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Code · REGISTER · 2008-01-25 · Federal Aviation Administration (FAA), Department of Transportation (DOT) · Proposed Rules

Proposed Rules. Notice of proposed rulemaking (NPRM)

20,961 words·~95 min read·/register/2008/01/25/08-292

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 3510-22-M 73 17 Friday, January 25, 2008 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0070; Directorate Identifier 2007-CE-098-AD] RIN 2120-AA64 Airworthiness Directives; Pilatus Aircraft Ltd. Model PC-12, PC-12/45, and PC-12/47 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above. 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. This proposed AD would require inserting changes into the airworthiness limitations of the FAA-approved maintenance program. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by February 25, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4059; fax:
(816)329-4090. SUPPLEMENTARY INFORMATION: Comments Invited 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 ADDRESSES section. Include “Docket No. FAA-2008-0070; Directorate Identifier 2007-CE-098-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion Based on the results of a full-scale fatigue test of the pitch trim actuator on Pilatus Aircraft Ltd. (Pilatus) PC-12 series airplanes, the life-limit is being extended and the time between overhaul
(TBO)is being reduced. In addition, based on the result of the fatigue test, a life-limit of the pitch trim actuator attachment has been established. These new limitations have been incorporated into the Airworthiness Limitations section of the Pilatus PC-12 Airplane Maintenance Manual
(AMM)12-A/AMP-04, chapter 4, revision 10, dated October 26, 2007. The life-limit of the pitch trim actuator has been increased based on the owner/operator complying with the new reduced TBO of 5,000 hours time-in-service
(TIS)or 5 years, whichever occurs first. The new limitations for the pitch trim actuator TBO have been moved from Chapter 5: Time Limits/Maintenance Checks, to Chapter 4: Structural, Component and Miscellaneous—Airworthiness Limitations. Since both chapter 4 and chapter 5 are mandatory within the European and Swiss airworthiness systems, it is not necessary for the European Aviation Safety Agency
(EASA)and the Federal Office of Civil Aviation
(FOCA)to issue an AD to mandate these new limitations. Proposing AD action is the only way the FAA can mandate change to the airworthiness limitations section of an FAA-approved maintenance program. If these new limitations are not mandated, the pitch trim actuator and the pitch trim actuator components could fail. This failure could lead to an unsafe flying configuration. Revisions to the Airworthiness Limitations section of AMM 12-A/AMP-04 incorporate the following: • TBO for the pitch trim actuator is reduced from 6,000 hours TIS or 5 years, whichever occurs first, to 5,000 hours TIS or 5 years, whichever occurs first; • The life-limit for the pitch trim actuator is increased from 10,000 hours TIS or 13,500 flights, whichever occurs first, to 20,000 hours TIS or 27,000 flights, whichever occurs first; and • A life-limit of 10,000 hours TIS is introduced for the pitch trim actuator attachment parts. FAA's Determination and Requirements of the Proposed AD 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 this State of Design Authority, they have notified us of the unsafe condition described above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. Differences Between This Proposed AD and the MCAI or Service Information 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. Costs of Compliance We estimate that this proposed AD would affect about 500 products of U.S. registry. We also estimate that it would take about .5 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $20,000, or $40 per product. In addition, we estimate that any necessary follow-on actions (the replacements required by the limitations changes) would take about 3.5 work-hours and require parts costing $11,960, for a cost of $12,240 per product. Authority for This Rulemaking 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. Regulatory Findings 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); 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. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Pilatus Aircraft Ltd.:** Docket No. FAA-2008-0070; Directorate Identifier 2007-CE-098-AD. Comments Due Date
(a)We must receive comments by February 25, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Models PC-12, PC-12/45, and PC-12/47 airplanes, all serial numbers, certificated in any category. Subject
(d)Air Transport Association of America
(ATA)Code 27: Flight Controls. Reason
(e)This 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. We are issuing this AD to mandate new life-limits for the pitch trim actuator and pitch trim actuator attachment parts. If these new limitations are not mandated, the pitch trim actuator and the pitch trim actuator components could fail. This failure could lead to an unsafe flying configuration. Actions and Compliance
(f)Unless already done, do the following within the next 30 days after the effective date of this AD.
(1)Insert unclassified document 12-A/AMP-04, Structural, Component and Miscellaneous—Airworthiness Limitations, 12-A-04-00-00-00A-000A-A, dated October 26, 2007 (Pilatus PC-12 Airplane Maintenance Manual, Chapter 4), into the airworthiness limitations section of the FAA-approved maintenance program (e.g., maintenance manual). You may use any future amendment to this airworthiness limitations section provided it does not change the inspection intervals, requirements, or the life-limits for the pitch trim actuator and pitch trim actuator attachment parts of the document referenced above. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may do this action. Make an entry in the aircraft records showing compliance with this portion of the AD following section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).
(2)In order to avoid confusion with the new pitch trim actuator limitations now contained in chapter 4 (previously contained in chapter 5) make pen and ink changes in chapter 5 and line through references to limitations for the pitch trim actuator. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816)329-4059; fax:
(816)329-4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ), the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Issued in Kansas City, Missouri, on January 17, 2008. James E. Jackson, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-1245 Filed 1-24-08; 8:45 am] BILLING CODE 4910-13-P COMMODITY FUTURES TRADING COMMISSION 17 CFR Parts 3 and 30 RIN 3038-AC26 Exemption From Registration for Certain Firms With Regulation 30.10 Relief AGENCY: Commodity Futures Trading Commission. ACTION: Proposed rules. SUMMARY: The Commodity Futures Trading Commission (“Commission”) is proposing to amend the regulations regarding the registration of certain firms located outside the U.S. that are engaged in commodity interest activities with respect to trading on U.S. designated contract markets (“DCMs”) and U.S. derivative transaction execution facilities (“DTEFs”). 1 The amended regulation would codify past actions of the Commission's staff permitting certain foreign firms that have confirmed relief from registration as futures commission merchants (“FCMs”) in accordance with the regulations to introduce to registered FCMs certain U.S. customers in connection with trading U.S. DCM and DTEF listed futures and commodity options without having to register as an introducing broker pursuant to section 4d of the Commodity Exchange Act (“Act”). The Commission also is proposing to revoke the regulations regarding quarterly reporting requirements for foreign futures and foreign options transactions. 1 Commission regulations referred to herein are found at 17 CFR Ch. I (2007). References to trading on U.S. DCMs or DTEFs shall include trading that is subject to the rules of such entities as well. DATES: Comments must be received on or before February 25, 2008. ADDRESSES: Comments may be submitted, identified by RIN 3038-AC26, by any of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • E-mail: *secretary@cftc.gov.* Include “Exemption from Registration for Certain Firms with Regulation 30.10 Relief” in the subject line of the message. • Fax: 202/418-5521. • Mail or Courier: Send to David Stawick, Secretary, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st St., NW., Washington, DC 20581. All comments received will be posted without change to *http://www.cftc.gov* , including any personal information provided. FOR FURTHER INFORMATION CONTACT: Andrew V. Chapin, Special Counsel, at
(202)418-5465, Division of Clearing and Intermediary Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. Electronic mail: *achapin@cftc.gov.* SUPPLEMENTARY INFORMATION: I. Background Information A. Registration Requirements for Commodity Interest Activities on U.S. Markets Part 3 of the Commission's regulations governs the registration of intermediaries engaged in the offer and sale of, and providing advice concerning, futures and commodity options traded on U.S. markets, including both DCMs and DTEFs. In particular, Regulation 3.10 sets forth the manner in which FCMs, introducing brokers (“IBs”), commodity trading advisors (“CTAs”), commodity pool operators (“CPOs”) and leverage transaction merchants must apply for registration with the Commission. Regulation 3.10(c) also provides an exemption from registration for certain persons. For example, Regulation 3.10(c)(1) provides an exemption from registration as an FCM for any person trading solely for proprietary accounts, as defined in Regulation 1.3(y). The Commission recently adopted amendments to Regulation 3.10(c) to codify the Commission's longstanding policy towards certain foreign intermediaries, known as foreign brokers. 2 New Regulation 3.10(c)(2) provides an exemption from registration as an FCM to any foreign broker that limits its customers to persons located outside the U.S. and submits transactions executed on U.S. exchanges for clearing on an omnibus basis through a registered FCM. The Commission also promulgated Regulation 3.10(c)(3) to provide an exemption from registration to any foreign person engaged in the activity of an introducing broker, commodity pool operator or commodity trading advisor solely on behalf of customers located outside the U.S., provided that all commodity interest transactions are submitted for clearing to a registered FCM. 3 2 72 FR 63976 (November 14, 2007). 3 *Id.* B. Part 30 of the Commission's Regulations In 1987, the Commission adopted a new Part 30 of its regulations to govern the offer and sale to U.S. persons of futures and option contracts entered into on or subject to the rules of a foreign board of trade. 4 These regulations were promulgated pursuant to Sections 2(a)(1)(A), 4(b) and 4c of the Act, which vest the Commission with exclusive jurisdiction over the offer and sale, in the U.S., of futures and commodity option contracts traded on or subject to the rules of a board of trade, exchange or market located outside of the U.S. 4 52 FR 28980 (August 5, 1987). Part 30 sets forth regulations governing foreign futures and foreign option transactions executed on behalf of customers located in the U.S., referred to in the regulations as foreign futures or foreign options customers. 5 For example, Regulation 30.4 requires any person engaged in the activities that are described in the regulation to register with the Commission as an FCM, IB, CPO or CTA, respectively, unless such person claims relief from registration under Part 30. The activities described in Regulation 30.4 essentially are similar to those of an FCM, IB, CPO or CTA defined in the Act, except that the transactions that the person intermediates are conducted on or subject to the rules of a foreign board of trade. The transactions that are subject to regulation and require registration under Part 30 include the solicitation or acceptance of orders for trading any foreign futures or foreign option contract and acceptance of money, securities or property to margin, guarantee or secure any foreign futures or foreign option trades or contracts. 6 5 Regulations 30.1(a),
(b)and (c), define the terms “foreign futures,” “foreign options,” and “foreign futures or foreign options customer,” respectively. 6 *See* Regulation 30.4. Under Part 30, certain persons located outside the U.S. may obtain an exemption from registration and certain other requirements. For example, under Regulation 30.10 and Appendix A thereto, the Commission may exempt a foreign firm that solicits or accepts orders (and accepts money, securities or property to margin the trades made thereto) from customers located in the U.S. from compliance with certain Commission rules, including those rules pertaining to registration, provided that a comparable regulatory system exists in the firm's home country and that certain safeguards are in place to protect U.S. investors, including an information-sharing arrangement between the Commission and the firm's home country regulator. 7 Relief from registration pursuant to Regulation 30.10 does not extend to any activities related to acting as an intermediary with respect to trading, directly or indirectly, on any U.S. exchanges. 7 *See* Appendix A to Part 30; 62 FR 47792 (September 11, 1997). C. Interpretation of the Rule 30.10 Exemption The Division of Clearing and Intermediary Oversight (“Division”) has issued a series of no-action letters that permit, in limited circumstances, a foreign firm exempt from FCM registration pursuant to Regulation 30.10 (“Regulation 30.10 firm”), to intermediate transactions executed on U.S. exchanges on behalf of U.S. customers. Specifically, the Division confirmed that it would not recommend that the Commission commence any enforcement action against certain FCMs and affiliated Regulation 30.10 firms if such unregistered affiliates introduced certain sophisticated U.S. customers to a registered FCM for the purpose of trading on U.S. designated contract markets. 8 The relief in each no-action letter issued by the Division was predicated upon the relevant FCM's acknowledgment that it would be jointly and severally liable for any violations of the Act or the Commission's regulations committed by the foreign affiliate in connection with those activities, even if the FCM did not submit the trade for clearing. In addition, the no-action relief required that all U.S. customers be introduced on a fully-disclosed basis, and that any non-U.S. affiliate would not be permitted either to solicit any U.S. customer or handle any U.S. customer funds for trading on U.S. markets. 8 *See,* *e.g.* , CFTC Letter 07-23, [Current Transfer Binder] Comm. Fut. L. Rep.
