionally in recent years, there has been significant interest in delivery system reforms, such as patient-centered medical homes and making the primary care physician the focus of managing the patient's chronic conditions. The chronic conditions challenging the Medicare population include heart disease, diabetes, respiratory disease, breast cancer, allergy, Alzheimer's disease, and factors associated with obesity. Thus, as the focus of primary care has evolved from an episodic treatment-based orientation to a focus on comprehensive patient-centered care management in order to meet the challenges of preventing and managing chronic disease, we believed a more current review of E/M codes was warranted. We note that although physicians in primary care specialties bill a high percentage of their services using the E/M codes, physicians in non-primary care specialties also bill these codes for many of their services.
Since we believe the focus of primary care is evolving to meet the challenges of preventing and managing chronic disease, we noted in the proposed rule that we would like the AMA RUC to prioritize review of the E/M codes and provide us with recommendations on the physician times, work RVUs, and direct PE inputs of at least half of the E/M codes listed in Table 6 by July 2012 in order for us to include any revised valuations for these codes in the CY 2013 PFS final rule with comment period. We also noted that we would expect the AMA RUC to review the remaining E/M codes listed in Table 6 by July 2013 in order for us to complete the comprehensive re-evaluation of E/M services and include the revised valuations for these codes in the CY 2014 PFS final rule with comment period.
The majority of commenters requested that CMS withdraw its proposal to review all E/M codes because the current E/M codes, as written, do not fully encompass the work associated with patient-centered care management. The commenters noted that there are many codes that have been reviewed and valued by the AMA RUC for such services, including medical team conference, comprehensive preventive evaluation, physician supervision of a hospice patient, international normalized ratio management, smoking and alcohol counseling, case management, monthly medical home management, anticoagulation management, and phone or electronic evaluation. Some commenters noted that the AMA RUC has previously provided recommendations to value telephone and electronic evaluation services that complement coordinated care. While Medicare either does not pay separately for or does not cover many of these services, the commenters believed these services are part of a patient centered care management model and are necessary services for managing patients with chronic conditions. The commenters urged CMS to provide explicit payment for these coordination services rather than attempt to address the primary care issue through the comprehensive review of current E/M code values. For example, commenters suggested CMS “work with the medical community to develop and implement the patient-centered medical home, reward prevention and wellness, eliminate fragmentation and duplication, and produce a cohesive system of care that prevents unnecessary complications from acute or chronic illness, hospitalizations, and other avoidable expenses.”
Some commenters asserted that the current E/M codes have code descriptors and documentation requirements that do not capture the work necessary for chronic disease management. Commenters noted that the current E/M codes were developed 20 years ago and describe care of patients with acute problems. In addition, the commenters believed the current E/M codes do not describe care to treat chronic medical problems of patients in skilled nursing facilities which were treated in the hospital a few years ago. Commenters asserted that physicians are now caring for an increasingly complex elderly population with multiple chronic problems who require services such as extensive care coordination that was not part of standard medical practice when many of the E/M codes were created. Thus, while the commenters agreed that care coordination would help better manage chronic diseases in the elderly, they believed this care would be better described by new codes, and not the current E/M codes. Accordingly, the commenters recommended that CMS undertake a comprehensive review of the existing E/M service codes in collaboration with the AMA RUC and the CPT Editorial Panel. That is, the commenters envisioned and supported an extensive review that considers revisions to these codes that will better recognize the work of primary care physicians and cognitive specialists who provide care for patients with acute and chronic conditions before focusing on the valuation of the codes.
Many commenters, representing different medical specialties, noted that CMS' focus on primary care as the locus for care coordination and chronic disease management is misplaced. Commenters asserted that patient care coordination, prevention, performance measurement and the adoption of health information technology affects the entire medical community. These commenters argued that that these trends and initiatives will pose challenges for specialty medicine as well. Specifically, a commenter stated, “We believe that high quality provision of such services is not defined by the specialty of the provider and thus we cannot support policy options that focus on provider specialty rather than on the content and the quality of the service being provided.”
Other commenters noted that the E/M codes are used by many surgeons and other specialists because nearly every procedural CPT code involves one or more E/M service within the code's global period. Commenters suggested that CMS unbundle E/M services from surgical codes in order to ensure that surgical patients received the appropriate follow-up care and management of post-procedure activity to achieve desired outcomes. That is, CMS should apply zero-day global periods to surgical codes, such that post-operative hospital and office visits must meet the medical necessity and documentation requirements for evaluation and management coding in order to be paid separately.
Finally, some commenters noted that the previous comprehensive review of the evaluation and management codes in 2006 did not improve the emphasis on chronic care management, stating that “the third 5-Year Review failed to achieve the goals of properly compensating primary physicians for chronic care management, so there is no expectation that another review within the existing system will result in a different outcome.” A few commenters supported the proposal to review the E/M codes and they “consider the review and re-evaluation of E&M codes as a critical immediate step to ensure patient access to care and to maintaining the viability of the [their] workforce.”
We would like to assure the commenters that we, as well as the HHS' Assistant Secretary for Planning and Evaluation (ASPE), are actively researching our current coding and payment systems to appropriately value these services. As detailed in the proposed rule (75 FR 42917), we are considering several approaches to improve coordinated care and health care transitions to reduce readmissions or subsequent illnesses, improve beneficiary outcomes, and avoid additional financial burden on the health care system. We are committed to achieving better care for individuals, better health for populations, and reduced expenditure growth. Reforms such as Accountable Care Organizations and Medical Homes and reforms of our current fee-for-service payment system are designed to achieve these goals.
As an example, we recently launched the Partnership for Patients (in April 2011), a national public-private patient safety initiative for which more than 6,000 organizations—including physician and nurses' organizations, consumer groups, employers and over 3,000 hospitals—have pledged to help achieve the Partnership's goals of reducing hospital complications and improving care transitions. The Partnership for Patients includes the Community-Based Care Transitions Program, which provides funding to community-based organizations partnering with eligible hospitals to coordinate a continuum of post-acute care in order to test models for improving care transitions for high risk Medicare beneficiaries. Achieving the goals of the Partnership for Patients will take the combined effort of many key stakeholders across the health care system—physicians, nurses, hospitals, health plans, employers and unions, patients and their advocates, as well as the Federal and State governments. Many important stakeholders have already pledged to join this Partnership in a shared effort to save thousands of lives, stop millions of injuries and take important steps toward a more dependable and affordable health care system. We are currently working with these stakeholders to improve care processes and systems, enhance communication and coordination to reduce complication for patients, raise public awareness and develop information, tools and resources to help patients and families effectively engage with their providers to avoid preventable complications, and provide the incentives and support that will enable clinicians and hospitals to deliver high-quality health care to their patients, with minimal burdens. (For more information regarding the Partnership for Patients Initiative, we refer readers to
Additionally, the Center for Medicare and Medicaid Innovation (Innovation Center) of CMS has undertaken several demonstrations to support care coordination and primary care. Most recently, on September 28, 2011, we released a request for applications for the Comprehensive Primary Care Initiative, a CMS-led multipayer initiative to provide enhanced support for comprehensive primary care. A primary care practice is a key point of contact for patients' health care needs. In recent years, new ways have emerged to strengthen primary care by improving care coordination, making it easier to work together, and helping clinicians spend more time with their patients. Under the Comprehensive Primary Care Initiative, we intend to pay primary care providers a monthly care management fee on behalf of Medicare fee-for-service beneficiaries and, in participating states, Medicaid fee-for-service beneficiaries for improved and comprehensive care management. Specifically, participating primary care practices will be given support to better coordinate primary care for their Medicare patients, including creating personalized care plans for patients with serious or chronic diseases follow personalized care plans, give patients 24-hour access to care and health information, more preventive care, and more patient centered care management. The work of the Comprehensive Primary Care Initiative could inform and help further develop innovative revisions to the PFS. (For more information regarding the Comprehensive Primary Care Initiative, we refer readers to
Further, HHS' ASPE has convened a Technical Expert Panel (TEP) to conduct studies that could inform efforts to accurately align physician payments in Medicare, which may help expand the supply of primary care physicians and improve the value of care for beneficiaries. One of the major tasks being undertaken by this TEP is to develop new approaches to defining visits and paying for primary care services under the physician fee schedule. There are a number of services that are increasingly viewed as key to high-quality primary care but that do not require a face-to-face encounter with the patient. While the valuations of current E/M services include care coordination, communication and other management, this project will consider how visits are defined and will examine whether we need to adjust payments to appropriately pay for primary care activities. It makes sense to reassess how visits are defined because it is becoming increasingly more common for primary care physicians to be engaged in the management of multiple established chronic conditions rather than evaluation and treatment of acute, new problems. The complexity and time for the physician is more often associated with decision-making than with the history-taking and physicals. Further, the chronic care model involves much greater attention to teaching patient self-management skills, doing more proactive care coordination, and anticipation of health care needs. We believe the TEP findings could provide us with improved information for the valuation of primary care services, including care coordination, which may be more effective than simply reviewing the work RVUs and direct PE inputs of current E/M services. In addition to ASPE's efforts that are focused directly on physician payment, they also have a second project underway to research effective methods for increasing the supply of primary care providers and services. This project will analyze what is known about the relative effectiveness of various strategies to increase the supply of primary care providers and services in order to meet these future health system needs.
Accordingly, given the significant concern expressed by the majority of commenters over the possible inadequacies of the current E/M coding and documentation structure to address evolving chronic care management and support primary care and our ongoing research on how to best provide payment for primary care and patient-centered care management, we are not finalizing the proposal to review the list of 91 E/M codes at this time. Instead, we believe allowing time for consideration of the findings of the Comprehensive Primary Care Initiative, the ASPE research on balancing physician incentives and evaluating payment for primary care services, demonstrations that we have undertaken on care coordination, as well as other initiatives assessing how to value and encourage primary care will provide improved information for the valuation of chronic care management, primary care, and care transitions. We also will continue to consider the numerous policy alternatives that commenters offered, such as separate E/M codes for established visits for patients with chronic disease versus a post-surgical follow-up office visits. We intend to continue to work with stakeholders on how to value and pay for primary care and patient-centered care management, and we continue to welcome ideas from the medical community for how to improve care management through the provision of primary care services. Second, we also proposed providing a select list of high PFS expenditure procedural codes representing services furnished by an array of specialties, as listed in Table 7. These procedural codes have not been reviewed since CY 2006 (before we began our potentially misvalued codes initiatives in CY 2008) and, based on the most recently available data, have CY 2010 allowed charges of greater than $10 million at the specialty level (based on the
Some commenters agreed that high expenditure codes should be reviewed on a periodic basis; however, the commenters suggested that the periodic basis should be a reasonably long length of time and 5 (or 6) years is not a sufficiently long period of time absent other evidence of potential changes in the service under review. The commenters suggested that CMS could automatically review high expenditure procedures every 10 or 15 years. MedPAC, commenting on the CY 2012 PFS proposed rule, agreed that accurate payments for high expenditure services “can improve the balance of payments between primary care and services such as imaging tests, and other procedures.”
Finally, we received a number of comments on specific codes where commenters provided arguments as to why CMS should remove these codes from the high expenditure code list. The commenters noted that specific codes had been considered by the AMA RUC in the past five years or that certain codes are currently scheduled to be considered by either the CPT Editorial Panel for new coding or the AMA RUC for revised valuations (for work RVUs and/or PE inputs) at an upcoming meeting.
Because of the concerns expressed by commenters about the burden associated with code reviews, we believe that it is appropriate to prioritize review of codes to a manageable subset that also have a high impact on the PFS and work with the specialty society to spread review of the remaining codes identified as potentially misvalued over a reasonable timeframe. In this spirit, we do not believe it would be appropriate to remove codes from the high expenditure list unless we find, as some commenters indicated, that we have reviewed both the work RVUs and direct PE inputs for the code during the
Finally, in reviewing the code specific comments, we noticed that in many cases, the commenters believed that the code should be removed from this code list because the work RVU had been reviewed within 6-years, or the code was recently considered at an AMA RUC meeting. We note that while a number of codes have been considered at an AMA RUC meeting, until we receive recommendations and review the codes for both work and direct PE inputs, we will continue to include these codes on the high expenditure list. We think some of the commenters may have believed that since a code was discussed at an AMA RUC meeting and sent to the CPT editorial panel or the code is being surveyed and prepared for a presentation at the AMA RUC, the code should be removed from the potentially misvalued high expenditure code list. We are clarifying that even if a code is about to be reviewed by the specialty society or AMA RUC, or referred to the CPT Editorial Panel, we would continue to include the code on our list of codes for review under the potentially misvalued codes initiative. Similarly, if a code is being reviewed by the CPT editorial panel, we would consider any replacement codes to address the potential misvaluation associated with the previous codes.
Accordingly, we are finalizing the proposed high expenditure/high volume list without modification.
On an ongoing basis, public stakeholders (including physician specialty societies, beneficiaries, and other members of the public) bring concerns to us regarding direct PE inputs and physician work. In the past, we would consider these concerns and address them through proposals in annual rulemaking, technical corrections, or by requesting that the AMA RUC consider the issue.
Since last year's rulemaking, the public has brought a series of issues to our attention that relate directly to direct PE inputs and physician work. We believe that some of these issues will serve as examples of codes that might be brought forward by the public as potentially misvalued in the proposed nomination process as discussed previously in section II.B.4. of this final rule with comment period.
As stated in the CY 2011 PFS final rule with comment period (75 FR 73350), we accepted the AMA RUC- recommended direct PE inputs for these codes, with refinements to the equipment minutes to assure that the time associated with the equipment items reflected the time during the intra-service period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. We believe that the direct PE inputs of the new codes reflect the typical resources required to furnish the services in question.
However, stakeholders have alerted us that the resulting PE RVUs for the new codes reflect an anomalous rank order in comparison to the previously existing stand-alone codes. Specifically, the PE RVUs for the codes that describe CT scans without contrast for either body region are greater than the PE RVUs for 74176, which describes a CT scan of both body regions. We believe that the anomalous rank order of the PE RVUs for this series of codes may be the result of outdated direct PE inputs for the previously existing stand-alone codes. The physician work for those codes was last reviewed by the AMA RUC during the Third Five-Year Review of Work for CY 2007. However, the direct PE inputs for the codes have not been reviewed since 2003. Therefore, we are requesting that the AMA RUC review both the direct PE inputs and work values of the following codes in accordance with the consolidated approach to reviewing potentially misvalued codes as outlined in section II.B.2.c. of this final rule with comment period:
• 72192Computed tomography, pelvis; without contrast material.
• 72193Computed tomography, pelvis; with contrast material(s).
• 72194Computed tomography, pelvis; without contrast material, followed by contrast material(s) and further sections.
• 74150Computed tomography, abdomen; without contrast material.
• 74160Computed tomography, abdomen; with contrast material(s).
• 74170Computed tomography, abdomen; without contrast material, followed by contrast material(s) and further sections.
While we acknowledge the occasional irregularities that result from the application of broad-based payment transitions, our longstanding policy in a PFS transition payment year is that if the CPT Editorial Panel creates a new code for that year, the new code would be paid at its fully implemented PFS amount and not at a transition rate for that year.
While the commenters suggested that the RUC reviewed the direct PE inputs of the component codes recently, we have received no recent recommendation from the RUC regarding the direct PE inputs for these codes. Had the RUC reviewed the direct PE inputs for the component codes and made recommendations either to maintain or amend the current direct PE inputs, we would have responded to those recommendations. After considering these comments and noting the technical refinements to the direct PE inputs of the combined codes, we continue to believe that the direct PE inputs of the component codes should be reviewed. Therefore, we are maintaining our request that the RUC review the component codes.
We acknowledge the RUC's concern that the commenter may have been comparing his perception of direct practice expense costs with broader practice expense payments for this code. We acknowledge the practice expense portion of PFS payment is developed in consideration of both direct and indirect practice expense costs. We also concur with the RUC that interested stakeholders can review the publicly available direct PE inputs associated with each code. Those inputs are available in the direct PE database on the CMS Web site under the downloads section for the “CY 2012 PFS final rule with comment period” at:
However, we note that the stakeholder's assessment of the direct costs associated with the typical service reported using CPT code 88305 is significantly lower than the summed direct practice expense inputs currently associated with the code. Additionally, as we stated in the CY 2012 PFS proposed rule, we are asking the RUC to review the direct PE inputs of the code because they have not been reviewed since 1999. We also point out that if the stakeholder had not brought the concern to us, this code would have appeared on our list of PFS high expenditure procedural codes that had not been reviewed since CY 2006. After consideration of these comments, we are maintaining our request that the RUC review CPT code 88305, but in the case of this code, we are only asking for a review of direct PE inputs.
For CY 2011, the AMA's CPT Editorial Panel created two new cytopathology codes that describe in situ hybridization testing using urine samples: CPT code 88120 (Cytopathology, in situ hybridization (
Because the descriptors indicate that the new codes account for approximately four probes, whereas 88367 and 88368 describe each probe, there are more PE RVUs associated with the new codes than with the previously existing codes that are currently still used for any specimen except for urine. However, because the previously existing codes are billed per probe, the payment for a test using a different specimen type could vary depending upon the number of probes. For example, a practitioner furnishing a test involving a blood specimen and using three probes would bill CPT code 88368 (total RVUs: 6.28) three times with the result of 18.84 RVUs. A practitioner furnishing the same test but using a urine sample instead of a blood sample would receive payment based on the 13.47 RVUs associated with CPT code 88120.
