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assemblies, which could result in reduced Repair Removal Threshold Publications Dept., P.O. Box 2206, Savannah, controllability of the airplane, accomplish (d) For repairs specified in Appendix A of Georgia 31402–2206. To inspect copies of the following: Gulfstream GI CB 337B, dated August 17, this service information, go to the FAA, Note 1: A note in the Accomplishment 2005: Within 144 months after the date of the Transport Airplane Directorate, 1601 Lind Instructions of the Gulfstream customer repair installation, remove the repaired Avenue, SW., Renton, Washington; to FAA, bulletin instructs operators to contact component and replace it with a new or Atlanta Aircraft Certification Office, One Gulfstream if any difficulty is encountered in serviceable component, in accordance with Crown Center, 1895 Phoenix Boulevard, suite accomplishing the customer bulletin. Gulfstream GI CB 337B, including Appendix 450, Atlanta, Georgia; or to the National However, any deviation from the instructions A, dated August 17, 2005. Archives and Records Administration provided in the customer bulletin must be (NARA). For information on the availability approved as an alternative method of Prior Blending in the Riser Areas of this material at the NARA, call (202) 741– 6030, or go to http://www.archives.gov/ compliance (AMOC) under paragraph (h) of (e) If, during the performance of the federal_register/code_of_federal_regulations/ this AD. inspections required by paragraph (c) or (f) of _ this AD, the inspection reveals that prior ibr locations.html. Non-Destructive Testing Inspections of the blending has been performed on the riser Effective Date Fuselage, Empennage, and Flight Controls areas: Before further flight, perform an eddy (j) This amendment becomes effective on current or fluorescent penetrant inspection, (a) Within 9 months after the effective date January 11, 2007. of this AD, perform a non-destructive test as applicable, to evaluate the blending, and (NDT) to detect corrosion of the skins of the accomplish appropriate corrective actions, in Issued in Renton, Washington, on elevators, ailerons, rudder and rudder trim accordance with the Accomplishment November 20, 2006. tab, flaps, aft lower fuselage, and vertical and Instructions of Gulfstream GI CB 337B, Ali Bahrami, horizontal stabilizers; in accordance with the including Appendix A, dated August 17, Manager, Transport Airplane Directorate, Accomplishment Instructions of Gulfstream 2005. If any blend-out is outside the limits Aircraft Certification Service. specified in the CB, before further flight, GI Customer Bulletin (CB) 337B, including [FR Doc. E6–20620 Filed 12–6–06; 8:45 am] repair in a manner approved by the Manager, Appendix A, dated August 17, 2005. The BILLING CODE 4910–13–P corrosion criteria must be determined by the Atlanta ACO. Manager, Atlanta Aircraft Certification Office For Airplanes with New Lower Wing Planks (ACO), FAA. Gulfstream Tool ST905–377 is (f) For airplanes with new lower wing also an acceptable method of determining the DEPARTMENT OF HEALTH AND planks: Within 144 months after replacement corrosion criteria. HUMAN SERVICES of the lower wing planks with new lower (1) If no corrosion or cracking is detected, wing planks, or within 9 months after the repeat the inspection thereafter at intervals Food and Drug Administration effective date of this AD, whichever occurs not to exceed 18 months. later, perform all of the actions, including all (2) If any corrosion is detected that meets related investigative actions and corrective 21 CFR Part 2 the criteria of ‘‘light’’ or ‘‘mild’’ corrosion, actions, specified in paragraph (c) of this AD. repeat the NDT inspections of that [Docket No. 2006N–0416] component thereafter at intervals not to Reporting Requirement RIN 0910–AF93 exceed 12 months. (g) Within 30 days of performing the (3) If any corrosion is detected that meets inspections required by this AD: Submit a Use of Ozone-Depleting Substances; the criteria of ‘‘moderate’’ corrosion: Within report of inspection findings (both positive Removal of Essential Use 9 months after the initial inspection, repeat and negative) to Gulfstream Aerospace Designations the NDT inspection of that component, and Corporation; Attention: Technical within 18 months since the initial inspection, Operations—Structures Group, Dept. 893, AGENCY: Food and Drug Administration, repair or replace the component with a Mail Station D–25, 500 Gulfstream Road, HHS. serviceable component in accordance with Savannah, Georgia 31408. Information ACTION: Direct final rule. the CB. collection requirements contained in this (4) If any corrosion is detected that meets regulation have been approved by the Office SUMMARY: The Food and Drug the criteria of ‘‘severe’’ corrosion, before of Management and Budget (OMB) under the Administration (FDA) is amending its further flight, replace the component with a provisions of the Paperwork Reduction Act regulation on the use of ozone-depleting serviceable component in accordance with (44 U.S.C. 3501 et seq.) and have been substances (ODSs) in pressurized the CB. assigned OMB Control Number 2120–0056. containers to remove the essential use Existing Repairs Alternative Methods of Compliance designations for beclomethasone, (b) If any existing repairs are found during (h)(1) The Manager, Atlanta ACO, has the dexamethasone, fluticasone, bitolterol, the inspections required by paragraph (a) of authority to approve AMOCs for this AD, if salmeterol, ergotamine tartrate, and this AD, before further flight, ensure that the requested in accordance with the procedures ipratropium bromide used in oral repairs are in accordance with a method found in 14 CFR 39.19. pressurized metered-dose inhalers approved by the Manager, Atlanta ACO. (2) Before using any AMOC approved in (MDIs). Under the Clean Air Act, FDA, accordance with § 39.19 on any airplane to Inspections of the Lower Wing Plank in consultation with the Environmental which the AMOC applies, notify the Protection Agency (EPA), is required to (c) Except as provided in paragraph (f) of appropriate principal inspector in the FAA this AD: Within 9 months after the effective Flight Standards Certificate Holding District determine whether an FDA-regulated date of this AD, perform NDT inspections to Office. product that releases an ODS is detect corrosion and cracking of the lower essential. None of these products is wing plank splices, in accordance with the Incorporation by Reference currently being marketed, which Accomplishment Instructions of Gulfstream (i) Unless otherwise specified in this AD, provides grounds for removing their GI CB 337B, including Appendix A, dated the actions must be done in accordance with essential use designation. We are using August 17, 2005. Gulfstream GI Customer Bulletin 337B, direct final rulemaking for this action (1) If no corrosion or cracking is detected, including Appendix A, dated August 17, because the agency expects that there repeat the NDT inspection at intervals not to 2005. This incorporation by reference was exceed 18 months. approved by the Director of the Federal will be no significant adverse comment (2) If any corrosion or cracking is detected, Register in accordance with 5 U.S.C. 552(a) on the rule. In the proposed rule section before further flight, perform all applicable and 1 CFR part 51. To get copies of this in this issue of the Federal Register, we investigative actions and corrective actions in service information, contact Gulfstream are concurrently proposing and accordance with the customer bulletin. Aerospace Corporation, Technical soliciting comments on this rule. If

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significant adverse comments are heading of the SUPPLEMENTARY FR 48370). Among other provisions, the received, we will withdraw this final INFORMATION section of this document. rule removed the essential use rule and address the comments in a Docket: For access to the docket to designations of various specific subsequent final rule. FDA will not read background documents or products that, at the time the rule was provide additional opportunity for comments received, go to http:// being prepared, were no longer being comment. www.fda.gov/ohrms/dockets/ marketed. The rule went into effect on DATES: The direct final rule is effective default.htm and insert the docket January 20, 2003. That rule also revised § 2.125(g)(1) (21 CFR 2.125(g)(1)) to April 23, 2007, except for number, found in brackets in the provide that if any product that releases § 2.125(e)(4)(v) (21 CFR 2.125(e)(4)(v)), heading of this document, into the an ODS is no longer being marketed, the which is effective August 1, 2007. ‘‘Search’’ box and follow the prompts product may have its essential use Submit written or electronic comments and/or go to the Division of Dockets designation revoked through notice-and- on or before February 20, 2007. If we Management, 5630 Fishers Lane, rm. comment rulemaking. receive no timely significant adverse 1061, Rockville, MD 20852. comments, we will publish a document FOR FURTHER INFORMATION CONTACT: II. Citizen Petition From in the Federal Register before March 22, Martha Nguyen or Wayne H. Mitchell, Glaxosmithkline Center for Drug Evaluation and Research 2007, confirming the effective date of In a citizen petition dated November (HFD–7), Food and Drug the direct final rule. If we receive any 15, 2005, GlaxoSmithKline (GSK) Administration, 5600 Fishers Lane, timely significant adverse comments, requested that MDIs containing the Rockville, MD 20857, 301–594–2041. we will publish a document of single active moieties beclomethasone, significant adverse comment in the SUPPLEMENTARY INFORMATION: fluticasone, and salmeterol be removed Federal Register withdrawing this I. Background from the essential use list of ODSs. GSK direct final rule before April 23, 2007. stated that because beclomethasone, ADDRESSES: You may submit comments, FDA, in consultation with EPA, fluticasone, and salmeterol are no longer identified by Docket No. 2006N–0416 determines whether a medical product being marketed in MDIs that release and RIN Number 0910–AF93, by any of is essential for purposes of Title VI of ODSs, all three active moieties meet the the following methods: the Clean Air Act (42 U.S.C. 7671 et criterion under revised § 2.125(g) for seq.). If a medical product, including a being removed from the essential use Electronic Submissions drug, is determined to be essential and list. GSK requested that the essential use Submit electronic comments in the meets the other elements of the designation for beclomethasone, following ways: definition found in section 601 of the fluticasone, and salmeterol be revoked • Federal eRulemaking Portal: http:// Clean Air Act, the product will be through a direct final rule. www.regulations.gov. Follow the considered a ‘‘medical device.’’ In addition, we have determined that instructions for submitting comments. ‘‘Medical devices’’ are exempt from the dexamethasone, bitolterol, ergotamine • Agency Web site: http:// general prohibition on nonessential uses tartrate, and ipratropium bromide are no www.fda.gov/dockets/ecomments. of chlorofluorocarbons (CFCs) (a class of longer being marketed in MDIs that Follow the instructions for submitting ODSs) found in section 610 of the Clean release ODSs, which provides grounds comments on the agency Web site. Air Act. ODSs produced for use in for removing their essential use ‘‘medical devices’’ may also be exempt, designation. Written Submissions if other conditions are met, from the Submit written submissions in the general prohibitions on production and III. Direct Final Rulemaking following ways: consumption of ODSs found in sections We have determined that the subject • FAX: 301–827–6870. 604 and 605 of the Clean Air Act. of this rulemaking is suitable for a direct • Mail/Hand delivery/Courier [For In 1978, we published a rule listing final rule. The actions taken should be paper, disk, or CD–ROM submissions]: several essential uses of CFCs and noncontroversial, and the agency does Division of Dockets Management (HFA– providing criteria for adding new not anticipate receiving any significant 305), Food and Drug Administration, essential uses (43 FR 11301 at 11316, adverse comments on this rule. 5630 Fishers Lane, rm. 1061, Rockville, March 17, 1978). The rule was codified However, in the even that significant MD 20852. as § 2.125 (21 CFR 2.125) and § 2.125 adverse comment is received, we are To ensure more timely processing of was amended at various times to add also publishing a companion proposed comments, FDA is no longer accepting new essential uses. rule to satisfy the requirement under comments submitted to the agency by e- Over the years, alternatives were § 2.125(g) that essential uses be removed mail. FDA encourages you to continue developed to ODS products whose uses through notice-and-comment to submit electronic comments by using were listed in § 2.125 as being essential, rulemaking. the Federal eRulemaking Portal or the while other listed ODS products were If we receive no significant adverse agency Web site, as described in the removed from the market. In light of comment, we will publish a document Electronic Submissions portion of this these facts, and in furtherance of our in the Federal Register, confirming the paragraph. obligations under the Clean Air Act and effective date of the direct final rule. A Instructions: All submissions received the Montreal Protocol on Substances significant adverse comment is one that must include the agency name and that Deplete the Ozone Layer explains why the rule would be docket number and Regulatory (September 16, 1987, 26 I.L.M. 1541 inappropriate, including challenges to Information Number (RIN) for this (1987)), we determined that it would be the rule’s underlying premise or rulemaking. All comments received will appropriate to revise § 2.125 to remove approach, or would be ineffective or be posted without change to http:// the essential use designations of some unacceptable without a change. A www.fda.gov/ohrms/dockets/ products and provide criteria for the comment recommending a rule change default.htm, including any personal removal of additional essential use in addition to this rule will not be information provided. For additional designations in the future. Thus, the considered a significant adverse information on submitting comments, rule revising § 2.125 was published in comment, unless the comment states see the ‘‘Request for Comments‘‘ the Federal Register of July 24, 2002 (67 why this rule would be ineffective

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without the additional change. If timely bromide from the list of essential use 25, 2002, Schering informed us that they significant adverse comments are drugs found in § 2.125(e) (21 CFR were removing VANCERIL 42 µg/inh received, we will publish a notice of 2.125(e)). Essential uses for metered- from the market. On April 14, 2005, significant adverse comment in the dose corticosteroid human drugs for oral Schering requested withdrawal of Federal Register withdrawing this inhalation, metered-dose short-acting approval of NDA 17–573 for VANCERIL direct final rule within 30 days after the adrenergic bronchodilator human drugs 42 µg/inh. comment period ends. for oral inhalation, and metered-dose B. Dexamethasone Elsewhere in this issue of the Federal salmeterol, ergotamine tartrate, and Register, we are publishing a ipratropium bromide drug products for Oral pressurized MDIs that contain companion proposed rule, identical in oral inhalation, are listed in dexamethasone are listed in substance to this direct final rule, that § 2.125(e)(1), (e)(2), and (e)(4) by active § 2.125(e)(1)(ii) as an essential use. provides a procedural framework from moiety. ‘‘Active moiety’’ is defined in DEXACORT ORAL MDI is the only oral which to proceed with standard notice 21 CFR 314.108(a) as follows: ‘‘the pressurized MDI that has been marketed and comment rulemaking in the event molecule or ion, excluding those and contains dexamethasone with an the direct final rule is withdrawn appended portions of the molecule that ODS. On September 13, 2002, Celltech because of significant adverse comment. cause the drug to be an ester, salt Pharmaceuticals, Inc., the manufacturer The comment period for the direct final (including a salt with hydrogen or of DEXACORT ORAL MDI, requested rule runs concurrently with that of the coordination bonds), or other that we withdraw approval of NDA 01– companion proposed rule. Any noncovalent derivative (such as a 3413 for DEXACORT ORAL MDIs and comments received under the complex, chelate, or clathrate) of the informed us that they had stopped companion proposed rule will be molecule, responsible for the marketing DEXACORT ORAL MDIs on treated as comments regarding the direct physiological or pharmacological action August 15, 1996. of the drug substance.’’ final rule. Likewise, significant adverse C. Fluticasone comments submitted to the direct final MDIs that contain the active moieties rule will be considered as comments to beclomethasone, dexamethasone, Oral pressurized MDIs that contain the companion proposed rule, and we fluticasone, bitolterol, salmeterol, fluticasone are listed in § 2.125(e)(1)(iv) will consider those comments in ergotamine tartrate, and ipratropium as an essential use. FLOVENT CFC MDI developing a final rule. We will not bromide, use certain forms of these is the only oral pressurized MDI that has provide additional opportunity for moieties. Specifically, MDIs that have been marketed and contains fluticasone comment on the companion proposed beclomethasone or fluticasone as their with an ODS. GSK, the manufacturer of rule. active moieties use those moieties in the FLOVENT CFC MDIs, has informed us If a significant adverse comment forms of beclomethasone dipropionate that they stopped marketing FLOVENT applies to part of this rule and that part and fluticasone propionate, CFC MDIs in November 2004. respectively. Similarly, MDIs that have may be severed from the remainder of D. Bitolterol the rule, we may adopt as final those dexamethasone, bitolterol, or salmeterol Oral pressurized MDIs that contain parts of the rule that are not the subject as their active moieties use those bitolterol are listed in § 2.125(e)(2)(ii) as of a significant adverse comment. A full moieties in the forms of dexamethasone an essential use. TORNALATE MDI is description of our policy on direct final sodium phosphate, bitolterol mesylate, the only oral pressurized MDI that has rule procedures may be found in a and salmeterol xinafoate, respectively. Ergotamine tartrate is a salt of been marketed and contains bitolterol guidance document published in the ergotamine, and it was used in oral with an ODS. On January 28, 2003, Federal Register of November 21, 1997 MDIs for the treatment of migraines. Its Sanofi-Synthelabo, Inc., the (62 FR 62466). essential use designation is for the manufacturer of TORNALATE MDIs, IV. Beclomethasone, Dexamethasone, ergotamine tartrate salt rather than the informed us that they had stopped Fluticasone, Bitolterol, Salmeterol, active moiety ergotamine. marketing TORNALATE MDIs on Ergotamine Tartrate, and Ipratropium October 1, 2000. A. Beclomethasone Bromide Oral pressurized MDIs that contain E. Salmeterol The manufacturers of all approved beclomethasone are listed in Metered-dose salmeterol drug beclomethasone, dexamethasone, § 2.125(e)(1)(i) as an essential use. products are listed in § 2.125(e)(4)(i) as fluticasone, bitolterol, salmeterol, BECLOVENT and VANCERIL are the an essential use. SEREVENT MDI is the ergotamine tartrate, and ipratropium only two oral pressurized MDIs that only metered-dose salmeterol drug bromide oral pressurized MDIs have been marketed and contain product with an ODS that has been containing an ODS have provided beclomethasone with an ODS. On marketed. GSK, the manufacturer of information that leads us to conclude January 10, 2002, GSK, the SEREVENT MDIs, has informed us that that they have removed these products manufacturer of BECLOVENT, they stopped marketing SEREVENT from the market.1 Accordingly, we are requested that we withdraw approval of MDIs in January 2003. amending our regulation to remove their new drug application (NDA) for beclomethasone, dexamethasone, BECLOVENT ODS MDIs (NDA 18–153) F. Ergotamine Tartrate fluticasone, bitolterol, salmeterol, and informed us that they had stopped Oral pressurized MDIs that contain ergotamine tartrate, and ipratropium marketing BECLOVENT ODS MDIs. On ergotamine tartrate are listed in May 2, 2001, Schering-Plough Corp. § 2.125(e)(4)(ii) as an essential use. 1 The drug products discussed in this direct final rule were all approved for marketing under section (Schering), the manufacturer of MEDIHALER ERGOTAMINE is the only 505 of the Federal Food, Drug, and Cosmetic Act VANCERIL, requested that we withdraw oral pressurized MDI that has been (21 U.S.C. 355). We are unaware of any unapproved approval of NDA, for VANCERIL ODS marketed and contains ergotamine beclomethasone, dexamethasone, fluticasone, MDIs, 84 micrograms per inhalation (µg/ tartrate with an ODS. 3M bitolterol, salmeterol, ergotamine tartrate, and inh), and informed us that they had Pharmaceuticals, the manufacturer of ipratropium bromide oral pressurized MDIs using µ an ODS as a propellant that are marketed in the stopped marketing VANCERIL 84 g/inh MEDIHALER ERGOTAMINE, has United States. MDIs in November 1999. Also, on July informed us that they stopped

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marketing MEDIHALER ERGOTAMINE necessary, to select regulatory comments on the federalism in November 1991. approaches that maximize net benefits implications of this direct final rule. (including potential economic, G. Ipratropium Bromide IX. Request for Comments environmental, public health and safety, Oral pressurized MDIs that contain and other advantages; distributive Interested persons may submit to the ipratropium bromide are listed in impacts; and equity). The agency Division of Dockets Management (see § 2.125(e)(4)(v) as an essential use. believes that this direct final rule is not ADDRESSES) written or electronic ATROVENT CFC MDI is the only oral a significant regulatory action as defined comments regarding this document. pressurized MDI that has been marketed by the Executive order. Submit a single copy of electronic and contains ipratropium bromide with The Regulatory Flexibility Act comments or two copies of any written an ODS. Boehringer Ingelheim requires agencies to analyze regulatory comments are to be submitted, except Pharmaceuticals, the manufacturer of options that would minimize any that individuals may submit one paper ATROVENT CFC MDI, has informed us significant impact of a rule on small copy. Comments are to be identified that they stopped marketing entities. Because we are removing the with the docket number found in ATROVENT CFC MDIs in January 2006. essential use designations for certain brackets in the heading of this This direct final rule does not affect drug products that are either no longer document. Received comments may be MDIs containing ipratropium bromide being marketed or are no longer being seen in the Division of Dockets and albuterol sulfate in combination, marketed in a formulation containing Management between 9 a.m. and 4 p.m., marketed as COMBIVENT, which are ODSs, the agency certifies that the direct Monday through Friday. listed in § 2.125(e)(4)(viii) as a separate final rule will not have a significant essential use. economic impact on a substantial List of Subjects in 21 CFR Part 2 number of small entities. H. Wholesale and Retail Stocks Administrative practice and Section 202(a) of the Unfunded procedure, Cosmetics, Drugs, Foods. Based on information given to us by Mandates Reform Act of 1995 requires the manufacturers, we have concluded that agencies prepare a written n Therefore, under the Federal Food, that any beclomethasone, statement, which includes an Drug, and Cosmetic Act, the Clean Air dexamethasone, fluticasone, bitolterol, assessment of anticipated costs and Act, and under authority delegated to salmeterol, and ergotamine tartrate ODS benefits, before proposing ‘‘any rule that the Commissioner of Food and Drugs, MDIs that may be in retail or wholesale includes any Federal mandate that may after consultation with the stocks will have passed their expiration result in the expenditure by State, local, Administrator of the Environmental dates by the effective date for removal and tribal governments, in the aggregate, Protection Agency, 21 CFR part 2 is of § 2.125(e)(1)(i), (e)(1)(ii), (e)(1)(iv), or by the private sector, of $100,000,000 amended as follows: (e)(2)(ii), (e)(4)(i), and (e)(4)(ii). or more (adjusted annually for inflation) PART 2—GENERAL ADMINISTRATIVE Boehringer Ingelheim Pharmaceuticals, in any one year.’’ The current threshold RULINGS AND DECISIONS the manufacturer of ipratropium after adjustment for inflation is $118 bromide, has informed us that any million, using the most current (2004) n 1. The authority citation for 21 CFR ipratropium bromide that may be in Implicit Price Deflator for the Gross part 2 continues to read as follows: retail or wholesale stocks will have Domestic Product. FDA does not expect passed its expiration date by July 2007. this direct final rule to result in any 1- Authority: 15 U.S.C. 402, 409; 21 U.S.C. Accordingly, we have set the effective year expenditure that would meet or 321, 331, 335, 342, 343, 346a, 348, 351, 352, date for removal of § 2.125(e)(4)(v) as exceed this amount. 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671 et seq. August 1, 2007. VII. The Paperwork Reduction Act of § 2.125 [Amended] V. Environmental Impact 1995 We have carefully considered, under This direct final rule contains no n 2. Section 2.125 is amended by 21 CFR part 25, the potential collections of information. Therefore, removing and reserving paragraphs environmental effects of this action. We clearance by the Office of Management (e)(1)(i), (e)(1)(ii), (e)(1)(iv), (e)(2)(ii), have concluded that the action will not and Budget under the Paperwork (e)(4)(i), (e)(4)(ii), and (e)(4)(v). have a significant impact on the human Reduction Act of 1995 is not required. Dated: October 13, 2006. environment and that an environmental VIII. Federalism Jeffrey Shuren, impact statement is not required. Our Assistant Commissioner for Policy. FDA has analyzed this direct final finding of no significant impact and the [FR Doc. E6–20797 Filed 12–6–06; 8:45 am] evidence supporting that finding, rule in accordance with the principles BILLING CODE 4160–01–S contained in an environmental set forth in Executive Order 13132. FDA assessment, may be seen in the Division has determined that the rule does not of Dockets Management (see ADDRESSES) contain policies that have substantial DEPARTMENT OF HEALTH AND between 9 a.m. and 4 p.m., Monday direct effects on the States, on the HUMAN SERVICES through Friday. relationship between the National Government and the States, or on the Food and Drug Administration VI. Analysis of Impacts distribution of power and FDA has examined the impacts of the responsibilities among the various 21 CFR Part 80 direct final rule under Executive Order levels of government. Accordingly, the 12866 and the Regulatory Flexibility Act agency has concluded that the rule does [Docket No. 2005N–0077] (5 U.S.C. 601–612), and the Unfunded not contain policies that have Mandates Reform Act of 1995 (Public federalism implications as defined in Color Additive Certification; Increase Law 104–4). Executive Order 12866 the Executive order and, consequently, in Fees for Certification Services directs agencies to assess all costs and we do not plan to prepare a federalism benefits of available regulatory summary impact statement for this AGENCY: Food and Drug Administration, alternatives and, when regulation is rulemaking procedure. We invite HHS.

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