Notices. Notice
10,583 words·~48 min read·
/register/2007/11/07/07-5555·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2003-0237; FRL-8155-9] Methyl Parathion; Notice of Receipt of Requests to Voluntarily Cancel and/or Amend to Terminate Uses of Certain Methyl Parathion Pesticide Registrations AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel some registrations and amend other registrations to terminate uses of certain end-use products containing the pesticide methyl parathion.
The requests would terminate methyl parathion use in or on cabbage, dried beans, dried peas, hops, lentils, pecans, and sugar beets. The requests would not terminate the last methyl parathion products registered for use in the U.S. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests within this period.
Upon acceptance of these requests, any sale, distribution, or use of products listed in this notice will be permitted only if such sale, distribution, or use is consistent with the terms as described in the final order. DATES: Comments must be received on or before December 7, 2007. ADDRESSES: Submit your comments, identified by docket identification
(ID)number EPA-HQ-OPP-2003-0237, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2003-0237. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-8195; fax number:
(703)308-8005; e-mail address: *pates.john@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background on the Receipt of Requests to Cancel and/or Amend Registrations to Delete Uses This notice announces receipt by EPA of requests from registrants Helena Chemical Company (Company #5905), Drexel Chemical Company (Company #19713), and Cheminova A/S to cancel product registrations 5905-533, 5905-534, 19713-511, 19713-512, and Special Local Need
(SLN)WA000019, respectively. In addition, this notice announces receipt by EPA of requests from registrants Cheminova A/S (Company #4787), Cheminova, Inc. (Company #67760), and Cerexagri, Inc. (Company #4581) to amend to terminate uses from Cheminova Declare (EPA Reg. No. 4787-48), Cheminova Methyl Parathion 4EC (EPA Reg. No. 67760-43), and Penncap-M (EPA Reg. No. 4581-393) methyl parathion product registrations. Methyl parathion is an insecticide/miticide for use on various terrestrial food and feed crops to control many types of pests, including mites, thrips, weevils, aphids, and leafhoppers. In letters dated August 30, 2007 (Helena Chemical Company), June 12, 2006 (Drexel Chemical Company), and October 14, 2005 (Cheminova A/S) each registrant requested EPA to cancel affected product registrations. Also, in letters dated May 3, 2007 (Cerexagri, Inc.) and June 5, 2007 (Cheminova A/S and Cheminova, Inc.) registrants requested EPA to amend to terminate uses of pesticide product registrations identified in this notice (Tables 1 and 2). Specifically, Helena Chemical Company, Drexel Chemical Company, and Cheminova A/S have agreed to voluntarily cancel all methyl parathion product registrations which include: 4lb Methyl Parathion (EPA Reg. No. 5905-533), Malathion-Methyl Parathion Emulsifiable Liquid (EPA Reg. No. 5905-534), Drexel Methyl Parathion 4 (EPA Reg. No. 19713-511), Drexel Methyl Parathion 4E (EPA Reg. No. 19713-512), Cheminova Declare (EPA Reg. No. 4787-48), and SLN #WA-0000194 (Parent EPA No. 4787-48). In addition, Cerexagri, Inc., Cheminova A/S, and Cheminova, Inc. have requested voluntary cancellation of the following uses from their methyl parathion end product registrations: Cabbage, dried beans, dried peas, hops, lentils, pecans, and sugar beets. The registrants' requests will not terminate the last methyl parathion products registered in the United States; however, it does terminate pesticide products registered in the United States for these uses. III. What Action is the Agency Taking? This notice announces receipt by EPA of requests from registrants to cancel and/or amend to terminate uses of methyl parathion product registrations. The affected products and the registrants making the requests are identified in Tables 1-3 of this unit. Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that their pesticide registrations be canceled or amended to terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, section 6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless: 1. The registrants request a waiver of the comment period, or 2. The Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. The methyl parathion registrants have requested that EPA waive the 180-day comment period. EPA will provide a 30-day comment period on the proposed requests. Unless a request is withdrawn by the registrant within 30 days of publication of this notice, or if the Agency determines that there are substantive comments that warrant further review of this request, an order will be issued canceling and amending the affected registrations. **Table 1.—Methyl Parathion Product Registrations with Pending Requests for Cancellation** Registration No. Product name Company 5905-533 4 lb Methyl Parathion Helena Chemical Company 5905-534 Malathion-Methyl Parathion Emulsifiable Liquid Helena Chemical Company 19713-511 Methyl Parathion 4 Drexel Chemical Company 19713-512 Drexel Methyl Parathion 4E Drexel Chemical Company SLN WA000019 4787-48 (Declare) Cheminova A/S **Table 2.—Methyl Parathion Product Registrations with Pending Requests for Amendment to Delete Uses** Registration No. Product name Company 4787-48 Declare Cheminova A/S 67760-43 Methyl Parathion 4EC Cheminova, Inc. 4581-393 Penncap-M Cerexagri, Inc. Table 3 of this unit includes the names and addresses of record for the registrants of the products listed in Table 1 and Table 2 of this unit. **Table 3.—Registrants Requesting Voluntary Cancellation and/or Amendments** EPA Company No. Company name and address 4581 Cerexagri, Inc. 630 Freedom Business Center Suite 402 King of Prussia, PA 19406 4787 Cheminova A/S Washington Office 1600 Wilson Boulevard Suite 700 Arlington, VA 22209 5905 Helena Chemical Company 225 Schilling Boulevard Suite 300 Collierville, TN 38017 67760 Cheminova, Inc. Washington Office 1600 Wilson Boulevard Suite 700 Arlington, VA 22209 19713 Drexel Chemical Company 1700 Channel Avenue P.O. Box 13327 Memphis, TN 38113-0327 IV. What is the Agency's Authority for Taking this Action? Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the **Federal Register** . Thereafter, following the public comment period, the Administrator may approve such a request. V. Procedures for Withdrawal of Request and Considerations for Reregistration of Methyl Parathion Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT , postmarked before December 7, 2007. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6(f)(1) request listed in this notice. If the products have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. VI. Provisions for Disposition of Existing Stocks Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. If the request for voluntary cancellation and/or use termination is granted as discussed above, the Agency intends to issue a cancellation order that will allow persons other than the registrant to continue to sell and/or use existing stocks of cancelled products until such stocks are exhausted, provided that such use is consistent with the terms of the previously approved labeling on, or that accompanied, the cancelled product. The order will specifically prohibit any use of existing stocks that is not consistent with such previously approved labeling. If, as the Agency currently intends, the final cancellation order contains the existing stocks provision just described, the order will be sent only to the affected registrants of the cancelled products. If the Agency determines that the final cancellation order should contain existing stocks provisions different than the ones just described, the Agency will publish the cancellation order in the **Federal Register** . List of Subjects Environmental protection, Pesticides and pests. Dated: October 31, 2007. Peter Caulkins, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [FR Doc. E7-21787 Filed 11-6-07; 8:45 am] BILLING CODE 6560-507-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2007-0946; FRL-8154-9] Pesticides; Guidance for Pesticide Registrants on Labeling Revisions Required by the Final Rule “Pesticide Management and Disposal; Standards for Pesticide Containers and Containment”; Pesticide Registration Notice 2007-4 AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Availability. SUMMARY: The Agency is announcing the availability of a Pesticide Registration Notice titled “Labeling Revisions Required by the Final Rule ‘Pesticide Management and Disposal; Standards for Pesticide Containers and Containment.' ” PR Notices are issued by the Office of Pesticide Programs
(OPP)to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions and serve to provide guidance to pesticide registrants and OPP personnel. This particular PR Notice provides guidance to registrants on how to change their labels to comply with the new labeling requirements established by the container and containment rule. By August 17, 2009, all pesticide products distributed or sold by a registrant must bear labels that comply with the new requirements. FOR FURTHER INFORMATION CONTACT: Kimberly Nesci, Field and External Affairs Division (FEAD), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-8059; fax number:
(703)308-2962; e-mail address: * nesci.kimberly@epa.gov* or Nancy Fitz, FEAD, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-7385; fax number:
(703)308-2962; e-mail address: *fitz.nancy@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. You may be affected by this action if you are a pesticide registrant. This action may be of particular interest to those persons who are required to register pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket* . EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0946. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . II. What Guidance Does this PR Notice Provide? On August 16, 2006, the Agency published a Final Rule titled “Pesticide Management and Disposal; Standards for Pesticide Containers and Containment” (71 FR 47330) (FRL 8076-2) that established standards for pesticide containers and containment structures. Among other things, the final rule established requirements for label language to include the following: A statement identifying the container as refillable or nonrefillable; instructions to facilitate the removal of pesticides from containers prior to disposal or recycling; and, for nonrefillable containers, instructions for managing the container. This notice provides instructions to pesticide registrants on revising their product labels in order to implement the new requirements. Most registrants may be able to make the necessary label amendments by notification; however, in some cases an application for amendment and EPA approval may be required. By August 17, 2009, all pesticide products distributed or sold by a registrant must have labels that comply with the new requirements (40 CFR 156.159).The Agency is releasing this PR Notice as a final document and not for comment because it implements final regulations currently in place. The container and containment rule was released for public comment before the final rule was published. III. Do PR Notices Contain Binding Requirements? The PR Notice discussed in this document is intended to provide guidance to EPA personnel and decision makers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, this PR Notice is not binding on pesticide registrants. List of Subjects Environmental protection, Pesticides and pests, Pesticide labels, Pesticide labeling, Pesticide containers, Pesticide containment. Dated: October 29, 2007. Debra Edwards, Director, Office of Pesticide Programs. [FR Doc. E7-21860 Filed 11-6-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [FRL-8492-9] Proposed Administrative Cost Recovery Settlement Under Section 122(h) of the Comprehensive Environmental Response Compensation and Liability Act, as Amended, 42 U.S.C. 9622(h), Part of PCB Treatment Inc. Superfund Site AGENCY: Environmental Protection Agency (EPA). ACTION: Notice; request for public comment. SUMMARY: In accordance with Section 122(i) of the Comprehensive Environmental Response Compensation and Liability Act, as amended (CERCLA), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement with Anthony Prunsky for recovery of past response costs concerning part of the PCB Treatment Inc. Superfund Site located at 45 Ewing Street, Wyandotte County, Kansas City, Kansas, also known as the Unified Government of Wyandotte County/Kansas City, Kansas. The settlement requires Mr. Prunsky to pay to the Hazardous Substance Superfund the Net Sale Proceeds it receives through the sale of the 45 Ewing Street Property ($62,000) less the closing costs, taxes owed to Unified Government of Wyandotte County/Kansas City, Kansas and attorneys fees. The settlement requires Mr. Prunsky to pay $5000.00 to the Hazardous Substance Superfund. The settlement includes a covenant not to sue the settling parties pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a). For thirty
(30)days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the EPA Region VII office located at 901 N. 5th Street, Kansas City, Kansas. DATES: Comments must be submitted on or before December 7, 2007. ADDRESSES: The proposed settlement is available for public inspection at the EPA Region VII office, 901 N. 5th Street, Kansas City, Kansas, Monday through Friday, between the hours of 7 a.m. through 5 p.m. A copy of the proposed settlement may be obtained from the Regional Hearing Clerk, 901 N. 5th Street, Kansas City, Kansas,
(913)551-7567. Comments should reference the PCB Treatment, Inc. Superfund Site, EPA Docket No.07-2007-0009 and should be addressed to Audrey Asher, Senior Assistant Regional Counsel, 901 N. 5th Street, Kansas City, Kansas 66101. FOR FURTHER INFORMATION CONTACT: Audrey Asher at telephone:
(913)551-7255; fax number:
(913)551-7925; E-mail address: *asher.audrey@epa.gov.* Dated: October 23, 2007. Cecilia Tapia, Director, Superfund Division, Region VII. [FR Doc. E7-21894 Filed 11-6-07; 8:45 am] BILLING CODE 6560-50-P COUNCIL ON ENVIRONMENTAL QUALITY The National Environmental Policy Act and Collaboration AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Collaboration in NEPA—A Handbook for NEPA Practitioners. SUMMARY: The Council on Environmental Quality
(CEQ)has published “Collaboration in NEPA—A Handbook for NEPA Practitioners.” Designed to assist Federal agencies in more effective use of collaboration throughout the National Environmental Policy Act
(NEPA)process, the handbook is a product of an interagency work group. Public comments were solicited and the handbook was finalized after considering the comments received. “Collaboration in NEPA” is available from CEQ and can be accessed at *http://www.NEPA.gov* under the heading “Current Developments.” ADDRESSES: Electronic or facsimile requests are preferred because Federal agencies often experience mail delays as a result of security screening. Requests can be submitted via electronic mail to *hgreczmiel@ceq.eop.gov* with the subject line “NEPA Modernization (Collaboration-NEPA).” Fax requests to “NEPA Modernization (Collaboration-NEPA)” at
(202)456-0753. Requests can also be mailed to NEPA Modernization (Collaboration-NEPA), Attn: Associate Director for NEPA Oversight, 722 Jackson Place, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Horst Greczmiel at
(202)395-5750. SUPPLEMENTARY INFORMATION: The Council on Environmental Quality
(CEQ)established a National Environmental Policy Act
(NEPA)Task Force and is implementing recommendations to modernize the implementation of NEPA and make the NEPA process more effective and efficient. More information about the task force is posted on the task force Web site at *http://ceq.eh.doe.gov/ntf.* CEQ requested public comments on the proposed handbook on March 26, 2007, 72 FR 14103. Comments received are posted at *http://ceq.eh.doe.gov/ntf/implementation.html.* The handbook suggests ways in which Federal agencies can use collaboration and environmental conflict resolution strategies when preparing NEPA analyses and documentation. Collaboration is encouraged during the NEPA process as a whole and toward that end the handbook emphasizes engaging a balanced set of affected and interested parties in seeking agreement at one or more stages of the NEPA process by cultivating shared vision, trust, and communication. Acknowledging that collaboration during the NEPA process can vary considerably depending on the phase of the process and the roles by the lead agency assigns to each party, the handbook notes that providing opportunities for participation on the part of stakeholders, supplemented with outreach efforts, may be appropriate. The phases for collaboration outlined in the handbook begin with the assessment and planning phase, often referred to as “conflict” or “situation” assessments, when agencies clarify the issues and assess the opportunity for collaboration. This is followed by the convening and initiation phase when the lead agency brings parties together to inform them about the process and to develop a plan for how they can work together. Sharing interests, exchanging information, and identifying gaps in knowledge is then followed by the phase where participants seek agreement through deliberation and negotiation. That is often considered the heart of the collaborative process. The fifth and final phase is the decision-making and implementation phase. “Collaboration in NEPA” links those phases for collaboration to the stages of the NEPA process, including developing the proposed action, establishing the purpose and need, conducting scoping, developing alternatives, and analyzing impacts. The handbook concludes with a discussion of the challenges facing collaboration and providing tools for practitioners such as strategies for preventing conflicts, attitudes and behaviors to enhance collaboration, case studies, a compendium of resources, and examples of memoranda of agreement. In response to comments on the draft handbook the final handbook was improved in several ways. The discussion of collaboration at the various stages of the NEPA process was consolidated and the guide that provides examples and identifies options and tools for collaboration was augmented. Appendices were reorganized, references and case studies updated, roles of the lead agencies and applicants clarified, and the compendium of resources expanded. November 1, 2007. James L. Connaughton, Chairman, Council on Environmental Quality. [FR Doc. E7-21881 Filed 11-6-07; 8:45 am] BILLING CODE 3125-W8-P FEDERAL MARITIME COMMISSION Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the **Federal Register** . Copies of agreements are available through the Commission's Office of Agreements (202-523-5793 or *tradeanalysis@fmc.gov* ). *Agreement No.:* 012015-000. *Title:* BBC Chartering and Logistic—Dockwise Yacht Transport Agreement. *Parties:* BBC Chartering & Logistic GmbH & Co. KG, and Dockwise Yacht Transport LLC. *Filing Party:* Matthew Thomas; Troutman Sanders LLP; 401 9th Street, NW.; Suite 1000; Washington, DC 20004. *Synopsis:* The agreement authorizes BBC Chartering & Logistic GmbH & Co. KG to charter space to Dockwise Yacht Transport LLC for transport of yachts worldwide. *Agreement No.:* 012016-000. *Title:* Maersk Line / Wan Hai Space Charter Agreement. *Parties:* A.P. Moller-Maersk A/S trading under the name of Maersk Line and Wan Hai Lines Ltd. *Filing Party:* Wayne R. Rohde; Sher & Blackwell; 1850 M Street, NW., Ste 900; Washington, DC 20036. *Synopsis:* Agreement authorizes Maersk Line to charter space to Wan Hai in trade between ports of California and ports of South Korea and People's Republic of China. *Agreement No.:* 012017-000. *Title:* COSCON/SINOLINES Vessel Sharing Agreement. *Parties:* COSCO Container Lines Company Ltd. and Sinotrans Container Lines Co. Ltd. *Filing Party:* Robert B. Yoshitomi; Nixon Peabody, LLP; 555 West Fifth Street, 46th Floor; Los Angeles, CA 90013. *Synopsis:* Agreement authorizes COSCO Container Lines Company Ltd. and Sinotrans Container Lines Co., Ltd. to charter slots to each other and coordinate sailings between U.S. West Coast ports and ports in China, Korea and Japan. *Agreement No.:* 012018-000. *Title:* Matson/MELL Space Charter Agreement. *Parties:* Matson Navigation Company, Inc. and Marianas Express Lines Ltd. *Filing Party:* Sloan White; Assistant General Counsel; Matson Navigation Company; 555 12th Street; Oakland, CA 94607. *Synopsis:* The agreement authorizes Marianas Express to charter space to Matson between ports in Guam and ports in Palau and Yap. By order of the Federal Maritime Commission. Dated: November 2, 2007. Bryant L. VanBrakle, Secretary. [FR Doc. E7-21897 Filed 11-6-07; 8:45 am] BILLING CODE 6730-01-P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Applicants Notice is hereby given that the following applicants have filed with the Federal Maritime Commission an application for license as a Non-Vessel Operating Common Carrier and Ocean Freight Forwarder—Ocean Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. Chapter 409 and 46 CFR part 515). Persons knowing of any reason why the following applicants should not receive a license are requested to contact the Office of Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573. Non-Vessel Operating Common Carrier Ocean Transportation Intermediary Applicants: Atlantic Shipping Company, Inc., 56 Water Street, Fall River, MA 02721. Officers: Victor L. Depina, President (Qualifying Individual), Francisco P. Fernandes, Vice President. Speedfreight Transport, LLC, Speedfreight Cargo Transport, 1012 Grand Chanpion Drive, Rockville, MD 20850. Officers: Charity De Asis, V.P. of Marketing/Opera. (Qualifying Individual), Rimando D. Roxas, COO. Non-Vessel Operating Common Carrier and Ocean Freight Forwarder Transportation Intermediary Applicants: TBS Logistics Incorporated dba Magnum Lines, 11731 Jones Road, Suite 200, Houston, TX 77070, Officer: Kurt Miller, Vice President (Qualifying Individual). Livingston International, Inc. dba Livingston Customs Brokerage, 670 Young Street, Tonawanda, NY 14150. Officers: Henry Gayheart, Managing Director (Qualifying Individual), Maureen Anne Celmer, Senior Director. Chaucer Freight LLC, 909 Ace Drive, Wood Dale, IL 60191. Officers: Richard Tilford, Operations Director (Qualifying Individual), Mandy June Dunn, Manager (Qualifying Individual). Blue Ocean International Inc. dba Blue Ocean, Transport dba Blue Ocean Forwarding, 8424 Dundee Terrace, Miami Lakes, FL 33016. Officers: Juan Estelles, President (Qualifying Individual). Lazo Cargo/Envios Corp, 529 NW 12 Avenue, Miami, FL 33136. Officers: Jairo J. Lazo, President (Qualifying Individual), Cynthia E. Lovo, Vice President. Sifax Shipping Company, LLC, 2512 McAllister Road, Houston, TX 77092. Officers: Alfred Odetola, Operations Manager (Qualifying Individual). Clement O. Kembi, Director. Trans-System Logistics, LLC., 701 North Poast Oak, Suite 301, Houston, TX 77024. Officers: Angelica Garcia-Dunn, Asst. Vice President (Qualifying Individual), Eddie Lawson, President. Frami Freight IMP & EXP Inc., 8346 NW 68 Street, Miami, FL 33166. Officer: Franklin B. Cruz, President (Qualifying Individual). Ocean Freight Forwarder—Ocean Transportation Intermediary Applicants: Aprile USA, Inc., 1370 Broadway, Suite 1006, New York, NY 10018. Officers: Anna Cilento, Asst. Secretary (Qualifying Individual), Carlo Pozzi, President. Dated: November 2, 2007. Bryant L. VanBrakle, Secretary. [FR Doc. E7-21898 Filed 11-6-07; 8:45 am] BILLING CODE 6730-01-P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Revocations The Federal Maritime Commission hereby gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR part 515, effective on the corresponding date shown below: *License Number:* 013324N. *Name:* Competent Services, Inc. dba CSC Lines *Address:* 271 Route 46 West, Ste. C-205, Fairfield, NJ 07004. *Date Revoked:* October 9, 2007. *Reason:* Surrendered license voluntarily. *License Number:* 000132F. *Name:* I.L. Cohen Co., Inc. *Address:* 150-30 132nd Ave., Ste. 208, Jamaica, NY 11434. *Date Revoked:* October 21, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 003963F. *Name:* Natural Freight Ltd. dba Bronco Container Lines. *Address:* Transportation Bldg., 225 Broadway, Ste. 2406, New York, NY 10007. *Date Revoked:* October 20, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 016960N. *Name:* Sesco Group, Inc. *Address:* 4453 Durfee Ave., El Monte, CA 91732 *Date Revoked:* October 25, 2007. *Reason:* Surrendered license voluntarily. *License Number:* 017151N. *Name:* Ultra Air Cargo, Inc. *Address:* 555 S. Isis Ave., Inglewood, CA 90301. *Date Revoked:* October 26, 2007. *Reason:* Failed to maintain a valid bond. Sandra L. Kusumoto, Director, Bureau of Certification and Licensing. [FR Doc. E7-21892 Filed 11-6-07; 8:45 am] BILLING CODE 6730-01-P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Reissuance Notice is hereby given that the following Ocean Transportation Intermediary license has been reissued by the Federal Maritime Commission pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR part 515. License No. Name/address Date reissued 003963N Natural Freight Ltd., dba Bronco Container Lines, 225 Broadway, Suite 2406, New York, NY 10007 October 20, 2007. Sandra L. Kusumoto, Director, Bureau of Certification and Licensing. [FR Doc. E7-21891 Filed 11-6-07; 8:45 am] BILLING CODE 6730-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science. ACTION: Notice. Authority: 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. SUMMARY: The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill five positions on the Committee membership that will be vacated at scheduled intervals during the 2008 calendar year. DATES: Nominations for membership on the Committee must be received no later than December 7, 2007. ADDRESSES: Nominations should be mailed or delivered to: Dr. Ivor Pritchard, Acting Director, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200; Rockville, MD 20852. Nominations will not be accepted by e-mail or by facsimile. FOR FURTHER INFORMATION CONTACT: Dr. Kevin Prohaska, Acting Executive Director, SACHRP, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, telephone: 240-453-8231. A copy of the Committee charter and list of the current members can be obtained by contacting Dr. Prohaska, accessing the SACHRP Web site at *http://www.hhs.gov/ohrp/sachrp* , or requesting via e-mail at *sachrp@osophs.dhhs.gov.* SUPPLEMENTARY INFORMATION: The Committee provides advice on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. Specifically, the Committee provides advice relating to the responsible conduct of research involving human subjects with particular emphasis on special populations such as neonates and children, prisoners, the decisionally impaired, pregnant women, embryos and fetuses, individuals and populations in international studies, investigator conflicts of interest and populations in which there are individually identifiable samples, data, or information. In addition, the Committee is responsible for reviewing selected ongoing work and planned activities of the OHRP and other offices/agencies within HHS responsible for human subjects protection. These evaluations may include, but are not limited to, a review of assurance systems, the application of minimal research risk standards, the granting of waivers, education programs sponsored by OHRP, and the ongoing monitoring and oversight of institutional review boards and the institutions that sponsor research. *Nominations:* The Office for Human Research Protections is requesting nominations to fill five positions for voting members of SACHRP. The five positions will become vacant at scheduled intervals during the 2008 calendar year. Nominations of potential candidates for consideration are being sought from a wide array of fields, including, but not limited to: Public health and medicine, behavioral and social sciences, health administration, and biomedical ethics. To qualify for consideration of appointment to the Committee, an individual must possess demonstrated experience and expertise in any of the several disciplines and fields pertinent to human subjects protection and/or clinical research. The individuals selected for appointment to the Committee can be invited to serve a term of up to four years. Committee members receive a stipend and reimbursement for per diem and any travel expenses incurred for attending Committee meetings and/or conducting other business in the interest of the Committee. Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration:
(1)A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity), and a statement that the nominee is willing to serve as a member of the Committee;
(2)the nominator's name, address and daytime telephone number, and the home and/or work address, telephone number, and email address of the individual being nominated; and
(3)a current copy of the nominee's curriculum vitae. Federal employees should not be nominated for consideration of appointment to this Committee. The Department makes every effort to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made to ensure that individuals from a broad representation of geographic areas, women and men, ethnic and minority groups, and the disabled are given consideration for membership on HHS Federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Documentation must be included in the nomination to indicate that the nominated individual is willing to serve as a member of SACHRP. Individuals who are selected to be considered for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. Disclosure of this information is necessary in order to determine if the selected candidate is involved in any activity that may pose a potential conflict with the official duties to be performed as a member of SACHRP. Dated: October 31, 2007. Ivor A. Pritchard, Acting Director, Office for Human Research Protections, Acting Executive Secretary, Secretary's Advisory Committee on Human Research Protections. [FR Doc. E7-21824 Filed 11-6-07; 8:45 am] BILLING CODE 4150-36-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Minority Health AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office of Minority Health. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services
(DHHS)is hereby giving notice that the Advisory Committee on Minority Health
(ACMH)will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail *acmh@osophs.dhhs.gov.* DATES: The meeting will be held on November 27, 2007, from 9 a.m. to 4 p.m. ADDRESSES: The meeting will be held at the DoubleTree Hotel, Terrace Ballroom, 1515 Rhode Island Ave., NW., Washington, DC 20005. The meeting is accessible from the Dupont Circle and McPherson Square Metro Stations. From the Dupont Circle Metro Station meeting participants may walk 2 blocks south on Connecticut Avenue, turn left on Rhode Island Avenue for approximately 5 blocks. The DoubleTree is on the left after Logan Circle. From the McPherson Square Metro Station meeting participants may walk 5 blocks north on 14th Street, turn right on to Rhode Island Avenue for approximately 2 blocks. The DoubleTree will be on the left after Logan Circle. FOR FURTHER INFORMATION AND REGISTRATION CONTACT: Ms. Monica A. Baltimore, Tower Building, 1101 Wootton Parkway, Suite 600, Rockville, Maryland 20852; phone:
(240)453-2882; fax:
(240)453-2883. SUPPLEMENTARY INFORMATION: In accordance with Public Law 105-392, the ACMH was established to provide advice to the Deputy Assistant Secretary for Minority Health in improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of the Office of Minority Health. Topics to be discussed during this meeting will include Integrating Racially and Ethnically Diverse Communities into Emergency Preparedness and other strategies to improve the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities, as well as other related issues. Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person at least fourteen business days prior to the meeting. Members of the public will have an opportunity to provide comments at the meeting. Public comments will be limited to five minutes per speaker. Individuals who would like to submit written statements should mail or fax their comments to the Office of Minority Health at least five business days prior to the meeting. Any members of the public who wish to have printed material distributed to ACMH committee members should submit their materials to Garth N. Graham, M.D., M.P.H., Executive Secretary, ACMH, Tower Building, 1101 Wootton Parkway, Suite 600, Rockville, Maryland 20852, prior to close of business November 23, 2007. Dated: October 30, 2007. Garth N. Graham, Deputy Assistant Secretary for Minority Health. [FR Doc. E7-21822 Filed 11-6-07; 8:45 am] BILLING CODE 4150-29-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-07-07BS] Proposed Data Collections Submitted for Public Comment and Recommendations; Notice This 60 Day **Federal Register** Notice published on September 27, 2007 (72 FR 54915-54916) has been inadvertently republished. This is a duplicate document of the previous FRN that was published on October 27, 2006. Therefore, we would like to retract it. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-21864 Filed 11-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): State Based Occupational Safety and Health Surveillance Review, Program Announcement
(PA)PAR04-106 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Time and Date:* 8 a.m.-5 p.m., November 30, 2007 (Closed). *Place:* Renaissance Hotel, 6th Avenue, Pittsburgh, PA 15222. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “State Based Occupational Safety and Health Surveillance Review, PA PAR04-106. *For Further Information Contact:* Stephen Olenchock, Ph.D., Scientific Review Administrator, Office of Extramural Coordination and Special Projects, National Institute for Occupational Safety and Health, CDC, 1095 Willowdale Road, Morgantown, WV 26505, Telephone
(304)285-6271. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: October 29, 2007. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-21842 Filed 11-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0427] Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is withdrawing approval of 73 new drug applications
(NDAs)and 62 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. EFFECTIVE DATE : December 7, 2007. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing. Application No. Drug Applicant NDA 6-459 Hetrazan (diethylcarbamaxine citrate) Tablets and Syrup Lederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 6-799 Rubramin and Rubramin PC (cyanocobalamin injection USP) Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000 NDA 7-517 Tapazole (methimazole tablets USP), 5 milligrams
(mg)and 10 mg King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620 NDA 7-942 Sus-Phrine (epinephrine) Injection Forest Laboratories, Inc., Harborside Financial Center, Plaza Three, suite 602, Jersey City, NJ 07311 NDA 9-319 Ambenyl Expectorant and Ambenyl Cough Syrup Do. NDA l0-533 PBZ SR (tripelennamine HCl USP) Extended-Release Tablets Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080 NDA 10-744 Darbid (isopropamide iodide) Tablets SmithKline Beecham Corp., d/b/a/ GlaxoSmith Kline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709 NDA 10-909 Miradon (anisindione) Tablets Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 NDA 11-213 Trilafon (perphenazine) Injection, 5 mg/milliliter
(mL)Do. NDA 11-283 Kenacort (tramcinolone) Tablets Bristol-Myers Squibb Co. NDA 11-808 Mellaril (thioridazine HCl) Tablets Novartis Pharmaceuticals Corp. NDA 12-145 Prolixin (fluphenazine HCl) Elixir, 0.5 mg/mL Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500 NDA 12-313 BIO-CLEAR (dibenzothiophene) Cream Helena Rubinstein, 202 Rodney Bldg., 3411 Silverside Rd., Wilmington, DE 19810 NDA 12-665 Velban (vinblastine sulfate) for Injection Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 NDA 12-678 Tolbutamide Tablets Sandoz Inc., 227-15 North Conduit Ave., Laurelton, NY 11413 NDA 12-796 Quinidex Extentabs (quinidine sulfate extended-release tablets USP) Wyeth Pharmaceuticals, Inc. NDA 14-103 Oncovin (vincristine sulfate) Injection Eli Lilly and Co. NDA 14-242 Dexacort (dexamethasone sodium phosphate) Turbinaire UCB, 755 Jefferson Rd., Rochester, NY 14623 NDA 14-262 Solbar (dioxybenzone and oxybenzone) Cream Person & Covey, Inc., 616 Allen Ave., Glendale, CA 91201 NDA 16-363 Lasix (furosemide) 10-mg/mL Injection Sanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807-0977 NDA 16-408 WILDROOT (pyrithione zinc) Hair Groom and Grenadier Hair Groom Colgate-Palmolive Co., 909 River Rd., Piscataway, NJ 08854-5596 NDA 16-729 Ferrous Citrate Fe 59 Injection Mallinckrodt Inc., 675 McDowell Blvd., P.O. Box 5840, St. Louis, MO 63134 NDA 16-820 Emete-Con (benzquinamide HCl) Injection Pfizer, Inc., 235 East 42nd St., New York, NY 10017 NDA 16-847 Isopaque 440 (metrizoate sodium, meglumine metrizoate, calcium metrizoate, and metrizoate magnesium) Injection GE Healthcare, 101 Carnegie Center, Princeton, NJ 08540 NDA 17-430 Neggram (nalidixic acid USP) Suspension Sanofi-Aventis NDA 17-466 Bricanyl (terbutaline sulfate) Injection Sanofi-Aventis NDA 17-506 Isopaque 280 (metrizoic acid, meglumine, and calcium) Injection GE Healthcare NDA 17-613 Lotrimin (clotrimazole) Topical Solution, 1% Schering Corp. NDA 17-618 Bricanyl (terbutaline sulfate) Tablets Sanofi-Aventis NDA 17-619 Lotrimin (clotrimazole) Cream, 1% Schering Corp. NDA 17-668 Tenuate (diethylpropion HCl) Tablets, 25 mg Sanofi-Aventis NDA 17-669 Tenuate (diethylpropion HCl) Extended-Release Tablets, 75 mg Sanofi-Aventis NDA 17-688 Lasix (furosemide) Oral Solution, 10 mg/mL Sanofi-Aventis NDA 17-719 Dimeray (iocarmate meglumine) Injection Mallinckrodt Inc. NDA 17-725 Sodium Pertechnetate Tc-99m (technectium Tc-99m sodium pertechnetate) Mallinckrodt Inc. NDA 17-730 Isopaque 370 (metrizoic acid and meglume) Injection GE Healthcare NDA 17-769 Calcimar (calcitonin salmon) Injection Sanofi-Aventis NDA 17-838 Lungaggregate Reagent GE Healthcare NDA 17-848 Tc-99m Lungaggregate Do. NDA 17-907 Glucoscan Kit for the Preparation of Technetium Tc-99m Gluceptate Bristol-Myers Squibb Pharma Co., Chestnut Run Plaza, 974 Centre Rd., Wilmington, DE 19805 NDA 17-923 Mellaril-S (thioridazine HCl) Oral Suspension Novartis Pharmaceuticals Corp. NDA 17-956 Tepanil (diethylpropion HCl) Ten-Tabs 3M Pharmaceuticals, 3M Center, Bldg 0275-05-W-12, St. Paul, MN 55144-1000 NDA 18-000 Bricanyl (terbutaline sulfate) Inhaler Sanofi-Aventis NDA 18-067 Cinobac (cinoxacin) Capsules, 250 mg and 500 mg Eli Lilly and Co. NDA 18-088 Krypton Kr-81m Gas Generator GE Healthcare NDA 18-148 Nasalide (flunisolide) Nasal Spray IVAX Research, Inc., 4400 Biscayne Blvd., Miami, FL 33137 NDA 18-489 Technescan HIDA (kit for the preparation of technetium Tc-99m lidofenin injection) Draximage, 16751 Autoroute TransCanada Highway, Kirkland, Quebec, H9H 4J4, Canada NDA 18-519 Irrigation Solution G (citric acid and sodium carbonate) Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085 NDA 18-554 Eulexin (flutamide) Capsules Schering Corp. NDA 18-700 Inocor (inamrinone lactate) Injection, 5 mg base/mL Sanofi-Synthelabo Inc., c/o Sanofi-Aventis, 300 Somerset Corporate Blvd., P.O. Box 6977, Bridgewater, NJ 08807-0977 NDA 18-770 Tornalate (bitolterol mesylate) Metered-Dose Inhaler Sanofi-Aventis NDA 18-813 Lotrimin (clotrimazole) Lotion, 1% Schering Corp. ANDA 18-862 Betatrex (betamethasone valerate cream USP, 0.1%) Savage Laboratories, 60 Baylis Rd., Melville, NY 11747 ANDA 18-863 Betatrex (betamethasone valerate ointment USP, 0.1%) Do. ANDA 18-867 Betatrex (betamethasone valerate lotion USP, 0.1%) Do. NDA 19-084 Nizoral (ketoconazole) Cream, 2% Johnson & Johnson Pharmaceutical Research & Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560 NDA 19-284 Oral Colonic Lavage
(OCL)(sodium chloride, sodium bicarbonate, sodium sulfate, potassium chloride, and polyethelene glycol 3350) Hospira, Inc., 275 North Field Dr., Bldg. 2-J45-2, Lake Forest, Il 60045-5046 NDA 19-408 Diprolene (betamethasone dipropionate) Schering Corp. NDA 19-459 Photoplex (7% padimate O and 3% avobenzone) Lotion Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534 NDA 19-520 Travasol (amino acid) in Dextrose Injection Baxter Healthcare Corp. NDA 19-545 Didronel (etidronate disodium) Injection MGI Pharma, Inc., 5775 West Old Shakopee Rd., suite 100, Bloomington, MN 55437-3174 NDA 19-548 Tornalate (bitolterol mesylate) Inhalatioon Solution, 0.2% Sanofi-Aventis NDA 19-576 Nizoral (ketoconazole) Cream, 2% Johnson & Johnson Pharmaceutical & Development, LLC NDA 19-648 Nizoral (ketoconazole) Cream, 2% Do. NDA 20-091 Imagent (perflubron) Alliance Pharmaceuticals Corp., 4660 La Jolla Dr., suite 740, San Diego, CA 92122 NDA 20-147 Travasol (amino acid) with Electrolytes in Dextrose Injection Baxter Healthcare Corp. NDA 20-228 Atrovent (ipratropium bromide) Inhalation Solution Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 NDA 20-303 Prempro/Premphase (conjugated estrogens and medroxyprogesterone acetate) Tablets Wyeth Pharmaceuticals, Inc. NDA 20-315 Orlaam (levomethadyl acetate HCl) Oral Solution Roxane Laboratories, P.O. Box 16532, Columbus, OH 43216-6532 NDA 20-486 Vanceril (beclomethasone dipropionate) Double Strength Aerosol Schering Corp. NDA 20-887 AcuTect Kit for the Preparation of Technetium Tc-99m Apticide Injection CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730 NDA 21-012 Neo-Tect Kit for the Preparation of Technetium Tc-99m Depreotide Injection Do. NDA 21-075 Nutropin Depot (somatropin recombinant) Genentech Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990 ANDA 40-098 Acetaminophen and Codeine Phosphate Oral Solution USP Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512 NDA 50-477 Nebcin (tobramycin sulfate) for Injection Eli Lilly and Co. NDA 50-519 Nebcin (tobramycin sulfate) for Injection Do. NDA 50-678 Dynabac (dirithromycin delayed-release tablets USP) Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 ANDA 60-212 Grisactin (griseofulvin microcrystalline) Tablets, 500 mg Wyeth Ayerst Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101 ANDA 60-570 Fungizone (amphotericin B lotion USP), 3% Apothecon, c/o Bristol-Myers Squibb Co. ANDA 60-751 NEO-CORTEF (neomycin sulfate and hydrocortisone acetate) Ointment Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017 ANDA 61-007 Terramycin (oxytetracycline HCl, polymyxin B sulfate) Topical Ointment with Polymyxin B Sulfate Pfizer, Inc. ANDA 61-131 Nystatin Powder USP Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 61-411 Veetids (penicillin V potassium tablets USP), 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 61-737 ZIBA-Rx (bacitracin zinc USP) X-GEN Pharmaceuticals, Inc., P.O. Box 1148, Elmira, NY 14902 ANDA 61-859 Anspor (cephradine) Capsules, 250 mg and 500 mg GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 ANDA 61-866 Anspor (cephradine) for Oral Suspension Do. ANDA 61-876 Cerubidine Injection (daunorubice HCl for injection USP) Sanofi-Aventis ANDA 62-519 Nystex (nystatin) Oral Suspension USP, 100,000 units/mL Savage Laboratories ANDA 62-560 Mandol (cefamadole nafate for injection USP) Eli Lilly and Co. ANDA 62-739 Tazidime (ceftazidime) Do. ANDA 62-745 Cephalexin Tablets USP Do. ANDA 62-888 Principen (ampicillin capsules USP), 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 62-926 Rubex (doxorubicin HCl for injection USP) Bristol-Myers Squibb Co. ANDA 63-021 Kanamycin Sulfate Injection USP, 75 mg/2 mL Loch Pharmaceuticals, c/o Bedford Laboratories, A Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146 ANDA 63-022 Kanamycin Sulfate Injection USP, 500 mg/2 mL Do. ANDA 63-025 Kanamycin Sulfate Injection USP, 1 gram (g)/3 mL Do. ANDA 63-099 Trimox (amoxicillin capsules USP), 250 mg and 500 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 70-867 Vincrex (vincristine sulfate for injection USP), 5 mg/vial Bristol-Myers Squibb Co. ANDA 71-742 Clorazepate Dipotassium Capsules, 3.75 mg Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 71-743 Clorazepate Dipotassium Capsules, 7.5 mg Do. ANDA 71-744 Clorazepate Dipotassium Capsules, 15 mg Do. ANDA 72-326 Fenoprofen Calcium Tablets USP, 600 mg Do. ANDA 72-507 Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg Do. ANDA 72-508 Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg Do. ANDA 72-509 Methyldopa and Hydrochlorothiazide Tables USP, 500 mg/30 mg Do. ANDA 72-510 Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg Do. ANDA 72-705 Prazosin HCl Capsules USP, 1 mg Do. ANDA 72-706 Prazosin HCl Capsules USP, 2 mg Do. ANDA 72-707 Prazosin HCL Capsules USP, 5 mg Do. ANDA 74-258 Metoprolol Tartrate Tablets USP, 50 mg and 100 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 74-423 Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Clonmel Healthcare, Ltd., c/o of STADA Pharmaceuticals Inc. ANDA 74-472 Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Apothecon, c/o Bristol-Myers Squibb Co. ANDA 75-407 Morphine Sulfate Extended-Release Tablets USP, 15 mg Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 80-745 Aristocort (triamcinolone acetonide) Ointment, 0.5% Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2537 ANDA 80-750 Aristocort (triamcinolone acetonide) Ointment, 0.1% Do. ANDA 83-015 Aristocort (triamcinolone acetonide) Cream, 0.5% Do. ANDA 83-016 Aristocort (triamcinolone acetonide) Cream, 0.1% Do. ANDA 83-017 Aristocort (triamcinolone acetonide) Cream, 0.025% Do. ANDA 83-149 PBZ (tripelennamine HCl) Tablet, 25 mg Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936-1080 ANDA 83-317 Propoxyphene HCl Capsules, 65 mg Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ANDA 83-380 Aristogel (triamcinolone acetonide) Gel, 0.1% Astellas Pharma US, Inc. ANDA 83-881 Aristocort A (triamcinolone acetonide) Spray Do. ANDA 86-212 Chlordiazepoxide HCl Capsules, 25 mg Impax Laboratories, Inc. ANDA 86-213 Chlordiazepoxide Capsules, 5 mg Do. ANDA 86-358 Mexate (methotrexate sodium for injection) Bristol-Myers Squibb Co. ANDA 86-926 Tolbutamide Tablets USP, 500 mg Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc. ANDA 87-011 Quinidine Sulfate Tablets USP, 200 mg Do. ANDA 87-677 Hydrocodone Bitartrate and Acetaminophen B.F. Ascher & Co., Inc., 15501 West 109th St., Lenexa, KS 66219 ANDA 87-887 TRYSUL (triple sulfa vaginal cream USP) Savage Laboratories ANDA 88-584 DHC Plus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules The Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431 ANDA 88-760 Mexate-AQ (methotrexate sodium injection USP), 25 mg Bristol-Myers Squibb Co. ANDA 88-780 Aristocort A Ointment (triamcinolone acetonide ointment USP), 0.1% Astellas Pharma US, Inc. ANDA 88-781 Aristocort A (triamcinolone acetonide) Ointment, 0.5% Do. ANDA 88-944 Sedapap (butalbital and acetaminophen) Tablets, 50 mg/650 mg Merz Pharmaceuticals, LLC, 4215 Tudor Lane, Greensboro, NC 27410 ANDA 89-887 Mexate-AQ Preserved (methotrexate sodium injection USP), 25 mg/mL Bristol-Myers Squibb Co. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective December 7, 2007. Dated: October 26, 2007. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E7-21886 Filed 11-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [CIS No. 2427-07; DHS Docket No. USCIS-2007-0054] RIN No. 1615-ZA62 Announcement of a Stakeholder Meeting on the Evaluation of E-Verify AGENCY: U.S. Citizenship and Immigration Services, DHS. ACTION: Notice of meeting. SUMMARY: The E-Verify program, formerly Basic Pilot, is an online tool that allows participating employers to confirm the employment eligibility of their newly hired employees, regardless of citizenship, to help maintain a stable, legal workforce. The purpose of this Notice is to announce to interested members of the public a stakeholder meeting on the evaluation of the E-Verify Program to identify program strengths and weaknesses from multiple perspectives and to assist the evaluation staff in prioritizing research topics. *Date and Time:* The meeting will be held on Tuesday, November 27, 2007, from 8:30 a.m. to 5 p.m. ADDRESSES: The meeting will be held at the Washington Court Hotel, 525 New Jersey Avenue, NW., Washington, DC 20001. FOR FURTHER INFORMATION CONTACT: Sara Speckhard, U.S. Citizenship and Immigration Services (USCIS), Department of Homeland Security, Office of Policy & Strategy, 20 Massachusetts Avenue, NW., Room 4012, Washington, DC 20529. Telephone:
(202)272-1470. *Research contact:* Ms. Marsha Lyons, Westat, 1650 Research Boulevard, Rockville, MD 20850. Telephone:
(301)517-4050, Fax:
(301)294-3992. E-mail: *MarshaLyons@westat.com.* SUPPLEMENTARY INFORMATION: On September 15, 1997, the legacy Immigration and Naturalization Service
(INS)published a notice in the **Federal Register** describing pilot programs that were required by section 403 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA). On December 20, 2004, the U.S. Citizenship and Immigration Services (USCIS) announced the extension of one of these programs, the Basic Pilot, to November 30, 2008. Renamed E-Verify, the current program constitutes an online modification of the Basic Pilot and allows participating employers to confirm the employment eligibility of their newly hired employees regardless of citizenship to help maintain a stable, legal workforce. E-Verify is operated jointly by USCIS and the Social Security Administration. An evaluation of the current E-Verify program is being conducted by Westat, Inc. This notice announces a public meeting to seek stakeholder input regarding the E-Verify program. Summary of Agenda • Introductions and Purpose. • Update on E-Verify. • Overview of the Key Findings of the FY2007 evaluation and the current evaluation goals. • Break-out group discussions to address topics such as using biometrics for verification, resolving tentative confirmations, timing of employee verifications, and focusing on specific types of employers (i.e., designated agents, employers using designated agents, employment agencies and temporary help agencies, inactive employers). • Reports from break-out groups. • Questions and comments. Public Participation The meeting is open to the public, but advance notice of attendance is requested to ensure adequate seating. In the event that requests for attendance exceed available space, it may not be possible to honor all requests. Persons planning to attend should notify Ms. Lyons at least 5 days prior to the meeting. Dated: November 1, 2007. Jonathan R. Scharfen, Deputy Director, U.S. Citizenship and Immigration Services. [FR Doc. E7-21829 Filed 11-6-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WO-260-09-1060-00-24 1A] Notice of Extension for the Call for Nominations for the Wild Horse and Burro Advisory Board AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Extension. SUMMARY: The purpose of this notice is to extend the submission date to solicit nominations for the Wild Horse and Burro Advisory Board. The **Federal Register** notice for nominations published in the **Federal Register** on September 17, 2007 [72 FR 52906]. DATES: This notice extends the date to December 7, 2007. ADDRESSES: The nominations should be submitted to the National Wild Horse and Burro Program, Bureau of Land Management, Department of Interior, P.O. Box 12000, Reno, Nevada 89520-0006, *Attn:* Ramona DeLorme: fax
(775)861-6711. FOR FURTHER INFORMATION CONTACT: Don Glenn, Acting Division Chief, Wild Horse and Burro Group,
(202)452-5082. Individuals who use a telecommunications device for the deaf
(TDD)may reach Ms. DeLorme at any time by calling the Federal Information Relay Service at 1
(800)877-8339. Dated: October 30, 2007. Bud Cribley, Deputy Assistant Director, Renewable Resources and Planning. [FR Doc. E7-21887 Filed 11-6-07; 8:45 am] BILLING CODE 4310-84-P INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-613] In the Matter of Certain 3G Mobile Handsets and Components Thereof; Notice of Commission Decision Not To Review an Initial Determination Granting Complainants' Motion To Amend the Complaint and Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 3) issued by the presiding administrative law judge (“ALJ”) granting complainants’ motion to amend the complaint and notice of investigation. FOR FURTHER INFORMATION CONTACT: Michelle Walters, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone
(202)708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone
(202)205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at *http://www.usitc.gov.* The public record for this investigation may be viewed on the Commission's electronic docket
(EDIS)at *http://edis.usitc.gov.* Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on
(202)205-1810. SUPPLEMENTARY INFORMATION: The Commission instituted Inv. No. 337-TA-613 on September 11, 2007, based on a complaint filed by InterDigital Communications Corporation of King of Prussia, Pennsylvania, and InterDigital Technology Corporation of Wilmington, Delaware (collectively, “InterDigital”). The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain 3G mobile handsets and components thereof by reason of infringement of various claims in United States Patent Nos. 7,117,004 and 7,190,966. The complaint named Nokia Corporation of Finland and Nokia Inc. of Irving, Texas as respondents. On September 28, 2007, InterDigital filed a motion to amend the complaint and notice of investigation to add allegations of unfair trade practices in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain 3G mobile handsets and components thereof by reason of infringement of various claims in United States Patent No. 6,973,579 (“the ‘579 patent”). The Commission investigative attorney supported the motion. On October 11, 2007, the ALJ granted InterDigital's motion, finding that, pursuant to Commission Rule 210.14(b)(1) (19 CFR 210.14(b)(1)), there was good cause to add the allegations based on the ‘579 patent. No petitions for review were filed. The Commission has determined not to review the ALJ's ID. The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.42 of the Commission's Rules of Practice and Procedure (19 CFR 210.42). By order of the Commission. Issued: November 1, 2007. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E7-21837 Filed 11-6-07; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Advanced Media Workflow Association, Inc. (Formerly AAF Association, Inc.) Notice is hereby given that, on September 19, 2007, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (``the Act''), Advanced Media Workflow Association, Inc. has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, BPI Improve, Princes Risborough, UNITED KINGDOM; Discovery Communications, Silver Spring, MD; Marquis Broadcast Ltd., Pangbourne, UNITED KINGDOM; National Geographic, Washington, DC; and SAIC, McLean, VA have been added as parties to this venture. Also, Blue Order, Kaiserslautern, GERMANY; Closed Captioning Service, Inc., Burbank, CA; Grizzly Systems, Bellvue, CO; ITSSO, Mapogu, REPUBLIC OF KOREA; and Mediaware International, Arlington, VA have withdrawn as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Advanced Media Workflow Association, Inc. intends to file additional written notifications disclosing all changes in membership. On March 28, 2000, advanced Media Workflow Association, Inc. filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to Section 6(b) of the Act on June 29, 2000 (65 FR 40127). The last notification was filed with the Department on June 22, 2007. A notice was published in the **Federal Register** pursuant to Section 6(b) of the Act on September 11, 2007 (72 FR 51838). Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. 07-5555 Filed 11-06-07; 8:45 am]
Connectionstraces to 8
Traces to 8 documents
U.S. Code
5 references not yet in our index
- 40 CFR 2
- 40 CFR 156.159
- 46 CFR 515
- Pub. L. 92-463
- Pub. L. 105-392
Citation graph
cites case law
Notices
Notice
Cite40 CFR 2
Cite40 CFR 156.159
Cite46 CFR 515
Pub. L.Pub. L. 92-463
Cites 13 · showing 12Cited by 0 across 0 sources