We accepted the RUC-recommended work values and direct PE inputs, without refinement, for the two new cytopathology codes that describe in situ hybridization testing using urine samples. We reviewed the direct PE recommendations made by the AMA RUC and considered the inputs to be appropriate. However, we shared LUGPA's concerns regarding the potential payment discrepancies between the codes that describe the same test using different specimen media. Therefore, in the CY 2012 PFS proposed rule, we asked the AMA RUC to review the both the direct PE inputs and work values of the following codes
However, we continue to share the commenter's concerns regarding the potential payment discrepancies between the codes that describe the same test using different specimen media. If the direct resources required for conducting the test using urine specimens are different from the direct resources required for conducting the test using other specimen media, we do not believe it would be appropriate to assume the typical direct practice expense inputs for the non-specific specimen media codes that were previously valued based upon all the specimen media including urine are still accurate now that services using urine will be reported using different codes.
Therefore, we maintain our request as stated in the in the CY 2012 PFS proposed rule (76 FR 42795 and 42796) that the AMA RUC review both the direct PE inputs and work values of the existing codes that describe the test using specimen media other than urine.
After consideration of these comments, and in anticipation of forthcoming review of codes 88365, 88367, and 88368, we are maintaining for CY 2012 the current direct PE inputs for CPT codes 88120 and 88121 on an interim basis subject to public comment.
In the past, the AMA RUC has provided us with valuable recommendations regarding particular categories of equipment and supply items that are used as direct PE inputs for a range of codes. For example, in the 2011 PFS final rule (75 FR 73204), we made changes to a series of codes following the RUC's review of services that include the radiographic fluoroscopic room (CMS Equipment Code EL014) as a direct PE input. The RUC review revealed the use of the item to no longer be typical for certain services in which it had been specified within the direct cost inputs. These recommendations have often prompted our proposals that have served to maintain appropriate relativity within the PFS, and we hope that the RUC will continue to address issues relating to equipment and supply inputs that affect many codes. Furthermore, we believe that in these kinds of cases, it may be appropriate to make changes to the related direct PE inputs for a series of codes without reevaluating the physician work or other direct PE inputs for the individual codes. In other words, while we generally believe that both the work and the direct practice expense inputs should be reviewed whenever the RUC makes recommendations regarding either component of a code's value, we recognize the value of discrete RUC reviews of direct PE items that serve as inputs for a series of service codes.
• 22523 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
• 22524 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
• 22525 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (
In the case of these codes, we are asking the RUC to make recommendations regarding the appropriateness of creating nonfacility direct PE inputs. If the RUC were to make direct PE recommendations, we would review those recommendations as part of the annual process.
We thank the public for bringing these issues to our attention and kindly request that the public continue to do so.
Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same patient by the same physician on the same day, largely based on the presence of efficiencies in the practice expense (PE) and pre- and post-surgical physician work. Effective January 1, 1995, the MPPR policy, with the same percentage reduction, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we would consider applying the policy to other diagnostic tests in the future.
Consistent with recommendations of MedPAC in its March 2005 Report to the Congress on Medicare Payment Policy, under the CY 2006 PFS, the MPPR policy was extended to the technical component (TC) of certain diagnostic imaging procedures performed on contiguous areas of the body in a single session (70 FR 70261). The reduction recognizes that, for the second and subsequent imaging procedures, there are some efficiencies in clinical labor, supplies, and equipment time. In particular, certain clinical labor activities and supplies are not duplicated for subsequent procedures and, because equipment time and indirect costs are allocated based on clinical labor time, those would also be reduced accordingly.
The imaging MPPR policy originally applied to computed tomography (CT) and computed tomographic angiography (CTA), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), and ultrasound services within 11 families of codes based on imaging modality and body region. When we adopted the policy in CY 2007, we stated that we believed efficiencies were most likely to occur when imaging procedures are performed on contiguous body areas because the patient and equipment have already been prepared for the second and subsequent procedures, potentially yielding resource savings in areas such as clerical time, technical preparation, and supplies (70 FR 45850). The MPPR policy originally applied only to procedures furnished in a single session involving contiguous body areas within a family of codes, not across families. Additionally, while the MPPR policy applies to TC-only services and to the TC of global services, it does not apply to professional component (PC) services.
Under the current imaging MPPR policy, full payment is made for the TC of the highest paid procedure, and payment is reduced by 50 percent of the TC for each additional procedure when an MPPR scenario applies. We originally planned to phase in the imaging MPPR policy over a 2-year period, with a 25 percent reduction in CY 2006 and a 50 percent reduction in
In the July 2009 GAO report entitled, “Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved when Services are Provided Together,” the GAO recommended that we take further steps to ensure that fees for services paid under the PFS reflect efficiencies that occur when services are furnished by the same physician to the same beneficiary on the same day. The GAO recommended the following: (1) expanding the existing imaging MPPR policy for certain services to the PC to reflect efficiencies in physician work for certain imaging services; and (2) expanding the MPPR to reflect PE efficiencies that occur when certain nonsurgical, nonimaging services are furnished together. The GAO report also encouraged us to focus on service pairs that have the most impact on Medicare spending.
In its March 2010 report, MedPAC noted its concerns about mispricing of services under the PFS. MedPAC indicated that it would explore whether expanding the unit of payment through packaging or bundling would improve payment accuracy and encourage more efficient use of services.
In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as well as PE, in any expansion of the MPPR policy.
Section 1848(c)(2)(K) of the Act (as added by section 3134(a) of the Affordable Care Act) specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service, and review and make appropriate adjustments to their relative values. As a first step in applying this provision, in the CY 2010 final rule with comment period, we implemented a limited expansion of the imaging MPPR policy to additional combinations of imaging services.
Effective January 1, 2011 the imaging MPPR applies regardless of code family; that is, the policy applies to multiple imaging services furnished within the same family of codes or across families. This policy is consistent with the standard PFS MPPR policy for surgical procedures that does not group procedures by body region. The current imaging MPPR policy applies to CT and CTA, MRI and MRA, and ultrasound procedure services furnished to the same patient in the same session, regardless of the imaging modality, and is not limited to contiguous body areas.
We note that section 1848(c)(2)(B)(v)(VI) of the Act (as added by section 3135(b) of the Affordable Care Act) specifies that reduced expenditures attributable to the increase in the imaging MPPR from 25 to 50 percent (effective for fee schedules established beginning with 2010 and for services furnished on or after July 1, 2010) are excluded from the PFS budget neutrality adjustment. That is, the reduced payments for code combinations within a family of codes (contiguous body areas) are excluded from budget neutrality. However, this exclusion only applies to reduced expenditures attributable to the increase in the MPPR percentage from 25 to 50 percent, and not to reduced expenditures attributable to our policy change regarding additional code combinations across code families (non-continguous body areas) that are subject to budget neutrality under the PFS
The complete list of codes subject to the CY 2012 MPPR policy for diagnostic imaging services is included in Addendum F.
As a further step in applying the provisions of section 3134(a) of the Affordable Care Act, effective January 1, 2011, we implemented an MPPR for therapy services. The MPPR applies to separately payable “always therapy” services, that is, services that are only paid by Medicare when furnished under a therapy plan of care. Contractor-priced codes, bundled codes, and add-on codes are excluded because an MPPR would not be applicable for “always therapy” services furnished in combination with these codes. The complete list of codes subject to the MPPR policy for therapy services is included in Addendum H.
In the CY 2011 proposed rule (75 FR 44075), we proposed to apply a 50 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single patient in a single day. However, in response to public comments, in the CY 2011 PFS final rule with comment period (75 FR 73232), we adopted a 25 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single patient in a single day.
Subsequent to publication of the CY 2011 PFS final rule with comment period, section 3 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. 111-286) revised the payment reduction percentage from 25 percent to 20 percent for therapy services furnished in office settings. The payment reduction percentage remains at 25 percent for services furnished in institutional settings. Section 4 of the Physician Payment and Therapy Relief Act of 2010 exempted the reduced expenditures attributable to the therapy MPPR policy from the PFS budget neutrality provision. Under our current policy as amended by the Physician Payment and Therapy Relief Act, for institutional services, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedures or additional units of the same service is reduced by 25 percent. For non-institutional services, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedures or additional units of the same service is reduced by 20 percent.
The MPPR policy applies to multiple units of the same therapy service, as well as to multiple different services, when furnished to the same patient on the same day. It applies to services furnished by an individual or group practice or “incident to” a physician's service. The MPPR applies when multiple therapy services are billed on the same date of service for one patient by the same practitioner or facility under the same National Provider Identifier (NPI), regardless of whether the services are furnished in one therapy discipline or multiple
The MPPR policy applies in all settings where outpatient therapy services are paid under Part B. This includes both services paid under the PFS that are furnished in the office setting, as well as to institutional services paid at the PFS rates that are furnished by outpatient hospitals, home health agencies, comprehensive outpatient rehabilitation facilities (CORFs), and other entities that are paid under Medicare Part B for outpatient therapy services.
In its June 2011 Report to the Congress, MedPAC further discussed its concern about the significant growth in ancillary services, specifically services for which physicians can self-refer under the in office ancillary exceptions list for the Ethics in Patient Referrals Act (also known as the Stark Law) including imaging, other diagnostic tests, and therapeutic services such as physical therapy and radiation therapy. MedPAC argues, in its June 2011 Report, that inaccurate pricing has played a role in this growth, and that there are additional efficiencies to be achieved in pricing imaging services notwithstanding a series of payment adjustments for imaging services over the past several years. MedPAC specifically recommended a multiple procedure payment reduction to the professional component of diagnostic imaging services provided by the same practitioner in the same session.
Over the past few years, as part of the potentially misvalued service initiative, the AMA RUC has examined several services that are billed together 75 percent or more of the time as part of the potentially misvalued service initiative. In several cases, the AMA RUC-recommended work values for new codes that describe the combined services, and those recommended values reflected the expected efficiencies. For example, for CY 2011, the AMA RUC valued the work for a series of new codes that describe CT of the abdomen and pelvis, specifically CPT codes:
• 74176 (Computed tomography, abdomen and pelvis; without contrast material).
• 74177 (Computed tomography, abdomen and pelvis; with contrast material).
• 74178 (Computed tomography, abdomen and pelvis; without contrast material in one or both body regions, followed by with contrast material(s) and further sections in one or both body regions).
We accepted the work values recommended by the AMA RUC for these codes in the CY 2011 PFS final rule with comment period (75 FR 73229). The recommended work values reflected an expected efficiency for the typical combined service that paralleled the reductions that would typically result from a MPPR adjustment. For example, in support of the recommended work value of 1.74 RVUs for 74176, the AMA RUC explained that the full value of 74150 (Computed tomography, abdomen; without contrast material) (Work RVU = 1.19) plus half the value of 72192 (Computed tomography, pelvis; without contrast material) (
We continue to believe that there may be additional imaging and other diagnostic services for which there are efficiencies in work when furnished together, resulting in potentially excessive payment for these services under current policy. MedPAC also made this same observation in their recent June 2011 Report to the Congress.
As noted, Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures and nuclear medicine diagnostic procedures furnished to the same patient by the same physician on the same day.
In continuing to apply the provisions of section 3134(a) of the Affordable Care Act, for CY 2012 we proposed to expand the MPPR to the PC of Advanced Imaging Services (CT, MRI, and Ultrasound), that is, the same list of codes to which the MPPR on the TC of advanced imaging already applies (see Addendum F). Thus, the MPPR would apply to the PC and the TC of the codes. Specifically, we proposed to expand the 50 percent payment reduction currently applied to the TC to apply also to the PC of the second and subsequent advanced imaging services furnished in the same session. Full payment would be made for the PC and TC of the highest paid procedure, and payment would be reduced by 50 percent for the PC and TC for each additional procedure furnished to the same patient in the same session. This proposal was based on the expected efficiencies in furnishing multiple services in the same session due to duplication of physician work—primarily in the pre- and post-service periods, with smaller efficiencies in the intra-service period.
The proposal is consistent with the statutory requirement for the Secretary to identify, review, and adjust the relative values of potentially misvalued services under the PFS as specified by section 3134(a) of the Affordable Care Act. The proposal is also consistent both with our longstanding policy on surgical and nuclear medicine diagnostic procedures, which apply a 50 percent reduction to second and subsequent procedures. Furthermore, it is responsive to continued concerns about significant growth in imaging spending, and to MedPAC (March 2010, June 2011) and GAO (July 2009) recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies.
Finally, as noted, the proposal is consistent with the AMA RUC's recent methodology and rationale in valuing the work for a combined CT of the pelvis (CPT codes 72192, 72193 and 72194), and abdomen (CPT codes 74150, 74160 and 74170) where the AMA RUC assumed the work efficiency for the second service was 50 percent. Savings resulting from this proposal would be redistributed to other PFS services as required by the general statutory PFS budget neutrality provision.
In contrast, a few commenters, including MedPAC, supported the proposal. MedPAC indicated that the proposal is consistent with the recommendation from its June 2011
Commenters opposed to our proposal raised several issues about the basis for CMS' proposed 50 percent reduction to the professional component for second and subsequent imaging services Many commenters cited a recent article entitled, “Professional Component Payment Reductions for Diagnostic Imaging Examinations When More Than One Service Is Rendered by the Same Provider in the Same Session: An Analysis of Relevant Payment Policy,” published June 29, 2011, in the Journal of the American College of Radiology”
Commenters point out that neither GAO nor MedPAC supported a specific percentage reduction, but recommended that CMS conduct a review and analysis to determine the extent of efficiencies associated with the PC of multiple imaging services, and suggested that such efficiencies may vary by modality. Commenters highlighted several perceived deficiencies in the GAO's technical methodology, including a failure to distinguish between pre- post- and intra- physician work intensity, failure to recognize the wide variability in pre- and post- service time allocation among varied imaging services which makes a blanket policy more imprecise, and failure to consider clinical practice. Commenters argued that CMS provided no analysis to support the proposed MPPR level of 50 percent and did not identify potential areas of duplication in the pre-, post- and intra-service periods.
Commenters expressed views regarding our reference to the AMA RUC valuation of the work for bundled codes for CT of the pelvis and abdomen. Many commenters did not believe it was appropriate to propose a 50 percent MPPR to the PC for all advanced imaging services based on the AMA RUC's 50 percent reduction in work RVUs when valuing the combined pelvis and abdomen CT codes. Commenters indicated that the bundled code pair is not representative of most code pairs in that it is a focused contiguous body area using the same modality with significant overlap in the regions evaluated. Commenters noted that the AMA RUC has not consistently found a 50 percent reduction in physician work when imaging services are performed together.
The AMA RUC also objected to CMS using its recommended work values for the CT of Abdomen/Pelvis to substantiate our proposal. The AMA RUC asserted that it developed the recommended physician work values by estimating the magnitude of the physician work of the surveyed codes relative to physician work values of MRI, MRA, and evaluation and management services. When valuing the code for CT of Abdomen/Pelvis, the AMA RUC did not believe that the recommended physician work RVUs should be lower than the total RVUs resulting from applying a 50 percent MPPR to the professional component of the second and subsequent imaging service in the CT Abdomen/Pelvis code pair. The AMA RUC pointed out that the committee arrived at the recommended values using magnitude estimation and did not sum values for the component codes as suggested by CMS in the proposed rule.
Some commenters acknowledged that there are some efficiencies in the combined CT of the abdomen and pelvis, noting that overlapping images on a CT of the abdomen and pelvis may require less scrutiny. Commenters also noted that the physician has to review the patient history and provide dictation only once for multiple scans. Other commenters rejected the idea that there are efficiencies in the CT of the abdomen and pelvis. Commenters indicated that the service included only about 75 images 5 years ago. Today, it includes approximately 375 images, with the addition of thinner slice images and multiplanar reformatting.
Many commenters maintained that the proposed 50 percent MPPR for the PC of advanced imaging services is based on erroneous assumptions and a misunderstanding of the practice of medicine. These commenters argued that, generally, patients who are having multiple imaging studies on the same day tend to be patients who are seriously ill or injured patients, including cancer, trauma and stroke patients who invariably have significantly more complex pathology, requiring more time, rather than less. In some cases, the image using an initial modality may be inconclusive, requiring use of another imaging modality. Commenters argued that there are no efficiencies in physician work for interpretation of multiple advanced imaging scans for trauma and cancer patients, where images are less likely to be of contiguous anatomic areas.
Commenters maintained that, on average, studies with comparisons take longer than those that do not have comparison studies. The radiologists must look at more films and, when abnormalities are present, must compare each finding to the previous exam. The more studies there are, the more time it takes to interpret each one. Commenters asserted that radiologists are morally and professionally obligated to spend an equal amount of time, effort, and skill on interpreting images, irrespective of whether previous examinations have been performed on the same patient on the same day.
