Notices. Request for Information

7,804 words·~35 min read·/register/2010/01/06/2010-8

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

BILLING CODE 6560-50-S FEDERAL TRADE COMMISSION Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification Rules Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans.

Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the **Federal Register** . The following transactions were granted early termination of the waiting period provided by law and the premerger notification rules. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice.

Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period. Transaction Granted Early Termination ET date Trans. No. ET req status Party name 30-NOV-09 20100139 G German Efromovich. G 5K Holdings Limited. G 5K Holdings Limited. 20100140 G Jose Efromovich. G SK Holdings Limited. G SK Holdings Limited. 20100156 G Welsh, Carson, Anderson & Stowe XI, L.P. G Spectrum Holding Company, Inc. G Spectrum Holding Company, Inc. 20100158 G Superior Plus Corp.

G CH Energy Group, Inc. G Griffith Energy Services, Inc. 20100168 G Logitech International S.A. G LifeSize Communications, Inc. G LifeSize Communications, Inc. 20100174 G Warburg Pincus Equity Partners, L.P. G InterMune, Inc. G InterMune, Inc. 20100181 G Inergy, L.P. G High Sierra Energy, LP. G Monroe Gas Storage Company, LLC. 20100186 G Denbury Resources Inc. G Encore Acquisition Company. G Encore Acquisition Company. 01-DEC-09 20090570 G Watson Pharmaceuticals, Inc. G Quiver Trust.

G Robin Hood Holdings Limited. 20100093 G Roper Industries, Inc. G Verathon, Inc. G Verathon, Inc. 20100138 G Bristol-Myers Squibb Company. G Alder Biopharmaceuticals Inc. G AiderBio Holdings, LLC. 20100149 G JLL Partners Fund V, L.P. G KIMC Investments, Inc. G KIMC Investments, Inc. 20100153 G Ares Corporation. G Allied Capital Corporation. G Allied Capital Corporation. 20100173 G Brian Pratt. G James Construction Group, LLC. G James Construction Group, LLC. 20100180 G Mr. Li Tzar Kai, Richard.

G AIG Credit Facility Trust. G Pine Bridge Investments Fund Management Ltd. G Pine Bridge Investments Schweiz GmbH. G AIG Investments Japan Co., Ltd. G AIG Japan Capital Investment Co., Ltd. G Pine Bridge Investments Canada Inc. G Pine Bridge Investments Asia Limited. G Pine Bridge Global Investments LLC. G Pine Bridge Capital Partners LLC. G Brazos Capital Management, L.P. G New Brazos GP LLC. 20100185 G Telapex, Inc. G Bryan A. Corr, Sr. and Tina N. Corr. G CWC License Holding, Inc.

G Corr Wireless Communications, LLC. 20100194 G Lightyear Fund II, L.P. G ING Groep NV. G PrimeVest Financial Services, Inc. G ING Brokers Network, LLC. G FNI International, Inc. 03-DEC-09 20100178 G Windstream Corporation. G NuVox, Inc. G NuVox, Inc. 20100179 G ALLETE, Inc. G Square Butte Electric Cooperative. G Square Butte Electric Cooperative. 04-DEC-09 20100199 G Rockwell Collins, Inc. G AR Group, Inc. G AR Group, Inc. 20100200 G Berkshire Hathaway Inc. G Burlington Northern Santa Fe Corporation.

G Burlington Northern Santa Fe Corporation. 20100201 G Clarus Lifesciences I, L.P. G Globus Medical, Inc. G Globus Medical, Inc. 20100205 G Vista Equity Partners Fund Ill, L.P. G Intuit Inc. G Intuit Inc. 20100211 G Jacobs Engineering Group Inc. G TYBRIN Corporation. G TYBRIN Corporation. 20100222 G SandRidge Energy, Inc. G Forest Oil Corporation. G Forest Oil Permian Corporation. 05-DEC-09 20100191 G GDF SUEZ. G Astoria Project Partners LLC. G Astoria Project Partners LLC. 09-DEC-09 20100108 G SPX Corporation.

G Connell Limited Partnership. G Yuba Heat Transfer LLC. 20100113 G Corinthian Colleges, Inc. G Heald Investment, LLC. G Heald Capital, LLC. 20100141 G Sonova Holding AG Alfred E. Mann. G Advanced Bionics Corporation. G Advanced Bionics, LLC. 20100204 G Dover Corporation. G Mr. David C. Orlowski. G Isotech of Illinois, Inc. 08-DEC-09 20100142 G Odyssey Investment Partners Fund IV AIV I, L.P. G ThyssenKrupp AG. G ThyssenKrupp Safway, LLC. 20100176 G Healthcare Technology Holdings, Inc.

