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Comments Invited (IFR) operations at Seamans Field. This proposes to amend 14 CFR part 71 as Interested parties are invited to proposal would increase current Class E follows: airspace from a 6.2-mile radius to an participate in this proposed rulemaking PART 71—DESIGNATION OF CLASS A, by submitting such written data, views 8.2-mile radius of Seamans Field and including the airspace within 5.3 miles CLASS B, CLASS C, CLASS D, AND or arguments, as they may desire. CLASS E AIRSPACE AREAS; Comments that provide the factual basis each side of the Lake Henry VORTAC 299° radial extending from the 8.2-mile AIRWAYS; ROUTES; AND REPORTING supporting the views and suggestions POINTS presented are particularly helpful in radius of Seamans Field to the developing reasoned regulatory VORTAC. Class E airspace designations 1. The authority citation for part 71 decisions on the proposal. Comments for airspace areas extending upward continues to read as follows: are specifically invited on the overall from 700 feet or more above the surface of the earth are published in Paragraph Authority: 49 U.S.C. 106(g); 40103, 40113, regulatory, aeronautical, economic, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– environmental, and energy-related 6005 of FAA Order 7400.9R, signed 1963 Comp., p. 389. aspects of the proposal. August 15, 2007, and effective Communications should identify both September 15, 2007, which is § 71.1 [Amended] docket numbers and be submitted in incorporated by reference in 14 CFR 2. The incorporation by reference in triplicate to the address listed above. 71.1. The Class E airspace designation 14 CFR 71.1 of Federal Aviation Persons wishing the FAA to listed in this document would be Administration Order 7400.9R, Airspace acknowledge receipt of their comments published subsequently in the Order. Designations and Reporting Points, on this notice must submit with those The FAA has determined that this signed August 15, 2007, and effective comments a self-addressed, stamped proposed regulation only involves an September 15, 2007, is amended as postcard on which the following established body of technical follows: statement is made: ‘‘Comments to regulations for which frequent and Paragraph 6005 Class E Airspace Areas Docket No. FAA–2007–29361/Airspace routine amendments are necessary to Extending Upward From 700 Feet or More Docket No. 07–AEA–5.’’ The postcard keep them operationally current. It, Above the Surface of the Earth. will be date/time stamped and returned therefore, (1) is not a ‘‘significant * * * * * to the commenter. All communications regulatory action’’ under Executive AEA PA E5 Factoryville, PA [Amended] received before the specified closing Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies Seamans Field, PA date for comments will be considered ° ′ ″ ° ′ ″ before taking action on the proposed and Procedures (44 FR 11034; February (Lat. 41 35 22 N., long. 75 45 22 W.) 26, 1979); and (3) does not warrant Lake Henry VORTAC rule. The proposal contained in this ° ′ ″ ° ′ ″ preparation of a Regulatory Evaluation (Lat. 41 28 33 N., long. 75 28 57 W.) notice may be changed in light of the That airspace extending upward from 700 comments received. A report as the anticipated impact is so minimal. Since this is a routine matter that will feet above the surface within an 8.2-mile summarizing each substantive public radius of Seamans Field and including the contact with FAA personnel concerned only affect air traffic procedures and air airspace within 5.3 miles each side of the with this rulemaking will be filed in the navigation, it is certified that this rule, Lake Henry VORTAC 299° radial extending docket. when promulgated, will not have a from the 8.2-mile radius of Seamans Field to significant economic impact on a the VORTAC. Availability of NPRMs substantial number of small entities * * * * * An electronic copy of this document under the criteria of the Regulatory Flexibility Act. Issued in College Park, Georgia, on may be downloaded through the December 17, 2007. The FAA’s authority to issue rules Internet at http://www.regulations.gov. Mark D. Ward, Recently published rulemaking regarding aviation safety is found in the Title 49 of the United States Code. Manager, System Support Group, Eastern documents can also be accessed through Service Center. Subtitle I, Section 106 describes the the FAA’s web page at http:// [FR Doc. 08–350 Filed 