Finally, several commenters argued that technological advances in imaging have increased the intra-service work requiring radiologists to review many more images and more complex images than when the services were originally valued. They argue that contrary to the CMS proposal, clinical practice has become more time consuming because of the need to review hundreds of images per study compared to earlier imaging methods which took far fewer images. In addition to axial images, there frequently are coronal, sagittal, and oblique sequences as well as maximal intensity 3D images with each study. Images of non-contiguous body areas, for example, a CT of the brain and abdomen, are unrelated and are often read by different specialists, each separately requiring dedicated time for interpretation. Further, the search patterns used to identify possible issues in the images are different; technical aspects of viewing non-contiguous images are different; and the mental process used to formulate differential diagnoses are often unrelated. In some cases, such as when it is necessary to re-review prior images, commenters stated
Our claims analysis revealed that the majority of multiple imaging studies were for contiguous anatomic areas including thorax and abdomen/pelvis, and head/brain and neck/spine, and utilized the same modality. This suggests that multiple studies are typically performed to view a single underlying pathology that spans either multiple regions or lies in the region of overlap where a single study might be suboptimal. If the reasons for the studies were relatively unrelated, the observed association between contiguous areas and same modality would not exist. Conversely, the observation of this firm association between multiple studies on the same day implies that there are some efficiencies in interpreting history; predicting pathology; selecting protocols; reviewing scout and technique scans; focusing on particular tissue types and imaging windows; reviewing overlapping fields; reporting preliminary if not final results; and follow-up discussions with patients, staff and physicians. In contrast to the analysis published by the ACR, we found—
• Significant duplication in the pre-service work, which consists of reviewing patient history and any prior imaging studies, and determining the protocol and communicating that protocol with technologists;
• Significant duplication in the post-service work, which almost always consists of reviewing and signing a final report and discussing findings with the referring physician; and
• Moderate efficiencies in intra-service work. Specifically, supervising contrast (where appropriate), interpreting the examination and comparing it to other studies, and dictating the report for the medical record.
In conclusion, our analysis showed that, after applying a reduction percentage to each vignette component for the second and subsequent scans, identified as the code(s) in the code pair with the lower professional component RVU, and adjusting for intensity differences between pre-service and post-service work and intra-service work, the total RVU reduction ranges from 27.3 to 43.1 percent for second and subsequent procedures in the 12 code pairs.
Based on our further analysis and in response to comments, we believe that a 25 percent reduction would more appropriately capture the range of physician work efficiencies for second and subsequent imaging services furnished by the same physician (including physicians in the same group practice) to the same patient in the same session on the same day.
Commenters expressed concerns that there is wide variation in the potential efficiencies among different code pairs that such variability precludes broad application of a single percentage reduction, and that establishing new combined codes is the only mechanism for capturing accurate payment, for multiple imaging services. In general, we believe that MPPR policies capture efficiencies when several services are furnished in the same session and that it is appropriate to apply a single percentage reduction to second and subsequent procedures to capture those efficiencies. Because of the myriad potential combinations of advanced imaging scans, establishing new combined codes for each combination of advanced imaging scans is unwieldy and impractical. An MPPR policy is not precise, but reflects efficiencies in the aggregate, such as common patient history, interpretation of multiple images involving the same patient and same anatomical structures, and, typically, same modality. Our analysis of the specific activities included in furnishing advanced imaging scans together supports a reduction between 27.3 and 43.1 percent. The implementation of a 25 percent reduction in the PC for second and subsequent imaging services furnished by the same physician in the same session is less than range of reductions we observed for second and subsequent scans in our analysis. Therefore, while we acknowledge that efficiencies may vary across code pairs, we believe that a 25 percent reduction in the PC is reasonable and supported by our analysis. We note that, as with many of our policies, we will continue to review this MPPR policy and refine it as needed in future years to ensure that we continue to provide accurate payments under the PFS.
We disagree with commenters' assertions that there are no efficiencies in physician work for the interpretation of multiple advanced imaging scans for trauma and cancer patients. As noted previously, our analysis indicates that the typical multiple imaging case involves contiguous body areas, and only a very small percentage involve more than one modality. We note that this analysis included all claims data, including trauma and cancer patient imaging studies. In addition, we used conservative estimates of the reduction percentages for the observed efficiencies for second and subsequent procedures in our analysis. Finally, we believe there are efficiencies in work for all multiple imaging studies, including the review of medical history and prior imaging studies; contrast administration; review of the final report; and discussion of findings with the referring physician, regardless of the type of injury or patient's diagnosis.
Concerning comparison studies, we note that when interpreting previous studies, the radiologist would interpret not just the prior image itself, but also the patient history or, at a minimum, the portfolio of similar available studies. While we understand that time spent reviewing prior studies adds work by requiring the radiologist to review such studies, we believe that the availability of prior studies may also reduce work by creating a baseline against which new images can be quickly compared.
Commenters were also concerned with technological advances that may exponentially multiply the number of images that are produced in a single imaging session. While we agree with commenters that technology has multiplied the number of images produced, we note that that same technology has vastly improved viewability. The use of shuttles to scan through a series of images along imaged axis, 3-D rendering to allow visualization, rotation and zoom, and modeling to enhance suspect findings and increase the utility of pattern recognition all exist to improve the efficiency of data extraction that at one time had to be visualized entirely in the mind of the radiologist from a series of side-by-side flat images. Therefore, we believe that, in the aggregate, technological advances in imaging have not significantly increased the work of interpretation. Efficiencies resulting from technological advances are even more evident in cases of multiple contiguous images, where rendering allows joystick maneuvering through a single continuous image that may be billed independently, but which may be acquired as a single activity. Finally, we note that other commenters, and the study cited by the American College of Radiology, have acknowledged some efficiencies do exist and are not currently recognized in the coding and payment structure of these codes.
As explained previously, section 1848(c)(2)(K)(i) of the Act requires the Secretary to identify services within several specific categories as being potentially misvalued, and to make appropriate adjustments to their relative values. One of the specific categories listed under section 1834(c)(2)(K)(ii) of the Act is “multiple codes that are frequently billed in conjunction with furnishing a single service.”
Therefore, we do not agree with the commenters that the MPPR policy undermines the goals of the Affordable Care Act. It appears the commenter may have misunderstood the point of the quoted statement from the proposed rule that, “[b]ecause of the different pieces of equipment used for CT/CTA, MRI/MRA, and ultrasound procedures, it would be highly unlikely that a single practitioner would furnish more than one imaging procedure involving two different modalities to one patient in a single session where the proposed MPPR would apply.” The commenter is correct that we conceded, in the circumstance where two different modalities are used, it is unlikely that two advanced imaging codes would be billed by a single physician for a single patient in a single session. However, the point of this statement was to indicate that the proposed MPPR would not apply in the vast majority of these situations. Although there remains the remote possibility that the MPPR would apply in a scenario where the codes for multiple advanced imaging services are not “frequently billed in conjunction with furnishing a single service,” we believe this would be exceedingly rare. Moreover, we would expect there to be some level of efficiencies in work even in these cases. As we indicated in the CY 2011 PFS final rule with comment period (75 FR 73231), application of a general MPPR policy to numerous imaging service combinations may result in an overestimate of efficiencies in some cases and an underestimate in others. But this can be true for any service paid under the PFS, and we believe it is important to establish a general policy to pay appropriately for the typical service or services furnished. Given that, based on our review of CY 2010 claims data, 97 percent of second and subsequent advanced imaging services furnished to the same patient on the same day involved the use of the same imaging modality, and that some of the cases that did involve different modalities might have been furnished by different physicians in different group practices (in which case the MPPR would not apply), we do not believe it is necessary to adjust our MPPR policy to address an uncommon scenario. Therefore, we believe the MPPR policy is fully consistent with section 1848(c)(2)(K) of the statute, as added by section 3134(a) of the Affordable Care Act, and that the policy fulfills several of our key statutory obligations by more appropriately valuing combinations of imaging services furnished to patients and paid under the PFS.
Commenters noted that imaging tests utilizing different modalities are rarely performed in the same session. For example, a patient may undergo an ultrasound, which would be interpreted by the physician to determine whether the patient requires a CT for further diagnostic evaluation. The physician supervises and/or performs and interprets each test separately, at different times, and speaks to the patient about the results of each test on separate occasions during the patient's visit. Also, separate written reports are required for each test.
Commenters further noted that in multiple trauma cases, the same radiologist would not interpret the entire series of exams. In addition, there are cases when a radiologist determines upon review that X-rays were insufficient to determine the problem and, therefore, recommends another type of imaging study be performed. The same radiologist may review the results of this second imaging test for the same
• A physician does not read both scans together, for example, in emergency situations even though both scans were performed in the same session;
• Two physicians with different specialties each read a separate scan of a patient, though both scans were taken during the same session; and
• Physicians are in the same group practice.
We believe the term “advanced imaging” has confused commenters because this term has been used to define different sets of imaging services for different Medicare initiatives. We have not revised the definition of advanced imaging services that we have used for the imaging MPPR policy regarding the TC of the second and subsequent imaging services Since 2006, for payment under the PFS, the imaging MPPR for the TC has included CT, MRI and ultrasound. While ultrasound services are included in both the existing imaging MPPR for the TC and in the MPPR policy we are finalizing for the PC beginning in CY 2012, we do not consider ultrasound services to be advanced imaging procedures for purposes of accreditation. Section 135(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) required the Secretary to designate organizations to accredit suppliers, including but not limited to physicians, non-physician practitioners and Independent Diagnostic Testing Facilities that furnish the technical component (TC) of advanced diagnostic imaging services, which include MRI, CT, and nuclear medicine imaging such as positron emission tomography (PET). The MIPPA provision expressly excludes ultrasound, X-ray, and fluoroscopy from this requirement.
With respect to the ordering and scheduling of imaging services for Medicare beneficiaries, we require that Medicare-covered services be appropriate to patient needs. We would not expect the adoption of an MPPR for the PC of imaging services to result in imaging services being furnished on separate days by one provider merely so that the practitioner or provider may garner increased payment. We agree with the commenters who noted that such an unprofessional response on the part of practitioners would be inefficient and inappropriate. We will continue to monitor access to care and patterns of delivery for imaging services, with particular attention focused on identifying any changes in the delivery of same day imaging services that may be clinically inappropriate.
In summary, after consideration of the public comments received, we are adopting our CY 2012 proposal to apply an MPPR to the PC of advanced imaging services, with a modification to apply a 25 percent reduction for CY 2012 rather than the 50 percent reduction we had proposed. We continue to believe that efficiencies exist in the PC of multiple imaging services, and we will continue to monitor code combinations for possible future adjustments to the reduction percentage applied through this MPPR policy.
Specifically, beginning in CY 2012 we are adopting an MPPR that applies a 25 percent reduction to the PC of second and subsequent advanced imaging services furnished by the same physician to the same patient, in the same session, on the same day. We are proposing to add CPT 74174 (Computed tomographic angiography, abdomen and pelvis; with contrast material(s), including noncontrast images, if performed, and image postprocessing), which is a new code for CY 2012, to the imaging MPPR list. This code is being added on an interim final basis and is open to public comment on this final rule with comment period. We note that the MPPR will apply when the combined new procedure is furnished in conjunction with another procedure(s). The complete list of services subject to the MPPR for the PC of imaging services is the same as for the MPPR currently applied to the TC of imaging services, and is shown in Addendum F. The PFS budget neutrality provision is applicable to the new MPPR for the PC of advanced imaging services. Therefore, the estimated reduced expenditures for imaging services have been redistributed to increase payment for other PFS services. We refer readers to section IX.C. of this final rule with comment period for further discussion of the impact of this policy.
Currently, the MPPR policies focus only on a select number of codes. We will be aggressively looking for efficiencies in other sets of codes during the coming years and will consider implementing more expansive multiple procedure payment reduction policies in CY 2013 and beyond. In the proposed rule, we invited public comment on the following MPPR policies which are under consideration. Any proposals would be presented in future rulemaking and subject to further public comment:
• Apply the MPPR to the TC of All Imaging Services. This approach would apply a payment reduction to the TC of the second and subsequent imaging services performed in the same session. Such an approach could define imaging consistent with our existing definition of imaging for purposes of the statutory cap on payment at the OPPS rate (including X-ray, ultrasound (including echocardiography), nuclear medicine (including positron emission tomography), magnetic resonance imaging, computed tomography, and fluoroscopy, but excluding diagnostic and screening mammography). Add-on codes that are always furnished with another service and have been valued accordingly could be excluded.
Such an approach would be based on the expected efficiencies due to duplication of clinical labor activities, supplies, and equipment time. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statutory PFS budget neutrality provision.
• Apply the MPPR to the PC of All Imaging Services. This approach would apply a payment reduction to the PC of the second or subsequent imaging services furnished in the same encounter. Such an approach could define imaging consistent with our existing definition of imaging for the cap on payment at the OPPS rate. Add-on codes that are always furnished with another service and have been valued accordingly could be excluded.
This approach would be based on efficiencies due to duplication of physician work primarily in the pre- and post-service periods, with smaller efficiencies in the intra-service period. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statutory PFS budget neutrality provision.
• Apply the MPPR to the TC of All Diagnostic Tests. This approach would apply a payment reduction to the TC of the second and subsequent diagnostic tests (such as radiology, cardiology, audiology, etc.) furnished in the same encounter. Add-on codes that are always furnished with another service and have been valued accordingly could be excluded.
The approach would be based on the expected efficiencies due to duplication of clinical labor activities, supplies, and equipment time. The approach would apply to approximately 700 HCPCS codes, including the approximately 560 HCPCS codes subject to the OPPS cap. The savings would be redistributed to other PFS services as required by the statutory PFS budget neutrality provision.
We received several comments concerning the future expansion of the MPPR. We will take the comments under consideration as we develop future proposals. Any proposals would be presented in future rulemaking and subject to further public comment.
We are proposing to add the new codes in Table 9 to the list of procedures subject to the OPPS cap, effective January 1, 2012. These procedures meet the definition of imaging under section 5102(b) of the DRA. These codes are being added on an interim final basis and are open to public comment in this final rule with comment period.
Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: work, PE, and malpractice. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expense percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 4505(f) of the BBA amended section 1848(c) of the Act which required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. Therefore, initial implementation of resource-based malpractice RVUs occurred in 2000.
The statute also requires that we review, and if necessary adjust, RVUs no less often than every 5-years. The first review and update of resource-based malpractice RVUs was addressed in the CY 2005 PFS final rule with comment period (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and update of malpractice RVUs. For a discussion of the second review and update of malpractice RVUs, see the CY 2010 PFS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758).
As explained in the CY 2011 PFS final rule with comment period, malpractice RVUs for new and revised codes effective before the next Five-Year Review of Malpractice (for example, effective CY 2011 through CY 2014, assuming that the next review of malpractice RVUs occurs for CY 2015) are determined either by a direct crosswalk to a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code (75 FR 73208). For the modified crosswalk approach, we adjust (or “scale”) the malpractice RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work value (or, if greater, the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code is 10 percent higher than the work RVU for its source code, the malpractice RVU for the revised code would be increased by 10 percent over the source code RVU. This approach presumes the same risk factor for the new/revised code and source code but uses the work RVU for the new/revised code to adjust for risk-of-service.
Section 1848(e)(1)(A) of the Social Security Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (that is, physician work, practice expense (PE), and malpractice). While requiring that the PE and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier States beginning January 1, 2011.
Section 1848(e)(1)(E) of the Act provides for a 1.0 floor for the work GPCIs which was set to expire at the end of 2009 until it was extended through December 31, 2010 by section 3102(a) of the Affordable Care Act. Because the work GPCI floor was set to expire at the end of 2010, the GPCIs published in Addendum E of the CY 2011 PFS final rule with comment period did not reflect the 1.0 physician work floor. However, section 1848(e)(1)(E) of the Act was amended on December 15, 2010, by section 103 of the Medicare and Medicaid Extenders Act (MMEA) of 2010 (P.L. 111-309) to extend the 1.0 work GPCI floor through December 31, 2011. Appropriate changes to the CY 2011 GPCIs were made to reflect the 1.0 physician work floor required by section 103 of the MMEA. Since the work GPCI floor provided in section 1848(e)(1)(E) of the Act is set to expire prior to the implementation of the CY 2012 PFS, the CY 2012 physician work GPCIs, and summarized geographic adjustment factors (GAFs), presented in this final rule with comment period do not reflect the 1.0 work GPCI floor. As required by section 1848(e)(1)(G) and section 1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier States will be applicable in CY 2012. Moreover, the limited recognition of cost differences in employee compensation and office rent for the PE GPCIs, and the related hold harmless provision, required under section 1848(e)(1)(H) of the Act was only applicable for CY 2010 and CY 2011 (75 FR 73253) and, therefore, is no longer effective beginning in CY 2012.
Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs not less often than every 3 years. This section also specifies that if more than 1 year has elapsed since the last GPCI revision, we must phase in the adjustment over 2 years, applying only one-half of any adjustment in the first year.
As noted in the CY 2011 PFS final rule with comment period (75 FR 73252 through 73262), for the sixth GPCI update, we updated the data used to
Since more than 1-year had elapsed since the fifth GPCI update, as required by law, the sixth GPCI update changes are being phased in over a 2-year period. The current CY 2011 GPCIs reflect the first year of the transition. The final CY 2012 GPCIs reflect the full implementation with modifications reflecting the revisions contained in this final rule with comment period.