G IMS Health Incorporated. G IMS Health Incorporated. 20100193 G Abbott Laboratories. G PanGenetics 110 B.V. G PanGenetics 110 B.V. 10-DEC-09 20100120 G Qiagen N.V. G SA Biosciences Corporation. G SA Biosciences Corporation. 20100152 G Emergency Medical Service Corporation. G Pinnacle Consultants Limited Partnership. G MSO Newco, LLC. G Pinnacle Consultants Mid-Atlantic, L.L.C. 20100221 G TransUnion Corporation. G Verl O. Purdy. G MedData Health LLC. 11-DEC-09 20100129 G Birch Holdco, LP.

G Northrop Grumman Corporation. G TASC, Inc. 20100177 G The Edward W. Scripps Trust. G TCM Parent, LLC. G TCM Parent, LLC. 20100210 G TeleCommunication Systems, Inc. G Networks in Motion, Inc. G Networks in Motion, Inc. 20100218 G Odyssey Investment Partners Fund IV, L.P. G TA IX L.P. G One Call Medical, Inc. 20100219 G Excellere Capital Fund, L.P. G Med Tech Holdings, Inc. G Med Tech College, L.L.C. 20100225 G Mitsui Sumitomo Insurance Group Holdings, Inc. G Aioi Insurance Company, Limited.

G Aioi Insurance Company, Limited. 20100226 G Odyssey Investment Partners Fund IV, L.P. G New S Corp. I, Inc. G Wencor Holdings LLC. 20100230 G JPMorgan Chase & Co. G HTS Stiftung. G Constantia Packaging AG. 20100232 G Trow Global Holdings Inc. G Ivan Dvorak. G Teng & Associates, Inc. 20100233 G Carl C. Icahn. G Tropicana Entertainment Inc. G Tropicana Entertainment Inc. 20100235 G H.I.G Capital Partners IV, LP. G Tennessee Valley Ventures, L.P. G Food Holdings, Inc. G Southern Quality Meats, Inc. 20100236 G People's United Financial, Inc.

G Financial Federal Corporation. G Financial Federal Corporation. 11-DEC-09 20100238 G Berkshire Hathaway Inc. G American Electric Power Company, Inc. G AEP Texas Central Company. G AEP Texas North Company. 20100242 G The Procter & Gamble Company. G MDVIP, Inc. G MDVIP, Inc. FOR FURTHER INFORMATION CONTACT: Sandra M. Peay, Contact Representative or Renee Hallman, Contact Representative, Federal Trade Commission, Premerger Notification Office, Bureau of Competition, Room H-303, Washington, DC 20580,

(202)326-3100. By Direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E9-31207 Filed 1-5-10; 8:45 am] BILLING CODE 6750-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Extramural Support Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program AGENCY: Health Resources and Services Administration, HHS. ACTION: Request for Information. SUMMARY: Congress has provided specific authority under section 377 of the Public Health Service

(PHS)Act, 42 U.S.C. 274f, as amended by Public Law 108-216 for providing reimbursement of travel and subsistence expenses for certain individuals donating their organs. Additionally, Congress authorized the Secretary to provide reimbursement for other incidental non-medical expenses as the Secretary determines by regulation to be appropriate. Accordingly, under the existing Program launched in October 2007, individuals who meet Program eligibility guidelines may receive reimbursement for qualifying travel and subsistence expenses related to live organ donation. The existing Program structure is based on Section 377(a)(1) of the PHS Act. This section explicitly allows the Secretary to provide reimbursement of travel and subsistence expenses incurred by living organ donors. HRSA wishes to implement Section 377(a)(2) of the PHS Act which authorizes the Secretary to issue regulations describing other incidental nonmedical expenses appropriate for reimbursement under this Program. The Department is considering initiating rulemaking proposing that reimbursement be extended to additional expenses incurred by living donors as “incidental nonmedical expenses” under 42 U.S.C. 274f(a)(2). Before initiating such rulemaking, HRSA is soliciting input from the community on specific incidental nonmedical expenses to be considered for reimbursement. HRSA is looking for guidance from the community on the mechanism(s) to determine the appropriate reimbursement amount for these additional expenses and to validate that donors incurred or will incur these additional expenses as a result of making living donations of their organs. For example, if the community thinks lost wages and childcare expenses are incidental nonmedical expenses the Program should consider for reimbursement, how much the Program should reimburse donors for these expenses and on what basis should this determination be made? Individuals can send their comments either by mail, fax, or email to the Division of Transplantation at the address listed below. In addition, the Division plans to sponsor three conference calls to discuss the Program. DATES: To be considered, written comments must be postmarked no later than March 22, 2010. The conference calls will be held on Tuesday, February 23, 2010 from 10 a.m. to 11:30 a.m.; Wednesday, February 24, 2010 from 2:30 p.m. to 4 p.m.; and Friday, March 5, 2010 from 1 p.m. to 2:30 p.m. All listed times are eastern standard times. Participants must register for the conference calls by contacting Richard Laeng, Public Health Analyst, at