(CCH)¶___ (November 23, 2007). In granting the above no-action relief, the Division recognized that a U.S. institutional customer may achieve greater operational and economic efficiencies by eliminating the need to use multiple order entry systems to engage in transactions in both U.S. and non-U.S. markets. In addition, the Division acknowledged that, by consolidating orders into a single execution system, an intermediating FCM may mitigate more effectively the increased systemic and liquidity risks associated with such activities. Given that the no-action relief provided by the Division applies only to the recipients of each no-action letter, the Commission believes that it may be appropriate to provide relief for all FCMs and their affiliates that provide brokerage services to U.S. institutional investors in like cirumstances. Like those FCMs addressed by the Division's no-action relief, these FCMs also have institutional U.S. customers that trade globally throughout the 24-hour trading day, and who currently must use multiple order entry systems to execute transactions both domestically and abroad. Accordingly, the Commission has determined to propose to amend Regulation 3.10(c) to address the issue without the need for separate no-action letters, and invites public comment on all aspects of the proposed rule. II. Proposed Regulations The Commission proposes to codify the staff interpretations described in Section I.C above. Specifically, the Commission proposes to promulgate Regulation 3.10(c)(4) to exempt from registration as an IB a firm located outside the U.S. that introduces certain sophisticated U.S. customers to a registered FCM for the purpose of trading on a DCM or DTEF. The exemption would be limited to those foreign firms that are affiliated with an FCM and have obtained confirmation of relief pursuant to the terms and conditions of an order issued by the Commission pursuant to Regulation 30.10. Any account introduced pursuant to this exemption must be introduced on a fully-disclosed basis in accordance with Regulation 1.57 and the foreign firm would not be permitted to solicit any U.S. customers nor handle any U.S. customer funds for trading on U.S. markets. The Commission has proposed to limit the exemption in Regulation 3.10(c)(4) to Regulation 30.10 firms because Regulation 30.10 relief is predicated on the existence of a comparable regulatory program in the jurisdiction in which the affiliate is located, and the presence of certain safeguards to protect U.S. investors, including standards for fitness and an information-sharing arrangement between the Commission and the authorities in the affiliate's home country. The Commission notes that the Division's existing no-action letters provide exemptive relief to foreign firms acting on behalf of certain “institutional” and “commercial” entities. In search of a workable universal standard, the Commission has proposed to structure the exemption so as to limit the offer and sale of U.S. contracts to institutional customers, as defined in Regulation 1.3(g). The Commission also proposes Regulation 3.10(c)(6) that, for the purposes of this regulation, the term “affiliate” means any person that:
(i)Owns 50 percent or more of the FCM;
(ii)is owned 50 percent or more by the FCM; or
(iii)is owned 50 percent or more by a third person that also owns 50 percent or more of the FCM. 9 9 *See,* *e.g.* , CFTC Staff Letter 07-06, [Current Transfer Binder], Comm. Fut. L. Rep.
(CCH)¶ _____ at _____, n.3 (May 24, 2007). CFTC Letter 07-06 is one of a series of letters issued by the Division of Market Oversight that permits members of a particular foreign exchange located in the U.S. to connect directly to the foreign exchange's order and trade matching system without the exchange having to register as a DCM or DTEF. For the purposes of the no-action relief, the term “members” includes “affiliates” as defined consistent with this proposal. The Commission notes that, as a condition of the no-action relief, members connected directly to the foreign exchange are ultimately responsible for the conduct of any affiliate. Consistent with the terms and conditions of relief established by the Division in the no-action process, the Commission also proposes to predicate the availability of the exemption upon the relevant FCM's acknowledgment, to be filed with NFA pursuant to proposed Regulation 3.10(c)(4)(iii), that it would be jointly and severally liable for any violations of the Act or the Commission's regulations committed by the foreign affiliate in connection with those activities, even if the FCM ultimately did not submit the trade for clearing. As such, the Commission has proposed to limit the exemption to firms affiliated with an FCM so that the FCM may maintain the appropriate level of oversight to ensure that the foreign affiliate complies with the conditions for relief as set forth in the proposed regulation. Proposed regulation 3.10(c)(4), in keeping with the no-action letters issued to date, prohibits the firm wishing to take advantage of the IB registration exemption from soliciting customer orders for trading on U.S. exchanges. This registration exemption only is intended to be a convenience for institutional customers so that they need not use multiple order entry processes to transact related business. For example, an institutional customer seeking to establish a position on the London Metal Exchange
(LME)may desire to hedge that position with contracts listed on the New York Mercantile Exchange (NYMEX). Absent relief, a Regulation 30.10 firm executing and/or submitting for clearing the LME transaction may not participate in the acceptance of orders for any NYMEX contracts. Pursuant to the proposed regulation, a Regulation 30.10 firm may introduce the institutional customer to a registered FCM for the purposes of submitting the NYMEX transaction for clearing, provided that the institutional customer initiates the transaction. The exemption from registration also is not intended to be used by firms as a promotional vehicle. The proposed regulation would not permit a Regulation 30.10 firm to solicit new customers based on its ability to access U.S. markets. As stated above, the Commission is proposing to create a limited-purpose exemption from IB registration so that existing institutional customers may reduce transactional costs associated with the use of multiple order entry processes. The Commission also notes that the proposed amendments to Regulation 3.10(c) are intended to provide a limited-purpose registration exemption available only to those foreign firms engaging in *bona fide* global futures brokerage activities on behalf of institutional customers located in the U.S. Absent such relief, these firms would be required to register with the Commission in the appropriate capacity, because the applicable Regulation 30.10 relief does not extend to brokerage activities undertaken, directly or indirectly, on U.S. exchanges on behalf of any U.S. person. A foreign firm not engaged in *bona fide* global futures brokerage activities on behalf of institutional customers, *e.g.* , a firm limiting its brokerage activities on behalf of U.S. customers to trading solely on U.S. exchanges, may not rely on the proposed exemptions to circumvent the IB registration requirement. An FCM submitting the acknowledgment set forth in proposed Regulation 3.10(c)(4)(iii) could be held liable for any violations of a foreign affiliate in an attempt to circumvent the Commission's registration requirements in this regard. The Commission further notes that proposed Regulation 3.10(c)(4) would replace prior staff letters as the sole source of authorization for those unregistered foreign firms that introduce to an FCM U.S. customers for the purpose of trading on U.S. markets. 10 A firm that fails to comply with any of the terms or conditions of the applicable Regulation 30.10 order, including a failure to comply with any element of the regulatory program on which relief was predicated, would make the firm ineligible for relief set forth in proposed Regulation 3.10(c)(4). 10 The following letters for no-action relief will be superceded if the proposed rules are adopted: CFTC Letters 03-28, 04-09, 04-14, 05-06, 07-05, 07-08, 07-16, 07-17, 07-20 and 07-23. The Commission seeks comments from any party adversely affected by the determination to rescind these CFTC Letters. In each of the existing no-action letters on this subject cited in the footnote, the Division considered the size of the FCM and its relationship with its particular non-U.S. affiliate prior to determining that relief would not be contrary to the public interest. More specifically, the Division determined that the financial strength and organizational structure of each FCM provided a reasonable basis upon which to rely that it could honor the acknowledgement of joint and several liability. Accordingly, the Commission solicits comments as to whether it would be appropriate to establish minimum capital or other standards for the affiliated FCM as a condition for exemptive relief. 11 11 *Compare* Regulation 30.12, 17 CFR 30.12 (Direct Foreign Order Transmittal). Pursuant to Regulation 30.12(b)(1)(i), an FCM must possess, for example, $20,000,000 in adjusted net capital in order for one of its “authorized customers” to engage in direct foreign order transmittal with an unregistered foreign futures and options broker for the purpose of trading foreign futures or options through the FCM's customer omnibus account. The Commission also solicits comment as to whether the proposed limited-purpose registration exemption should be extended to otherwise qualified foreign persons that advise institutional customers for the purposes of trading on U.S. markets. This relief would be available, for example, to the foreign affiliate of an FCM that provides trading advice tailored to the particular circumstances of U.S. customers that meet the institutional customer standards regarding the trading of both domestic and foreign futures as part of an overall global strategy. The Commission also is proposing to revoke Regulation 30.8. Regulation 30.8 requires each FCM to provide NFA with a quarterly report containing data for the total volume of foreign futures and options contracts effected on foreign boards of trade. From its experience, the Commission recognizes that FCMs are engaging in both domestic and foreign futures and options transactions on behalf of customers located in the U.S., and therefore are subject to other extensive reporting and recordkeeping requirements set forth in Part 1 of its regulations. As such, the Commission believes that the reporting requirement set forth in Regulation 30.8 is overly burdensome and no longer necessary. The Commission solicits comments as to whether remaining reporting requirements are sufficient for FCMs engaged in foreign futures and options transactions on behalf of customers located in the U.S. III. Related Matters A. Regulatory Flexibility Act The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601-611, requires that agencies, in proposing regulations, consider the impact of those regulations on small businesses. The Commission has previously established certain definitions of “small entities” to be used by the Commission in evaluating the impact of its regulations on such entities in accordance with the RFA. 12 The Commission previously has determined that registered FCMs are not small entities for the purpose of the RFA because each FCM has an underlying fiduciary relationship with its customers, regardless of the size of the FCM. 13 The Commission notes that the foreign persons affected by the proposed changes to the Commission's regulations would be registered as FCMs if not for the exemption provided therein and, as such, would maintain a fiduciary relationship with customers similar to the relationship maintained by each registered FCM. Therefore, the Acting Chairman, on behalf of the Commission, hereby certifies, pursuant to 5 U.S.C. 605(b), that these proposed regulations will not have a significant economic impact on a substantial number of small entities. Nonetheless, the Commission specifically requests comment on the impact these proposed rules may have on small entities. 12 47 FR 18618-18621 (April 30, 1982). 13 47 FR 18619-18620. B. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501 *et seq.* (Supp. I 1995)) imposes certain requirements on federal agencies (including the Commission) in connection with their conducting or sponsoring any collection of information as defined by the PRA. While the proposed rule discussed herein has no burden, the group of rules (3038-0023, Rules, Regulations and Forms for Domestic and Foreign Futures and Options Related to Registration with the Commission) of which it is a part has the following burden: *Average Burden Hours per Response* : 18.11. *Number of Respondents* : 76,750. *Frequency of Response* : Annually and on occasion. The Office of Management and Budget (“OMB”) approved the collection of information associated with this group of rules on August 17, 2004. Copies of the OMB-approved information collection submission are available from the CFTC Clearance Officer, 1155 21st Street, NW., Washington, DC 20581,
(202)418-5160. C. Costs and Benefits of the Proposed Rules Section 15(a) of the Act requires the Commission to consider the costs and benefits of its actions before issuing new regulations under the Act. By its terms, Section 15(a) does not require the Commission to quantify the costs and benefits of new regulations or to determine whether the benefits of the proposed regulations outweigh their costs. Rather, Section 15(a) requires the Commission to “consider the cost and benefits” of the subject regulations. Section 15(a) further specifies that the costs and benefits of the proposed regulations shall be evaluated in light of five broad areas of market and public concern:
(1)Protection of market participants and the public;
(2)efficiency, competitiveness, and financial integrity of futures markets;
(3)price discovery;
(4)sound risk management practices; and
(5)other public interest considerations. The Commission may, in its discretion, give greater weight to any one of the five enumerated areas of concern and may, in its discretion, determine that, notwithstanding its costs, a particular regulation is necessary or appropriate to protect the public interest or to effectuate any of the provisions or to accomplish any of the purposes of the Act. The proposed regulations should foster the protection of market participants and the public by providing greater legal certainty to the commodity interest activities of persons located outside the U.S. As the activity set forth in the proposed regulations presently is permitted under staff interpretation and no-action, the proposed regulations should have no material impact from the standpoint of imposing costs or creating benefits, on efficiency, competitiveness and financial integrity of financial markets, price discovery, sound risk management practices, or any other public interest considerations. List of Subjects 17 CFR Part 3 Definitions, Foreign futures, Consumer protection, Foreign options, Registration requirements. 17 CFR Part 30 Definitions, Foreign futures, Consumer protection, Foreign options, Registration requirements. In consideration of the foregoing, and pursuant to the authority contained in the Commodity Exchange Act and, in particular, sections 2(a)(1), 4(b), 4c and 8a thereof, 7 U.S.C. 2, 6(b), 6c and 12a (1982), and pursuant to the authority contained in 5 U.S.C. 552 and 552b (1982), the Commission hereby proposes to amend Chapter I of Title 17 of the Code of Federal Regulations as follows: PART 3—REGISTRATION 1. The authority citation for part 3 continues to read as follows: Authority: 5 U.S.C. 522, 522b; 7 U.S.C. 1a, 2, 4, 6, 6a, 6b, 6c, 6d, 6e, 6f, 6g, 6h, 6i, 6k, 6m, 6n, 6o, 6p, 8, 9, 9a, 12, 12a, 13b, 13c, 16a, 18, 19, 21, 23, unless otherwise noted. 2. Section 3.10 is amended by adding paragraph (c)(4) to read as follows: § 3.10 Registration of futures commission merchants, introducing brokers, commodity trading advisors, commodity pool operators and leverage transaction merchants.