The Affordable Care Act requires that we analyze the current methodology and data sources used to calculate the PE GPCI component. Specifically, section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of the Affordable Care Act) requires the Secretary to “analyze current methods of establishing practice expense adjustments under subparagraph (A)(i) and evaluate data that fairly and reliably establishes distinctions in the cost of operating a medical practice in different fee schedule areas.” Section 1848(e)(1)(H)(iv) of the Act also requires that such analysis shall include an evaluation of the following:
• The feasibility of using actual data or reliable survey data developed by medical organizations on the costs of operating a medical practice, including office rents and non-physician staff wages, in different fee schedule areas.
• The office expense portion of the practice expense geographic adjustment; including the extent to which types of office expenses are determined in local markets instead of national markets.
• The weights assigned to each area of the categories within the practice expense geographic adjustment.
In addition, the weights for different categories of practice expense in the GPCIs have historically matched the weights developed by the CMS Office of the Actuary (OACT) for use in the Medicare Economic Index (MEI), the measure of inflation used as part of the basis for the annual update to the physician fee schedule payment rates. In response to comments received on the CY 2011 Physician Fee Schedule proposed rule, however, we delayed moving to the new MEI weights developed by OACT for CY 2011 pending further analysis.
Lastly, we asked the Institute of Medicine (IOM) to evaluate the accuracy of the geographic adjustment factors used for Medicare physician payment. IOM will prepare two reports for the Congress and the Secretary of the Department of Health and Human Services. The revised first report (Phase I), which includes supplemental recommendations to the initial IOM release of June1, 2011, was released on September 28, 2011, and includes an evaluation of the accuracy of geographic adjustment factors for the hospital wage index and the GPCIs, and the methodology and data used to calculate them. The second report, expected in spring 2012, will evaluate the effects of the adjustment factors on the distribution of the health care workforce, quality of care, population health, and the ability to provide efficient, high value care. Given the timing of the release of IOM's revised report, we are unable to address the full scope of the IOM recommendations in this final rule with comment period. These reports can be accessed on the IOM's Web site at:
The recommendations that relate to or would have an effect on the GPCIs included in IOM's revised Phase I report are summarized as follows:
• Recommendation 2-1: The same labor market definition should be used for both the hospital wage index and the physician geographic adjustment factor. Metropolitan statistical areas and Statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.
• Recommendation 2-2: The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all health care employers.
• Recommendation 5-1: The GPCI cost share weights for adjusting fee-for-service payments to practitioners should continue to be national, including the three GPCIs (work, practice expense, and liability insurance) and the categories within the practice expense (office rent and personnel).
• Recommendation 5-2: Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified.
• Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process.
• Recommendation 5-4: The practice expense GPCI should be contructed with the full range of occupations employed in physicians' offices, each with a fixed national weight based on the hours of each occupation employed in physicians' offices nationwide.
• Recommendation 5-5: CMS and the Bureau of Labor Statistics should develop an agreement allowing the Bureau of Labor Statistics to analyze confidential data for the Centers for Medicare and Medicaid Services.
• Recommendation 5-6: A new source of information should be developed to determine the variation in the price of commercial office rent per square foot.
• Recommendation 5-7: Nonclinical labor-related expenses currently included under practice expense office expenses should be geographically adjusted as part of the wage component of the practice expense.
The revised GPCI values we proposed were developed by a CMS contractor. As mentioned previously, there are three GPCI components (physician work, PE, and malpractice), and all GPCIs are developed through comparison to a national average for each component. Additionally, each of the three GPCIs relies on its own data source(s) and methodology for calculating its value. As discussed in more detail later in this section, we proposed to revise the PE GPCIs for CY 2012, as well as the cost share weights which correspond to all three GPCIs.
The physician work GPCIs are designed to capture the relative cost of physician labor by Medicare PFS locality. Previously, the physician work GPCIs were developed using the median hourly earnings from the 2000 Census of workers in seven professional specialty occupation categories which we used as a proxy for physicians' wages. Physicians' wages are not included in the occupation categories because Medicare payments are a key determinant of physicians' earnings. That is, including physicians' wages in the physician work GPCIs would, in effect, have made the indices dependent upon Medicare payments. As required by law, the physician work GPCI reflects one quarter of the relative wage differences for each locality compared to the national average.
The physician work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based on professional earnings data from the 2000 Census. For the sixth GPCI update in CY 2011, we used the 2006 through 2008 Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) data as a replacement for the 2000 Census data. We did not propose to revise the physician work GPCI data source for CY 2012. However, we note that the work GPCIs will be revised to account for the expiration of the statutory work floor. The 1.5 work floor for Alaska is permanent and will be applicable in CY 2012. In addition, we proposed to revise the physician work cost share weight from 52.466 to 48.266 in line with the 2011 MEI weights, which are based on 2006 data (referred to hereinafter as the 2006-based MEI).
(1) Affordable Care Act Analysis and Revisions for PE GPCIs
(A) General Analysis for the CY 2012 PE GPCIs
As previously mentioned, section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of the Affordable Care Act) requires the Secretary to “analyze current methods of practice expense adjustments under subparagraph (A)(i) and evaluate data that fairly and reliably establishes distinctions in the cost of operating a medical practice in the different fee schedule areas.”
Moreover, section 1848 (e)(1)(H)(v) of the Act requires the Secretary to make appropriate adjustments to the PE GPCIs as a result of the required analysis, no later than January 1, 2012. We proposed to make four revisions to the PE data sources and cost share weights discussed herein effective January 1, 2012. Specifically, we proposed to: (1) Revise the occupations used to calculate the employee wage component of PE using BLS wage data specific to the office of physicians' industry; (2) utilize two bedroom rental data from the 2006-2008 American Community Survey as the proxy for physician office rent; (3) create a purchased service index that accounts for regional variation in labor input costs for contracted services from industries comprising the “all other services” category within the MEI office expense and the stand alone “other professional expenses” category of the MEI; and (4) use the 2006-based MEI (most recent MEI weights finalized in the CY 2011 final rule with comment period) to determine the GPCI cost share weights. These proposals were based on analyses we conducted to address commenter concerns in the CY 2011 final rule with comment period and a continuation of our PE evaluation as required by the Affordable Care Act. The main comments were related to: (1) the occupational groups used to calculate the employee wage component of PE, and (2) concerns by commenters stating that regional variation in purchased services such as legal and accounting were not sufficiently included in the GPCI methodology.
We began analyzing the current methods and data sources used in the establishment of the PE GPCIs during the CY 2011 rulemaking process (75 FR 40084). With respect to our CY 2011 analysis, we began with a review of the Government Accountability Office's (GAO) March 2005 Report entitled, “Medicare Physician Fees: Geographic Adjustment Indices Are Valid in Design, but Data and Methods Need Refinement” (GAO-05-119). While we have raised concerns in the past about some of the GAO's GPCI recommendations, we noted that with respect to the PE GPCIs, the GAO did not indicate any significant issues with the methods underlying the PE GPCIs. Rather, the report focused on some of the data sources used in the method. For example, the GAO stated that the wage data used for the PE GPCIs are not current. Similarly, commenters on previous PE GPCI updates predominantly focused on either the data sources used in the method or raised issues such as incentivizing the provision of care in different geographic areas. However, the latter issue (incentivizing the provision of care) is outside the scope of the statutory requirement that the PE GPCIs reflect the relative costs of the mix of goods and services comprising practice expenses in the different fee schedule areas relative to the national average.
To further analyze the PE office expense in accordance with section 1848(e)(1)(H)(iv) of the Act, we examined the following issues: the appropriateness of expanding the number of occupations included in the employee wage index; the appropriateness of replacing rental data from the Department of Housing and Urban Development (HUD) with data from the 2006-2008 American Community Survey (ACS) two bedroom rental data as a proxy for the office rent subcomponent of PE; and the appropriateness of adjusting the “all other services” and “other professional expenses” MEI categories for geographic variation in labor-related costs. We also examined available ACS occupational group data for potential use in determining geographic variation in the employee wage component of PE.
An additional component of the analysis under section 1848(e)(1)(H)(iv) of the Act is to evaluate the weights assigned to each of the categories within the practice expense geographic adjustment. As discussed in the CY 2011 final rule with comment period (75 FR 73256), in response to concerns raised by commenters and to allow us time to conduct additional analysis, we did not revise the GPCI cost share weights to reflect the weights used in the revised and rebased 2006 MEI that we adopted beginning in CY 2011. In response to those commenters who raised many points regarding the appropriateness of assigning labor-related costs in the medical equipment and supplies and miscellaneous component which do not reflect locality cost differentials, we agreed to address the GPCI cost share weights again in the CY 2012 PFS proposal. These issues are discussed in greater detail in section II.D.2.b.(1).(E). of this final rule with comment period that discusses our determination of the cost share weights.
We also stated in the CY 2011 final rule with comment period that we would review the findings of the Secretary's Medicare Geographic Payment Summit and the MEI technical advisory panel during future rulemaking (75 FR 73256). The Secretary convened the National Summit on Health Care Quality and Value on October 4, 2010. This Summit was attended by a number of policy experts that engaged in detailed discussions regarding geographic adjustment factors and geographic variation in payment and the promotion of high quality care. This National Summit was useful by informing us on issues that we are studying further through two Institute of Medicine studies. In accordance with section 3102(b) of the Affordable Care Act, we are also continuing to consider these issues in the course of this notice and comment rulemaking for the CY 2012 PFS, which includes revisions to the GPCI, and through preparation of a report to the Congress that we will be submitting later this year in accordance with section 3137(b) of the Affordable Care Act on a plan for reforming the hospital wage index. In addition, we announced the establishment of the MEI Technical Advisory Panel and request for nominations of members on October 7, 2011 (76 FR 62415 through 62416). We note that the panel will conclude by September 28, 2012 and we look forward to examining the recommendations of this panel once it has issued its report.
In the CY 2011 final rule with comment period, we finalized our policy to use the 2010 Fair Market Rent (FMR) data produced by HUD at the 50th percentile as the proxy for relative cost differences in physician office rents. However, as part of our analysis required by section 1848(e)(1)(H)(iv) of the Act, we have now examined the suitability of utilizing 3-year (2006-2008) ACS rental data to serve as a proxy for physician office rents. We believe that the ACS rental data provide a sufficient degree of reliability and are an appropriate source on which to base our PE GPCI office rent proxy. We also believe that the ACS data provide a higher degree of accuracy than the HUD data since the ACS data are updated annually and not based on data collected by the 2000 Census long form. Moreover, it is our understanding that the Census “long form,” which is utilized to collect the necessary base year rents for the HUD Fair Market Rent (FMR) data, will no longer be available in future years. Therefore, we proposed to use the available 2006 through 2008 ACS rental data for two bedroom residential units as the proxy for physician office rent. We also sought comment regarding the potential use of 5-year ACS rental data as a proxy for physician office rent in future rulemaking.
We believe the ACS data will more accurately reflect geographic variation in the office rent component. As in past GPCI updates, we proposed to apply a nationally uniform weight to the office rent component. We proposed to use the 2006-based MEI weight for fixed capital and utilities as the weight for the office rent category in the PE GPCI, and to use the ACS residential rent data to develop the practice expense GPCI value.
Accurately evaluating the relative price that physicians pay for labor inputs requires both a mechanism for selecting the occupations to include in the employee wage index and identifying an accurate measure of the wages for each occupation. We received comments during the CY 2011 rulemaking cycle noting that the current employee wage methodology may omit key occupational categories for which cost varies significantly across regions. Commenters suggested including occupations such as accounting, legal, and information technology in the employee wage component of the PE GPCI. To address these concerns, we proposed to revise the employee wage index framework within the practice expense (PE) GPCI. Under this new methodology, we would only select occupational categories relevant to a physician's practice. We would use a comprehensive set of wage data from the Bureau of Labor Statistics Occupational Employment Statistics (BLS OES) specific to the offices of physicians industry. Utilizing wage and national cost share weight data from the BLS OES would not only provide a more systematic approach to determining which occupations should be included in the non-physician employee wage category of the PE GPCI, but would also enable us to determine how much weight each occupation should receive within the index.
Due to its reliability, public availability, level of detail, and national scope, we proposed to use BLS OES data to estimate both occupation cost shares and hourly wages for purposes of determining the non-physician employee wage component of the PE GPCI. The OES panel data are collected from approximately 200,000 establishments, and provide employment and wage estimates for about 800 occupations. At the national level, OES provides estimates for over 450 industry classifications (using the 3, 4, and 5 digit North American Industry Classification System (NAICS)), including the Offices of Physicians industry (NAICS 621100). As described in the census, the Offices of Physicians industry comprises establishments of health practitioners having the degree of M.D. (Doctor of Medicine) or D.O. (Doctor of Osteopathy) primarily engaged in the independent practice of general or specialized medicine (except psychiatry or psychoanalysis) or surgery. These practitioners operate private or group practices in their own offices (such as centers, clinics) or in the facilities of others (such as hospitals or Health Maintenance Organization (HMO) medical centers). The OES data provide significant detail on occupational categories and offer national level cost share estimates for the offices of physicians industry.
In the BLS OES data methodology, we weighted each occupation based on its share of total labor cost within the offices of physician industry. Specifically, each occupation's weight is proportional to the product of its occupation's employment share and average hourly wage. In this calculation, we used each occupation's employment level rather than hours worked, because the BLS OES does not contain industry-specific information describing the number of hours worked in each occupation (see:
We also evaluated available ACS occupational data as a potential data source for the non-physician employee wage PE GPCI subcomponent. Based on the occupations currently used to calculate employee wages, the BLS OES captures occupations with greater relevancy to physician office practices and is a more appropriate data source than the currently available ACS data. In addition, since our publication of the CY 2012 proposed rule, we have conducted an analysis of ACS wage data including an expanded mix of occupations. A review of this analysis can be found in our contractors “Revisions to the Sixth Update of the Geographic Practice Cost Index: Final Report” located on the physician fee schedule CY 2012 final rule with comment period Web site at:
For CY 2012, we proposed to geographically adjust the labor-related industries within the “all other services” and “other professional expenses” categories of the MEI. In response to commenters who stated that these purchased services were labor-related and should be adjusted geographically, we agreed to examine this issue further in the CY 2011 final rule with comment period and refrained from making any changes. Based on our subsequent examination of this issue, we believe it would be appropriate to geographically adjust for the labor-related component of purchased services within the “All Other Services” and “Other Professional Expenses” categories using BLS wage data. In total, there are 63 industries, or cost categories, accounted for within the “all other services” and “other professional services” categories of the 2006-based MEI. For purposes of the hospital wage index at 74 FR 43845, we defined a cost category as labor-related if the cost category is defined as being both labor intensive and its costs vary with, or are influenced by the local labor market.
In order to calculate the labor-related and non labor- related shares, we would use a similar methodology that is employed in estimating the labor-related share of various CMS market baskets. A more detailed explanation of this methodology can be found under the supporting documents section of the CY 2012 PFS final rule with comment period Web page at
We believe our analysis, during 2010 and this year, of the current methods of establishing PE GPCIs and our evaluation of data that fairly and reliably establish distinctions in the cost of operating a medical practice in the different fee schedule areas meet the statutory requirements of section 1848(e)(1)(H)(iv) of the Act. A more detailed discussion of our analysis of current methods of establishing PE GPCIs and evaluation of data sources is included in our contractor's draft report entitled, “Proposed Revisions to the Sixth Update of the Geographic Practice Cost Index.” Our contractor's final report and associated analysis of the GPCI revisions, including the PE GPCIs, will be made publicly available on the CMS Web site. The final report may be accessed from the PFS Web site at:
Additionally, see section IX.F. of this final rule with comment period for Table 86, which reflects the GAF impacts resulting from these proposals. As the table demonstrates, the primary driver of the CY 2012 impact is the expiration of the work GPCI floor which had produced non budget-neutral increases to the CY 2011 GPCIs for lower cost areas as authorized under the Affordable Care Act the Medicare and Medicaid Extenders Act (MMEA).
To determine the cost share weights for the CY 2012 GPCIs, we proposed to use the weights established in the 2006-based MEI. The MEI was rebased and revised in the CY 2011 final rule with comment period to reflect the weighted-average annual price change for various inputs needed to provide physicians' services. As discussed in detail in that section (75 FR 73262 through 73277), the proposed expense categories in the MEI, along with their respective weights, were primarily derived from data collected in the 2006 AMA PPIS for self-employed physicians and selected self-employed non-medical doctor specialties. Since we have historically updated the GPCI cost share weights consistent with the most recent update to the MEI, and because we have addressed commenter concerns regarding the inclusion of the weight assigned to utilities with office rent and geographically adjusted for the labor intensive industries within the “all other services” and “other professional expenses” MEI categories, we believe it is appropriate to adopt the 2006-based MEI cost share weights.
For the cost share weight for the CY 2012 PE GPCIs, we used the 2006-based MEI weight for the PE category of 51.734 percent minus the professional liability insurance category weight of 4.295 percent. Therefore, we proposed a cost share weight for the PE GPCIs of 47.439 percent.
For the employee compensation portion of the PE GPCIs, we proposed to use the non-physician employee compensation category weight of 19.153 percent reflected in the 2006-based MEI.