1–30–08; 8:45 am] www.faa.gov or the Federal Register’s authority of the FAA administrator. BILLING CODE 4910–13–M web page at http://www.gpoaccess.gov/ Subtitle VII, Aviation Programs, fr/index.html. Persons interested in describes in more detail the scope of the being placed on a mailing list for future agency’s authority. DEPARTMENT OF JUSTICE NPRMs should contact the FAA’s Office This rulemaking is promulgated of Rulemaking, (202) 267–9677, to under the authority described in Drug Enforcement Administration request a copy of Advisory Circular No. Subtitle VII, Part, A, Subpart I, Section 11–2A, Notice of Proposed Rulemaking 40103. Under that section, the FAA is 21 CFR Part 1308 Distribution System, which describes charged with prescribing regulations to the application procedure. assign the use of airspace necessary to [Docket No. DEA–283P] ensure the safety of aircraft and the The Proposal efficient use of airspace. This regulation Schedules of Controlled Substances: The FAA is considering an is within the scope of that authority as Placement of Indiplon Into Schedule IV amendment to Title 14, Code of Federal it amends Class E Airspace at AGENCY: Drug Enforcement Regulations (14 CFR) part 71 to amend Factoryville, PA. Administration, Department of Justice. Class E airspace at Factoryville, PA. A List of Subjects in 14 CFR Part 71 ACTION: Notice of proposed rulemaking. new Runway 4 Standard Instrument Approach Procedure (SIAP) has been Airspace, Incorporation by reference, SUMMARY: This proposed rule is issued developed for Seamans Field. As a Navigation (air). by the Deputy Administrator of the Drug result, controlled airspace extending Enforcement Administration (DEA) to The Proposed Amendment upward from 700 feet Above Ground place the substance indiplon (N-methyl- Level (AGL) is needed to contain the In consideration of the foregoing, the N-[3-[3-(2-thienylcarbonyl)- SIAP and for Instrument Flight Rules Federal Aviation Administration pyrazolo[1,5-a]pyrimidin-7-

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yl]phenyl]acetamide), including its If you want to submit personal should state, with particularity, the salts, and all products containing identifying information (such as your issues concerning which the person indiplon into schedule IV of the name, address, etc.) as part of your desires to be heard. All correspondence Controlled Substances Act (CSA). This comment, but do not want it to be regarding this matter should be proposed action is based on a posted online or made available in the submitted to the DEA using the address recommendation from the Assistant public docket, you must include the information provided above. Secretary for Health of the Department phrase ‘‘PERSONAL IDENTIFYING Background of Health and Human Services (DHHS) INFORMATION’’ in the first paragraph and an evaluation of the relevant data of your comment. You must also place Indiplon acts as an agonist at by DEA. This scheduling of indiplon in all the personal identifying information sites of the GABAA schedule IV will not be finalized until you do not want posted online or made receptor-channel complex. It has a New Drug Application (NDA) for an available in the public docket in the first comparable / action to indiplon product is approved by the paragraph of your comment and identify that of the , Food and Drug Administration (FDA). If what information you want redacted. and , and non-benzodiazepines finalized, this action will impose the If you want to submit confidential that bind to the GABAA complex, such regulatory controls and criminal business information as part of your as , and , all sanctions applicable to schedule IV non- comment, but do not want it to be of which are controlled as narcotics on those who handle indiplon posted online or made available in the in schedule IV of the CSA. Indiplon has and products containing indiplon. public docket, you must include the a similar pharmacological profile as phrase ‘‘CONFIDENTIAL BUSINESS these substances in addition to a short DATES: Written comments must be plasma half-life and short duration of postmarked, and electronic comments INFORMATION’’ in the first paragraph of your comment. You must also action. In a human abuse-liability study must be sent, on or before March 3, in individuals with known histories of 2008. prominently identify confidential business information to be redacted sedative abuse, oral administration of ADDRESSES: To ensure proper handling