(c)*Exemption from registration for certain persons.*
(4)A person located outside the United States, its territories or possessions that is exempt from registration as a futures commission merchant in accordance with § 30.10 of this chapter is not required to register as an introducing broker in accordance with section 4d of the Act if:
(i)Such a person is affiliated with a futures commission merchant registered in accordance with section 4d of the Act;
(ii)Such a person introduces, on a fully-disclosed basis in accordance with § 1.57 of this chapter, any institutional customer, as defined in § 1.3(g) of this chapter, to a registered futures commission merchant for the purpose of trading on a designated contract market or derivatives execution facility;
(iii)Prior to a person located outside the United States, its territories or possessions, that is exempt from registration as a futures commission merchant pursuant to § 30.10 of this chapter, engaging in the introducing activities described in this paragraph, the affiliated futures commission merchant has filed with the National Futures Association (ATTN: Vice President, Compliance) an acknowledgement that it will be jointly and severally liable for any violations of the Act or the Commission's regulations committed by such person in connection with those introducing activities, whether or not the affiliated futures commission merchant submits for clearing any trades resulting from those introducing activities; and
(iv)Such person does not solicit any person located in the United States, its territories or possessions for trading on a designated contract market or derivatives transaction execution facility, nor does such person handle the customer funds of any person located in the United States, its territories or possessions for the purpose of trading on any designated contract market or derivatives transaction execution facility.
(v)For the purposes of this paragraph, a person shall be affiliated with a futures commission merchant if such a person:
(A)Owns 50 percent or more of the futures commission merchant;
(B)Is owned 50 percent or more by the futures commission merchant; or
(C)Is owned 50 percent or more by a third person that also owns 50 percent or more of the futures commission merchant. PART 30—FOREIGN FUTURES AND FOREIGN OPTIONS TRANSACTIONS 3. The authority citation for part 30 continues to read as follows: Authority: 7 U.S.C. 1a, 2, 4, 6, 6c, and 12a, unless otherwise noted. § 30.8 [Removed and reserved] 4. Section 30.8 is removed and reserved: Dated: January 15, 2008. By the Commission. David Stawick, Secretary of the Commission. [FR Doc. E8-979 Filed 1-24-08; 8:45 am] BILLING CODE 6351-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 70 [EPA-R05-OAR-2007-1198; FRL-8521-4] State Operating Permits Program; Ohio; Revision to the Acid Rain Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA proposes to approve into the Ohio operating permits program revisions submitted by the State of Ohio for the purpose of amending the Acid Rain Permits and Compliance portion of the program. The changes made to OAC 3745-103, which comprises the revisions, include rules for phase II acid rain permits and new information on items incorporated by reference. DATES: Comments must be received on or before February 25, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-1198, by one of the following methods: 1. *www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail:* *angelbeck.richard@epa.gov* . 3. *Fax:*
(312)886-5824. 4. *Mail:* Pamela Blakley, Chief, Air Permits Section, Air Programs Branch (AR 18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. *Hand Delivery:* At the previously listed EPA Region 5 address. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Richard Angelbeck, Environmental Scientist, Air Permits Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-9698, *angelbeck.richard@epa.gov* . SUPPLEMENTARY INFORMATION: In the Final Rules section of this **Federal Register** , EPA is approving the State's operating permits program revision submittal as a direct final rule without prior proposal, because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule, and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this **Federal Register** . Dated: January 15, 2008. Margaret Guerriero, Acting Regional Administrator, Region 5. [FR Doc. E8-1319 Filed 1-24-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 424 [CMS-6036-P] RIN 0938-AO90 Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Supplier Enrollment Safeguards AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule clarifies, expands, and adds to the existing enrollment requirements that Durable Medical Equipment and Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must meet to establish and maintain billing privileges in the Medicare program. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 25, 2008. ADDRESSES: In commenting, please refer to file code CMS-6036-P. 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. *Electronically.* You may submit electronic comments on specific issues in this regulation to *http://www.regulations.gov.* Follow the instructions under the “Comment or Submission” tab and enter the file code to find the document accepting comments. 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6036-P, P.O. Box 8012 Baltimore, MD 21244-8012. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6036-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number
(410)786-4696 or
(410)786-1161 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. *Submission of comments on paperwork requirements.* You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: August Nemec,
(410)786-0612. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-6036-P and the specific “issue identifier” that precedes the section on which you choose to comment. *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *https://www.cms.hhs.gov/eRulemaking* . Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will 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. I. Background Medicare services are furnished by two types of entities, providers and suppliers. At § 400.202, “provider” is defined as a hospital, a critical access hospital (CAH), a skilled nursing facility, a comprehensive outpatient rehabilitation facility, a home health agency (HHA), or a hospice that has in effect an agreement to participate in Medicare, or a clinic, a rehabilitation agency, or a public health agency that has in effect a similar agreement but only to furnish outpatient physical therapy or speech pathology services, or a community mental health center that has in effect a similar agreement but only to furnish partial hospitalization services. The term “provider” is also defined in sections 1861(u) and 1866(e) of the Social Security Act (the Act). For purposes of the DMEPOS supplier standards, the term “supplier” is defined in § 424.57(a) as an entity or individual, including a physician or Part A provider, that sells or rents Part B covered DMEPOS items to Medicare beneficiaries that meet the DMEPOS supplier standards. This proposed rule applies to all DMEPOS suppliers and amends the DMEPOS supplier standards set forth at § 424.57(c). Those individuals or entities that do not furnish DMEPOS items but furnish other types of health care services only (for example, physician services or nurse practitioner services) would not be subject to this requirement. A supplier that furnishes durable medical equipment, prosthetics, orthotics, and suppliers (DMEPOS) is one category of supplier. Other supplier categories may include, for example, physicians, nurse practitioners, and physical therapists. If a supplier, such as a physician or physical therapist, also provides DMEPOS to a patient, then the supplier is also considered to be a DMEPOS supplier. The term “DMEPOS” encompasses the types of items included in the definition of medical equipment and supplies found at section 1834(j)(5) of the Act. In FY 2007, the Medicare program spent more than $10 billion for DMEPOS supplies, and in April 2007, there were 116,471 individual DMEPOS suppliers. However, due to the affiliation of some DMEPOS suppliers with chains, there were 65,984 unique billing numbers. The largest concentration of DMEPOS suppliers were located in five States: California (approximately 9 percent), Texas (approximately 7 percent), Florida (approximately 7 percent), New York (approximately 6 percent) and Pennsylvania (approximately 5 percent). We believe that approximately 30 percent of the DMEPOS suppliers are located in rural areas throughout the United States and that the vast majority of DMEPOS suppliers are small entities (based on Medicare reimbursement alone). The term DMEPOS is defined at section 1861(n) of the Act. This definition, in part, excludes from coverage as DMEPOS, items furnished in skilled nursing facilities and hospitals. Also, the term DMEPOS is included in the definition of “medical and other health services” found at section 1861(s)(6) of the Act. Furthermore, the term is defined in § 414.202 as equipment furnished by a supplier or a HHA that— • Can withstand repeated use; • Is primarily and customarily used to serve a medical purpose; • Generally is not useful to an individual in the absence of an illness or injury; and • Is for use in the home. Examples of DMEPOS supplies include items such as blood glucose monitors, hospital beds, nebulizers, oxygen delivery systems, and wheelchairs. Prosthetic devices are included in the definition of “medical and other health services” under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as “devices (other than dental) which replace all or part of an internal body organ (including colostomy bags and supplies directly related to colostomy care), including replacement of such devices, and including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens.” Other examples of prosthetic devices include cardiac pacemakers, cochlear implants, electrical continence aids, electrical nerve stimulators, and tracheostomy speaking valves. Section 1861(s)(9) of the Act provides for the coverage of “leg, arm, back, and neck braces, and artificial legs, arms, and eyes, including replacement of required because of a change in the patient's physical condition.” As indicated by section 1834(h)(4)(C) of the Act, these items are often referred to as “orthotics and prosthetics.” Under section 1834(h)(4)(B), prosthetic devices do not include parenteral and enteral nutrition nutrients and implantable items payable under section 1833(t) of the Act.” Section 1861(s)(5) of the Act includes “surgical dressings, splints, casts, and other devices used for reduction of fractures and dislocation” as one of the “medical and other health services” that is covered by Medicare. Other items that may be furnished by suppliers would include (among others): • Prescription drugs used in immunosuppressive therapy furnished to an individual who receives an organ transplant for which payment is made under this title, and that are furnished within a certain time period after the date of the transplant procedure as noted at section 1861(s)(2)(j) of the Act. • Extra-depth shoes with inserts or custom molded shoes with inserts for an individual with diabetes as listed at section 1861(s)(12) of the Act. • Home dialysis supplies and equipment, self-care home dialysis support services, and institutional dialysis services and supplies included at section 1861(s)(2)(F) of the Act. • Oral drugs prescribed for use as an anticancer therapeutic agent as specified in section 1861(s)(2)(Q) of the Act. • Self-administered erythropoietin as described in section 1861(s)(2)(O) of the Act. The National Supplier Clearinghouse
(NSC)is the Center for Medicare & Medicaid Services'
(CMS)designated national enrollment contractor for DMEPOS suppliers. The primary functions of the NSC are to:
(1)Ensure that only qualified suppliers of DMEPOS are enrolled or remain enrolled in the Medicare program, and
(2)take the necessary actions to revoke enrolled suppliers who no longer meet supplier standards. A. Statutory Authority Various sections of the Act and the regulations require providers and suppliers to furnish information concerning the amounts due and the identification of individuals or entities that furnish medical services to beneficiaries before payment can be made. The following is an overview of the sections that grant this authority. • Sections 1102 and 1871 of the Act provide general authority for the Secretary of Health and Human Services (the Secretary) to prescribe regulations for the efficient administration of the Medicare program. Under this authority, this proposed rule will require the collection of information from providers and suppliers for the purpose of enrolling in the Medicare program and granting privileges to bill the program for health care services furnished to Medicare beneficiaries. • Sections 1814(a), 1815(a), and 1833(e) of the Act require the submission of information necessary to determine the amounts due a provider or other person. • Section 1834(j)(1)(A) of the Act states that no payment may be made for items furnished by a supplier of medical equipment and supplies unless such supplier obtains (and renews at such intervals as the Secretary may require) a supplier number. In order to obtain a supplier billing number, a supplier must comply with certain supplier standards as identified by the Secretary. • Section 1842(r) of the Act requires CMS to establish a system for furnishing a unique identifier for each physician who furnishes services for which payment may be made. To complete this, we need to collect information unique to that physician. • Section 1862(e)(1) of the Act states that no payment may be made when an item or service was at the medical direction of an individual or entity that is excluded in accordance with sections 1128, 1128A, 1156, or 1842(j)(2) of the Act. • Section 4313 of the Balanced Budget Act of 1997
(BBA)(Pub. L. 105-33) amended sections 1124(a)(1) and 1124A of the Act to require disclosure of both the Employer Identification Number
(EIN)and Social Security Number
(SSN)of each provider or supplier, each person with ownership or control interest in the provider or supplier, any subcontractor in which the provider or supplier directly or indirectly has a 5 percent or more ownership interest, and any managing employees including Directors and Board Members of corporations and non-profit organizations and charities. The “Report to Congress on Steps Taken to Assure Confidentiality of Social Security Account Numbers as Required by the Balanced Budget Act” was signed by the Secretary and sent to the Congress on January 26, 1999. This report outlines the provisions of a mandatory collection of SSNs and EINs effective on or after April 26, 1999. • Section 31001(i)(1) of the Debt Collection Improvement Act of 1996
(DCIA)(Pub. L. 104-134) amended section 7701 of 31 U.S.C. by adding paragraph
(c)to require that any person or entity doing business with the Federal Government must provide their Tax Identification Number (TIN). • Section 936(j)(1)(A) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)(Pub. L. 108-173) amended the Act to require the Secretary to establish a process for the enrollment of providers of services and suppliers. We are authorized to collect information on the Medicare enrollment application (that is, the CMS-855, (Office of Management and Budget