We proposed that the weight for the office rent component be revised from 12.209 percent to 10.223 percent. The 12.209 percent office rent GPCI weight was set equal to the 2000-based MEI cost weight for office expenses, which was calculated using the American Medical Association's (AMA) Socioeconomic Monitoring Survey (SMS). The 12.209 percent reflected the expenses for rent, depreciation on medical buildings, mortgage interest, telephone, and utilities. We proposed to set the GPCI office rent equal to 10.223 percent reflecting the 2006-based MEI cost weights (75 FR 73263) for fixed capital (reflecting the expenses for rent, depreciation on medical buildings and mortgage interest) and utilities. We are no longer including telephone costs in the GPCI office rent cost weight because we believe these expenses do not vary by geographic area.
Consistent with the revised and rebased 2006-based MEI which was adopted in the CY 2011 final rule with comment period (75 FR 73263), we disaggregated the broader office expenses component for the PE GPCI into 10 new cost categories. In this disaggregation, the fixed capital component is the office expense category applicable to the office rent component of the PE GPCI. As discussed in the section dealing with office rent, we proposed to use 2006-2008 ACS rental data as the proxy for physician office rent. These data represent a gross rent amount and includes data on utilities expenditures. Since it is not possible to separate the utilities component of rent for all ACS survey respondents, it was necessary to combine these two components to calculate office rent and by extension, we proposed combining those two cost categories when assigning a weight to the office rent component.
As discussed in the previous paragraphs, a new purchased services index was created to geographically adjust the labor-related components of the “All Other Services” and “Other Professional Expenses” categories of the 2006-based MEI office market basket. In order to calculate the purchased services index, we proposed to merge the corresponding weights of these two categories to form a combined purchased services weight of 8.095 percent. However, we proposed to only adjust for locality cost differences of the labor-related share of the industries comprising the “All Other Services” and “Other Professional Expenses” categories. We have determined that only 5.011 percentage points of the 8.095 percentage points would be adjusted for locality cost differences (5.011 adjusted purchased service + 3.084 non-adjusted purchased services = 8.095 total cost share weight).
To calculate the proposed medical equipment, supplies, and other miscellaneous expenses component, we removed professional liability (4.295 percentage points), non-physician employee compensation (19.153 percentage points), fixed capital/utilities (10.223 percentage points), and
Furthermore, we proposed to use the physician compensation cost category weight of 48.266 percent as the work GPCI cost share weight; and we proposed to use the professional liability insurance weight of 4.295 percent for the malpractice GPCI cost share weight. We believe our analysis and evaluation of the weights assigned to each of the categories within the PE GPCIs satisfies the statutory requirements of section 1848(e)(1)(H)(iv) of the Act.
The cost share weights for the CY 2012 GPCIs are displayed in Table 10. For a detailed discussion regarding the GPCI cost share weights and how the weights account for local and national adjustments, see our contractor's “Proposed Revisions to the Sixth Update of the Geographic Practice Cost Index” draft report at (
Section 10324(c) of the Affordable Care Act added a new subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0 PE GPCI floor for physicians' services furnished in frontier States effective January 1, 2011. In accordance with section 1848(e)(1)(I) of the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for physicians' services furnished in States determined to be frontier States. There are no changes to those States identified as “Frontier States” for the CY 2012 final rule with comment period. The qualifying States are reflected in Table 11. In accordance with statute, we will apply a 1.0 GPCI floor for these States in CY 2012.
The PE GPCIs include four components: employee compensation, office rent, purchased services, and medical equipment, supplies and miscellaneous expenses. Our proposals relating to each of these components are as follows:
• Employee Compensation: We proposed to geographically adjust the employee compensation using the 2006 through 2008 BLS OES data specific to the offices of physicians industry along with nationwide wage data to determine the employee compensation component of the PE GPCIs. The employee compensation component accounts for 19.153 percent of total practice costs or 40.4 percent of the total PE GPCIs.
• Office Rents: We proposed to geographically adjust office rent using the 2006 through 2008 ACS residential rental data for two bedroom units as a proxy for the relative cost differences in physician office rents. In addition, we proposed to consolidate the utilities into the office rent weight to account for the utility data present in ACS gross rent data. The office rent component accounts for 10.223 percent of total practice cost or 21.5 percent of the PE GPCIs.
• Purchased Services: We proposed to geographically adjust the labor-related component of purchased services within the “All Other Services” and “Other Professional Expenses “categories using BLS wage data. The methodology employed to estimate purchased services expenses is based on the same data used to estimate the employee wage index. Specifically, the purchased services framework relies on BLS OES wage data to estimate the price of labor in industries that physician offices frequently rely upon for contracted services. As previously mentioned, the labor-related share adjustment for each industry was derived using a similar methodology as is employed for estimating the labor-related shares of CMS market baskets. Furthermore, the weight assigned to each industry within the purchased services index was based on the 2006-based MEI. A more detailed discussion regarding CMS market baskets, as well as the corresponding definitions of a “labor-related share” and a “non-labor-related share” can be viewed at (74 FR 43845). The total purchased services component accounts for 8.095 percent of total practice cost or 17.1 percent of the PE GPCI. However, the proportion of purchased services that is geographically adjusted for locality cost difference is 5.011 percentage points of the 8.095 percentage points or 10.6 percent of the PE GPCI.
• Medical Equipment, Supplies, and other Miscellaneous Expenses: We continue to believe that items such as medical equipment and supplies have a national market and that input prices do not vary appreciably among geographic areas. As discussed in previous GPCI updates in the CY 2008 and CY 2011 PFS proposed rules, specifically the fifth GPCI update (72 FR 38138) and sixth GPCI update (75 FR 73256), respectively, some price differences may exist, but we believe these differences are more likely to be based on volume discounts rather than on geographic market differences. For example, large physicians' practices may utilize more medical equipment and supplies and therefore may or may not receive volume discounts on some of these items. To the extent that such discounting may exist, it is a function of purchasing volume and not geographic location. The medical equipment, supplies, and miscellaneous expenses component was factored into the PE GPCIs with a component index of 1.000. The medical equipment, supplies, and other miscellaneous expense component account for 9.968 percent of total practice cost or 21.0 percent of the PE GPCI.
The malpractice GPCIs are calculated based on insurer rate filings of premium data for $1 million to $3 million mature “claims-made” policies (policies for claims made rather than services furnished during the policy term). We chose claims-made policies because they are the most commonly used malpractice insurance policies in the United States. We used claims-made policy rates rather than occurrence policies because a claims-made policy covers physicians for the policy amount in effect when the claim is made, regardless of the date of event in question; whereas an occurrence policy covers a physician for the policy amount in effect at the time of the event in question, even if the policy is expired. Based on the data we analyzed, we proposed to revise the cost share weight for the malpractice GPCI from 3.865 percent to 4.295 percent.
We received many public comments regarding the CY 2012 proposed GPCIs. Summaries of the comments and our responses follow.
We also agree with commenters who stated that the updated occupations better reflect the occupations found in physician practices and those who indicated we should expand the occupations to include the full range of
We disagree with commenters who provide radiation oncology services and suggested that we should include medical physicists wage data from the American Association of Physicists in Medicine or the American Academy of Pain Medicine. The use of a consistent and contemporaneous source for the employment and wage data included in the calculation is preferable to a mix of supplemental data sources. Also, while BLS does not collect employment and wage data for medical physicists or health physicists specifically, it does collect employment and wage data for physicists as a whole (SOC code 19-2012 specifically includes physicists, see
With respect to the commenters who indicated the occupational weights utilized by CMS are not representative of their actual practices or the MGMA data, we understand that national occupational weights may not match individual practices or subsets of practices. However, we agree with IOM's preference for “a consistent set of national weights applied to wage data from the full range of health sector occupations so that hourly wage comparisons can be made” (pp. 5-34).
With regards to surveying physicians directly to gather data to compute office rent, we note that development and implementation of a survey could take several years. Moreover, we have historically not sought direct survey data from physicians related to the GPCI to avoid issues of circularity and self-reporting bias. Also, in the CY 2011 final rule with comment period (75 FR 73259) we asked for specific public comments regarding the benefits of utilizing physician cost reports to potentially achieve greater precision in measuring the relative cost difference among Medicare localities. We also asked for comments related to the administrative burden of requiring physicians to routinely complete these cost reports and whether this should be mandatory for physicians practices. We did not receive any feedback specifically related to this comment solicitation during the open public comment period for the CY 2011 final rule with comment period.
With regard to comments requesting that CMS use data from the MGMA survey to develop the office rent index, as we stated in the CY 2011 final rule with comment period (75 FR 73257), we have concerns with both the sample size and representativeness of the MGMA data. For example, the responses represent only about 2,250 (or approximately 1 percent of physician practices nationwide) and have disproportionate sample sizes for each State, suggesting very uneven response rates geographically. In addition, we also have concerns that the MGMA data have the potential for response bias. The MGMA's substantial reliance on its membership base suggests a nonrandom selection into the respondent group. Some evidence for such issues in the MGMA data arises from the very different sample sizes by State. For example, in the MGMA data, 10 States have fewer than 10 observations each, and California, New York, and New Jersey have fewer than 10 observations per locality. Therefore, we continue to believe the MGMA survey data would not be a sufficient rental data source for all PFS localities.
With regards to comments that rents in Santa Clara increased 7 percent yet remained unchanged in the surrounding counties (San Francisco, San Mateo and Santa Cruz), we contacted the Census Bureau and verified that the data were correct. We also checked with the Census Bureau regarding commenter observations that the rent index value
With regards to comments on rents in Polk County, Iowa, compared to San Francisco County, California, Polk County has the second highest office rent index of any county in Iowa (at 0.848). In order to accurately compare the specific relationship between these two counties office rent indices, the Polk County specific office rent index of (.848) should be applied. However, the commenters applied the Iowa “Statewide” locality level index of (.696) to Polk County in their calculations. Because Iowa is a Statewide locality, the higher office rent index for Polk County is reduced when combined with lower cost counties in our GPCI methodology.
As we have stated previously, we did not receive a special tabulation from Census in time to analyze 5-year ACS rental data as a potential data source for physician office rent for the CY 2012 rulemaking cycle. We have now received the 5-year ACS special tabulation from Census and will examine its suitability as a potential proxy for physician office rent. We will also continue our evaluation of ACS rental data during the upcoming year, and may propose further modifications to our office rent methodology in the CY 2013 PFS proposed rule.
We also note that HUD has proposed a new FMR methodology for 2012 that abandons the use of Census long-form data, which are no longer being collected, and instead relies exclusively on ACS data. We will be examining this new proposed methodology to potentially inform future rulemaking.
We disagree with commenters who think there is insufficient statutory basis for a purchased services index. The incorporation of a purchased services index improves the accuracy of the GPCI consistent with the statute. It will allow for the GPCI to account for geographic variation in the price of a wider range of inputs.
We also disagree with commenters who asserted that the proposed methodology does not adequately capture geographic variation in purchased services, including the cost of capital, and asserted that our data sources were inadequate. To adjust for regional variation in the labor inputs of purchased services requires four key elements. These elements include: Wage data by occupation, industry employment levels, labor-related classifications by industry, and the share of physician practice expense. We are using a combination of BLS OES data and MEI weight data for these elements. The BLS OES data is the best currently available data source for this purpose and is used in many aspects of the GPCI calculation. The MEI weights represent our actuaries' best estimate for the weights for these categories. For a fuller discussion of the derivation of the MEI weights, see the CY 2011 final rule with comment period (75 FR 73262). With respect to capital, it is important to note that the proposed purchased services index does not assume that the cost of capital for physician practices is constant across the nation; instead, it assumes that the cost of capital for contracted firms is constant across the nation. Within the purchased services index, we assume a constant cost of capital for the purchased service firm primarily because we do not believe a reliable data source to measure capital costs for each purchased service industry currently exists.
With respect to commenters who recommended that we consult with physician organizations and others to test our categorizations, methodologies, and assumptions, we have been and will continue to be transparent with respect to our calculation of the purchased services index. We solicited comments on our proposed approach and have given consideration to all comments received.
We disagree with commenters who indicated that the cost share weights
Moreover, section 1848(e)(1)(H)(v) of the Act requires the Secretary to make appropriate adjustments to the PE GPCIs as a result of the required analysis no later than January 1, 2012. As a result of our analysis, we proposed the four changes to the PE GPCI calculation as discussed previously in this section. While we fully intend to continue our review of the recently released revised IOM Phase I report on the Medicare GPCIs, it is important and consistent with the statute to proceed with appropriate improvements to the GPCI methodology in conjunction with our review of IOM's reports and IOM's continuing work in this area. We may propose further improvements and modifications to the GPCIs methodology in future rulemaking once we have had an opportunity to assess IOM's recommendations in their entirety.
We received other public comments on matters that were not related to our proposed CY 2012 changes to the GPCIs. We thank the commenters for sharing their views and suggestions. Because we did not make proposals regarding these matters, we do not generally summarize or respond to such comments in this final rule with comment period. For example, we received numerous comments related to the physician work GPCI and the aforementioned expiration of the 1.000 work floor. Since we only proposed to update the cost share weights attributed to physician work, and noted that the statutorily required 1.0 physician work floor would be expiring at the end of CY 2011 in the CY 2012 proposed rule, we will not be responding to comments related to our methodologies or calculations of physician work in this final rule with comment period. For an in-depth discussion of our most recent physician work GPCI update, see the CY 2011 final rule with comment period (75 FR 73252 and 75 FR 73256 through 73260). We look forward to reviewing and evaluating the IOM's recommendations related to physician work included in its revised Phase I report. After we have reviewed the IOM's recommendations in their entirety, we may propose modifications to the physician work GPCI in future rulemaking.
We also received several comments regarding the calculations and methodology used to calculate the MEI, although we did not propose any changes in the methodology used to calculate the MEI. Many commenters reiterated concerns regarding the assignment of MEI weights to the 10 office expense subcategories as outlined in the 2011 Medicare physician payment schedule final rule with comment period. According to some commenters, it is not clear that the AMA PPIS survey expense categories match up with the industry-level data from the Bureau of Economic Analysis in a way that makes this assignment of subcategory weights possible. These commenters further state that the MEI technical advisory panel should revisit this issue, and consider whether other sources of data are available to split office rent from other types of office expenses, and to validate the office rent share as a percent of total expense.
While this issue is outside the scope of this final rule with comment, we note that the costs reported in the 2006 AMA PPIS survey questions for office expenses were crosswalked as closely as possible to the 2002 BEA I/O benchmark categories. The weights for Office Expenses found in the MEI were appropriately based on information reported by self-employed physicians and selected self-employed non-medical doctor specialties found in the 2006 American Medical Association Physician Practice Information Survey (PPIS). The PPIS was developed by medical associations and captures the costs of operating a medical practice, including office rents and non-physician wages. The survey results were further disaggregated using data from the Bureau of Economic Analysis' Benchmark Input/Output tables for Offices of Physicians, Dentists, and
After consideration of the public comments received on the GPCIs, we are finalizing the revisions to the 6th GPCI update using the most current data, with modifications. We are also finalizing the proposal to change the GPCI cost share weights for CY 2012. As a result, the cost share weight for the physician work GPCI (as a percentage of the total) will be 48.266 percent, and the cost share weight for the PE GPCI will be 47.439 percent with a change in the employee compensation component from 18.654 to 19.153 percentage points. The cost share weight for the office rent component of the PE GPCI will be 10.223 percentage points (fixed capital with utilities), and the medical equipment, supplies, and other miscellaneous expenses component will be 9.968 percentage points. Moreover, the cost share weight for the malpractice GPCI will be 4.295 percent. In addition, we are finalizing the weight for purchased services at 8.095 percentage points (5.011 percentage points will be adjusted for geographic cost differences). Additionally, we will review the complete findings and recommendations from the Institute of Medicine's studies on geographic adjustment factors for physician payment and the MEI technical advisory panel once that information becomes fully available to CMS. We will once again consider the GPCIs for CY 2013 rulemaking in the context of our annual PFS rulemaking beginning in CY 2012 based on the information available at that time. We are finalizing the use of 2006 through 2008 ACS two bedroom rental data as a proxy for the relative cost difference in physicians' offices. Moreover, we will examine 5-year ACS rental data to determine its appropriateness as a potential data source for physician office rent. We will also examine HUDs CY 2012 proposed methodology, which utilizes ACS data exclusively, for potential use in future rulemaking. We are also finalizing our proposal to create a purchased services index to account for labor-related services with the “all other services” and “other professional expenses” MEI components. In response to public commenters who recommended we utilize BLS data to capture the “full range” of occupations included in the offices of physician industry to calculate employee wage, we are modifying our original proposal and expanding the number of occupations utilized in our calculation of non-physician employee wages to reflect 100 percent of the total wage share of non-physician occupations in the offices of physicians' industry.
As we indicated previously in this section, section 103 of the Medicare and Medicaid Extenders Act (MMEA) of 2010 (Pub. L. 111-309) extended the 1.0 work GPCI floor only through December 31, 2011. Therefore, the CY 2012 physician work GPCIs and summarized GAFs do not reflect the 1.0 work floor. Moreover, the limited recognition of cost differences in employee compensation and office rent for the PE GPCIs, and the related hold harmless provision, required under section 1848 (e)(1)(H) of the Act was only applicable for CY 2010 and CY 2011 (75 FR 73253) and, therefore under current law, is no longer effective beginning in CY 2012. However, the permanent 1.5 work GPCI floor for Alaska (as established by section 134(b) of the MIPPA) will remain in effect for CY 2012. We are finalizing the CY 2012 GPCIs shown in Addendum E. The GPCIs have been budget neutralized to ensure that nationwide, total RVUs are not impacted by changes in locality GPCIs. The 1.0 PE GPCI floor for frontier States was applied to the budget neutralized GPCIs. The frontier States are the following: Montana; Wyoming; North Dakota; Nevada; and South Dakota. The CY 2012 updated GAFs and GPCIs may be found in Addenda D and E of this final rule with comment period.