within the comment. If a comment has indiplon (30 mg, 50 mg and 80 mg) of comments, please reference ‘‘Docket so much confidential business produced dose-dependent increases in No. DEA–283’’ on all written and information that it cannot be effectively drug-liking and decreases in electronic correspondence. Written redacted, all or part of that comment psychomotor and cognitive functioning comments being sent via regular mail may not be posted online or made comparable to those produced by the should be sent to the Deputy available in the public docket. schedule IV benzodiazepine, triazolam. Administrator, Drug Enforcement Personal identifying information and Indiplon is likely to be diverted and Administration, Washington, DC 20537, confidential business information abused in the same manner as other Attention: DEA Federal Register identified and located as set forth above schedule IV depressants. Representative/ODL. Written comments will be redacted and the comment, in The FDA has received two NDAs for indiplon products, Somposure and sent via express mail should be sent to redacted form, will be posted online and  the Deputy Administrator, Drug placed in the Drug Enforcement Somposure MR. These products are Enforcement Administration, Attention: Administration’s public docket file. If currently under review for the treatment DEA Federal Register Representative/ you wish to inspect the agency’s public of , as characterized by ODL, 8701 Morrissette Drive, docket file in person by appointment, difficulty in sleep onset or sleep Springfield, VA 22152. Comments may please see the FOR FURTHER INFORMATION maintenance. Indiplon is a new be directly sent to DEA electronically by paragraph. chemical entity and has not been marketed in the United States or in sending an electronic message to FOR FURTHER INFORMATION CONTACT: other countries. [email protected]. Christine A. Sannerud, PhD, Chief, Drug On January 23, 2006, the Assistant Comments may also be sent and Chemical Evaluation Section, Drug Secretary for Health of the DHHS sent electronically through http:// Enforcement Administration, the Administrator of the DEA a www.regulations.gov using the Washington, DC 20537, (202) 307–7183. scientific and medical evaluation and a electronic comment form provided on SUPPLEMENTARY INFORMATION: that site. However, persons wishing to letter recommending that indiplon be request a hearing should note that such Note Regarding This Proposed placed into schedule IV of the CSA. requests must be written and manually Scheduling Action Enclosed with the January 23, 2006, signed; requests for a hearing will not be letter was a document prepared by the In accordance with the provisions of FDA entitled, ‘‘Basis for the accepted via electronic means. DEA will the Controlled Substances Act (21 accept electronic comments containing Recommendation for Control of U.S.C. 811(a)), this action is a formal Indiplon in Schedule IV of the MS Word, WordPerfect, Adobe PDF, or rulemaking ‘‘on the record after Excel file formats only. DEA will not Controlled Substances Act (CSA).’’ The opportunity for a hearing.’’ Such document contained a review of the accept any file format other than those proceedings are conducted pursuant to specifically listed here. factors which the CSA requires the the provisions of the Administrative Secretary to consider (21 U.S.C. 811(b)). Posting of Public Comments: Please Procedure Act (5 U.S.C. 556 and 557). The factors considered by the note that all comments received are Interested persons are invited to submit Assistant Secretary of Health and DEA considered part of the public record and their comments, objections or requests with respect to Indiplon were: made available for public inspection for a hearing with regard to this (1) Its actual or relative potential for online at http://www.regulations.gov proposal. Persons wishing to request a abuse; and in the Drug Enforcement hearing should note that such requests (2) Scientific evidence of its Administration’s public docket. Such must be written and manually signed; pharmacological effects; information includes personal requests for a hearing will not be (3) The state of current scientific identifying information (such as your accepted via electronic means. Requests knowledge regarding the drug; name, address, etc.) voluntarily for a hearing should be made in (4) Its history and current pattern of submitted by the commenter. accordance with 21 CFR 1308.44 and abuse;