(OMB)approval number 0938-0685)) to ensure that correct payments are made to providers and suppliers under the Medicare program as established by Title XVIII of the Act. B. Historical Enrollment Initiatives For many years, concern about easy entry into the Medicare program by unqualified or even fraudulent providers or suppliers has led us to increase our efforts to establish more stringent controls on provider and supplier entry into the Medicare program. The following is a summary of the regulations that we have published to ensure that only qualified providers and suppliers are participating in the Medicare program. In the October 11, 2000 **Federal Register** , we published the Additional Supplier Standards final rule with comment period where we listed the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. In this rule, we established additional standards that a DMEPOS supplier must comply with in order to receive and maintain a Medicare billing number. This final rule with comment period outlined the supplier requirements to ensure that suppliers of DMEPOS are qualified to furnish DMEPOS items and to help safeguard the Medicare program and its beneficiaries from fraudulent or abusive billing practices. In the April 21, 2006 **Federal Register** , we published the Requirements for Providers and Suppliers to Establish and Maintain Medicare Enrollment final rule. This final rule implemented section 1866(j)(1)(A) of the Act. In this final rule, we required that all providers and suppliers (other than physicians or practitioners who have elected to “opt-out” of the Medicare program) must complete an enrollment form and submit specific information to CMS in order to obtain Medicare billing privileges. This final rule also required that all providers and suppliers must periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. These statutory provisions include requirements meant to protect beneficiaries and the Medicare Trust Funds by trying to prevent unqualified, fraudulent or excluded providers and suppliers from providing items or services to Medicare beneficiaries or billing the Medicare program or its beneficiaries. In the April 10, 2007 **Federal Register** (72 FR 17992), we published Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) final rule implemented section 302 of the MMA and established DME competitive bidding. In addition, it created incentives for suppliers to provide quality items and services while at the same time providing Medicare with reasonable prices for payment. This final rule also incorporated provisions from section 5101 of the Deficit Reduction Act of 2005, which concerns beneficiary ownership of certain DMEs. II. Provisions of the Proposed Rule To ensure that DMEPOS suppliers understand how CMS interprets the DMEPOS supplier standards, we are revising certain supplier standards specified in § 424.57(c). We are also proposing several new DMEPOS supplier standards. We believe that these revisions and additions would help to ensure that legitimate DMEPOS suppliers are furnishing items of DMEPOS to Medicare beneficiaries. A. Proposed Clarifications and Revisions of Existing DMEPOS Supplier Standards The supplier standard at § 424.57(c)(1) states, “Operates its business and furnishes Medicare-covered items in compliance with all applicable Federal and State licensure and regulatory requirements.” The purpose of this standard is to ensure that DMEPOS suppliers obtain and maintain the necessary State licenses required to furnish the services provided to Medicare beneficiaries. In addition, we believe that each DMEPOS supplier is responsible for determining what licenses are required to operate a DMEPOS supplier's business. While the NSC maintains information regarding State licensure laws, we do not believe that the NSC is responsible for notifying any supplier of what licenses are required or that any changes have occurred in the State licensing requirements. Further, we do not believe that there are any exceptions to State licensing requirements, unless the State in which the DMEPOS supplier furnishes services provides for such an exception. If a State requires a specific license to furnish certain services, we believe that a DMEPOS supplier cannot contract with an individual or other entity to provide these licensed services, but rather, the DMEPOS supplier could hire the individual as a W-2 employee. The owner of the supplier, or full-time W-2 employee, must obtain and maintain this licensing requirement. We are proposing to revise this supplier standard by adding language to clarify that a DMEPOS supplier must be licensed to provide licensed service(s) and cannot contract with an individual or entity to provide the licensed service(s). We believe that we are enrolling DMEPOS suppliers, not third party agents that subcontract their operations to suppliers that are not enrolled or cannot enroll in the Medicare program. Therefore, to ensure that only qualified suppliers are enrolled or maintain enrollment in the Medicare program, we maintain that a DMEPOS supplier must be licensed to provide licensed service(s) and cannot contract with an individual or entity to provide the licensed service(s). In general, to ensure compliance, the NSC verifies that DMEPOS suppliers meet the supplier standards in § 424.57, comply with State business and product licensing requirements, and meet applicable local zoning requirements. The supplier standard at § 424.57(c)(7) specifies that the DMEPOS supplier maintains a physical facility on an appropriate site and that the physical facility must contain space for storing business records including the supplier's delivery, maintenance, and beneficiary communication records. We are proposing to revise this standard to require that DMEPOS suppliers maintain business records for 7 years after the claim has been paid and to clarify the term, “appropriate site.” An appropriate site includes, but is not limited to, the following features: • The supplier location must be accessible during posted business hours to beneficiaries and to CMS, and must maintain a visible sign and posted hours of operation. We believe that all DMEPOS suppliers must have a permanent, durable sign that is visible at the main entrance of the facility and positioned so that it is visible to the public, including customers using wheelchairs. • The supplier location must be accessible during posted hours of operation to beneficiaries and to CMS, and must maintain a permanent visible sign in plain view and posted hours of operation. We believe that DMEPOS suppliers must have its hours of operation posted and in plain view and that suppliers submit changes to their posted hours of operation in advance of any change by notifying the NSC via the Medicare enrollment application. If the supplier's place of business is located within a building complex, the sign must be visible at the main entrance of the building where the place of business is located. • The supplier's place of business must be staffed during the supplier's posted hours of operation. The supplier's place of business must be accessible to the public, CMS, the NSC and any of its agents during the supplier's posted hours of operation regardless of whether beneficiaries routinely visit the facility. • The supplier's place of business may be a “closed door” business, such as pharmacies or suppliers providing services only to beneficiaries residing in a nursing home, that complies with all applicable Federal, State, and local laws and regulations. A supplier is not in compliance with this standard if no one is available during the posted hours of operation. In addition, we believe that an “appropriate site” applies to “closed door” businesses, (such as pharmacies/suppliers providing services only to beneficiaries residing in a nursing home) and are responsible for being in compliance with all applicable Federal, State, and local laws and regulations. We believe that “closed door” businesses must comply with all the requirements of § 424.57(c)(7), and all DMEPOS supplier standards. Additionally, the facility has to be accessible to beneficiaries, CMS or its agents regardless of whether beneficiaries routinely visit the facility. We are soliciting comments on whether we should establish a minimum square footage requirement to the definition of an appropriate site and what, if any, appropriate exceptions would apply to a minimum square footage requirement. The supplier standard at § 424.57(c)(8) states, “Permits CMS, or its agents to conduct on-site inspections to ascertain supplier compliance with the requirements of this section. The supplier location must be accessible during posted business hours to beneficiaries and to CMS, and must maintain a visible sign and posted hours of operation.” We are proposing to revise (c)(8) to limit the provision to on-site inspection. The proposed revision would read as follows: “Permits CMS, the NSC, or agents of CMS or the NSC to conduct on-site inspections to ascertain supplier compliance with the requirements of this section.” If the NSC or its agents are unable to perform a site visit during a supplier's posted business hours, the NSC would deny billing privileges for prospective applicants or would revoke the billing privileges of DMEPOS suppliers enrolled in the Medicare program. The supplier standard at § 424.57(c)(9) states, “Maintains a primary business telephone listed under the name of the business locally or toll-free for beneficiaries. The exclusive use of a beeper number, answering service, pager, facsimile machine, car phone, or an answering machine can not be used as the primary business telephone for purposes of this regulation.” We are proposing to revise this supplier standard to exclude the use of cell phones and beepers/pagers as a method of receiving calls or using “call forwarding” to forward a call to a cell phone or beeper/pager from the public or beneficiaries during the supplier's posted hours of operation. Therefore, we are proposing to revise this standard to read, “Maintains a primary business telephone that is operating at the appropriate site listed under the name of the business locally or toll-free for beneficiaries. The use of cellular phones, beeper numbers, and pagers is prohibited. Additionally, DMEPOS suppliers are prohibited from forwarding calls from the primary business telephone listed under the name of the business to a cellular phone, or a beeper/pager. The exclusive use of answering machines, answering services or facsimile machine (or combination of these options) cannot be used as the primary business telephone during posted operating hours.” We maintain that DMEPOS suppliers who are utilizing cell phones, call forwarding, beeper numbers, pagers, answering services or other methods to receive telephone calls in a location other than the place of business for business calls during their posted hours of operations are not in compliance with this standard and that DMEPOS suppliers who exclusively use answering machines or answering services during their posted hours of operations are not in compliance with this standard. The supplier standard at § 424.57(c)(10) states, “has a comprehensive liability insurance policy in the amount of at least $300,000 that covers both the supplier's place of business and all customers and employees of the supplier. In the case of a supplier that manufactures its own items, this insurance must also cover product liability and completed operations. Failure to maintain required insurance at all times will result in revocation of the supplier's billing privileges retroactive to the date the insurance lapsed.” We are proposing to revise this provision to specify that the DMEPOS supplier has a comprehensive liability insurance policy in the amount of at least $300,000 per incident that covers both the supplier's place of business and all customers and employees of the supplier and ensures that insurance policy must remain in force at all times. The DMEPOS supplier must list the NSC as a certificate holder on the policy and notify the NSC in writing within 30 days of any policy changes or cancellations. In the case of a supplier that manufactures its own items, this insurance must also cover product liability and completed operations. Failure to maintain required insurance at all times will result in revocation of the supplier's billing privileges retroactive to the date the insurance lapsed. DMEPOS suppliers are responsible for providing the contact information of an individual employed with the underwriter.” While the NSC routinely verifies comprehensive insurance coverage with an insurance agent, it may be necessary to contact the underwriter to verify the policy's coverage. Specifically, the NSC may need to verify insurance coverage with an underwriter when:
(1)Self-insurance is used; or
(2)when the NSC believes that the insurance agent is misrepresenting the terms and conditions of coverage. This would not preclude the use of self-insurance to demonstrate compliance with the comprehensive liability insurance policy as long as CMS or the NSC can verify the policy and its coverage provisions with an independent underwriter. Therefore we are also proposing that to add a provision stating that self-insurance may be used to demonstrate compliance with the comprehensive liability insurance policy as long as CMS or the NSC can verify the policy and its coverage provisions with an independent underwriter. DMEPOS suppliers are responsible for providing the contact information of an individual employed with the underwriter, who can verify coverage. To ensure that coverage is actually issued and the policy is in effect, we believe that the NSC should be able to verify policy coverage with an insurance agent, or when necessary, the underwriter, since this is the company affording coverage. This proposed revision would not preclude the use of self-insurance to demonstrate compliance with the comprehensive liability insurance policy as long as CMS or its designated contractor can verify the policy and its coverage provisions with an independent underwriter. Moreover, we propose that a DMEPOS supplier obtain the appropriate liability coverage prior to submitting its Medicare enrollment application and supporting documentation to the NSC. (When a policy is issued, up to 90 days may pass before the underwriter receives notification that the policy has been issued by the insurance agent or broker.) In addition, we believe if the NSC is unable to verify the issuance and validity of liability insurance with an insurance agent, or when necessary, an underwriter at the time of filing, then the NSC should deny Medicare billing privileges without further action, including an onsite review. Accordingly, the NSC must be able to verify the issuance and validity of a DMEPOS liability insurance policy on the day a prospective DMEPOS supplier submits a Medicare enrollment application to the NSC for review. If the NSC is unable to verify the issuance and validity of a liability insurance policy with an insurance agent, or when necessary, the underwriter for a DMEPOS supplier enrolled in the Medicare program, then the NSC may revoke the billing privileges of that supplier. In addition, we believe that it is the responsibility of the DMEPOS supplier to list the NSC as a certificate holder on the policy. By listing the NSC as a certificate holder on the policy, the NSC would be able to verify coverage with the underwriter. A DMEPOS supplier who fails to list the NSC as a certificate holder on the policy may have their enrollment application denied or billing privileges revoked because the NSC may not be able to verify the issuance and validity of the policy. Finally, we believe that it is the DMEPOS supplier's responsibility to:
(1)Ensure that insurance policy must remain in force at all times and provide coverage of at least $300,000 per incident; and