The current PFS locality structure was developed and implemented in 1997. There are currently 89 total PFS localities; 34 localities are Statewide areas (that is, only one locality for the entire State). There are 52 localities in the other 16 States, with 10 States having 2 localities, 2 States having 3 localities, 1 State having 4 localities, and 3 States having 5 or more localities. The District of Columbia, Maryland, Virginia suburbs, Puerto Rico, and the Virgin Islands are additional localities that make up the remaining 3 of the total of 89 localities. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and the subsequent final rule with comment period (61 FR 59494).
As we have previously noted in the CYs 2008 and 2009 proposed rules (72 FR 38139 and 73 FR 38513), any changes to the locality configuration must be made in a budget neutral manner within a State and can lead to significant redistributions in payments. For many years, we have not considered making changes to localities without the support of a State medical association in order to demonstrate consensus for the change among the professionals whose payments would be affected (since such changes would be redistributive, with some increasing and some decreasing). However, we have recognized that, over time, changes in demographics or local economic conditions may lead us to conduct a more comprehensive examination of existing payment localities.
For the past several years, we have been involved in discussions with physician groups and their representatives about recent shifts in relative demographics and economic conditions. We explained in the CY 2008 PFS final rule with comment period that we intended to conduct a thorough analysis of potential approaches to reconfiguring localities and would address this issue again in future rulemaking. For more information, we refer readers to the CY 2008 PFS proposed rule (72 FR 38139) and subsequent final rule with comment period (72 FR 66245).
As a follow-up to the CY 2008 PFS final rule with comment period, we acquired a contractor to conduct a preliminary study of several options for revising the payment localities on a nationwide basis. The final report entitled, “Review of Alternative GPCI Payment Locality Structures—Final Report,” is accessible from the CMS PFS Web page
We did not make any proposals regarding the PFS locality configurations for CY 2012. However, we did receive some comments regarding IOM's recommendation to modify Medicare PFS localities to reflect metropolitan statistical areas (MSA)-based definitions. We will
At our request, the Institute of Medicine is conducting a study of the geographic adjustment factors in Medicare payment. It is a comprehensive empirical study of the geographic adjustment factors established under sections 1848(e) (GPCI) and 1886(d)(3)(E) of the Act (hospital wage index). These adjustments are designed to ensure Medicare payment fees and rates reflect differences in input costs across geographic areas. The factors IOM is evaluating include the—
• Accuracy of the adjustment factors;
• Methodology used to determine the adjustment factors, and
• Sources of data and the degree to which such data are representative.
Within the context of the U.S. health care marketplace, the IOM is also evaluating and considering the—
• Effect of the adjustment factors on the level and distribution of the health care workforce and resources, including—
++ Recruitment and retention taking into account mobility between urban and rural areas;
++ Ability of hospitals and other facilities to maintain an adequate and skilled workforce; and
++ Patient access to providers and needed medical technologies;
• Effect of adjustment factors on population health and quality of care; and
• Effect of the adjustment factors on the ability of providers to furnish efficient, high value care.
The revised first report “Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy” that was released September 28, 2011 and is available on the IOM Web site
The recommendations included in IOM's revised Phase I report that relate to or would have an effect on the GPCIs are summarized as follows:
• Recommendation 2-1: The same labor market definition should be used for both the hospital wage index and the physician geographic adjustment factor. Metropolitan statistical areas and Statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.
• Recommendation 2-2: The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all health care employers.
• Recommendation 5-1: The GPCI cost share weights for adjusting fee-for-service payments to practitioners should continue to be national, including the three GPCIs (work, practice expense, and liability insurance) and the categories within the practice expense (office rent and personnel).
• Recommendation 5-2: Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified.
• Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process.
• Recommendation 5-4: The practice expense GPCI should be constructed with the full range of occupations employed in physicians' offices, each with a fixed national weight based on the hours of each occupation employed in physicians' offices nationwide.
• Recommendation 5-5: CMS and the Bureau of Labor Statistics should develop an agreement allowing the Bureau of Labor Statistics to analyze confidential data for the Centers for Medicare and Medicaid Services.
• Recommendation 5-6: A new source of information should be developed to determine the variation in the price of commercial office rent per square foot.
• Recommendation 5-7: Nonclinical labor-related expenses currently included under practice expense office expenses should be geographically adjusted as part of the wage component of the practice expense.
We note that the GPCI revisions we are finalizing in this final rule with comment period address three of the IOM recommendations referenced above. Specifically, our final GPCIs utilize the full range of non-physician occupations in the non-physician employee wage calculation consistent with IOM recommendation 5-4. Additionally, we created a new purchased service index to account for non-clinical labor-related expenses similar to IOM recommendation 5-7. Lastly, we have consistently used national cost share weights (MEI) to determine the appropriate weight attributed to each GPCI component, which is supported by recommendation 5-1. We may propose further improvements to the GPCI methodology in future rulemaking to address the remaining IOM recommendations once we have had an opportunity to assess IOM's recommendations in their entirety.
Prior to January 1, 1999, Medicare coverage for services delivered via a telecommunications system was limited to services that did not require a face-to-face encounter under the traditional model of medical care. Examples of these services included interpretation of an x-ray, or electrocardiogram, or electroencephalogram tracing, and cardiac pacemaker analysis.
Section 4206 of the BBA provided for coverage of, and payment for, consultation services delivered via a telecommunications system to Medicare beneficiaries residing in rural health professional shortage areas (HPSAs) as defined by the Public Health Service Act. Additionally, the BBA required that a Medicare practitioner (telepresenter) be with the patient at the time of a teleconsultation. Further, the BBA specified that payment for a teleconsultation had to be shared between the consulting practitioner and the referring practitioner and could not exceed the fee schedule payment which would have been made to the consultant for the service provided. The BBA prohibited payment for any telephone line charges or facility fees associated with the teleconsultation. We implemented this provision in the CY 1999 PFS final rule with comment period (63 FR 58814).
Effective October 1, 2001, section 223 of the Medicare, Medicaid and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106-554) (BIPA) added a new section, 1834(m), to the Act which significantly expanded Medicare telehealth services. Section 1834(m)(4)(F)(i) of the Act defines
As specified in regulations at § 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under § 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real time interactive communication between the patient and the practitioner at the distant site. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act does allow the use of asynchronous “store-and-forward” technology in delivering these services when the originating site is a Federal telemedicine demonstration program in Alaska or Hawaii. As specified in regulations at § 410.78(a)(1), store and forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.
Medicare telehealth services may be provided to an eligible telehealth individual notwithstanding the fact that the individual practitioner providing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual means an individual enrolled under Part B who receives a telehealth service furnished at an originating site. As specified in BIPA, originating sites are limited under section 1834(m)(3)(C) of the Act to specified medical facilities located in specific geographic areas. The initial list of telehealth originating sites included the office of a practitioner, a critical access hospital (CAH), a rural health clinic (RHC), a Federally qualified health center (FQHC) and a hospital (as defined in Section 1861(e) of the Act). More recently, section 149 of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA) expanded the list of telehealth originating sites to include hospital-based renal dialysis centers, skilled nursing facilities (SNFs), and community mental health centers (CMHCs). In order to serve as a telehealth originating site, these sites must be located in an area designated as a rural health professional shortage area (HPSA), in a county that is not in a metropolitan statistical area (MSA), or must be an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000. Finally, section 1834(m) of the Act does not require the eligible telehealth individual to be presented by a practitioner at the originating site.
As noted previously, Medicare telehealth services can only be furnished to an eligible telehealth beneficiary in an originating site. An originating site is defined as one of the specified sites where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system. In general, originating sites must be located in a rural HPSA or in a county outside of an MSA. The originating sites authorized by the statute are as follows:
• Offices of a physician or practitioner.
• Hospitals.
• CAHs.
• RHCs.
• FQHCs.
• Hospital-Based Or Critical Access Hospital-Based Renal Dialysis Centers (including Satellites).
• SNFs.
• CMHCs.
Currently approved Medicare telehealth services include the following:
• Initial inpatient consultations.
• Follow-up inpatient consultations.
• Office or other outpatient visits.
• Individual psychotherapy.
• Pharmacologic management.
• Psychiatric diagnostic interview examination.
• End-stage renal disease (ESRD) related services.
• Individual and group medical nutrition therapy (MNT).
• Neurobehavioral status exam.
• Individual and group health and behavior assessment and intervention (HBAI).
• Subsequent hospital care.
• Subsequent nursing facility care.
• Individual and group kidney disease education (KDE).
• Individual and group diabetes self-management training services (DSMT).
In general, the practitioner at the distant site may be any of the following, provided that the practitioner is licensed under State law to furnish the service being furnished via a telecommunications system:
• Physician.
• Physician assistant (PA).
• Nurse practitioner (NP).
• Clinical nurse specialist (CNS);
• Nurse-midwife.
• Clinical psychologist.
• Clinical social worker.
• Registered dietitian or nutrition professional.
Practitioners furnishing Medicare telehealth services are located at a distant site, and they submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system. Distant site practitioners must submit the appropriate HCPCS procedure code for a covered professional telehealth service, appended with the -GT (Via interactive audio and video telecommunications system) or -GQ (Via asynchronous telecommunications system) modifier. By reporting the -GT or -GQ modifier with a covered telehealth procedure code, the distant site practitioner certifies that the beneficiary was present at a telehealth originating site when the telehealth service was furnished. The usual Medicare deductible and coinsurance policies apply to the telehealth services reported by distant site practitioners.
Section 1834(m)(2)(B) of the Act provides for payment of a facility fee to the originating site. To be paid the originating site facility fee, the provider or supplier where the eligible telehealth individual is located must submit a claim with HCPCS code Q3014 (Telehealth originating site facility fee), and the provider or supplier is paid according to the applicable payment methodology for that facility or location. The usual Medicare deductible and coinsurance policies apply to HCPCS code Q3014. By submitting HCPCS code Q3014, the originating site certifies that it is located in either a rural HPSA or non-MSA county or is an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000 as specified in section 1834(m)(4)(C)(i)(III) of the Act.
As previously described, certain professional services that are commonly
As noted previously, in the December 31, 2002
• Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter. We also look for similarities in the telecommunications system used to deliver the proposed service, for example, the use of interactive audio and video equipment.
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the use of a telecommunications system to deliver the service produces similar diagnostic findings or therapeutic interventions as compared with the in-person delivery of the same service. Requestors should submit evidence showing that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to in-person delivery of the requested service.
Since establishing the process to add or remove services from the list of approved telehealth services, we have added the following to the list of Medicare telehealth services: individual and group HBAI services; psychiatric diagnostic interview examination; ESRD services with 2 to 3 visits per month and 4 or more visits per month (although we require at least 1 visit a month to be furnished in-person by a physician, CNS, NP, or PA in order to examine the vascular access site); individual and group MNT; neurobehavioral status exam; initial and follow-up inpatient telehealth consultations for beneficiaries in hospitals and skilled nursing facilities (SNFs); subsequent hospital care (with the limitation of one telehealth visit every 3 days); subsequent nursing facility care (with the limitation of one telehealth visit every 30 days); individual and group KDE; and individual and group DSMT services (with a minimum of 1 hour of in-person instruction to ensure effective injection training).
Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, requests submitted before the end of CY 2011 will be considered for the CY 2013 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, we refer readers to the CMS Web site at
We received requests in CY 2010 to add the following services as Medicare telehealth services effective for CY 2012: (1) Smoking cessation services; (2) critical care services; (3) domiciliary or rest home evaluation and management services; (4) genetic counseling services; (5) online evaluation and management services; (6) data collection services; and (7) audiology services. The following presents a discussion of these requests, including our proposals for additions to the CY 2012 telehealth list.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add smoking cessation services, reported by CPT codes 99406 (Smoking and tobacco use cessation counseling visit; intermediate, greater than 3 minutes up to 10 minutes) and 99407 (Smoking and tobacco use cessation counseling visit; intensive, greater than 10 minutes) to the list of approved telehealth services for CY 2012 on a category 1 basis.
Smoking Cessation services are defined as face-to-face behavior change interventions. We believe the interaction between a practitioner and a beneficiary receiving smoking cessation services is similar to the education, assessment, and counseling elements of individual KDE reported by HCPCS code G0420 (Face-to-face educational services related to the care of chronic kidney disease; individual, per session, per 1 hour), and individual MNT services, reported by HCPCS code G0270 (Medical nutrition therapy; reassessment and subsequent intervention(s) following second referral in the same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), individual, face-to-face with the patient, each 15 minutes); CPT code 97802 (Medical nutrition therapy; initial assessment and intervention, individual, face-to-face with the patient, each 15 minutes); and CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes), all services that are currently on the telehealth list.
Therefore, we proposed to add CPT codes 99406 and 99407 to the list of telehealth services for CY 2012 on a category 1 basis. Additionally, we proposed to add HCPCS codes G0436 (Smoking and tobacco cessation
Consistent with this proposal, we also proposed to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include these smoking cessation services as Medicare telehealth services.
After consideration of the public comments we received, we are finalizing our CY 2012 proposal to add CPT codes 99406 and 99407 to the list of telehealth services for CY 2012 on a category 1 basis. Additionally, we are finalizing our proposal to add HCPCS codes G0436 (Smoking and tobacco cessation counseling visit for the asymptomatic patient; intermediate, greater than 3 minutes, up to 10 minutes) and G0437 (Smoking and tobacco cessation counseling visit for the asymptomatic patient; intensive, greater than 10 minutes) to the list of telehealth services for CY 2012 and to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include smoking cessation services as Medicare telehealth services.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add critical care service CPT codes 99291 (Critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes) and 99292 (Critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes) to the list of approved telehealth services. We previously received this request for the CY 2009 and CY 2010 PFS rulemaking cycles (73 FR 38517, 73 FR 69744 and 69745, 74 FR 33548, and 74 FR 61764) and did not add the codes on a category 1 basis due to the acute nature of the typical patient. We continue to believe that patients requiring critical care services are more acutely ill than those patients typically receiving any service currently on the list of telehealth services. Therefore, we cannot consider critical care services on a category 1 basis.
In the CY 2009 PFS proposed rule (73 FR 38517), we explained that we had no evidence suggesting that the use of telehealth could be a reasonable surrogate for the in-person delivery of critical care services; therefore, we would not add the services on a category 2 basis. Requestors submitted new studies for CY 2012, but none demonstrated that comparable outcomes to a face-to-face encounter can be achieved using telehealth to deliver these services. The studies we received primarily addressed other issues relating to telehealth services. Some studies addressed the cost benefits and cost savings of telehealth services. Others focused on the positive outcomes of telehealth treatment when compared with no treatment at all. One submitted study addressed the equivalency of patient outcomes for telehealth services delivered to patients in emergency rooms, but the study's authors specifically restricted their population to patients whose complaints were not considered to be genuine emergencies. Given that limitation, it seems unlikely that any of these patients would have required critical care services as defined by CPT codes 99291 and 99292.
We note that consultations are included on the list of Medicare telehealth services and may be billed by practitioners furnishing services to critically ill patients These services are described by the following HCPCS codes: G0425 (Initial inpatient telehealth consultation, typically 30 minutes communicating with the patient via telehealth), G0426 (Initial inpatient telehealth consultation, typically 50 minutes communicating with the patient via telehealth), G0427 (Initial inpatient telehealth consultation, typically 70 minutes or more communicating with the patient via telehealth), G0406 (Follow-up inpatient telehealth consultation, limited, physicians typically spend 15 minutes communicating with the patient via telehealth), G0407 (Follow-up inpatient telehealth consultation, intermediate, physicians typically spend 25 minutes communicating with the patient via telehealth), and G0408 (Follow-up inpatient telehealth consultation, complex, physicians typically spend 35 minutes or more communicating with the patient via telehealth). Critical care services, as reported by the applicable CPT codes and described in the introductory language in the CPT book, consist of direct delivery by a physician of medical care for a critically ill or injured patient, including high complexity decision-making to assess, manipulate, and support vital system functions. Critical care requires interpretation of multiple physiologic parameters and/or application of advanced technologies, including temporary pacing, ventilation management, and vascular access services. The payment rates under the PFS reflect this full scope of physician work. To add the critical services to the telehealth list would require the physician to be able to deliver this full scope of services via telehealth. Based on the code descriptions, we have previously believed that it is not possible to deliver the full range of critical care services without a physical physician presence with the patient.
We note that there are existing Category III CPT codes (temporary codes for emerging services that allow data collection) for remote real-time interactive video-conferenced critical care services that, consistent with our treatment of other Category III CPT codes, are not nationally priced under the PFS. The fact that the CPT Editorial Panel created these additional Category III CPT codes suggests to us that these video-conferenced critical care services are not the same as the in-person critical care services requested for addition to the telehealth list.