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(5) The scope, duration, and administrative, civil and criminal proceedings are conducted pursuant to significance of abuse; sanctions applicable to the manufacture, the provisions of 5 U.S.C. 556 and 557 (6) What, if any, risk there is to the distribution, dispensing, importing and and, as such, are exempt from review by public health; exporting of a schedule IV controlled the Office of Management and Budget (7) Its psychic or physiological substance, including the following: pursuant to Executive Order 12866, dependence liability; and Registration. Any person who section 3(d)(1). (8) Whether the substance is an manufactures, distributes, dispenses, immediate precursor of a substance imports, exports, engages in research or Regulatory Flexibility Act already controlled under this conducts instructional activities with subchapter (21 U.S.C. 811(c)). The Deputy Administrator, in indiplon, or who desires to accordance with the Regulatory Based on the recommendation of the manufacture, distribute, dispense, Flexibility Act (5 U.S.C. 601–612), has Assistant Secretary for Health, received import, export, engage in instructional reviewed this proposed rule and by in accordance with section 201(b) of the activities or conduct research with approving it certifies that it will not Act (21 U.S.C. 811(b)), and the indiplon, would need to register with have a significant economic impact on independent review of the available the DEA to conduct such activities in a substantial number of small entities. data by the DEA, the Deputy accordance with part 1301 of Title 21 of Administrator of the DEA, pursuant to the Code of Federal Regulations. Indiplon products will be prescription section 201(a) and 201(b) of the Act (21 Security. Indiplon would be subject to drugs used for the treatment of U.S.C. 811(a) and 811(b)), finds that: schedule III-V security requirements insomnia. Handlers of indiplon often (1) Based on information now and must be manufactured, distributed handle other controlled substances available, indiplon has a low potential and stored in accordance with 21 CFR which are already subject to the for abuse relative to the drugs or other 1301.71, 1301.72(b), (c), and (d), regulatory requirements of the CSA. substances in schedule III; 1301.73, 1301.74, 1301.75(b) and (c), Executive Order 12988 (2) Once approved for marketing, 1301.76, and 1301.77. indiplon will have a currently accepted Labeling and Packaging. All labels This regulation meets the applicable medical use in treatment in the United and labeling for commercial containers standards set forth in section 3(a) and States; and of indiplon which are distributed on or 3(b)(2) of Executive Order 12988 Civil (3) Abuse of indiplon may lead to after finalization of this rule would need Justice Reform. limited physical dependence or to comply with requirements of 21 CFR psychological dependence relative to 1302.03–1302.07. Executive Order 13132 the drugs or other substances in Inventory. Every registrant required to This rulemaking does not preempt or schedule III. keep records and who possesses any Based on these findings, the Deputy modify any provision of state law; nor quantity of indiplon would be required Administrator of the DEA concludes does it impose enforcement to keep an inventory of all stocks of that indiplon, including its salts, and all responsibilities on any state; nor does it indiplon on hand pursuant to 21 CFR products containing indiplon, warrant diminish the power of any state to 1304.03, 1304.04 and 1304.11. Every control in schedule IV of the CSA, if and enforce its own laws. Accordingly, this registrant who desires registration in when a NDA for indiplon is approved. rulemaking does not have federalism schedule IV for indiplon would be Interested persons are invited to implications warranting the application required to conduct an inventory of all submit their comments, objections or of Executive Order 13132. stocks of the substance on hand at the requests for a hearing with regard to this time of registration. proposal. Requests for a hearing should Unfunded Mandates Reform Act of 1995 Records. All registrants would be state, with particularity, the issues required to keep records pursuant to 21 This rule will not result in the concerning which the person desires to CFR 1304.03, 1304.04, 1304.05, 1304.21, expenditure by state, local and tribal be heard. All correspondence regarding 1304.22, and 1304.23. governments, in the aggregate, or by the this matter should be submitted to the Prescriptions. All prescriptions for private sector, of $120,000,000 or more Drug Enforcement Administration using indiplon or prescriptions for products (adjusted for inflation) in any one year, the address information provided above. containing indiplon would be required and will not significantly or uniquely Persons wishing to request a hearing to be issued pursuant to 21 CFR affect small governments. Therefore, no should note that such requests must be 1306.03–1306.06, 1306.21–1306.27. actions were deemed necessary under written and manually signed; requests Importation and Exportation. All provisions of the Unfunded Mandates for a hearing will not be accepted via importation and exportation of indiplon Reform Act of 1995. electronic means. In the event that would need to be in compliance with 21 comments, objections, or requests for a Congressional Review Act CFR Part 1312. hearing raise one or more issues which Criminal Liability. Any activity with This rule is not a major rule as the Deputy Administrator finds warrant indiplon not authorized by, or in a hearing, the Deputy Administrator defined by section 804 of the Small violation of, the Controlled Substances Business Regulatory Enforcement shall order a public hearing by notice in Act or the Controlled Substances Import the Federal Register, summarizing the Fairness Act of 1996 (Congressional and Export Act occurring on or after Review Act). This rule will not result in issues to be heard and setting the time finalization of this proposed rule would for the hearing. an annual effect on the economy of be unlawful. $100,000,000 or more; a major increase Requirements for Handling Indiplon Regulatory Certifications in costs or prices; or, significant adverse If this rule is finalized as proposed, effects on competition, employment, indiplon and all products containing Executive Order 12866 investment, productivity, innovation, or indiplon would be subject to the In accordance with the provisions of on the ability of United States-based Controlled Substances Act and the the CSA (21 U.S.C. 811(a)), this action companies to compete with foreign Controlled Substances Import and is a formal rulemaking ‘‘on the record based companies in domestic and Export Act regulatory controls and after opportunity for a hearing.’’ Such export markets.

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List of Subjects in 21 CFR Part 1308 organic compounds (VOCs) from the you submit. If EPA cannot read your Administrative practice and Kraft Foods Global, Inc.—Richmond comment due to technical difficulties procedure, Drug traffic control, Bakery located in Henrico County, and cannot contact you for clarification, Narcotics, Prescription drugs. Virginia. The submittal is for the EPA may not be able to consider your purpose of meeting the requirements for comment. Electronic files should avoid Under the authority vested in the reasonably available control technology the use of special characters, any form Attorney General by § 201(a) of the CSA (RACT) in order to implement the of encryption, and be free of any defects (21 U.S.C. 811(a)), and delegated to the maintenance plan for the Richmond 8- or viruses. Administrator of DEA by Department of hour ozone maintenance area. EPA is Docket: All documents in the Justice regulations (28 CFR 0.100), and proposing to approve the revision to the electronic docket are listed in the redelegated to the Deputy Administrator Virginia SIP in accordance with the www.regulations.gov index. Although pursuant to 28 CFR 0.104, the Deputy requirements of the Clean Air Act listed in the index, some information is Administrator hereby proposes that 21 (CAA). not publicly available, i.e., CBI or other CFR part 1308 be amended as follows: DATES: Written comments must be information whose disclosure is PART 1308—SCHEDULES OF received on or before March 3, 2008. restricted by statute. Certain other material, such as copyrighted material, CONTROLLED SUBSTANCES ADDRESSES: Submit your comments, is not placed on the Internet and will be identified by Docket ID Number EPA– 1. The authority citation for 21 CFR publicly available only in hard copy R03–OAR–2007–1139, by one of the part 1308 continues to read as follows: form. Publicly available docket following methods: materials are available either Authority: 21 U.S.C. 811, 812, 871(b) A. www.regulations.gov. Follow the electronically in www.regulations.gov or unless otherwise noted. on-line instructions for submitting in hard copy during normal business 2. Section 1308.14 is amended by comments. B. E-mail: hours at the Air Protection Division, redesignating paragraphs (c)(25) through U.S. Environmental Protection Agency, (c)(51) as (c)(26) through (c)(52) and [email protected]. C. Mail: EPA–R03–OAR–2007–1139, Region III, 1650 Arch Street, adding a new paragraph (c)(25) to read Philadelphia, Pennsylvania 19103. as follows: Cristina Fernandez, Chief, Air Quality Planning Branch, Mailcode 3AP21, U.S. Copies of the State submittal are § 1308.14 Schedule IV. Environmental Protection Agency, available at the Virginia Department of * * * * * Region III, 1650 Arch Street, Environmental Quality, 629 East Main (c) * * * Philadelphia, Pennsylvania 19103. Street, Richmond, Virginia 23219. (25) indiplon (N-methyl-N-[3-[3-(2- D. Hand Delivery: At the previously- FOR FURTHER INFORMATION CONTACT: thienylcarbonyl)-pyrazolo[1,5- listed EPA Region III address. Such Irene Shandruk, (215) 814–2166, or by a]pyrimidin-7-yl]phenyl]-acetamide)— deliveries are only accepted during the e-mail at [email protected]. 2726 Docket’s normal hours of operation, and SUPPLEMENTARY INFORMATION: On * * * * * special arrangements should be made October 29, 2007, the Commonwealth of for deliveries of boxed information. Virginia submitted a revision to its State Dated: January 22, 2008. Instructions: Direct your comments to Implementation Plan (SIP) for the Michele M. Leonhart, Docket ID No. EPA–R03–OAR–2007– control of emissions of VOCs from the Deputy Administrator. 10139. EPA’s policy is that all Kraft Foods Global, Inc.—Richmond [FR Doc. E8–1692 Filed 1–30–08; 8:45 am] comments received will be included in Bakery located in Henrico County, BILLING CODE 4410–09–P the public docket without change, and Virginia. The submittal is for the may be made available online at purpose of meeting the requirements for www.regulations.gov, including any Reasonably Available Control ENVIRONMENTAL PROTECTION personal information provided, unless Technology (RACT) in order to AGENCY the comment includes information implement the maintenance plan for the claimed to be Confidential Business Richmond 8-hour ozone maintenance 40 CFR Part 52 Information (CBI) or other information area. whose disclosure is restricted by statute. [EPA–R03–OAR–2007–1139; FRL–8523–4] Do not submit information that you I. Background Approval and Promulgation of Air consider to be CBI or otherwise RACT is the lowest emission limit Quality Implementation Plans; Virginia; protected through www.regulations.gov that a particular source is capable of Control of Volatile Organic Compound or e-mail. The www.regulations.gov Web meeting by the application of control (VOCs) Emissions From the Kraft site is an ‘‘anonymous access’’ system, technology that is reasonably available Foods Global, Inc.—Richmond Bakery which means EPA will not know your with the consideration of technological located in Henrico County, VA identity or contact information unless and economic feasibility. When the you provide it in the body of your Richmond area was originally AGENCY: Environmental Protection comment. If you send an e-mail designated as an ozone nonattainment Agency (EPA). comment directly to EPA without going area under the 1-hour standard, it was ACTION: Proposed rule. through www.regulations.gov, your classified as moderate and thereby had e-mail address will be automatically to meet the non-CTG RACT SUMMARY: EPA is proposing to approve captured and included as part of the requirements of section 182 of the CAA. a State Implementation Plan (SIP) comment that is placed in the public As part of the 1-hour ozone attainment revision submitted by the docket and made available on the plan, one of the sources located in the Commonwealth of Virginia on October Internet. If you submit an electronic area identified as being subject to non- 29, 2007. This revision pertains to a comment, EPA recommends that you CTG RACT was Nabisco Brands (now federally enforceable state operating include your name and other contact Kraft Foods). Cookies, crackers, and permit containing terms and conditions information in the body of your pretzels are produced at this plant. The for the control of emissions of volatile comment and with any disk or CD–ROM sources of VOC emissions at this plant

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