(2)notify the NSC in writing within 30 days of any policy changes or cancellations. The supplier standard at § 424.57(c)(11) states, “Must agree not to contact a beneficiary by telephone when supplying a Medicare-covered item unless one of the following applies:
(i)The individual has given written permission to the supplier to contact them by telephone concerning the furnishing of a Medicare-covered item that is to be rented or purchased;
(ii)the supplier has furnished a Medicare-covered item to the individual and the supplier is contacting the individual to coordinate the delivery of the item; and
(iii)if the contact concerns the furnishing of a Medicare-covered item other than a covered item already furnished to the individual, the supplier has furnished at least one covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact.” We are proposing to revise this supplier standard to clarify that suppliers can not directly solicit patients, which includes, but is not limited to, a prohibition on telephone, computer e-mail or instant messaging, coercive response internet advertising on sites unrelated to DMEPOS products, or in-person contacts. The DMEPOS supplier may only contact the Medicare beneficiary under the current provisions at § 424.57(c)(11)(i) through (iii). We believe that if CMS or the NSC through on-site inspection obtains or develops evidence that a DMEPOS supplier has made prohibited contacts with Medicare beneficiaries in violation of the provisions found in this section that CMS or the NSC may revoke that supplier's billing privileges, and may determine if such billing may be for fraudulent or unnecessary supplies. The supplier standard at § 424.57(c)(12) currently states that the supplier must be responsible for the delivery of Medicare-covered items to beneficiaries and maintain proof of delivery. The supplier must document that it or another qualified party has, at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively. We are proposing to revise paragraph (c)(12) provision to clarify its intent. A DMEPOS supplier— • Is responsible for maintaining proof of the delivery in the beneficiary's file; • The supplier must furnish information to beneficiaries at the time of delivery of items as to how the beneficiary can contact the supplier by telephone; • Must provide the beneficiary with instructions on how to safely and effectively use the equipment or contract this service to a qualified individual; • Is responsible for providing instruction on the safe and effective use of the equipment that should be completed at the time of delivery; and • Must document that this instruction has taken place. We believe that a DMEPOS supplier is solely responsible for delivery of Medicare-covered items and for instruction on the use of those items. While we believe that a DMEPOS supplier may choose to contract out the delivery of Medicare-covered items to another individual or entity, the DMEPOS supplier has ultimate responsibility for ensuring delivery in accordance with this standard and for maintaining all necessary documentation to demonstrate that the beneficiary received the Medicare-covered item and appropriate instructions for its use. We believe that our revised interpretation of this section will help to ensure that instructions for the safe and appropriate use of products will be given to beneficiaries. B. Proposed New DMEPOS Supplier Standards At § 424.57(c)(27), we are proposing a new standard that specifies that the DMEPOS supplier must obtain oxygen from a State-licensed oxygen supplier. To ensure that DMEPOS suppliers meet and maintain this standard, we believe that DMEPOS suppliers who are supplying oxygen must contract with a supplier licensed by the State to provide them with oxygen. Obviously, this standard does not apply when the State does not license oxygen suppliers. We understand that in certain areas, DMEPOS suppliers may obtain oxygen from oxygen suppliers in other States. However, when a DMEPOS supplier is located in a State where licensure is required, then they must obtain their oxygen from a state-licensed oxygen supplier, regardless of which State the oxygen supplier obtained their licensure. For example in State A, a license is required when supplying oxygen. If a DMEPOS supplier located in State A is supplying oxygen, they must get their oxygen from a state-licensed oxygen supplier. To extend this example, in State B, where no license is required for an oxygen supplier, a DMEPOS supplier may obtain their oxygen from a non-licensed supplier within State B, or a licensed supplier (in a State where you must have a State license to supply oxygen), or from a non-State-licensed supplier outside of State B (where there is no State license required for supplying oxygen). We believe that this standard would help to protect Medicare beneficiaries and promote quality in the furnishing of oxygen. At § 424.57(c)(28), we are proposing a new supplier standard that states that the supplier is required to maintain ordering and referring documentation, including the National Provider Identifier, received from a physician, nurse practitioner, physician assistant, clinical social worker, or certified nurse midwife, for 7 years after the claim has been paid. Since all DMEPOS supplies are ordered and referred by physicians, nurse practitioners, physician assistants, clinical social workers, or certified nurse midwives, we believe that it is essential that DMEPOS suppliers maintain documentation regarding the specific individual who ordered or referred a Medicare beneficiary for DMEPOS. In addition, we are codifying the requirement to maintain ordering and referring documentation for 7 years as required in Publication 100-08, Chapter 5, Section 8. We maintain that a DMEPOS supplier should retain the necessary ordering and referring documentation received from physicians, nurse practitioners, physician assistants, clinical social workers, or certified nurse midwives to assure themselves that coverage criterion for an item has been met. If the information in the patient's medical record does not adequately support the medical necessity for the item, the supplier is liable for the dollar amount involved unless a properly executed Advance Beneficiary Notice of possible denial has been obtained. At § 424.57(c)(29), we are proposing a new standard that specifies that the supplier is prohibited from sharing a practice location with another Medicare supplier. DMEPOS suppliers may not share a practice location with any other Medicare supplier, including a physician/physician group or another DMEPOS supplier. We believe that allowing DMEPOS suppliers to commingle practice locations, operations, staff, inventory and other aspects of supplier's operations constitutes a significant risk to the Medicare program. Moreover, to allow a DMEPOS supplier to commingle its practice location with another DMEPOS supplier effectively limits the ability of CMS and the NSC to ensure that each DMEPOS supplier meets all of the supplier standards specified at § 424.57. Finally, we do not believe that legitimate DMEPOS suppliers routinely share practice locations with another Medicare supplier. Since we are aware that physicians and other licensed nonphysician practitioners may obtain their own DMEPOS supplier number and furnish DMEPOS from their office, we are soliciting comments on whether we should establish an exception to this space sharing proposal for physicians and nonphysician practitioners and the circumstances which warrant an exception. At § 424.57(c)(30), we are proposing a new supplier standard that specifies, “Is open to the public a minimum of 30 hours per week, except for those DMEPOS suppliers who are working with custom-made or fitted orthotics and prosthetics.” We are proposing this new standard because the NSC has found that a number of existing DMEPOS suppliers have posted restrictive or limited business hours, and in some cases, have posted business hours that are so restrictive that it makes it nearly impossible for a NSC to conduct on onsite visit or for a beneficiary or the public to obtain DMEPOS services. Since we question the legitimacy of any DMEPOS supplier with posted operating hours of less than 4 hours a day, we are proposing to establish a minimum number of operational hours for DMEPOS suppliers. Moreover, we believe that most legitimate DMEPOS suppliers are open to the public at least 30 hours per week. We believe that most legitimate DMEPOS suppliers are open to the public for more than 40 hours per week and that all legitimate DMEPOS would need to be open a minimum of at least 30 hours per week (either 6 hours a day, 5 days a week or 5 hours a day, 6 days a week) in order to attract, retain and serve Medicare beneficiaries. We believe that a minimum number of operating hours will help to ensure that DMEPOS suppliers are open to the public and are able to serve the needs of Medicare beneficiaries. Given that Medicare beneficiaries may not be able to find transportation during limited operating hours, the DMEPOS supplier must be open and available for periods long enough for beneficiaries to readily access their facility. To ensure that DMEPOS suppliers are able to report any change in their posted business hours, we are proposing to revise the CMS-855S Medicare enrollment application to accommodate this proposed change. At § 424.57(c)(31), we propose adding a new supplier standard that specifies, “Does not have an Internal Revenue Service
(IRS)or a State taxing authority tax delinquency.” Currently, we do not consider whether a DMEPOS supplier that is seeking enrollment or one that is currently enrolled in the Medicare program has an IRS or a State taxing authority tax delinquency. To ensure that Medicare payments are only being made to organizations and individuals who have satisfied existing tax debts, we will have a basis to revoke the billing privileges of a DMEPOS supplier, including physicians and nonphysician practitioners who are also enrolled as a DMEPOS supplier, that has failed to comply with this standard. The Government Accountability Office
(GAO)found that over 21,000 of the physicians, health professionals, and suppliers paid under Medicare Part B during the first 9 months of calendar year 2005 had tax debts totaling over $1 billion. The GAO report titled, “Medicare, Thousands of Medicare Part B Providers Abuse the Federal Tax System (GAO-07-587T)” found abusive and potentially criminal activity, including failure to remit to IRS individual income taxes or payroll taxes or both withheld from their employees. Moreover, we are proposing to revise the Medicare enrollment application (that is, CMS-855S) to require that DMEPOS suppliers:
(1)Certify that the supplier does not have an IRS or a State taxing authority tax delinquency; and
(2)consent to having CMS or its designated contractor verify that the information submitted by a DMEPOS supplier regarding a tax delinquency is correct and accurate as determined by the IRS or State taxing authority. We believe that this change will allow CMS and its designated contractors to verify that the information submitted by a DMEPOS supplier is accurate. We would propose to define a “tax delinquency” as meaning an amount of money owed to the United States or a State: A conviction or civil judgment for tax evasion, a criminal or civil charge of tax evasion, or the filing of a tax lien. In § 424.57(d), we would redesignate the current text as paragraph (d)(1). We would add a new paragraph (d)(2) specifying that “CMS, the NSC, or CMS designated contractor establishes a Medicare overpayment from the date of an adverse legal action or felony conviction (including felony convictions within the 10 years preceding enrollment or revalidation of enrollment) that precludes payment.” In addition, we are proposing that any overpayment assessed by CMS or its designated contractor due to a lack of reporting would follow the existing rules governing Medicare overpayments set forth at § 405.350 et seq. We believe that proposed § 424.57(d)(2) is necessary because some DMEPOS suppliers fail to report adverse legal actions and felony convictions to the NSC within the 30 days of the reportable event. Since it is essential that DMEPOS suppliers notify the NSC of all adverse legal actions and felony convictions within 30 days of the reportable event, we believe that it is essential to establish this new provision. This new provision would allow the CMS, the NSC, or a designated Medicare contractor the authority to assess and collect an overpayment from the time of the reportable event. In addition, the CMS, the NSC, or a designated CMS contractor would revoke the DMEPOS supplier's Medicare billing privileges, in accordance with § 424.57(d)(1), if the adverse legal action or felony conviction precludes participation in or payment from the Medicare program. III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 60-day notice in the **Federal Register** and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget
(OMB)for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comments on the following issues: • Whether the information collection is necessary and useful to carry out the proper functions of the agency; • The accuracy of the agency's estimate of the information collection burden; • The quality, utility, and clarity of the information to be collected; and • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of the following issues pertaining to the information collection requirements contained in this proposed rule. Section II.A. of this proposed rule provides proposed clarifications and revisions of the existing DMEPOS supplier standards. The following is a discussion of the information collection requirements contained in the § 424.57(c) that are clarified and revised by this proposed rule. Section II.A. of this proposed rule provides proposed clarifications of the information collection requirements contained in § 424.57(c)(1). The standard at § 424.57(c)(1) states that a supplier must operate its own business and furnish Medicare-covered items in compliance with all applicable Federal and State licensure and regulatory requirements. As stated in section II.A. of this proposed rule, the purpose of this standard is to ensure that DMEPOS suppliers obtain and maintain the necessary State licenses required to furnish services provided to Medicare beneficiaries. While there is burden associated with complying with this standard, we believe it is exempt from the PRA as stated in 5 CFR 1320.3(b)(3). A collection of information conducted or sponsored by a Federal agency that is also conducted or sponsored by a unit of State, local, or tribal government is presumed to impose a Federal burden except to the extent that the agency shows that such State, local, or tribal requirement would be imposed even in the absence of a Federal requirement. In addition, we believe the burden associated with the maintenance of the required documentation is exempt from the PRA as stated in 5 CFR 1320.3(b)(2), to the extent that the time, effort, and financial resources necessary to comply with collection of information that would be incurred by persons in the normal course of their activities. Maintaining State license documentation is part of usual and customary business practices. In § 424.57(c)(12)(ii) we propose to specify that a supplier must furnish information to beneficiaries at the time of delivery of items on how the beneficiary can contact the supplier by telephone. The burden associated with complying with the standard is the time and effort required for the supplier to provide its contact information to beneficiary at the time of delivery of the Medicare-covered item(s). While the burden is subject to the PRA, we believe it is exempt under 5 CFR 1320.3(b)(2) to the extent that the time, effort, and financial resources necessary to comply with collection of information that would be incurred by persons in the normal course of their activities. In § 424.57(c)(32), we are proposing that each supplier must report changes in hours of operation to the NSC 15 calendar days prior to the proposed change. The burden associated with this requirement is the time and effort associated with notifying the NSC of the change in hours of operation. We estimate that 1,000 suppliers will be subject to this requirement. The estimated time required to report the information to the NSC is 10 minutes. The estimated total annual burden associated with this requirement is 167 hours. Section 424.57(c)(10)(iii) states that with respect to liability insurance, it is the responsibility of the DMEPOS supplier to, “promptly notify the NSC in writing of any policy changes or cancellations.” The burden associated with this requirement is the time and effort associated with drafting and submitting notification to the NSC of any policy changes or cancellations. While this burden is subject to the PRA, we believe it is exempt under 5 CFR 1320.3(h)(6). Facts or opinions collected from a single person or entity are not subject to the PRA. The aforementioned information collection request will be reviewed on a case by case basis, as they submitted individual DMEPOS suppliers. Section 424.57(c)(12) states that a supplier, “Must be responsible for the delivery of Medicare-covered items to beneficiaries and maintain proof of delivery.” In addition, the supplier must, “Document that it or another qualified party has at an appropriate time, provided beneficiaries with information and instructions on how to use the Medicare-covered items safely and effectively.” This standard imposes reporting and recordkeeping requirements. The burden associated with this section is the time and effort required to: Document the delivery of the Medicare-covered item; document the provision of information or instructions to the beneficiary by the supplier itself or another qualified party; maintain the documentation of delivery of the Medicare-covered items and the necessary information and instructions. The burden associated with these requirements is subject to the PRA. However, we believe it is exempt under 5 CFR 1320.3(b)(2) to the extent that the time, effort, and financial resources necessary to comply with collection of information that would be incurred by persons in the normal course of their activities. If you comment on any of these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group Attn.: William Parham, CMS-6036-P Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503. Attn.: Carolyn Lovett, CMS Desk Officer, CMS-6036-P, *carolyn_lovett@omb.eop.gov* . Fax
(202)395-6974. IV. Response to Comments Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V. Regulatory Impact Statement We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act
(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts; and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule. To ensure that Medicare is making correct payments to only legitimate DMEPOS suppliers, we implemented a comprehensive payment and enrollment strategy. This strategy includes developing and implementing the statutorily mandated competitive bidding program, making revisions to the National Supplier Clearinghouse contract, implementing a DMEPOS demonstration project, and publishing a proposed rule that would require DMEPOS suppliers to obtain a surety bond. We began implementation of the statutorily mandated competitive bidding program (72 FR 17992) for DMEPOS suppliers on April 10, 2007. Competitive bidding changes the way that Medicare pays for certain DMEPOS categories under Part B of the Medicare program by using bids submitted by DMEPOS suppliers to establish payment amounts. Beginning in 2007, we initiated and began implementation of the program which initially involves ten product categories in the first Metropolitan Statistical Areas. We have received bids and anticipate contract awards in 2008. In addition, DMEPOS suppliers will be required to submit bids for all items within a product category for which they are bidding. The product categories and bid items may vary by competitive bidding area (CBAs). For 2007, using 2005 data and the item selection criteria in the competitive bidding regulation, we selected the following items for competitive bidding:
(1)Oxygen supplies and equipment;
(2)standard power wheelchairs, scooters, and related accessories;
(3)complex rehabilitative power wheelchairs and related accessories;
(4)mail-order diabetic supplies;
(5)enteral nutrients, equipment, and supplies;
(6)continuous positive airway pressure
(CPAP)devices, respiratory assist devices (RADs), and related accessories;
(7)hospital beds and related accessories;
(8)negative pressure wound therapy
(NPWT)pumps and related accessories;
(9)walkers and related accessories; and
(10)support surfaces (group 2 and 3 mattresses and overlays). The statute requires that competition under the program begin in 10 of the largest Metropolitan Statistical Areas
(MSAs)and then expand to 70 additional MSAs during the second phase of implementation. Additional competitive bidding areas will then be phased in over time. The final rule requires a formula-driven methodology for selecting the 80 MSAs for the first two phases of implementation and it will be sometime after 2008 before DMEPOS suppliers will participate in the competitive bidding initiative in these 80 MSAs and only for the product categories that are included in the first two phases of implementation. It is important to note while competitive bidding will reduce the number of DMEPOS suppliers eligible for payment of selected product categories, competitive bidding will not totally prevent unscrupulous DMEPOS suppliers from gaining entry into the program and fraudulently billing for any of those products. Accordingly, it is essential that we further develop and implement administrative and regulatory changes which prevent unscrupulous DMEPOS suppliers from enrolling or maintaining their enrollment in the Medicare program. To this end, we have implemented the following administrative changes and are seeking comments on mandated DMEPOS surety bonding requirements. As part of our administrative change, we revised the contract with the National Supplier Clearinghouse
(NSC)in FY 2008 and are currently recompeting this contract through full and open competition. The revised contract requires that the NSC conduct and increase the number of site visits to ensure that DMEPOS suppliers are in compliance with the provisions found at § 424.57. We are also expanding the funding for NSC operations to support the increased number of sites visits. These expanded measures will help to ensure that only legitimate DMEPOS suppliers are enrolled or maintain enrollment in the Medicare program. In addition, we announced plans on June 28, 2007, to implement a 2-year demonstration involving DMEPOS suppliers. The goal of this initiative is to strengthen our ability to detect and prevent fraudulent activity and will focus specifically on DMEPOS suppliers in South Florida and the Los Angeles metropolitan area. Based on the findings of this initiative, we will determine if the administrative processes and procedures used in this demonstration should be expanded to other parts of the country. On August 1, 2007, we published a proposed rule (72 FR 42001) which would implement Section 4312(a) of the Balanced Budget Act of 1997
(BBA)by requiring all Medicare DMEPOS suppliers to furnish CMS with a surety bond. The public comment period for this proposed rule closed on October 1, 2007, and CMS is currently reviewing these comments. Accordingly, while the activities described above will promote compliance with the existing supplier standards and reduce payments for suppliers selected under competitive bidding, these activities do not supply CMS and the NSC with the needed authority to deny or revoke billing privileges to those DMEPOS suppliers that pose a significant risk to the program. Therefore, we believe that the provisions of this proposed rule are essential in expanding upon and strengthening the supplier standards in order to ensure that only legitimate suppliers are enrolled or maintain enrollment in the Medicare program. The RFA requires agencies to analyze options for regulatory relief for small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 to $31.5 million in any one year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we because we are certifying that this rule will not have a significant economic impact on a substantial number of small entities. We have determined that the RFA is reasonable given that the provisions contained in this proposed rule are primarily procedural and do not require DMEPOS suppliers to incur additional operating costs. We also believe that the regulatory impact of this proposed rule is negligible and not calculable. We maintain that this proposed rule would not have an adverse impact on a significant number of small entities because we believe that these suppliers are operating on standard business practices and therefore are already in compliance with these proposed standards. Since we believe that a significant number of small entities currently meet each of the revised or new proposed standard, we do not have information available to calculate the economic impact of any individual or combination of proposals would have on small entities. This proposed rule would merely clarify, expand, and update our current policy found in the DMEPOS supplier standards currently covered under § 424.57. Therefore, we anticipate a minimal economic impact, if any, on small entities. We are soliciting public comment regarding any specific impacts that these proposed provisions will have on suppliers. To encourage such comments we are providing the public with the relevant data that we possess on DMEPOS suppliers. The following table examines the allowed charges to the unique billing numbers (a DMEPOS supplier may have multiple locations, for example, a chain organization, but use only one unique billing number), the vast majority of DMEPOS suppliers are small entities (based on Medicare reimbursement alone). Table 1.—Total Number of Suppliers Arranged by Allowed Charges for Dates of Service [January through December 2005 based on Unique Billing Numbers] Allowed charge Number of suppliers reimbursed for DME Number of DMEPOS suppliers reimbursed for non-DME only $0 2,016 4,655 $0.01-$999 2,544 6,624 $1,000-$2,499 2,099 4,993 $2,500-$4,999 2,285 4,459 $5,000-$9,999 2,964 4,153 $10,000-$24,999 4,568 4,328 $25,000-$49,999 3,378 2,100 $50,000-$99,999 2,780 1,245 $100,000-$499,999 5,955 1,191 $500,000-$999,999 1,762 220 $1,000,000-$4,999,999 1,345 105 $5,000,000 or more 208 7 Total 31,904 34,080 In reviewing the table above, the term, durable medical equipment
(DME)is defined at section 1861(n) of the Act. This definition, in part, excludes from coverage as DME, items furnished in skilled nursing facilities and hospitals (equipment furnished in those facilities is paid for as part of their routine or ancillary costs). Also, the term DME is included in the definition of “medical and other health services” at section 1861(s)(6) of the Act. Furthermore, the term is defined in § 414.202 as equipment furnished by a supplier or a HHA that— • Can withstand repeated use; • Is primarily and customarily used to serve a medical purpose; • Generally is not useful to an individual in the absence of an illness or injury; and • Is appropriate for use in the home. Examples of DMEPOS supplies include items such as blood glucose monitors, hospital beds, nebulizers, oxygen delivery systems, and wheelchairs. Conversely, suppliers of non-DME only refers to items or services furnished by prosthetics, orthotist, and supplies found in section 1861(s)(5) of the Act. As of April 2007, there were 116,471 individual DMEPOS suppliers. However, due to the affiliation of some DMEPOS suppliers with chains, there were only approximately 65,984 unique billing numbers (31,904 + 34,080). We believe that approximately 30 percent of the 116,000 DMEPOS suppliers are located in rural areas. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals. We understand that a large number of DMEPOS suppliers fall into this category, however these proposed provisions are procedural in nature and we expect that legitimate DMEPOS suppliers are already meeting these provisions. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $120 million. That threshold is currently approximately $127 million. This rule does not mandate expenditures by State, local, or tribal governments, in the aggregate, or by the private sector of $127 million and therefore no analysis is required. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. We anticipate that this rule would codify certain procedural policies contained in the Program Integrity Manual
(PIM)that DMEPOS suppliers already are supposed to adhere to, and that legitimate DMEPOS suppliers should already be meeting. By establishing the standards in this rule, we are establishing our authority to deny or revoke the Medicare billing privileges of DMEPOS suppliers that have failed to comply with one or more of these supplier standards. We have considered alternatives to all of the proposed provisions, however only one of the provisions considered lends itself to other options. Initially, we considered establishing a 40-hour requirement for a DMEPOS supplier's hours of operation since most businesses are open to the public for a minimum of 40 hours each week. To reduce the burden associated with this provision, but also establish a minimum requirement for the hours of operation, we relaxed the initial 40-hour requirement to 30 hours per week because we believe that this is the minimum amount of time that a DMEPOS supplier is required to be open and legitimately operate as a business. We did not consider the alternative of not proceeding with the proposed provisions because we believe that they are necessary to ensure that only legitimate DMEPOS suppliers are enrolling and maintaining enrollment in the Medicare program. As a result of not having quantifiable data, we cannot effectively derive an estimate for the monetary impacts of these provisions. Accordingly, we are seeking public comment so that the public may provide any data available that provides a calculable impact or any alternative to the proposed provisions. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in 42 CFR Part 424 Emergency medical services, Health facilities, Health professionals, Medicare, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services would amend 42 CFR chapter IV as set forth below: PART 424—CONDITIONS FOR MEDICARE PAYMENT 1. The authority citation for part 424 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart D—To Whom Payment is Ordinarily Made 2. Section 424.57 is amended by— A. Adding in paragraph
(a)the definition of “tax delinquency” in alphabetical order. B. Revising paragraph
(c)introductory text and (c)(1). C. Revising paragraphs (c)(7) through (c)(12) and (c)(15). D. Adding new paragraphs (c)(26) through (c)(31). E. Revising paragraph (d). The additions and revisions read as follows: § 424.57 Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges. *Tax delinquency* means an amount of money owed to the United States taxing authority from any individual, entity organization, association, partnership or corporation and it can be evidenced through the following measures brought by either the United States or a State: a conviction or civil judgment for tax evasion, a criminal or civil charge of tax evasion, or the filing of a tax lien.
(c)*Application certification standards.* The supplier must meet and must certify in its application for billing privileges that it meets and will continue to meet the following standards:
(1)Operates its business and furnishes Medicare-covered items in compliance with the following applicable laws:
(i)Federal regulatory requirements that specify requirements for the provision of DMEPOS and ensure accessibility for the disabled.
(ii)State licensure and regulatory requirements. If a State requires licensure to furnish certain items or services, a DMEPOS supplier must be licensed to provide the item or service and cannot contract with an individual or other entity to provide the licensed services.
(iii)Local zoning requirements.
(7)Maintains a physical facility on an appropriate site that contains space for storing business records (including the supplier's delivery, maintenance, and beneficiary communication records) and retain the necessary ordering and referring documentation received from physicians, nurse practitioners, physician assistants, clinical social workers, or certified nurse midwives to assure themselves that coverage criterion for an item has been met, to facilitate an on site inspection by CMS or the NSC of the supplier's business records or ordering and referring documentation. An appropriate site includes, but is not limited to, the following:
(i)Is in a location that is accessible to the public, Medicare beneficiaries, CMS, NSC, and its agents. (The location must not be in a gated community or other area where access is restricted.)
(ii)Is accessible and staffed during posted hours of operation.
(iii)Maintains a permanent visible sign in plain view and posts hours of operation. If the supplier's place of business is located within a building complex, the sign must be visible at the main entrance of the building.
(iv)May be a “closed door” business, such as pharmacies or suppliers providing services only to beneficiaries residing in a nursing home, that complies with all applicable Federal, State, and local laws and regulations. “Closed door” businesses must comply with all the requirements in § 424.57(c)(7).
(8)Permits CMS, the NSC, or agents of CMS or the NSC to conduct on-site inspections to ascertain supplier compliance with the requirements of this section.
(9)Maintains a primary business telephone that is operating at the appropriate site listed under the name of the business locally or toll-free for beneficiaries. The use of cellular phones, beeper numbers, and pagers is prohibited. Additionally, DMEPOS suppliers are prohibited from forwarding calls from the primary business telephone listed under the name of the business to a cellular phone, or a beeper/pager. The exclusive use of answering machines, answering services or facsimile machine (or combination of these options) cannot be used as the primary business telephone during posted operating hours.
(10)Has a comprehensive liability insurance policy and meets the following insurance-related requirements:
(i)The comprehensive liability insurance is at least $300,000 per incident that covers both the supplier's place of business and all customers and employees of the supplier. If the supplier manufactures its own items, the insurance must also cover product liability and completed operations. Self insurance may be used to demonstrate compliance with the comprehensive liability insurance as long as CMS or the NSC can verify the policy and its coverage provisions with an independent underwriter. Failure to maintain required insurance at all times beginning with the date of filing will result in denial or revocation of the supplier's billing privileges retroactive to the date the insurance lapsed. DMEPOS suppliers are responsible for providing the contact information of an individual employed with the underwriter.
(ii)List the NSC as a certificate holder on the policy.
(iii)Notify the NSC in writing within 30 days of any policy changes or cancellations.
(11)Agree not to directly solicit patients, which includes, but is not limited to, a prohibition on telephone, computer e-mail or instant messaging, coercive response internet advertising on sites unrelated to DMEPOS products, or in-person contacts. The DMEPOS supplier may only contact the Medicare beneficiary when supplying a Medicare-covered item and only when one or more of the following applies:
(i)The individual has given written permission to the supplier to contact them concerning the furnishing of a Medicare-covered item that is to be rented or purchased.
(ii)The supplier has furnished a Medicare-covered item to the individual and the supplier is contacting the individual to coordinate the delivery of the item.
(iii)If the contact concerns the furnishing of a Medicare-covered item other than a covered item already furnished to the individual, the supplier has furnished at least one covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact.
(12)Has met the following delivering and beneficiary instruction requirements:
(i)Maintains proof of the delivery in the beneficiary's file.
(ii)Furnishes information to the beneficiary at the time of delivery of items on how the beneficiary can contact the supplier by telephone.
(iii)Provides the beneficiary with instructions on how to safely and effectively use the equipment or contract this service to a qualified individual.
(iv)Completes and documents beneficiary instruction on the safe and effective use of the equipment at the time of delivery or other appropriate time.
(26)[Reserved]
(27)Must obtain oxygen from a State-licensed oxygen supplier (applicable only to those suppliers in States that require oxygen licensure.)
(28)Is required to maintain ordering and referring documentation, including the National Provider Identifier, received from a physician, nurse practitioner, physician assistant, clinical social worker, or certified nurse midwife, for 7 years after the claim has been paid.
(29)Is prohibited from sharing a practice location with any other Medicare supplier.
(30)Is open to the public a minimum of 30 hours per week, except for those DMEPOS suppliers who are working with custom made or fitted orthotics and prosthetics.
(31)Does not have an Internal Revenue Service
(IRS)or a State taxing authority tax delinquency.
(d)*Failure to meet standards* .
(1)*Revocation* . CMS revokes a supplier's billing privileges if it is found not to meet the standards in paragraphs
(b)and
(c)of this section. The revocation is effective 15 days after the entity is sent notice of the revocation, as specified in § 405.874 of this subchapter.
(2)*Overpayments associated with adverse legal action and felony convictions* . CMS, the NSC or a CMS-designated contractor establishes a Medicare overpayment from the date an adverse legal action or felony conviction (including felony convictions within the 10 years preceding enrollment or revalidation of enrollment) that precludes payment. Authority: (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: May 31, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: August 21, 2007. Michael O. Leavitt, Secretary. Editor's note: This document was received by the Office of the Federal Register on January 22, 2008. [FR Doc. E8-1346 Filed 1-24-08; 8:45 am] BILLING CODE 4120-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 08-27; MB Docket No. 08-3; RM-11407] Radio Broadcasting Services; Wheatland, WY AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY: Appaloosa Broadcasting Company, Inc. (“Petitioner”), the licensee of Station KIMX(FM), Channel 244C2, Laramie, Wyoming, has filed a contingent application to modify the facilities of Station KIMX(FM) from Channel 244C2 to Channel 245A and to change that station's community of license from Laramie, Wyoming, to Nunn, Colorado. This *Notice of Proposed Rule Making* requests comments on a petition for rule making filed by Petitioner proposing the substitution of Channel 286A for vacant Channel 247A at Wheatland, Wyoming. This channel substitution would accommodate Petitioner's contingent modification application. In addition, to accommodate that application, Petitioner requests that FM Channel 246C1 be involuntarily substituted for Channel 245C1 at Station KCMI(FM), Terrytown, Nebraska. *See* SUPPLEMENTARY INFORMATION . DATES: Comments must be filed on or before February 28, 2008, and reply comments on or before March 14, 2008. ADDRESSES: Secretary, Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve counsel for Petitioner as follows: Barry A. Friedman, Esq., Thompson Hine LLP, 1920 N Street, NW., Suite 800, Washington, DC 20036. FOR FURTHER INFORMATION CONTACT: R. Barthen Gorman, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's *Notice of Proposed Rule Making* , MB Docket No. 08-3, adopted January 2, 2008, and released January 7, 2008. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Information Center, 445 Twelfth Street, SW., Washington, DC 20554. This document may also be purchased from the Commission's duplicating contractors, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com* . Channel 247A at Wheatland was allotted in MB Docket No. 05-98. *See* 71 FR 4527, published January 27, 2006. This vacant FM channel was inadvertently removed from the FM Table of Allotments. *See* 71 FR 76208, published December 20, 2006. This rulemaking proceeding is now proposing to remove Channel 247A at Wheatland and add Channel 286A at Wheatland to accommodate the change of community application for Station KIMX from Laramie to Nunn, Colorado. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, *see* 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of l980 do not apply to this proceeding. Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all *ex parte* contacts are prohibited in Commission proceedings, such as this one, which involve channel allotments. *See* 47 CFR 1.1204(b) for rules governing permissible *ex parte* contact. For information regarding proper filing procedures for comments, *see* 47 CFR 1.415 and 1.420. List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Wyoming, is amended by adding Wheatland, Channel 286A. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E8-1331 Filed 1-24-08; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 300, 600 and 697 [Docket No. 070717337-7338-01] RIN 0648-AV78 General Provisions for Domestic Fisheries; Specifications for Boarding Ladders AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Proposed rule, request for comments, reopening of comment period. SUMMARY: NMFS reopens the comment period for proposed regulations to require the operators of certain domestic fishing vessels to provide a U.S. Coast Guard-approved pilot ladder as a safer and more enforceable means for authorized personnel to board. DATES: Comments must be received at the following address by February 25, 2008. ADDRESSES: You may submit comments, identified by “RIN 0648-AV78,” by any one of the following methods: • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal *http://www.regulations.gov.* • Fax: 301-713-1175, Attn: William D. Chappell. • Mail: Alan Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. Please mark the outside of the envelope “Comments on Boarding Ladder Rule.” Instructions: All comments received are a part of the public record and will generally be posted to *http://www.regulations.gov* without change. All personal identifying information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information. NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only. FOR FURTHER INFORMATION CONTACT: William D. Chappell, 301-713-2337. SUPPLEMENTARY INFORMATION: The Magnuson-Stevens Act established U.S. management authority over the fishery resources in the exclusive economic zone (EEZ). NMFS is responsible for implementation of the Magnuson-Stevens Act and the Fishery Management Plans
(FMPs)prepared by eight Regional Fishery Management Councils (Councils) and for the FMP governing Atlantic Highly Migratory Species. While each Council prepares FMPs for those fishery resources within the Council's area of authority that require conservation, NMFS implements certain requirements common to all fisheries, such as facilitation of enforcement. Associated regulations are codified at 50 CFR parts 600 through 697. On December 11, 2007, NMFS published this proposed rule with a comment period ending January 10, 2008. Because the comment period extended through the December holiday period, many affected members of the fishing industry were unaware of the proposed rule until late in the comment period. As a result, NMFS received several requests to extend the comment period. Although the comment period ended before NMFS could publish an extension to this comment period, NMFS now reopens the comment period for an additional 30 days to allow the public adequate time to understand the rule, its effects on their circumstances, and provide their comments. Clarifications Comments received to date identified some misunderstandings and questions that need clarification. The most important misunderstanding is that the proposed rule would require fishing vessels to provide boarding ladders for the first time. Fishing vessel operators have been required to provide authorized officers “a safe ladder” since before 1988, when all facilitation of enforcement regulations were consolidated in one part. The intent of this proposed rule was to specify the type of ladder to meet the requirement, not to change the requirement to provide a ladder. Experience in many boardings has shown that ladders offered by many fishing vessel operators are, in reality, not safe. This negatively affects the ability of an authorized officer to safely board the fishing vessel at sea, resulting in an unacceptable safety hazard. In some instances, authorized officers entered the water as a direct result of ladder failures or inadequacies. Under current regulations, the safety of the ladder can only be determined unsafe after the fact, a situation that is unacceptable from both a safety and enforcement aspect. NMFS proposes to amend the existing regulation to require that a standard and safe ladder be made available. These commonly used ladders are available from many maritime suppliers, and can be constructed to meet the size of the vessel and can be rolled up to use minimal storage space. Another important misconception is that the proposed rule would require all fishing vessels to carry a Coast Guard approved ladder. The current regulations do not require vessels with a freeboard of 4 feet (1.25 m) or less to carry a ladder. The proposed rule will not alter this distinction. Instead, the proposed rule would define the term freeboard for the purposes of the rule as the working distance between the top rail of the gunwale of a vessel to the water's surface. This is somewhat different from the typical usage of the term freeboard, which usually means the difference between the lowest exposed or weather deck and the water. Several commenters asked whether the proposed rule would apply to recreational fishing vessels. The answer is yes, this proposed rule would apply to both recreational and commercial fishing vessels fishing under Federal fishing regulations. NMFS also received comments regarding alternative freeboard heights, purpose built ladders, and exemptions from the provision of a safe ladder based on vessel length, as well as other comments. All comments will be addressed in any final rule published for this rulemaking. Dated: January 18, 2008 Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service [FR Doc. E8-1348 Filed 1-24-08; 8:45 am] BILLING CODE 3510-22-S 73 17 Friday, January 25, 2008 Notices DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2008-0003] National Advisory Committee on Meat and Poultry Inspection AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of public meeting. SUMMARY: The Food Safety and Inspection Service
(FSIS)is announcing, pursuant to the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the National Advisory Committee on Meat and Poultry Inspection (NACMPI) will hold a public meeting on February 5-6, 2008, to review and discuss:
(1)The planned public health-based slaughter inspection system for young chickens and
(2)how a similar approach could be used for inspection in processing and other slaughter establishments. Both issues will be presented to the full Committee. The Committee will then divide into two subcommittees to discuss both issues. Each subcommittee will provide a report of their comments and recommendations to the full committee before the meeting concludes on February 6, 2008. DATES: The Committee will hold a public meeting on Wednesday, February 5, and Thursday, February 6, 2008, from 8:15 a.m. to 5:45 p.m. The subcommittees will hold open meetings during their deliberations and report preparation. ADDRESSES: The meetings will take place at the Key Bridge Marriott, 1401 Lee Highway, Arlington, VA 22209; telephone,
(703)524-6400. The meeting agenda is available on the Internet at the NACMPI Web site, *http://www.fsis.usda.gov/about_fsis/nacmpi/index.asp.* The NACMPI meeting agenda, together with information and resource materials on public health-based inspection, is also available on the Internet at, *http://www.fsis.usda.gov/regulations_&_policies/Public_Health_Based_Inspection/index.asp.* FSIS welcomes comments on the topics discussed at the NACMPI public meeting. Comments may be submitted by any of the following methods: Electronic mail: *NACMPI@fsis.usda.gov.* Mail, including floppy disks or CD-ROMs: Send to National Advisory Committee on Meat and Poultry Inspection, United States Department of Agriculture, Food Safety and Inspection Service, 14th & Independence Avenue, SW., Room 1180—South Building, Washington, DC 20250. Hand- or courier-delivered items: Deliver to Faye Smith at 14th & Independence Avenue, SW., Room 1180-S, Washington, DC. To deliver these items, the building security guard must first call
(202)720-9113. Facsimile: Send to Faye Smith,
(202)720-5704. All submissions received must include the Agency name and docket number FSIS-2008-0003. FOR FURTHER INFORMATION: Contact Robert Tynan for technical information at
(202)720-3884, or e-mail *robert.tynan@fsis.usda.gov,* and Faye Smith for meeting information at
(202)720-9113, Fax
(202)720-5704, or e-mail *faye.smith@fsis.usda.gov.* Persons requiring a sign language interpreter or other special accommodations should notify Faye Smith at the numbers above or by e-mail. SUPPLEMENTARY INFORMATION: Background The NACMPI provides advice and recommendations to the Secretary of Agriculture pertaining to the Federal and State meat and poultry inspection programs, pursuant to sections 7(c), 24, 205, 301(a)(3), 301(a)(4), and 301(c) of the Federal Meat Inspection Act (21 U.S.C. 607(c), 624, 645, 661(a)(3), 661(a)(4), and 661(c)) and sections 5(a)(3), 5(a)(4), 5(c), 8(b), and 11(e) of the Poultry Products Inspection Act (21 U.S.C. 454(a)(3), 454(a)(4), 454(c), 457(b), and 460(e)). The Administrator of FSIS is the chairperson of the Committee. Membership of the Committee is drawn from representatives of consumer groups; producers, processors, and marketers from the meat, poultry and egg product industries; State and local government officials; and academia. The current members of the NACMPI are: Ms. Kibbe M. Conti, Northern Plains Nutrition Consulting, Rapid City, SD; Mr. Brian R. Covington, Keystone Foods LLC, West Conshohocken, PA; Dr. Catherine N. Cutter, Pennsylvania State University, University Park, PA; Dr. James S. Dickson, Iowa State University, Ames, IA; Mr. Kevin M. Elfering, Minnesota Department of Agriculture, St. Paul, MN; Mr. Mike W. Finnegan, Montana Meat & Poultry Inspection Bureau, Helena, MT; Ms. Carol Tucker Foreman, Consumer Federation of America, Chevy Chase, MD; Dr. Andrea L. Grondahl, North Dakota Department of Agriculture, Bismarck, ND; Dr. Joseph J. Harris, Southwest Meat Association, Bryan, TX; Dr. Craig W. Henry, Food Products Association, Washington, DC; Ms. Cheryl D. Jones, Morehouse School of Medicine, Atlanta, GA; Mr. Michael E. Kowalcyk, DunnhumbyUSA LLC, Cincinnati, OH; Dr. Shelton E. Murinda, California State Polytechnic University, Pomona, CA; Dr. Edna Negron-Bravo, University of Puerto Rico, Mayaguez, PR; Dr. Michael L. Rybolt, National Turkey Federation, Washington, DC; Mr. Mark P. Schad, Schad Meats, Inc., Cincinnati, OH; and Dr. Stanley A. Stromberg, Oklahoma Department of Agriculture, Food, and Forestry, Oklahoma City, OK. The Committee will review a draft report outlining a public health-based slaughter inspection system for young chickens. The components of the planned system are science-based. The focus of the inspection activities in this system are the points within the poultry slaughter process that have the greatest risk for causing microbial or other contamination on young chicken carcasses or otherwise rendering the carcasses adulterated. These focused activities will be performed within the regulatory framework of current FSIS inspection activities regarding verification of Hazard Analysis Critical Control Point systems, Sanitation SOPs, sanitation performance standards, and other regulatory requirements. In addition, FSIS will utilize its inspection resources, including performing Food Safety Assessments on poultry slaughter establishments, as a means of assessing the design of an establishment's inspection system and whether it is under control and functions effectively. FSIS is considering proposing to require that young chicken slaughter establishments that participate in this inspection system meet public health-based performance standards for microorganisms, such as *Salmonella* and *Campylobacter.* FSIS is also considering to propose that participating young chicken slaughter establishments meet a performance standard for generic *E. coli.* FSIS is considering this standard as a measure of sanitary conditions. FSIS' traditional method of inspection for young chicken slaughter establishments was designed before microbial contamination was recognized as a leading cause of foodborne human illness. FSIS would like to update the inspection system for young chicken slaughter establishments so that it will function effectively with the significant advances that have been made in the processing methods employed by many of these establishments. FSIS believes that the inspection system that it is considering will be better able to protect public health because it will be better adapted to the methods being used in slaughter plants. FSIS activities will likely focus on establishments and points within the poultry slaughter process at which microbial contamination of young chicken carcasses is likely to occur. Similarly, FSIS believes that the performance standards it is considering will decrease the amount of microbial contamination occurring at the end of the poultry slaughter process. An approach to inspection that focuses on points within an establishment that present the greatest likelihood of causing microbial and other contamination, and on those establishments with evidence of a loss of process control, could also be applied to processing establishments and to other slaughter establishments in addition to those that slaughter young chickens. The Committee will also review a draft report outlining how a public-health based inspection system could be applied to those establishments and the scientific basis for such a system. All interested parties are welcome to attend the meetings and to submit written comments and suggestions concerning issues the Committee will review and discuss. The comments and the official transcript of the meeting, when they become available, will be kept in the FSIS Docket Room, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue, SW., Room 2534, South Building, Washington, DC 20250, and posted on the Agency's NACMPI Web site, *http://www.fsis.usda.gov/about_fsis/nacmpi/index.asp.* Members of the public will be required to register before entering the meeting. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at *http://www.fsis.usda.gov/regulations/2007_Notices_Index/index.asp.* FSIS also will make copies of this **Federal Register** publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, **Federal Register** notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The Update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at *http://www.fsis.usda.gov/news_and_events/email_subscription/.* Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. Done at Washington, DC, on January 22, 2008. Alfred V. Almanza, Administrator. [FR Doc. 08-292 Filed 1-22-08; 11:39 am]
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Traces to 18 documents
20 references not yet in our index
  • 14 CFR 39
  • 5 USC 601-611
  • 17 CFR 3
  • 17 CFR 30
  • 5 USC 522
  • 40 CFR 70
  • 42 CFR 424
  • Pub. L. 105-33
  • Pub. L. 104-134
  • Pub. L. 108-173
  • 5 CFR 1320.3(b)(3)
  • 5 CFR 1320.3(b)(2)
  • 5 CFR 1320.3(h)(6)
  • Pub. L. 96-354
  • Pub. L. 104-4
  • 47 CFR 73
  • Pub. L. 104-13
  • Pub. L. 107-198
  • 47 CFR 1.1204(b)
  • 47 CFR 1.415
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C.F.R.§ 43.7
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C.F.R.§ 39.19
U.S.C.§ 3501
C.F.R.§ 30.12
U.S.C.§ 605
Cite14 CFR 39
Cite5 USC 601-611
Cite17 CFR 3
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