Because we did not find evidence that use of a telecommunications system to deliver critical care services produces similar diagnostic or therapeutic outcomes as compared with the face-to-face deliver of the services, we did not propose to add critical care services (as described by CPT codes 99291 and 99292) to the list of approved telehealth services. We reiterated that our decision not to propose to add critical care services to the list of approved telehealth services does not preclude physicians from furnishing telehealth consultations to critically ill patients using the consultation codes that are on the list of Medicare telehealth services.
After consideration of the public comments we received, we are finalizing our decision not to add critical care services to the list of Medicare telehealth services for CY 2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add the following domiciliary or rest home evaluation and management CPT codes to the telehealth list for CY 2012:
• 99334 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused interval history; a problem focused examination; or straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self-limited or minor. Physicians typically spend 15 minutes with the patient and/or family or caregiver).
• 99335 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; An expanded problem focused examination; Medical decision making of low complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Physicians typically spend 25 minutes with the patient and/or family or caregiver).
• 99336 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Physicians typically spend 40 minutes with the patient and/or family or caregiver).
• 99337 (Domiciliary or rest home visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A comprehensive interval history; a comprehensive examination; medical decision making of moderate to high complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. The patient may be unstable or may have developed a significant new problem requiring immediate physician attention. Physicians typically spend 60 minutes with the patient and/or family or caregiver).
A domiciliary or rest home is not permitted under current statute to serve as an originating site for Medicare telehealth services. Therefore, we did not propose to add domiciliary or rest home evaluation and management services to the list of Medicare telehealth services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add domiciliary or rest home evaluation and management services to the list of Medicare telehealth services for CY2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add CPT code 96040 (Medical genetics and genetic counseling services, each 30 minutes face-to-face with patient/family) to the telehealth list for CY 2012. We note that CPT guidance regarding reporting genetic counseling and education furnished by a physician to an individual directs physicians to evaluation and management (E/M) CPT codes and that services described by CPT code 96040 are provided by trained genetic counselors. Physicians and nonphysician practitioners who may independently bill Medicare for their service and who are counseling individuals would generally report office or other outpatient evaluation and management (E/M) CPT codes for office visits that involve significant counseling, including genetic counseling, and these office visit CPT codes are already on the list of telehealth services. CPT code 96040 would only be reported by genetic counselors for genetic counseling services. These practitioners cannot bill Medicare directly for their professional services and they are also not on the list of practitioners who can furnish telehealth services (specified in section 1834(m)(4)(E) of the Act). As such, we do not believe that it would be necessary or appropriate to add CPT code 96040 to the list of Medicare
After consideration of the public comments we received, we are finalizing our decision not to add genetic counseling services to the list of Medicare telehealth services for CY 2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add CPT code 99444 (Online evaluation and management service provided by a physician to an established patient, guardian, or health care provider not originating from a related E/M service provided within the previous 7 days, using the Internet or similar electronic communications network) to the list of Medicare telehealth services.
As we explained in the CY 2008 PFS final rule with comment period (72 FR 66371), we assigned a status indicator of “N” (Non-covered service) to these services because: (1) These services are non-face-to-face; and (2) the code descriptor includes language that recognizes the provision of services to parties other than the beneficiary and for whom Medicare does not provide coverage (for example, a guardian).
According to section 1834(m)(2)(A) of the Act, Medicare is required to pay for telehealth services at an amount equal to the amount that a practitioner would have been paid had such service been furnished without the use of a telecommunications system. As such, we do not believe it would be appropriate to make payment for services furnished via telehealth when those services would not otherwise be covered under Medicare. Because CPT code 99444 is currently noncovered, we did not propose to add online evaluation and management services to the list of Medicare Telehealth Services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add online evaluation and management services to the list of Medicare telehealth services for CY 2012.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add CPT codes 99090 (Analysis of clinical data stored in computers (
As we explained in the in CY 2002 PFS final rule with comment period (66 FR 55309), we assigned a status indicator of “B” (Payment always bundled into payment for other services not specified) to these services because the associated work is considered part of the pre- and post-service work of an E/M service. We note that many E/M codes are on the list of Medicare telehealth services.
According to section 1834(m)(2)(A) of the Act, Medicare is required to pay for telehealth services an amount equal to the amount that a practitioner would have been paid had such service been furnished without the use of a telecommunications system. Similar to the point noted previously for online E/M services, we do not believe it would be appropriate to make separate payment for services furnished via telehealth when Medicare would not otherwise make separate payment for the services. Moreover, we believe the payment for these data collection services should be bundled into the payment for E/M services, many of which are already on the Medicare telehealth list. Because CPT codes 99090 and 99091 are currently bundled, we did not propose to add data collection services to the list of Medicare telehealth services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add data collection services to the list of Medicare telehealth services for CY 2012.
The American Academy of Audiology submitted a request that CMS add services that audiologists provide for balance disorders and hearing loss to the list of Medicare telehealth services. The request did not include specific HCPCS codes. Nevertheless, it is not within our administrative authority to pay audiologists for services furnished via telehealth. The statute authorizes the Secretary to pay for telehealth services only when furnished by a physician or a practitioner as physician or practitioner are defined in sections 1834(m)(4)(D) and (E) of the Act. Therefore, we did not propose to add services that are primarily provided by audiologists to the list of Medicare telehealth services for CY 2012.
After consideration of the public comments we received, we are finalizing our decision not to add audiology services to the list of Medicare telehealth services for CY 2012.
Along with its submission of codes for consideration as additions to the Medicare telehealth list for CY 2012, the American Telemedicine Association (ATA) also requested that CMS consider revising the annual process for adding to or deleting services from the list of telehealth services. The existing process, adopted in the CY 2003 PFS rulemaking cycle (67 FR 43862 through 43863 and 67 FR 79988 through 79989), is described in section II.E.1. of this final rule with comment period. The following discussion includes a summary of recent requests by the ATA and other stakeholders for changes to the established process for adding services to the telehealth list, an assessment of our historical experience with the current process including the request review criteria, and our proposed refinement to the process for adding services to the telehealth list that would be used in our evaluation of candidate telehealth services beginning for CY 2013.
The ATA asked CMS to consider two specific changes to the process, including—
• Broadening the factors for consideration to include shortages of health professionals to provide in-person services, speed of access to in-person services, and other barriers to care for beneficiaries; and
• Equalizing the standard for adding telehealth services with the standard for deleting telehealth services by adopting a standard that allows services that are safe, effective or medically beneficial when furnished via telehealth to be added to the list of Medicare telehealth services. Similarly, we have received recommendations that CMS place all codes payable under the PFS on the telehealth list and allow physicians and practitioners to make a clinical determination in each case about whether a medically reasonable and necessary service could be appropriately furnished to a beneficiary through telehealth. Under this scenario, stakeholders have argued that CMS would only remove services from the telehealth list under its existing policy for service removal; specifically, that a decision to remove a service from the list of telehealth services would be made using evidence-based, peer-reviewed data which indicate that a specific service is not safe, effective, or medically beneficial when furnished via telehealth (67 FR 79988).
While we share the interests of stakeholders in reducing barriers to health care access faced by some beneficiaries, given that section 1834(m)(2)(F)(ii) of the Act requires the Secretary to establish a process that provides, on an annual basis, for the addition or deletion of telehealth services (and HCPCS codes), as appropriate, we do not believe it would be appropriate to add all services for which payment is made under the PFS to the telehealth list without explicit consideration as to whether the candidate service could be effectively furnished through telehealth. For example, addition of all codes to the telehealth list could result in a number of services on the list that could never be furnished by a physician or nonphysician practitioner who was not physically present with the beneficiary, such as major surgical procedures and interventional radiology services. Furthermore, we do not believe it would be appropriate to add services to the telehealth list without explicit consideration as to whether or not the nature of the service described by a candidate code allows the service to be furnished effectively through telehealth. Section 1834(m)(2)(A) of the Act requires that the distant site physician or practitioner furnishing the telehealth service must be paid an amount equal to the amount the physician or practitioner would have been paid under the PFS has such service been furnished without the use of a telecommunications system. Therefore, we believe that candidate telehealth services must also be covered when furnished in-person; and that any service that would only be furnished through a telecommunications system would be a new service and, therefore, not a candidate for addition to the telehealth list. In view of these considerations, we will continue to consider candidate additions to the telehealth list on a HCPCS code-specific basis based on requests from the public and our own considerations.
We also believe it continues to be most appropriate to consider candidate services for the telehealth list based on the two mutually exclusive established categories into which all services fall—specifically, services that are similar to services currently on the telehealth list (category 1) and services that are not similar to current telehealth services (category 2). Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list with respect to the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter (67 FR 43862). Since CY 2003, we have added 35 services to the telehealth list on a category 1 basis based on public requests and our own identification of such services. We believe it is efficient and valuable to maintain the existing policy that allows us to consider requests for additions to the telehealth list on a category 1 basis and proposed to add them to the telehealth list if the existing criteria are met. This procedure expedites our ability to identify codes for the telehealth list that resemble those services already on this list, streamlining our review process and the public request and information-submission process for services that fall into this category. Therefore, we believe that any changes to the process for adding codes to the telehealth list should be considered with respect to category 2 additions, rather than category 1 additions.
Our existing criteria for consideration of codes that would be category 2 additions, specifically those candidate telehealth services that are not similar to any current telehealth services, include an assessment of whether the use of a telecommunications system to deliver the services produces similar diagnostic findings or therapeutic interventions as compared with a face-to-face in-person delivery of the same service (67 FR 43682). In other words, the discrete outcome of the interaction between the clinician and patient facilitated by a telecommunications system should correlate well with the discrete outcome of the clinician-patient interaction when performed face-to-face. In the CY 2003 PFS proposed rule (67 FR 43862), we explained that requestors for category 2 additions to the telehealth list should submit evidence that the use of a telecommunications systems does not affect the diagnosis or treatment plan as compared to in-person delivery of the service. We indicated that if evidence shows that the candidate telehealth service is equivalent when furnished in person or through telehealth, we would add it to the list of telehealth services. We refer to this standard in further discussion in this final rule with comment period as the “comparability standard.” We stated in the CY 2003 PFS proposed rule (67 FR 43862) that if we determine that the use of a telecommunications system changes the nature or outcome of the service, for
We believe it is most appropriate to address the ATA and other stakeholder requests to broaden the current factors we consider when deciding whether to add candidate services to the telehealth list—to include factors such as the effects of barriers to in-person care and the safety, effectiveness, or medical benefit of the service furnished through telehealth, as potential refinements to our category 2 criteria. We initially established these category 2 criteria in the interest of ensuring that the candidate services were safe, effective, medically beneficial, and still accurately described by the corresponding codes when delivered via telehealth, while also ensuring that beneficiaries furnished telehealth services receive high quality care that is comparable to in-person care. We believed that the demonstration of comparable clinical outcomes (diagnostic findings and/or therapeutic interventions) from telehealth and in-person services would prove to be the best indicator that all of these conditions were met. While we continue to believe that safety, effectiveness, and medical benefit, as well as accurate description of the candidate telehealth services by the CPT or HCPCS codes, are necessary conditions for adding codes to the list of Medicare telehealth services, our recent experience in reviewing public requests for telehealth list additions and our discussions with stakeholders regarding contemporary medical practice and potential barriers to care, have led us to conclude that the comparability standard for category 2 requests should be modified.
In our annual evaluation of category 2 requests since we adopted the process for evaluating additions to the telehealth list almost 10 years ago, we have consistently observed that requestors have difficulty demonstrating that clinical outcomes of a service delivered via telehealth are comparable to the outcomes of the in-person service. The medical literature frequently does not include studies of the outcomes of many types of in-person services that allow for comparison to the outcomes demonstrated for candidate telehealth services. Furthermore, we know that in some cases the alternative to a telehealth service may be no service rather than an in-person service. The comparability standard may not sufficiently allow for the opportunity to add candidate services to the telehealth list that may be safe, effective, and medically beneficial when delivered via telehealth, especially to beneficiaries who experience significant barriers to in-person care. While we continue to believe that beneficiaries receiving services through telehealth are deserving of high quality health care and that in-person care may be very important and potentially preferable for some services when in-person care is possible, we are concerned that we have not added any services to the telehealth list on a category 2 basis as a result of our reviews. While some candidate services appear to have the potential for clinical benefit when furnished through telehealth, the requests have not met the comparability standard.
Therefore, we proposed to refine our category 2 review criteria for adding codes to the list of Medicare telehealth services beginning in CY 2013 by modifying the current requirement to demonstrate similar diagnostic findings or therapeutic interventions with respect to a candidate service delivered through telehealth compared to in-person delivery of the service (the comparability standard). We proposed to establish a revised standard of demonstrated clinical benefit when the service is furnished via telehealth. We refer to this proposed standard in further discussion in this final rule with comment period as the “clinical benefit standard.” To support our review using this revised standard, we would ask requestors to specify in their request how the candidate telehealth service is still accurately described by the corresponding HCPCS or CPT code when delivered via telehealth as opposed to in-person.
We proposed that our refined criteria for category 2 additions would be as follows:
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests would include an assessment of whether the service is accurately described by the corresponding code when delivered via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. Requestors should submit evidence indicating that the use of a telecommunications system in delivering the candidate telehealth service produces clinical benefit to the patient.
The evidence submitted should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings and a list and copies of published peer-reviewed articles relevant to the service when furnished via telehealth. Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
We believe the adoption of this clinical benefit standard for our review of candidate telehealth services on a category 2 basis is responsive to the requests of stakeholders that we broaden the factors taken into consideration to include barriers to care for beneficiaries. It allows us to consider the demonstrated clinical benefit of telehealth services for beneficiaries who might otherwise have no access to certain diagnostic or treatment services. Furthermore, we believe the focus on demonstrated clinical benefit in our review of category 2 requests for addition to the telehealth lists is equivalent to our standard for deleting services from the telehealth list that rests upon evidence that a service is not safe, not effective, or not medically beneficial. Finally, we believe the proposed clinical benefit standard for our review of candidate telehealth services on a category 2 basis is fully consistent with our responsibility to ensure that telehealth services are safe, effective, medically beneficial, and still accurately described by the corresponding codes that would be used for the services when delivered in-person.
We solicited public comments on the proposed refinement to our established process for adding codes to the telehealth list, including the information that requestors should furnish to facilitate our full review of requests in preparation for the CY 2013 PFS rulemaking cycle during which we will use the category 2 review criteria finalized in this final rule with comment period.
We continue to believe safety, effectiveness, and medical benefit, as well as accurate description of the candidate telehealth services by the CPT or HCPCS codes, are necessary conditions for adding codes to the list of Medicare telehealth services. While we believe that in many cases, the existing standard has led to appropriate category 2 determinations not to add services to the telehealth benefit, we also believe that the current standard has prevented consideration of some services that could be clinically beneficial because there are no studies that compare patient outcomes when services are delivered via telehealth versus in person. This does not support our interests in identifying beneficial services for the telehealth benefit. Specifically, we observe that the medical literature frequently does not include studies of the outcomes of many types of in-person services that allow for comparison to the outcomes demonstrated for candidate telehealth services. We believe that the proposed revision to the existing criteria will allow thorough consideration of a greater number of requests for addition to the list. We would also remind commenters that the annual process will continue to provide stakeholders who support or oppose adding particular services to the list the opportunity to contribute to our evaluations of particular requests through public comment.
Additionally, we note that the established process for deleting services from the list would allow Medicare to consider any available evidence suggesting that the addition of particular services to the list of Medicare telehealth services had detrimentally changed the quality of medical care for Medicare beneficiaries in remote areas. Such evidence could be considered in the context of either a public request or internally generated proposal to delete services from the list of Medicare telehealth services during annual PFS rulemaking. This process was
Finally, we agree with the commenter that argued that we should not add services to the telehealth list based on demonstrated evidence of minor benefit. We would like to clarify that our evidentiary standard of clinical benefit would not include minor or incidental benefits.
We believe that establishing more rigid evaluation criteria (for example, criteria that rely on measurement of a series of demonstrated clinical outcomes specified by CMS) might present as many problems as has the current category 2 criteria, because under such a process requestors would be required to submit medical literature that passes a series of hurdles established by us prior to receiving a particular request. We would not be able to assess the benefit of the requested service within the context of the submitted evidence and the specific services. We also believe that such a process might lead to greater administrative burden for requestors and might require constant revision through annual rulemaking to adapt any specific criteria to changes in medical and communication technology as well as developments in medical literature.
Additionally, we note that the application of the proposed criteria to each request will remain subject to public notice and comment. Since we implemented the process to add or delete services, including the existing category 2 criteria, we have used the PFS notice and comment rulemaking process to propose, accept public comments, and ultimately explain how the established evaluation criteria apply to each service we evaluate for addition to the list of Medicare telehealth services. We are not proposing a change to that aspect of the process with this proposed change in category 2 criteria.
With regard to the request to add critical care services to the list of Medicare telehealth services, the application of the proposed category 2 criteria to that request is contingent on both the finalization of the proposed criteria and our receipt of a new request to add the services. However, as we noted in the CY 2012 PFS proposed rule with comment period (76 FR 42824), the fact that the CPT Editorial Panel created the Category III CPT codes suggests to us that these video-conferenced critical care services are not the same as the in-person critical care services requested for addition to the telehealth list.