(301)443-5410 or e-mail *rlaeng@hrsa.gov.* The registration deadline is Thursday, February 18, 2010. Because the same information will be discussed on all the calls, it is not necessary to register for multiple calls. Registration is not guaranteed; it is on a first come basis. ADDRESSES: Please send all written comments to Mesmin Germain, Public Health Analyst, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Department of Health and Human Services, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone:

(301)443-0053; fax:

(301)594-6095; e-mail: *mgermain@hrsa.gov.* FOR FURTHER INFORMATION CONTACT: Mesmin Germain, Public Health Analyst, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Department of Health and Human Services, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone:

(301)443-0053; fax:

(301)594-6095; e-mail: *mgermain@hrsa.gov.* SUPPLEMENTARY INFORMATION: Background On September 14, 2006, HRSA awarded a 4-year cooperative agreement to the Regents of the University of Michigan to establish a national Program to provide reimbursement to living donors for travel and subsistence expenses, as well as additional expenses authorized by any future regulations issued by the Secretary. The Regents of the University of Michigan in partnership with the American Society of Transplant Surgeons

(ASTS)established the National Living Donor Assistance Center (NLDAC) to operate this national Program. On October 17, 2007, The Regents of the University of Michigan and ASTS officially launched NLDAC. NLDAC is located at the ASTS Headquarter in Arlington, Virginia. NLDAC has officially partnered with 299 living transplant programs throughout the United States to submit applications for reimbursement on behalf of their living donors. Applications are filed through the transplant centers and reviewed by a committee at NLDAC. Program eligibility is based on donor and recipient incomes of 300 percent or less of the HHS Poverty Guidelines. Applicants who do not meet eligibility guidelines may request a waiver. All waiver requests are reviewed for approval by HRSA. The Program provides prospective reimbursement to living donors based on the estimated travel expenses related to the donation process. Funds are provided through a controlled value card, giving NLDAC the ability to add and subtract funds as needed. All expenses are monitored in real time by NLDAC to ensure that donors are using funds according to Program guidelines. HRSA sought input from the public from the conceptual stage of the Program through the determination of the Program's final eligibility criteria to ensure that the Program addresses the needs of the public: • On October 13, 2005, HRSA published a Request for Public Comments on the proposed Program to provide reimbursement of travel and subsistence expenses in the **Federal Register** (70 FR 59760). • On April 9, 2007, HRSA published a Request for Public Comments concerning the proposed Program eligibility criteria in the **Federal Register** (72 FR 17564). • On October 5, 2007, HRSA published a Response to Solicitation of Comments and Final Program Eligibility Guidelines in the **Federal Register** (72 FR 57049). • On March 5, 2008, HRSA published a Request for Public Comments on proposed changes to the reimbursement of travel and subsistence expenses Program eligibility criteria (concerning additional follow-up visits for donors) in the **Federal Register** (73 FR 11930). • On June 20, 2008, HRSA published a change to Program eligibility guidelines to provide reimbursement for additional follow-up visits for donors in the **Federal Register** (73 FR 35143). • On March 4, 2009, HRSA published a Request for Public Comments on a proposed change to the Program eligibility criteria (concerning the follow-up period) in the **Federal Register** (74 FR 9407). • On June 19, 2009, HRSA published an amendment to Program eligibility guidelines to extend follow-up period that donors may receive reimbursement for qualifying expenses in the **Federal Register** (74 FR 29218). Through September 30, 2009, the Program has facilitated 370 living organ transplants. Overall, 697 applications have been approved for funding under the established Program eligibility guidelines. The average reimbursement per living donor is approximately $2,600. HRSA initiated this Program to address the travel and subsistence expenses faced by potential donors, recipients, and family alike. Even with this support, living donors still face other financial barriers related to the donation process. Reimbursement of other incidental nonmedical expenses being considered would further diminish the financial barriers faced by many donors. Reimbursement for the additional expenses would be provided while maintaining the existing Program guidelines, including capping total reimbursement per donor and companions at $6,000. The expansion will be provided under the Qualified Expenses Section of the Program Eligibility Guidelines. Any payment permitted under this authority must not violate section 301 of the National Organ Transplant Act of 1984, which makes it “unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.” 42 U.S.C. 274e(a). Certain expenses are excluded from the scope of valuable consideration, including “expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.” 42 U.S.C. 274e(c)(2). As the Secretary considers rulemaking, she will consider this criminal prohibition in evaluating which expenses are appropriate for reimbursement under this Program. HRSA is seeking public comment as to whether the Secretary should initiate rulemaking to allow reimbursement under this Program for specific incidental nonmedical expenses and concerning which incidental nonmedical expenses should be included in such rulemaking. Dated: December 29, 2009. Mary K. Wakefield, Administrator. [FR Doc. E9-31312 Filed 1-5-10; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0525] Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance for industry entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,” dated December 2009. As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures commitment letter, FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. The final guidance announced in this document fulfills FDA's commitment to issue guidance called for by the commitment letter. The guidance supercedes the draft guidance of the same title dated September 30, 2008. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Patricia Y. Love, Office of Combination Products (HFG-3), Office of the Commissioner, Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 301-427-1934. SUPPLEMENTARY INFORMATION: I. Background As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures, Item I.N of the September 27, 2007, commitment letter, FDA agreed to publish draft guidance by September 30, 2008, for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. Further, the agreement stated that the “draft guidance will be published by the end of FY 2008, and will be subject to a 90-day comment period. FDA will issue a final guidance within one year of the close of the public comment period.” The draft guidance was dated September 30, 2008 (73 FR 58604, October 7, 2008); the comment period closed on January 5, 2009. FDA held meetings with imaging industry stakeholders in July 2008 and August 2009. The final guidance announced in this document fulfills FDA's commitment to issue final guidance called for by the commitment letter. The guidance supercedes the draft guidance of the same title dated September 30, 2008. FDA is announcing the availability of guidance for industry entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.” FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. Particularly, this guidance focuses on the following topics:

(1)When the imaging device developers may add certain new imaging contrast indications to their device for use with already approved imaging drugs without a need for a modification of the drug labeling,

(2)when the imaging drug developers may add certain new imaging contrast indications to their drug for use with already approved imaging devices without a need for a modification of the device labeling, and

(3)what type of marketing submission(s) imaging drug or imaging device developers should submit to FDA to request approval/clearance to add a new imaging contrast indication. FDA intends for the recommendations in this guidance to promote timely and effective review of, and consistent and appropriate regulation and labeling for imaging drugs and devices. FDA notes that during the comment period, certain topics identified in the docket were beyond the scope of the guidance document. These comments included requests for guidance on developing specific medical imaging indications (e.g., myocardial perfusion or breast cancer imaging) and offered suggestions for the type of acceptable data. FDA will consider whether separate guidance would be appropriate. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products”. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 807 have been approved under OMB control number 0910-0120. The collections of information in 21 CFR 814 have been approved under OMB control number 0910-0231. The collections of information in 21 CFR 314 have been approved under OMB control number 0910-0001. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm* or *http://www.regulations.gov* . Dated: December 30, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9-31307 Filed 1-5-10; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Notice of Meeting; National Commission on Children and Disasters AGENCY: Administration for Children and Families, Department of Health and Human Services. ACTION: Notice of meeting. DATES: The meeting will be held on Tuesday, February 2, 2010, from 9:30 a.m. to 3:30 p.m. ADDRESSES: The meeting will be held at the Administration for Children and Families, 901 D Street, SW., Washington, DC 20024. To attend either in person or via teleconference, please register by 5 p.m. Eastern Time, January 28, 2010. To register, please e-mail *jacqueline.haye@acf.hhs.gov* with “Meeting Registration” in the subject line, or call

(202)205—9560. Registration must include your name, affiliation, and phone number. If you require a sign language interpreter or other special assistance, please call Jacqueline Haye at

(202)205—9560 or e-mail *jacqueline.haye@acf.hhs.gov* as soon as possible and no later than 5 p.m. Eastern Time, January 19, 2010. *Agenda:* The Commission will discuss:

(1)Outcomes from the Commission's Long-Term Disaster Recovery Workshop on February 1, 2010;

(2)A National resource center on children and disasters; and

(3)Plans for future work of the Commission. Written comments may be submitted electronically to *roberta.lavin@acf.hhs.gov* with “Public Comment” in the subject line. The Commission recommends that you include your name, mailing address and an e-mail address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment, and it allows the Commission to contact you if further information on the substance of the comment is needed or if your comment cannot be read due to technical difficulties. The Commission's policy is that the Commission will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment placed in the official record. The Commission will provide an opportunity for public comments during the public meeting on February 2, 2010. Those wishing to speak will be limited to three minutes each; speakers are encouraged to submit their remarks in writing in advance to ensure their comment is received in case there is inadequate time for all comments to be heard on February 2, 2010. *Additional Information:* Contact Roberta Lavin, Office of Human Services Emergency Preparedness and Response, e-mail *roberta.lavin@acf.hhs.gov* or

(202)401—9306. SUPPLEMENTARY INFORMATION: The National Commission on Children and Disasters is an independent Commission that shall conduct a comprehensive study to examine and assess the needs of children as they relate to preparation for, response to, and recovery from all hazards, building upon the evaluations of other entities and avoiding unnecessary duplication by reviewing the findings, conclusions, and recommendations of these entities. The Commission shall then submit a report to the President and the Congress on the Commission's independent and specific findings, conclusions, and recommendations to address the needs of children as they relate to preparation for, response to, and recovery from all hazards, including major disasters and emergencies. Dated: December 28, 2009. David A. Hansell, Principal Deputy Assistant Secretary for Children and Families. [FR Doc. E9-31393 Filed 1-5-10; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Anesthetic and Life Support Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Anesthetic and Life Support Drugs Advisory Committee scheduled for January 28, 2010, is cancelled. This meeting was announced in the **Federal Register** of December 8, 2009 (74 FR 64702). This meeting has been cancelled to allow time for the FDA to review new information that is relevant to the benefit risk balance for the proposed new indication. The agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, email: *Kalyani.Bhatt@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512529. Please call the Information Line for up-to-date information on this meeting. Dated: December 30, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9-31306 Filed 1-5-10; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: E-Verify Data Collection Survey, New Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: E-Verify Data Collection Survey, Control No. OMB-55. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until March 8, 2010. Written comments and suggestions regarding items contained in this notice, and especially with regard to the estimated public burden and associated response time should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Products Division, Clearance Office, 111 Massachusetts Avenue, NW., Washington, DC 20529-2210. Comments may also be submitted to DHS via facsimile to 202-272-8352, or via e-mail *at rfs.regs@dhs.gov.* When submitting comments by e-mail, please add the Control Number OMB-55 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology, *e.g.,* permitting electronic submission of responses. Overview of This Information Collection

(1)*Type of Information Collection:* New information collection.

(2)*Title of the Form/Collection:* E-Verify Data Collection.

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* No form number. U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals or households. USCIS will use this collection to evaluate how the E-Verify program is working nationally and among a specific group of employers, to determine whether employers are using the program as intended, and to evaluate positive and negative impacts of the program in a mandatory environment.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* Web survey 2,400 respondents at 30 minutes (.50) per response. Telephone interviews with Designated Agents 20 respondents x 1 hour per response. Telephone interviews with Designated Agents Users 60 respondents x 1 hour per response.

(6)*An estimate of the total public burden (in hours) associated with the collection:* 1,280 annual burden hours. If you need a copy of the proposed information collection instrument, or need additional information, please visit: *http://www.regulations.gov/search/index.jsp.* We may also be contacted at: USCIS, Regulatory Products Division, 111 Massachusetts Avenue, Washington, DC 20529-2210,

(202)272-8377. Dated: December 31, 2009. Stephen Tarragon, Deputy Chief, Regulatory Products Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E9-31423 Filed 1-5-10; 8:45 am] BILLING CODE 9111-97-P DEPARTMENT OF INTERIOR Bureau of Reclamation Cancellation of the South Valley Facilities Expansion Project—Clark County, NV AGENCY: Bureau of Reclamation, Interior. ACTION: Cancellation of Notice of Intent to prepare the Environmental Impact Statement. SUMMARY: The Bureau of Reclamation, together with the Bureau of Land Management

(BLM)and the National Park Service

(NPS)as cooperating agencies are cancelling the Notice of Intent

(NOI)to prepare an Environmental Impact Statement

(EIS)for the South Valley Facilities Expansion

(SVFE)Project, published in the **Federal Register** on April 18, 2008 (73 FR 21155). FOR FURTHER INFORMATION CONTACT: Ms. Laureen Perry at 702-293-8392, *lperry@usbr.gov,* fax number 702-293-8418, or at Bureau of Reclamation, Lower Colorado Region, P.O. Box 61470, Boulder City, NV 89006-1470. SUPPLEMENTARY INFORMATION: The NOI was published in the **Federal Register** on April 18, 2008 by Reclamation, together with the BLM and the NPS as cooperating agencies, for the SVFE Project because the Southern Nevada Water Authority

(SNWA)had requested rights-of-way from Reclamation, the BLM, and the NPS—Lake Mead National Recreation Area. The SVFE Project was to be completed in several future phases with an anticipated completion by the year 2027. In consultation with its member agencies, SNWA continually evaluates infrastructure needs within its service area. At this time, SNWA has determined that service requirements for the southern Las Vegas Valley can continue to be met through existing infrastructure, and the Project is not needed. On September 22, 2009, SNWA provided written notice to Reclamation requesting the withdrawal of the submitted subject right-of-way application. Consequently, the preparation of an EIS to evaluate the proposed SVFE Project is no longer required, thus cancelling the EIS process. Dated: December 15, 2009. Lorri Gray-Lee, Regional Director, Lower Colorado Region. [FR Doc. E9-31430 Filed 1-5-10; 8:45 am] BILLING CODE 4310-MN-P INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-474 and 731-TA-1176 (Preliminary)] Drill Pipe From China AGENCY: International Trade Commission. ACTION: Institution of antidumping and countervailing duty investigations and scheduling of preliminary phase investigations. SUMMARY: The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigations Nos. 701-TA-474 and 731-TA-1176 (Preliminary) under sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from China of drill pipe, provided for in subheadings 7304.22, 7304.23, and 8431.43 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China. Unless the Department of Commerce extends the time for initiation pursuant to sections 702(c)(1)(B) or 732(c)(1)(B) of the Act (19 U.S.C. 1671a(c)(1)(B) or 1673a(c)(1)(B)), the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by February 16, 2010 (as a result of an intervening weekend and Federal holiday). The Commission's views are due at Commerce within five business days thereafter, or by February 23, 2010. For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207). DATES: *Effective Date:* December 31, 2009. FOR FURTHER INFORMATION CONTACT: Angela M. W. Newell (202-708-5409), Office of Investigations, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server ( *http://www.usitc.gov* ). The public record for these investigations may be viewed on the Commission's electronic docket

(EDIS)at *http://edis.usitc.gov.* SUPPLEMENTARY INFORMATION: *Background.* —These investigations are being instituted in response to a petition filed effective December 31, 2009, by VAM Drilling USA Inc., Houston, TX; Rotary Drilling Tools, Beasley, TX; Texas Steel Conversions, Inc., Houston, TX; TMK IPSCO, Downers Grove, IL; and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO-CLC, Pittsburgh, PA. *Participation in the investigations and public service list.* —Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission's rules, not later than seven days after publication of this notice in the **Federal Register** . Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance. *Limited disclosure of business proprietary information

(BPI)under an administrative protective order

(APO)and BPI service list.* —Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the **Federal Register** . A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. *Conference.* —The Commission's Director of Investigations has scheduled a conference in connection with these investigations for 9:30 a.m. on January 21, 2010, at the U.S. International Trade Commission Building, 500 E Street, SW., Washington, DC. Parties wishing to participate in the conference should contact Angela M. W. Newell (202-708-5409) not later than January 15, 2010, to arrange for their appearance. Parties in support of the imposition of antidumping and countervailing duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour within which to make an oral presentation at the conference. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the conference. *Written submissions.* —As provided in sections 201.8 and 207.15 of the Commission's rules, any person may submit to the Commission on or before January 26, 2010, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference no later than three days before the conference. If briefs or written testimony contain BPI, they must conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002). Even where electronic filing of a document is permitted, certain documents must also be filed in paper form, as specified in II

(C)of the Commission's Handbook on Electronic Filing Procedures, 67 FR 68168, 68173 (November 8, 2002). In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. *Authority:* These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules. By order of the Commission. Issued: December 31, 2009. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E9-31412 Filed 1-5-10; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-72,231] Lonza, Inc. Riverside Plant; Lonza Exclusive Synthesis Section Custom Manufacturing Division Including On-Site Leased Workers of Lab Support, Aerotek, Job Exchange, and Synerfac; Conshohocken, PA; Notice of Affirmative Determination Regarding Application for Reconsideration By application dated December 5, 2009, the United Steel Workers, Local 6816-18, requested administrative reconsideration of the negative determination regarding workers' eligibility to apply for Trade Adjustment Assistance

(TAA)applicable to workers and former workers of the subject firm. The determination was issued on November 5, 2009. The Notice of Determination will soon be published in the **Federal Register.** The initial investigation resulted in a negative determination based on the findings that imports of Trityl Losartan did not contribute importantly to worker separations at the subject firm and no shift of production to a foreign source occurred. In the request for reconsideration, the petitioner provided additional information regarding customers of the subject firm. The Department has carefully reviewed the request for reconsideration and the existing record, and has determined that the Department will conduct further investigation to determine if the workers meet the eligibility requirements of the Trade Act of 1974. Conclusion After careful review of the application, I conclude that the claim is of sufficient weight to justify reconsideration of the U.S. Department of Labor's prior decision. The application is, therefore, granted. Signed at Washington, DC, this 23rd day of December, 2009. Del Min Amy Chen, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E9-31385 Filed 1-5-10; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-64,897] Sanford, Including On-Site Leased Workers From Holland Employment and Willstaff, Lewisburg, TN; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on February 3, 2009, applicable to workers of Sanford, including on-site leased workers from Holland Employment, Lewisburg, Tennessee. The notice was published in the **Federal Register** on March 3, 2009 (74 FR 9282). At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers are engaged in the production of dymo labels, pencils, and other writing instruments. New information shows that the Lewisburg, Tennessee location of the subject firm employs on-site leased workers contracted from Willstaff. The Department has determined that Willstaff workers are sufficiently under the control of the subject firm to be considered leased workers. Based on these findings, the Department is amending this certification to include workers leased from Willstaff working on-site at the Lewisburg, Tennessee location of Sanford. The amended notice applicable to TA-W-64,897 is hereby issued as follows: All workers of Sanford, including on-site leased workers from Holland Employment and Willstaff, Lewisburg, Tennessee, who became totally or partially separated from employment on or after January 15, 2008, through February 3, 2011, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974. Signed at Washington, DC, this 17th day of December 2009. Michael W. Jaffe, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E9-31389 Filed 1-5-10; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-62,282] National Starch and Chemical Company Specialty Starches Division Including On-Site Leased Workers From Page Employment, Island Falls, ME; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on December 13, 2007, applicable to workers of National Starch and Chemical Company, Specialty Starches Division, Island Falls, Maine. The notice was published in the **Federal Register** on December 31, 2007 (72 FR 74343). At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers were engaged in the production of drum dried and modified food starches. New information shows that workers leased from Page Employment were employed on-site at the Island Falls, Maine location of National Starch and Chemical Company, Specialty Starches Division. The Department has determined that these workers were sufficiently under the control of the subject firm. Based on these findings, the Department is amending this certification to include leased workers of Page Employment working on-site at the Island Falls, Maine location of the subject firm. The amended notice applicable to TA-W-62,282 is hereby issued as follows: All workers of National Starch and Chemical Company, Specialty Starches Division, including on-site leased workers from Page Employment, Island Falls, Maine, who became totally or partially separated from employment on or after October 5, 2006, through December 13, 2009, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974. Signed at Washington, DC, this 16th day of December 2009 Richard Church, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E9-31386 Filed 1-5-10; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-70,351] National Semiconductor Corporation Arlington Manufacturing Site Including On-Site Leased Workers From GCA, CMPA (Silverleaf), Custom Foods, Allied Barton Security, ASIL, ASML and Construction Mechanical Systems Arlington, TX; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to apply for Worker Adjustment Assistance on September 23, 2009, applicable to workers of National Semiconductor Corporation, Arlington Manufacturing Site, including on-site leased workers from GCA, CMPA, Custom Foods, Allied Barton Security, and ASML, Arlington, Texas. The notice was published in the **Federal Register** November 17, 2009 (74 FR 59253). At the request of the State Agency, the Department reviewed the certification for workers of the subject firm. The workers are engaged in activities related to the production of integrated circuits. The company reports that on-site leased workers from ASML and Construction Mechanical Systems were employed on-site at the Arlington, Texas location of National Semiconductor Corporation. The Department has determined that these workers were sufficiently under the control of the subject firm to be considered leased workers. Information also shows that on-site leased workers separated from employment at CMPA had their wages reported under a separated unemployment insurance

(UI)tax account for Silverleaf. Based on these findings, the Department is amending the certification to include workers leased from ASML and Construction Mechanical Systems working on-site at the Arlington, Texas location of National Semiconductor Corporation, Arlington Manufacturing Site and to show that on-site leased workers from CMPS have their

(UI)wages reported to Silverleaf. The amended notice applicable to TA-W-70,351 is hereby issued as follows: All workers of National Semiconductor Corporation, Arlington Manufacturing Site, including on-site leased workers from GCA, CMPA (Silverleaf), Custom Foods, Allied Barton Security, ASML, and Construction Mechanical Systems, Arlington, Texas, who became totally or partially separated from employment on or after May 18, 2008, through September 23, 2011, and all workers in the group threatened with total or partial separation from employment on date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended. Signed in Washington, DC, this 16th day of December, 2009. Richard Church, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E9-31390 Filed 1-5-10; 8:45 am] BILLING CODE 4510-FN-P NATIONAL TRANSPORTATION SAFETY BOARD Sunshine Act Meeting Notice Agenda Time and Date: 9:30 a.m., Thursday, January 21, 2010. Place: NTSB Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594. Status: The one item is open to the public. Matter To Be Considered 8175 *Railroad Accident Report* —Collision of Metrolink Train 111 with Union Pacific Freight Train LOF62-12, Chatsworth, California, September 12, 2008. (DCA-08-MR-009). News Media Contact: Telephone:

(202)314-6100. The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating. Individuals requesting specific accommodations should contact Rochelle Hall at

(202)314-6305 by Friday, January 15, 2010. The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at *http://www.ntsb.gov* . FOR MORE INFORMATION CONTACT: Candi Bing,

(202)314-6403. Dated: December 31, 2009. Candi R. Bing, Federal Register Liaison Officer. [FR Doc. E9-31413 Filed 1-4-10; 4:15 pm] BILLING CODE 7533-01-P NUCLEAR REGULATORY COMMISSION Sunshine Act; Notice of Meetings Agency Holding the Meetings: Nuclear Regulatory Commission. Date: Week of January 4, 2010. Place: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. Status: Public and Closed. Additional Items To Be Considered: Week of January 4, 2010 Thursday, January 7, 2010 12:15 p.m. Affirmation Session (Public Meeting) (Tentative): c. *South Carolina Electric and Gas Co. and South Carolina Public Service Authority (also Referred to as Santee Cooper* ) (Virgil C. Summer Nuclear Station, Units 2 & 3), LBP-09-2 (Ruling on Standing and Contention Admissibility) (Tentative) d. *Progress Energy Florida, Inc.* (Combined License Application for Levy County Nuclear Power Plant, Units 1 and 2), LBP-09-10 (Tentative) e. Detroit Edison Co. (Fermi Power Plant Independent Spent Fuel Storage Installation), LBP-09-20 (Aug. 21, 2009), Docket No. 72-72-EA. (Tentative) f. *Southern Nuclear Operating Co.* (Early Site Permit for Vogtle ESP Site), Docket No. 52-011-ESP, *Petition for Review of LBP-09-7* (Tentative) g. *Tennessee Valley Authority* (Bellefonte Nuclear Power Plant Units 1 and 2) (Statutory Authority to Reinstate Construction Permits). (Tentative) The NRC Commission Meeting Schedule can be found on the Internet at: *http://www.nrc.gov/about-nrc/policy-making/schedule.html* . The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format ( *e.g.* braille, large print), please notify Angela Bolduc, Chief, Employee/Labor Relations and Work Life Branch, at 301-492-2230, TDD: 301-415-2100, or by e-mail at *angela.bolduc@nrc.gov* . Determinations on requests for reasonable accommodation will be made on a case-by-case basis. This notice is distributed electronically to subscribers. If you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301-415-1969), or send an e-mail to *darlene.wright@nrc.gov* . Dated: December 31, 2009 Kenneth R. Hart, Office of the Secretary. [FR Doc. 2010-8 Filed 1-4-10; 4:15 pm]

Connectionstraces to 8

Traces to 8 documents

U.S. Code