After consideration of the public comments we received, we are
Our revised criteria for category 2 additions are as follows:
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests will include an assessment of whether the service is accurately described by the corresponding code when delivered via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. Requestors should submit evidence indicating that the use of a telecommunications system in delivering the candidate telehealth service produces clinical benefit to the patient.
The evidence submitted should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit will not include minor or incidental benefits. Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
We have recently been asked to clarify instructions regarding appropriate reporting of telehealth services that, prior to our policy change regarding consultation codes, would have been reported as consultations furnished to patients in an emergency department. When we eliminated the use of consultation codes under the PFS beginning in CY 2010, we instructed practitioners, when furnishing a service that would have been reported as a consultation service, to report the E/M code that is most appropriate to the particular service for all office/outpatient or inpatient visits. Since section 1834(m) of the Act includes “professional consultations” (including the initial inpatient consultation codes “as subsequently modified by the Secretary”) in the definition of telehealth services, we established several HCPCS codes to describe the telehealth delivery of initial inpatient consultations. For inpatient hospital and skilled nursing facility care telehealth services, we instructed practitioners to use the inpatient telehealth consultation G-codes listed in Table 12 to report those telehealth services (74 FR 61763, 61774). However, we neglected to account for the fact that E/M emergency department visit codes (99281-99285) are not on the telehealth list. As a result, there has not been a clear means for practitioners to bill a telehealth consultation furnished in an emergency department. In order to address this issue, we proposed to change the code descriptors for the inpatient telehealth consultation G-codes to include emergency department telehealth consultations effective January 1, 2012. However, we requested public comment regarding other options, including creating G-codes specific to these services when furnished to patients in the emergency department.
However, the comments regarding site of service coding distinctions have prompted us to reconsider the need to provide a mechanism for follow-up consultations in the emergency department. While follow-up consultative services are furnished to hospital and SNF inpatients, we do not believe these services are furnished to patients in emergency departments since patients do not spend enough time in the emergency department to warrant a second consultative service by the same practitioner. Therefore, we are amending our proposal to pertain only to the G-codes that describe initial telehealth consultations.
After consideration of the public comments we received, we are finalizing our proposal to change the code descriptors for initial inpatient telehealth consultation G-codes to reflect telehealth consultations furnished to emergency department patients in addition to inpatient telehealth consultations effective January 1, 2012. The descriptors for these codes for CY 2012 appear in table 13. After consideration of the public comments we received, we are not finalizing our proposal to change the code descriptors for follow-up inpatient telehealth consultations, since we do not believe follow-up consultations are furnished to emergency department patients.
Section 1834(m)(2)(B) of the Act establishes the payment amount for the Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001, through December 31, 2002, at $20. For telehealth services provided on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2012 is 0.6 percent. Therefore, for CY 2012, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $24.24. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 14.
Under section 1848(c)(2)(B) of the Act, we review and make adjustments to RVUs for physicians' services at least once every 5 years. Under section 1848(c)(2)(K) of the Act (as added by section 3134 of the Affordable Care Act), we are required to identify and revise RVUs for services identified as potentially misvalued. Section 1848(c)(2)(K)(iii) specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In accordance with section 1848(c)(2)(K)(iii) of the Act, we develop and propose appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC, the Medicare Payment Advisory Commission (MedPAC), and others. To respond to concerns expressed by MedPAC, the Congress, and other stakeholders regarding the accuracy of values for services under the PFS, the AMA RUC has used an annual process to systematically identify, review, and provide CMS with recommendations for revised work values for many existing potentially misvalued services.
For many years, the AMA RUC has provided CMS with recommendations on the appropriate relative values for PFS services. In recent years CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. In addition to the Five-Year Reviews of Work, over the past several years CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens for codes at risk for being misvalued, such as codes with high growth rates, codes that are frequently billed together in one encounter, and codes that are valued as inpatient services but that are now predominantly performed as outpatient services. This annual review of work RVUs and direct PE inputs for potentially misvalued codes was further bolstered by the Affordable Care Act mandate to examine potentially misvalued codes, with an emphasis on the following categories specified in section 1848(c)(2)(K)(ii) (as added by section 3134 of the Affordable Care Act):
• Codes and families of codes for which there has been the fastest growth.
• Codes or families of codes that have experienced substantial changes in practice expenses.
• Codes that are recently established for new technologies or services.
• Multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes which have not been subject to review since the implementation of the RBRVS (the “Harvard-valued” codes).
• Other codes determined to be appropriate by the Secretary. (For example, codes for which there have been shifts in the site-of-service (site-of-service anomalies).)
In addition to providing recommendations to CMS for work RVUs, the AMA RUC's Practice Expense Subcommittee reviews, and then the AMA RUC recommends, direct PE inputs (clinical labor, medical supplies, and medical equipment) for individual services. To guide the establishment of malpractice RVUs for new and revised codes before each Five-Year Review of Malpractice, the AMA RUC also provides crosswalk recommendations, that is, “source” codes with a similar specialty mix of practitioners furnishing the source code and the new/revised code.
CMS reviews the AMA RUC recommendations on a code-by-code basis. For AMA RUC recommendations regarding physician work RVUs, we determine whether we agree with the recommended work RVUs for a service (that is, whether we agree the valuation is accurate). If we disagree, we determine an alternative value that
If we receive public comments on the interim final work RVUs for a specific code indicating that refinement of the interim final work value is warranted based on sufficient information from the commenters concerning the clinical aspects of the physician work associated with the service (57 FR 55917), we refer the service to a refinement panel, as discussed in further detail in section III.B.1.a. of this final rule with comment period.
In the interval between closure of the comment period and the subsequent year's PFS final rule with comment period, we consider all of the public comments on the interim final work, PE, and malpractice RVUs for the new, revised, and potentially misvalued codes and the results of the refinement panel, if applicable. Finally, we address the interim final RVUs (including the interim final direct PE inputs) by providing a summary of the public comments and our responses to those comments, including a discussion of any changes to the interim final work or malpractice RVUs or direct PE inputs, in the following year's PFS final rule with comment period. We then typically finalize the direct PE inputs and the work, PE, and malpractice RVUs for the service in that year's PFS final rule with comment period, unless we determine it would be more appropriate to continue their interim final status for another year and solicit further public comment.
We conducted a clinical review of each code identified in this section and reviewed the AMA RUC recommendations for work RVUs, time to perform the “pre-,” “intra-,” and “post-” service activities, as well as other components of the service which contribute to the value. Our clinical review generally includes, but is not limited to, a review of information provided by the AMA RUC, medical literature, public comments, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and healthcare care professionals within CMS and the Federal Government, and the views based on clinical experience of the physicians on the clinical team. We also assessed the AMA RUC's methodology and data used to develop the recommendations and the rationale for the recommendations. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), the AMA RUC uses a variety of methodologies and approaches to assign work RVUs, including building block, survey data, crosswalk to key reference or similar codes, and magnitude estimation. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Components may include pre-, intra-, or post-service time and post-procedure visits, or, when referring to a bundled CPT code, the components could be considered to be the CPT codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician work for that service relative to the physician work for similar service across the physician fee schedule without explicitly valuing the components of that work. The resource-based relative value system (RBRVS) has incorporated into it cross-specialty and cross-organ system relativity. This RBRVS requires assessment of relative value and takes into account the clinical intensity and time required to perform a service. In selecting which methodological approach will best determine the appropriate value for a service we consider the current physician work and time values, AMA RUC-recommended physician work and time values, and specialty society physician work and time values, as well as the intensity of the service, all relative to other services. During our clinical review to assess the appropriate values for the codes we developed systematic approaches to address particular areas of concern. Specifically, the application of work budget neutrality within clinical categories of CPT codes, CPT codes with site-of-service anomalies, and CPT codes for services typically furnished on the same day as an evaluation and management visit. A description of those methodologies follows.
We apply work budget neutrality to hold the aggregate work RVUs constant within a set of clinically related CPT codes, while maintaining the relativity of values for the individual codes within that set. In some cases, when the CPT coding framework for a clinically related set of CPT codes is revised by the creation of new CPT codes or existing CPT codes are revalued, the aggregate work RVUs recommended by the AMA RUC within that clinical category of CPT codes may change, although the actual physician work associated with the services has not changed. When this occurs, we may apply work budget neutrality to adjust the work RVUs of each clinically related code so that the sum of the new/revised code work RVUs (weighted by projected utilization) for a set of CPT codes would be the same as the sum of the current work RVUs (weighted by projected utilization) for that set of codes.
When the AMA RUC recommends work RVUs for new or revised CPT codes, we review the work RVUs and adjust or accept the recommended values as appropriate, making note of whether any estimated changes in aggregate work RVUs would result from true change in physician work, or from structural coding changes. We then determine whether the application of budget neutrality within sets of codes is appropriate. If the aggregate work RVUs would increase without a corresponding true increase in physician work, we generally view this as an indication that an adjustment to ensure work budget neutrality within the set of CPT codes is warranted. Ensuring work budget neutrality is an important principle so that structural coding changes are not unjustifiably redistributive among PFS services.
In the CY 2011 PFS final rule with comment period, there were four sets of clinically related CPT codes where we believed that the application of work budget neutrality was appropriate. These codes were in the areas of paraesophageal hernia procedures, esophageal motility and high resolution esophageal pressure topography, skin excision and debridement, and obstetrical care. The CY 2011 interim final values and CY 2012 final values for these services are discussed in section
Since CY 2009, CMS and the AMA RUC have reviewed a number of CPT codes that have experienced a change in the typical site-of-service since the original valuation of the codes. Specifically, these codes were originally furnished in the inpatient setting, but Medicare claims data show that the typical case has shifted to being furnished in the outpatient setting. As we discussed in the CY 2011 PFS final rule with comment period (75 FR 73221) and the CY 2012 PFS proposed rule (76 FR 42797), when the typical case for a service has shifted from the inpatient setting to an outpatient or physician's office setting, we do not believe the inclusion of inpatient hospital visits in the post-operative period is appropriate. Additionally, we believe that it is reasonable to expect that there have been changes in medical practice for these services, and that such changes would represent a decrease in physician time or intensity or both.
For CY 2009 and CY 2010, the AMA RUC reviewed and recommended—RVUs for 40 CPT codes we identified as being potentially misvalued under the Secretary's discretion to identify other categories of potentially misvalued codes (see section II.B. of this final rule) because a site-of-service anomaly exists. In the CYs 2009 and 2010 PFS final rule with comment period (73 FR 69883 and 74 FR 61776 through 61778, respectively), we indicated that although we would accept the AMA RUC valuations for these CPT codes on an interim basis, we had ongoing concerns about the methodology used by the AMA RUC to value these services, and in the CY 2010 PFS final rule with comment period (74 FR 61777) we encouraged the AMA RUC to utilize the building block methodology when revaluing services with site-of-service anomalies. In the CY 2011 final rule with comment period (75 FR 73221), we requested that the AMA RUC re-examine the site-of-service anomaly codes and adjust the work RVU, times, and post-service visits to reflect those typical of a service furnished in an outpatient or physician's office setting.
Following this request, the AMA RUC re-reviewed these site-of-service anomaly codes and recommended work RVUs to us for these services. Of the 40 CPT codes on the CY 2009 and CY 2010 site-of-service anomaly codes lists, 1 CPT code was not re-reviewed, as it was addressed in the CY 2011 PFS final rule with comment period. Ten of the remaining 39 site-of-service anomaly codes were addressed in the Fourth Five-Year Review of Work (76 FR 32410), and the remaining 29 CPT codes were addressed in the CY 2012 PFS proposed rule (76 FR 72798 through 42809). In addition, several other CPT codes were identified as having site-of-service anomalies and were addressed in the Fourth Five-Year Review of Work (76 FR 32410). In the CY 2012 PFS proposed rule (76 FR 42797), we stated that we would respond to public comments and adopt final work RVUs for these codes in the CY 2012 PFS final rule with comment period.
When Medicare claims data show that the typical setting for a CPT code has shifted from the inpatient setting to the outpatient setting, we believe that the work RVU, time, and post-service visits of the code should reflect a service furnished in the outpatient setting. For nearly all of the codes with site-of-service anomalies, the accompanying survey data suggest they are “23-hour stay” outpatient services. As we discussed in detail in the CY 2011 PFS final rule with comment period (75 FR 73226), the Fourth Five-Year Review of Work (76 FR 32410) and the CY 2012 PFS proposed rule (76 FR 42798), the “23-hour stay service” is a term of art describing services that typically have lengthy hospital outpatient recovery periods. For these 23-hour stay services, the typical patient is at the hospital for less than 24-hours, but often stays overnight at the hospital. Unless a treating physician has written an order to admit the patient as an inpatient, the patient is considered for Medicare purposes to be a hospital outpatient, not an inpatient, and our claims data support that the typical 23-hour stay service is billed as an outpatient service.
As we discussed in the Five-Year Review of Work (76 FR 32410), and CY 2012 PFS proposed rule (76 FR 42798) we believe that the values of the codes that fall into the 23-hour stay category should not reflect work that is typically associated with an inpatient service. However, as we stated in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227), while the patient receiving the outpatient 23-hour stay service remains a hospital outpatient, the patient would typically be cared for by a physician during that lengthy recovery period at the hospital. While we do not believe that post-procedure hospital visits would be at the inpatient level since the typical case is an outpatient who would be ready to be discharged from the hospital in 23-hours or less, we believe it is generally appropriate to include the intra-service time of the inpatient hospital visit in the immediate post-service time of the 23-hour stay code under review. In addition, we indicated that we believe it is appropriate to include a half day, rather than a full day, of a discharge day management service.
We finalized this policy in the CY 2011 PFS final rule with comment period (75 FR 73226 through 73227) and applied this methodology when valuing 23-hour stay codes in the Fourth Five-Year Review and CY 2012 PFS proposed rule in order to ensure the consistent and appropriate valuation of the physician work for these services. A full description of our methodology for revaluing the site-of-service anomaly codes can be found in the Fourth Five-Year Review of Work (76 FR 32410), and the CY 2012 PFS proposed rule (76 FR 72798 through 42809). In brief, where Medicare claims data suggested a site-of-service anomaly (more than 50 percent of the Medicare PFS utilization is outpatient) and the AMA RUC's recommended value continued to include inpatient visits in the post-operative period, we removed any post-procedure inpatient visits or subsequent observation care services included in the AMA RUC-recommended values for these codes and adjusted the physician times accordingly. We also consistently included the value of a half day of discharge management service.
There are many reasons that services move from the inpatient to outpatient setting that reduce the overall risk of adverse outcomes and intensity of physician work. Services frequently move to the outpatient setting when the technique matures; that is, the risk-benefit ratio of the service is better understood and the efficacy of the service is more clearly established. Services may move to the outpatient setting because technological advances decrease the need for intensive monitoring and allow the discharge of sicker patients. Patient-controlled analgesia, for example, reduces the iterative assessment and response work necessary to manage post-operative pain and allows earlier discharge. Technological advances in the procedures themselves also reduce the risk of adverse outcomes. Electronic imaging and robotic surgery both allow procedures to be performed with increasingly smaller incisions, decreasing post-operative morbidity. Accordingly, we believe that, generally, the valuation of the codes that fall into the 23-hour stay category should not reflect physician work that is typically associated with an inpatient service.
Since CY 2011, we have reviewed a number of CPT codes that are typically billed with an E/M service on the same day. In cases where a service is typically furnished with an E/M service on the same day, we believe that there may be overlap between the two services in some of the activities conducted during the pre- and post-service times of the procedure code. Accordingly, in cases where the most recently available Medicare PFS claims data show the code is typically billed with an E/M visit on the same day, and where we believe that the AMA RUC did not adequately account for overlapping activities in the recommended value for the code, we systematically adjusted the physician times for the code to account for the overlap. After clinical review of the pre- and post-service work, we believe that at least one-third of the physician time in both the pre-service evaluation and post-service period is duplicative of the E/M visit in this circumstance. Therefore, for a number of CPT codes discussed in the following paragraphs, we adjusted the pre-service evaluation portion of the pre-service time to two-thirds of the AMA RUC-recommended time. Similarly, we also adjusted the post-service time to two-thirds of the AMA RUC-recommended time.
In this section, we address the interim final values published in Appendix C of the CY 2011 PFS final rule with comment period (75 FR 73810 through 73815), as subsequently corrected in the January 11, 2011 (76 FR 1670) correction notice; the proposed values published in the Fourth Five-Year Review of Work (76 FR 32410 through 32813); and the proposed values published in the CY 2012 PFS proposed rule (76 FR 42772 through 42947). We discuss the results of the CY 2011 multi-specialty refinement panel, respond to public comments received on specific interim final and proposed values (including direct PE inputs), and address the other new, revised, or potentially misvalued codes with interim final or proposed values. In section II.B.3. of this final rule with comment period, we emphasized the importance of reviewing the full value for services (the work, PE, and malpractice components of codes) that are identified as part of the potentially misvalued code initiative in order to maintain appropriate relativity and key relationships within the components of codes. The final CY 2012 direct PE database that lists the direct PE inputs is available on the CMS Web site under the downloads for the CY 2012 PFS final rule with comment period at: