Notices. Notice

9,607 words·~44 min read·/register/2006/02/07/06-1176

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

BILLING CODE 4160-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0157] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 9, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80 (OMB Control Number 0910-0230)—Extension Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321, 352, 355, and 371) require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at §§ 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and recordkeeping requirements on the drug industry enabling FDA to take the action necessary to protect the public health from adverse drug experiences. All applicants who have received marketing approval of drug products are required to report to FDA serious, unexpected adverse drug experiences, as well as followup reports when needed (§ 314.80(c)(1)). This includes reports of all foreign or domestic adverse experiences as well as those obtained in scientific literature and from postmarketing epidemiological/surveillance studies. Under § 314.80(c)(2) applicants must provide periodic reports of adverse drug experiences. A periodic report includes, for the reporting interval, reports of serious, expected adverse drug experiences and all nonserious adverse drug experiences, a narrative summary and analysis of adverse drug experiences, and a history of actions taken because of adverse drug experiences. Under § 314.80(i), applicants must keep for 10 years records of all adverse drug experience reports known to the applicant. For marketed prescription drug products without approved new drug applications or abbreviated new drug applications, manufacturers, packers, and distributors are required to report to FDA serious, unexpected adverse drug experiences as well as followup reports when needed (§ 310.305(c)). Under § 310.305(f), each manufacturer, packer, and distributor shall maintain for 10 years records of all adverse drug experiences required to be reported. The primary purpose of FDA's adverse drug experience reporting system is to provide a signal for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provides, for the first time, the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product's labeling (such as adding a new warning) and when necessary, to initiate removal of a drug from the market. Respondents to this collection of information are manufacturers, packers, distributors, and applicants. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 310.305(c)(5) 1 1 1 1 1 314.80(c)(1)(iii) 5 1 5 1 5 314.80(c)(2) 530 20 10,600 60 636,000 Total 636,006 1 The reporting burden for §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB control number 0910-0291. The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 310.305(f) 25 1 25 16 400 314.80(i) 530 1 400,000 16 6,400,000 Total 6,400,400 1 There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually. These estimates are based on FDA's knowledge of adverse drug experience reporting, including the time needed to prepare the reports, and the number of reports submitted to the agency during 2004. In the **Federal Register** of May 3, 2005 (70 FR 22882), FDA published a 60-day notice requesting public comment on the information collection provisions (the May 2005 notice). One comment was received on the burden estimates. The comment said that it was not clear what methodology and assumptions were used by FDA to calculate either the annual reporting burden or the annual recordkeeping burden of the proposed collection of information. FDA responds that, as stated in the May 2005 notice, the estimates are based on FDA's knowledge of adverse dug experience reporting, including the time needed to prepare the reports, and the number of reports submitted to FDA during 2004. The comment said that §§ 310.305(c)(5) and 314.80(c)(1)(iii) in the first two rows of Table 1 in the May 2005 notice refer to drugs without approved marketing applications and nonapplicants, respectively, rather than applicants. The comment contended that the citations used for these rows should be § 314.80(c)(1)(i) and (c)(1)(ii), which refer to the requirements for submission of initial and followup 15-day alert reports by the holders of approved marketing applications, or additional rows should be added to the table to include these additional reporting requirements. The comment also said that FDA's estimates of the burden of adverse experience reporting for 15-day alerts, periodic reports, and recordkeeping seem grossly underestimated, and that the discrepancy cited above concerning § 314.80(c)(1)(i) and (c)(1)(ii) may account for the apparent underestimation of the number of respondents and annual frequency of responses. The comment noted that it submitted 6,107 15-day alert reports to FDA in 2004, and that this alone exceeds the total burden reported in Table 1 of the May 2005 notice. FDA responds that the agency agrees that Table 1, as presented in the May 2005 notice is misleading. There is an inadvertent omission of the first sentence of the footnote that appears under Table 1 of the May 2005 notice. That footnote reads: “There are no capital costs or operating and maintenance costs associated with this collection of information.” The footnote should read: “The reporting burden for §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB control number 0910-0291. There are no capital costs or operating and maintenance costs associated with this collection of information.” (This correct version of the footnote appeared in earlier **Federal Register** notices requesting OMB extension of this information collection. See, for example, the **Federal Register** of July 22, 2002 (67 FR 47821)). OMB control number 0910-0291 refers to the information collection package for FDA's MedWatch program and forms (“MedWatch: Food and Drug Administration Medical Products Reporting Program”). The most recent request for OMB approval of this package was published in the **Federal Register** of August 16, 2005 (70 FR 48157), and OMB recently approved the package until October 31, 2008. MedWatch Form FDA 3500A is used to comply with the requirements in §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii). The remaining requirements for adverse experience reporting for human drugs are covered in this package (OMB control number 0910-0230). Concerning periodic reports, the comment said the annual frequency per response (an estimate the comment assumed to be the average number of periodic reports submitted per company) is estimated by FDA to be 20, and that this is considerably less than the 218 periodic reports that the comment said it submitted in 2004. FDA responds that the column in Table 1 of the May 2005 notice, entitled “Total Annual Responses”, refers to the number of periodic reports submitted annually per company. FDA estimates 10,614 reports annually. The comment said that the estimate of the hours required to prepare each periodic report is underestimated and only seems to reflect the time needed to compile the report and write the narrative sections. The estimate does not reflect the additional time required to collect, prepare, solicit, and process followup information for each individual FDA Form 3500A report. The comment estimated that these activities take approximately 90 minutes for each FDA Form 3500A, and that a true estimate of the hours to prepare a periodic report should include at least an additional 1.5 hours for each non-15-day report that is contained within each periodic report. FDA responds that based on the information provided by the comment to prepare and submit in the periodic report information pertaining to 15-day alert reports and non-15-day alert reports, FDA has revised the estimate for the time required to prepare and submit each response under § 314.80(c)(2) to approximately 60 hours per response. The comment said that it does not understand how the annual frequency, total annual reports, and total hours are calculated for the estimated annual recordkeeping burden. The comment said that it needs to store each individual 15-day alert report, each individual non-15-day FDA Form 3500A, and each individual periodic report. The comment said that FDA's estimates seem to indicate that each company has one document to store. The comment said that it annually submits more than 6,000 15-day alert reports and 200 periodic reports containing many thousands of non-15-day FDA Form 3500As. Because of this, the comment said that it spends well over the one hour allotted by FDA to each company for these activities. FDA responds that the agency estimates that approximately 400,000 records are maintained by applicants under § 314.80(i). This estimate is based on the information provided by the comment concerning 15-day alert reports and non-15-day alert reports, on the approximate number of 15-day alert reports and non-15-day alert reports received by FDA annually, and the fact that § 314.80(i) also requires that records of “raw data and any correspondence relating to adverse drug experiences” be maintained. FDA also estimates that approximately 16 hours are required to maintain each record (under § 314.80(i) as well as § 310.305(f)). Therefore, the total hours for records maintenance under § 314.80(i) is approximately 6,400,000. The comment disagreed with FDA's statement that there are no capital costs, operating, or maintenance costs associated with the collection of 15-day alert and periodic reports. The comment said that it (and other pharmaceutical companies) develop and maintain or purchase expensive, validated databases to collect and process adverse event information. These systems must continually be enhanced to accommodate new regulatory initiatives, such as the electronic submission of individual case safety reports in accordance with the International Conference on Harmonisation

(ICH)E2B guidelines. The comment said that companies must purchase servers (sometimes multiple servers worldwide), and each employee needs hardware and software. Support services for these systems are also quite expensive. The comment also said that companies must license the Medical Dictionary for Regulatory Activities each year to meet the international standards for common reporting terminology. The comment said that costs for computer systems vary widely, but can amount to millions of dollars per year, especially for larger companies, and that capital and operational expenses for safety databases average $7.6 million per year. The comment also questioned the statement that there are no capital, operating, or maintenance costs associated with maintaining records of adverse experience reports for 10 years. The comment said that companies must maintain facilities to store what amounts to large volumes of paper records, in addition to backup records on other media (scanned optical images, microfilm, and so forth). The comment said that costs for storage and retrieval vary widely, depending on the volume of records, rental fees, transportation costs, and retrieval fees, but can be substantial (e.g., thousands of dollars per year). The comment said that its storage and retrieval expenses are approximately $22,000 per year. FDA responds that based on the information provided by the comment, FDA estimates that the capital costs or operating and maintenance costs associated with records maintenance is approximately $22,000 annually. The comment did not suggest a specific estimate for capital costs or operating and maintenance costs associated with reports submitted to FDA. FDA believes that many of the costs discussed by the comment that pertain to submitting reports to FDA are standard operating procedures for most pharmaceutical companies. However, FDA is estimating a cost of approximately $25,000 annually for maintenance costs resulting from the reporting requirements. FDA specifically requests comment on this estimate. The comment said that it is important for FDA to move quickly to change periodic reporting requirements to be consistent with ICH guidelines for periodic safety update reports. The comment said that this will enable companies to submit the same report to all regulatory authorities globally, and will decrease the burden involved with preparing unique periodic reports specifically for FDA. Additionally, for those companies who have received a waiver from FDA to submit periodic reports in the periodic safety update report format, the comment said that this would decrease the burden of adding U.S.-specific appendices to the reports. The comment also said that periodic safety update reports submitted to FDA should not routinely include any information in addition to that included in ICH guidelines for periodic safety update reports. The comment noted that FDA should not require full copies in either paper or electronic form of cases that were not subject to expedited reporting. If a potential signal arises about a specific product, FDA has the authority and opportunity to request all available information associated with any individual case(s). The comments said that greater collaboration between FDA and companies when FDA identifies a potential signal would facilitate better pharmacovigilance. For example, case reports should be shared and mutually discussed. The comment said that electronic submission of 15-day alert reports would decrease the reporting burden, and that FDA requirements for electronic submission should be harmonized with European Agency for the Evaluation of Medicinal Products requirements, so pharmaceutical companies do not have to develop and validate separate programs. The comment said that cost savings could be realized by both FDA and companies by eliminating the requirement for submitting original literature articles as attachments to 15-day alert reports. Articles would always be available to FDA on request. Alternatively, if there was electronic reporting, the literature article could be submitted electronically as an attachment in accordance with the ICH E2B guidance. The comment said that cost savings could also be realized by eliminating the requirement to collect non-serious labeled events. Costs associated with collecting information that has little, if any, value has a substantial financial impact on both companies and the agency. The comment also said that it supports FDA's efforts to consider provisions for alternate methods of data storage other than through hard copy paper records. Companies prefer to choose and maintain methods for storage and retrieval of records according to the individual companies' needs. Storing scanned optical images of records instead of paper copies would considerably decrease the need for large file rooms, extensive offsite storage facilities, and the costs associated with maintaining these facilities. FDA responds that the agency is in the process of revising its safety reporting and recordkeeping regulations. In the **Federal Register** of March 14, 2003 (68 FR 12406), FDA proposed to amend its pre- and postmarketing safety reporting regulations for human drug and biological products to implement definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and by the World Health Organization's Council for International Organizations of Medical Sciences. The rulemaking is also intended to codify FDA's expectations for timely acquisition, evaluation, and submission of relevant safety information for marketed drugs and licensed biological products, to require that certain information be submitted to FDA in an expedited manner, to clarify certain requirements, and to make other minor revisions. FDA also proposed to amend its postmarketing annual reporting regulations for human drug and licensed biological products to revise the content for these reports. In the proposed rule, FDA said that it is taking this action to strengthen its ability to monitor the safety of human drugs and biological products. The intended effect of the changes would be to further worldwide consistency in the collection of safety information and submission of safety reports, increase the quality of safety reports, expedite FDA's review of critical safety information, and enable FDA to protect and promote public health. FDA said that the proposed changes would be an important step toward global harmonization of safety reporting requirements and additional efforts are underway within the Department of Health and Human Services to harmonize the reporting requirements of U.S. Federal agencies (e.g., FDA and the National Institutes of Health are continuing to work together to address the best ways to streamline information sharing and to harmonize, to the extent possible, the safety reporting requirements of the two agencies). Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1587 Filed 2-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0045] Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. The Food and Drug Administration

(FDA)is announcing a public workshop entitled “Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT).” The purpose of the public workshop is to address regulatory and scientific challenges and opportunities in the development of policy concerning protection of the blood supply from transfusion-transmissible diseases by deferring blood donors based on high-risk behavior, and to request comments on this topic. *Date and Time* : The public workshop will be held on March 8, 2006, from 8 a.m. to 5:30 p.m. The deadline for registration via mail, fax, or e-mail is February 17, 2006 (see *Registration* ). Written or electronic comments will be accepted until May 8, 2006 (see *Comments* ). *Addresses* : The public workshop will be held at the National Institutes of Health, Lister Hill Auditorium, Bldg. 38A, 8600 Rockville Pike, Bethesda, MD 20894. Submit written comments 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.fda.gov/dockets/ecomments* . *Contact Person* : Rhonda Dawson, Center for Biologics Evaluation and Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, e-mail: *Rhonda.Dawson@fda.hhs.gov* . *Registration* : Mail, fax, or e-mail your registration information (including name, title, firm name, address, and telephone and fax numbers) to Rhonda Dawson (see *Contact Person* ) by February 17, 2006. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space-available basis beginning at 7:15 a.m. If you need special accommodations due to a disability, please contact Rhonda Dawson (see *Contact Person* ) at least 7 days in advance. *Comments* : Regardless of attendance at the public workshop, interested persons may submit to the Division of Dockets Management (see *Addresses* ) written or electronic comments regarding the public workshop. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . 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. SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to address regulatory and scientific challenges and opportunities in the development of policy concerning protection of the blood supply from transfusion-transmissible diseases by deferring blood donors based on high-risk behavior. The public workshop will feature presentations by national and international experts from government and academic institutions and industry. The following discussions will be included: • Current practices in the United States and in foreign countries regarding blood donor deferrals based on high-risk behavior, • Comparison of selected tissue donor deferral policies to blood donor deferral policies, • Behavioral risks for transfusion-transmitted diseases, • Residual risks of infection from transfusion, and • Potential alternative approaches to donor screening and testing. *Transcripts* : Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at *http://www.fda.gov/cber/minutes/workshop-min.htm* . Dated: January 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1588 Filed 2-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Independent Evaluation of the Food and Drug Administration's First Cycle Review Performance—Retrospective Analysis Final Report; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a report entitled “Independent Evaluation of FDA's First Cycle Review Performance—Retrospective Analysis Final Report.” This report describes an independent evaluation of the issues associated with FDA's conduct of first cycle reviews of new molecular entities for new drug applications (NMEs for NDAs), and biological license applications (BLAs). Applications covered by the report are those submitted to FDA in fiscal years 2002 to 2004. This independent study was conducted in relation to the Prescription Drug User Fee Amendments of 2002 (PDUFA III). This assessment includes a detailed evaluation of the events that occurred during the review process with a focus on identifying the best practices by FDA and industry that facilitated that process. ADDRESSES: Submit written requests for single copies of this report to the Office of Planning (HFP-10), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit electronic requests to *Carolyn.Staples@fda.hhs.gov* . This report will be available on FDA's Web site at a later date. FOR FURTHER INFORMATION CONTACT: Carolyn Staples, Office of Planning (HFP-10), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5274, or William Hagan, Office of Planning (HFP-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8816. SUPPLEMENTARY INFORMATION: I. Background On June 12, 2002, the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes PDUFA III. In conjunction with the passage of PDUFA III, FDA agreed to certain performance goals and procedures that were described in an enclosure to a June 4, 2002, letter from the Secretary of Health and Human Services, Tommy Thompson, to Congress entitled “PDUFA Reauthorization Performance Goals and Procedures” (PDUFA Goals and Procedures). One of the goals relates to FDA's performance of first cycle reviews of original NMEs for NDAs and BLAs (PDUFA Goals and Procedures, section 10). Related to this goal, FDA was to retain an independent expert consultant to undertake a study to evaluate issues associated with the agency's conduct of first cycle reviews. The study was to assess the following objectives:

(1)Current first cycle review performance and any changes that occur after FDA publishes guidance on Good Review Management Principles (GRMPs),

(2)the first cycle review history of all NDAs for new molecular entities and all BLAs during PDUFA III, and

(3)the effectiveness of FDA's staff training regarding GRMPs. FDA awarded a contract to an independent expert to study these issues. The report referred to in this document covers the retrospective portion of objectives

(1)and

(2)listed previously. In accordance with the PDUFA goal, the report is being made available to the public. Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1605 Filed 2-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Prevention; Notice of Meeting Pursuant to Public Law 92-463, notice is hereby given of the meeting of the SAMHSA Center for Substance Abuse Prevention

(CSAP)National Advisory Council on February 14, 2006. The meeting will be open and will include a Director's Report; discussions related to National Outcome Measures; an update on SAMHSA's Drug Free Communities programs; and a panel presentation on the roles of Project Officers, Grants Management staff and Contracts Management staff. A roster of Council members may be obtained either by accessing the SAMHSA Council Web site, *http://www.samhsa.gov/council/csap/csapnac.aspx* or by communicating with the contact listed below. Substantive program information, a summary of the meeting, and the transcript for the open session will also be available on the SAMHSA CSAP Council Web site as soon as possible after the meeting. Attendance by the public will be limited to space available. *Committee Name:* Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council. *Date/Time:* Tuesday, February 14, 2006, 12 p.m. to 5 p.m. *Place:* Washington DC Convention Center, 801 Mount Vernon Place, NW., Room 204 B, Washington, DC 20001. *Type:* Open. *Contact:* Tia Haynes, Committee Management Specialist, 1 Choke Cherry Road, Room 4-1066, Rockville, Maryland 20857. *Telephone:*

(240)276-2436. *Fax:*

(240)276-2430 *E-mail: Tia.haynes@samhsa.hhs.gov.* Dated: February 1, 2006. Toian Vaughn, Committee Management Officer, Substance Abuse and Mental Health Services Administration. [FR Doc. E6-1623 Filed 2-6-06; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2006-23795] Towing Safety Advisory Committee; Vacancies AGENCY: Coast Guard, DHS. ACTION: Request for applications. SUMMARY: The Coast Guard seeks applications for membership on the Towing Safety Advisory Committee (TSAC). TSAC advises the Coast Guard on matters relating to shallow-draft inland and coastal waterway navigation and towing safety. DATES: Application forms should reach us on or before April 30, 2006. ADDRESSES: You may request an application form by writing to Commandant (G-PSO-1); U.S. Coast Guard, Room 1210; 2100 Second Street, SW., Washington, DC 20593-0001; by calling 202-267-0214; or by faxing 202-267-4570. Send your original completed and signed application in written form to the above street address. Be sure to sign and include the short page that allows us to keep political affiliation on file. This notice is available on the Internet at *http://dms.dot.gov* in docket USCG-2006-23795 and the application form is also available at *http://www.uscg.mil/hq/g-m/advisory/index.htm.* (Click on “ACM Application”.) FOR FURTHER INFORMATION CONTACT: Mr. Gerald Miante; Assistant Executive Director of TSAC, telephone 202-267-0214, fax 202-267-4570, or e-mail *gmiante@comdt.uscg.mil.* SUPPLEMENTARY INFORMATION: The Towing Safety Advisory Committee

(TSAC)is a Federal advisory committee mandated by Congress and operates under 5 U.S.C. App. 2, (Pub. L. 92-463, 86 Stat. 770, as amended). It advises the Secretary of Homeland Security on matters relating to shallow-draft inland and coastal waterway navigation and towing safety. This advice also assists the Coast Guard in formulating the position of the United States in advance of meetings of the International Maritime Organization. TSAC meets at least once a year at Coast Guard Headquarters, Washington, DC, or another location selected by the Coast Guard. It may also meet for extraordinary purposes. Its working groups may meet to consider specific issues as required. The 16-person membership includes 7 representatives of the Barge and Towing Industry (reflecting a regional geographical balance); 1 member from the Offshore Mineral and Oil Supply Vessel Industry; and 2 members from each of the following areas: Maritime Labor; Shippers (of whom at least one shall be engaged in the shipment of oil or hazardous materials by barge); Port Districts, Authorities, or Terminal Operators; and the General Public. We are currently considering applications for two positions from the Barge and Towing Industry, one position from the Offshore Industry, one position from Shippers, and one position from the General Public. To be eligible, applicants should have particular expertise, knowledge, and experience relative to the position in towing operations, marine transportation, or business operations associated with shallow-draft inland and coastal waterway navigation and towing safety. Each member serves for a term of up to 4 years. A few members may serve consecutive terms. All members serve at their own expense and receive no salary, reimbursement of travel expenses, or other compensation from the Federal Government. When filling in the “Name of Committee you are interested in” block, please indicate “TSAC” followed by the position category for which you are applying. If you are selected as a member who represents the general public, we will require you to complete a Confidential Financial Disclosure Report (OGE Form 450). We may not release the report or the information in it to the public, except under an order issued by a Federal court or as otherwise provided under the Privacy Act (5 U.S.C. 552a). In support of the policy of the Department of Homeland Security on gender and ethnic diversity, we encourage qualified women and members of minority groups to apply. Dated: February 1, 2006. Howard L. Hime, Acting Director of Standards Prevention. [FR Doc. E6-1597 Filed 2-6-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [5101 ER J206] Notice of Request for Comments To Address Right-of-Way Applications Filed by Private Fuel Storage, LLC, for an Independent Spent Fuel Storage Installation on the Reservation of the Skull Valley Band of Goshute Indians and Related Transportation Facility in Tooele County, UT AGENCY: Bureau of Land Management, Interior. ACTION: Notice of request for comments. SUMMARY: Notice is hereby given that the Bureau of Land Management

(BLM)is requesting comments that will address right-of-way applications filed by Private Fuel Storage (PFS), LLC, for an independent spent fuel storage installation on reservation lands of the Skull Valley Band of Goshute Indians (Band or Skull Valley Band). The installation is described in an environmental impact statement

(EIS)prepared by the Nuclear Regulatory Commission (NRC), entitled Final Environmental Impact Statement for the Construction and Operation of an Independent Spent Fuel Storage Installation on the Reservation of the Skull Valley Band of Goshute Indians and the Related Transportation Facility in Tooele County, Utah (December 2001). This EIS is available online at *http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1714/v1/* . BLM was a cooperating agency in the preparation of this EIS, as were the Bureau of Indian Affairs (BIA), U.S. Department of the Interior, and the U.S. Surface Transportation Board. Your comments are sought pursuant to 40 CFR 1506.6(d). DATES: The Bureau of Land Management should receive your comments by May 8, 2006. ADDRESSES: You should address your comments to the attention of Pam Schuller, Bureau of Land Management, Salt Lake Field Office, 2370 S. 2300 W., Salt Lake City, Utah 84119. FOR FURTHER INFORMATION CONTACT: Pam Schuller, Environmental Specialist, Salt Lake Field Office, 801-977-4356. SUPPLEMENTARY INFORMATION: The applications filed by PFS seek rights-of-way under Title V of the Federal Land Policy and Management Act (FLPMA), 43 U.S.C. 1761, to transport spent nuclear fuel

(SNF)across public lands managed by BLM. As proposed, the fuel would be transported by rail from an existing Union Pacific railroad site to a PFS facility on the Reservation of the Skull Valley Band of Goshute Indians in Tooele County, Utah. The fuel would be stored in aboveground canisters on the Reservation, awaiting eventual disposal at a permanent geologic repository currently proposed for Yucca Mountain, Nevada, or other, further storage at a location off the Reservation. In order for PFS to construct a rail line and transport SNF to reservation lands, an amendment to BLM's Pony Express Resource Management Plan

(RMP)would be necessary and PFS would need a right-of-way grant from BLM. An alternative to this rail line would involve construction of an intermodal transfer facility

(ITF)on BLM lands. SNF would be transported by heavy-haul tractor/trailers to the reservation site under this alternative. Your comments are necessary to assist BLM in reviewing the applications of PFS. Regulations recently revised by BLM at 43 CFR part 2804.26 (70 FR 21067 (April 22, 2005)) call for BLM to consider a number of factors in deciding whether to grant or deny an application for a right-of-way. Among these factors are

(1)the project's consistency with BLM(s management of the public lands;

(2)the public interest;

(3)the applicant's qualifications to hold a grant;

(4)the project's consistency with FLPMA, other laws, or regulations;

(5)the applicant's technical or financial capability; and

(6)the applicant's compliance with information requests. BLM will apply these standards to the PFS applications in light of the data in the applications and in the EIS. Certain recent developments also merit consideration, including statements by the Energy Department and PFS members, and Congressional action. Public Law 109-163, the National Defense Authorization Act for Fiscal Year 2006, was signed by President Bush on January 6, 2006. 119 Stat. 3136. Section 384 of this Act designated certain lands as the Cedar Mountain Wilderness Area and withdrew these lands “from all forms of entry, appropriation, or disposal under the public land laws, from location, entry, and patent under the United States mining laws, and from disposition under all laws pertaining to mineral and geothermal leasing, and mineral materials, and all amendments to such laws.” These lands include the area described in PFS's application for a right-of-way for a rail line, but do not include the area described in PFS's application for a right-of-way for the ITF. Because a rail line would be incompatible with wilderness, designation of the Cedar Mountain Wilderness Area would appear to preclude the grant of a right-of-way for the proposed rail line and shift the focus of this project to the ITF alternative. On October 26, 2005, Secretary of Energy Samuel W. Bodman stated that the PFS facility initiative is not part of the Energy Department's overall strategy for the management of SNF and high-level radioactive waste. The Secretary noted that the Energy Department would be prohibited by statute from providing funding or financial assistance to the initiative because the PFS facility would be constructed and operated by the private sector outside the scope of the Nuclear Waste Policy Act of 1982 (NWPA). The Energy Department will continue to work toward the successful development of Yucca Mountain as a permanent geologic repository for the Nation's high-level radioactive waste. Development of Yucca Mountain would reduce, if not eliminate, the need for high-level radioactive waste to go to a private temporary storage facility in Utah, the Secretary remarked. Correspondence dated December 8, 2005, between the Chief Executive Officer of Xcel Energy and Senator Orrin Hatch indicates that Xcel Energy, the majority shareholder and most active proponent of the PFS project, will hold in abeyance future investments in the next phase of the PFS facility as long as there is progress in various initiatives toward federally sponsored interim storage, reuse, and/or disposal of the nation's spent nuclear fuel. The initiatives referred to include the Energy Department's examination of multi-purpose canister systems for Yucca Mountain; Congressional passage of the FY 2006 Energy and Water Development Act providing funds for grants to communities interested in hosting facilities that would accept and eventually recycle used fuel from civilian nuclear plants; and Congressional preparation of legislation that will promote the movement of waste early in the next decade. Correspondence dated December 7, 2005, between the Chief Executive Officer of Southern Company and Senator Hatch indicates that Southern Company, one of eight members of the PFS consortium, will no longer support the PFS facility, having concluded that the PFS facility “cannot be successfully developed as a spent fuel repository in a time frame to meet Southern's needs.” Southern will continue to work toward ensuring the eventual opening of Yucca Mountain, to which it is committed as the nation's spent fuel repository. Southern Company was one of six members of PFS that in July 2002 announced that they would commit no funds to construction of the PFS facility past the licensing phase so long as the Yucca Mountain project is approved by Congress and repository development proceeds in a timely fashion. Correspondence dated September 9, 2005, from the Utah Congressional delegation to Secretary of the Interior Gale Norton states that the proximity of the Goshute reservation to the Utah Test and Training Range makes it one of the most dangerous locations for the aboveground storage of high-level nuclear waste. The proposed storage site would sit within miles of the training range where 7,000 overflights of F-16s occur every year. Due to heavy commercial air traffic in the area, a principal low level approach by these F-16s passes directly over the proposed storage site. The aircraft sometimes use live ordnance, and 70 crashes of F-16s have occurred within the past 20 years at the Utah Test and Training Range, a number of these well outside the boundaries of the range. In this same correspondence, the Congressional delegation states that NRC refused to reopen its EIS, dated December 2001, to consider the threat of deliberate suicide air attacks, even though post September 11 studies have been completed at all other facilities licensed by NRC. Moreover, the EIS does not require PFS to have any on-site means to handle damaged or breached casks. NRC staff concluded that the risk of a cask breach is so minimal that this scenario need not be considered in the EIS. At the delegation's urging, the Department of Homeland Security has consented to review the location of the proposed site to consider its national security implications. This Congressional correspondence of September 9, 2005, further states that “the issuance of a license for a private away-from-reactor storage site has never been done and in our view runs counter to the Nuclear Waste Policy Act, which limits the NRC to license storage sites only at federal facilities or onsite at nuclear power plants.” Finally, in correspondence with Senator Hatch, dated July 8, 2002, Secretary of Energy Spencer Abraham concluded that the NWPA authorizes DOE to provide funding and financial assistance only for shipments of spent fuel to a facility constructed under that act. The Secretary found that the PFS/Goshute facility would be constructed outside the scope of the act, and as a result DOE would not fund or otherwise provide financial assistance for PFS. Nor could DOE monitor the safety precautions that a private facility may install. All costs associated with the PFS plan would have to be covered by the members of the PFS private consortium, the Secretary concluded. The proposed action (Alternative 1) involves the construction and operation of the proposed PFS facility at a site designated as Site A in the northwest corner of the Skull Valley Indian Reservation and a new rail line connecting the existing Union Pacific railroad to the site. The proposed facility would be designed to store a lifetime capacity of up to 40,000 metric tons of uranium

(MTU)(44,000 tons) of spent nuclear fuel. SNF is the primary by-product from a nuclear reactor. The capacity of the proposed facility would be sufficient to store all SNF from reactor sites owned by PFS members, as well as SNF from reactor sites that are not owned by PFS members. PFS is a limited liability company owned by eight U.S. electric power generating companies. These companies are: Entergy Corporation; Southern California Edison Company; Genoa FuelTech, Inc.; Indiana-Michigan Company (American Electric Power); Florida Power and Light Company; GPU Nuclear Corporation; Xcel Energy Inc.; and Southern Nuclear Operating Company. Construction of the proposed PFS facility would occur in three phases. Phase 1 construction, which would provide an operational facility, is planned to begin upon issuance of a license by the NRC and certification by the Secretary that the conditions under which a May 1997 lease between PFS and the Band was approved have been satisfied. The maximum term of the lease is 50 years. About one-fourth of the storage area for the proposed facility would be constructed during Phase 1, which would be completed in approximately 18 months. Another one-fourth would be completed during Phase 2, and the remaining portion constructed during Phase 3. The maximum amount of SNF that PFS could accept at the proposed facility over the term of the initial license and the proposed lease is 40,000 MTU. Once PFS had accepted 40,000 MTU of SNF, it could not accept any additional shipments, even if it had begun to ship the SNF off site. SNF to be shipped to the proposed PFS facility would be placed inside sealed metal canisters at commercial nuclear power plants. These canisters would then be placed inside NRC-certified steel shipping casks for transport by rail to the new rail siding at Skunk Ridge. Dedicated trains, stopping only for crew changes, refueling, and periodic inspections, would be used to transport SNF from the existing reactor sites to Skull Valley. PFS expects that it would receive 1 to 2 trains, each carrying 2 to 4 shipping casks, per week from the reactor sites. The number of loaded SNF canisters (inside shipping casks) is estimated to be between 100 and 200 annually. Each canister would contain approximately 10 MTU of SNF. The nearest main rail line is approximately 39 km (24 miles) north of the proposed site. PFS's preferred option for transporting SNF from the existing Union Pacific main line railroad to the site is to build a new rail line to the site. The new rail line, and its associated rail siding, would connect to the existing Union Pacific main rail line at Skunk Ridge (near Low, Utah). The proposed right-of-way for the rail corridor would be 51 km (32 miles) long and 60 m (200 ft) wide. It would run to the proposed PFS facility through public lands administered by BLM on the eastern side of the Cedar Mountains. Because these public lands are outside a transportation and utility corridor described in BLM's Pony Express RMP, an amendment to this RMP would be necessary before BLM could issue a right-of-way. Any amendment to this RMP would also await compliance by the Department of Defense with certain reporting duties under section 2815 of the National Defense Authorization Act for FY 2000, Pub. L. 106-65. As noted above, designation of the Cedar Mountain Wilderness Area by Congress in Pub. L. 109-163 appears to preclude the grant of a right-of-way for the rail line in Alternative 1. At the proposed PFS facility, a dry cask storage technology would be used. The sealed metal canisters containing the SNF would be unloaded from the shipping casks at the proposed PFS facility, loaded into steel-and-concrete storage casks, and then placed on concrete pads for aboveground storage. The canister-based cask system for confining the SNF would be certified by NRC in accordance with NRC requirements (10 CFR part 72). PFS proposes to employ the Holtec HI-STORM dual-purpose canister-based cask system for use at the proposed PFS facility. PFS anticipates storing as many as 4,000 sealed metal canisters inside individual storage casks, to store a maximum of 40,000 MTU of SNF. The proposed PFS facility would be licensed by NRC to operate for up to 20 years. The applicant has indicated that it may seek to renew the license for 20 years (total of 40 years). By the end of the licensed life of the proposed PFS facility and prior to the expiration of the lease, it is expected that the SNF would have been shipped to a permanent repository. Service agreements ( *i.e.* , contracts) between PFS and companies storing SNF at the proposed PFS facility will require that the utilities remove all SNF from the proposed PFS facility by the time the PFS license has terminated and PFS has completed its licensing or regulatory obligations under the NRC license. The service agreement requirement to remove the SNF from the proposed PFS facility is not dependent upon the availability of a permanent geological repository. Therefore, if the PFS license is terminated or revoked prior to the availability of a permanent geological repository, the reactor licensees storing SNF at the PFS facility would continue to retain responsibility for the fuel and must remove it from the proposed PFS facility before license termination. At the end of its useful life (or upon termination of the lease with the Band or termination of the NRC license, whichever comes first), the proposed PFS facility would be closed. As a condition of the lease with the Band and as required by NRC regulations, decommissioning of the proposed PFS facility would be required prior to closure of the facility and termination of the NRC license. Although the exact nature of decommissioning cannot be predicted at this time, the principal activities involved in decommissioning would include: 1. Removal of all remaining SNF from Skull Valley; 2. Removal or disposition of all storage casks; 3. Removal or disposition of the storage pads and crushed rock, at the option of the Band and the BIA; and 4. Removal of the buildings and other improvements or their transfer to the Band, at the option of the Band and the BIA. The objective of the radiological decommissioning would be to remove all materials having levels of radioactivity above the applicable NRC limits in order for the site to be released for unrestricted use. The SNF contained inside sealed metal canisters would be transferred to licensed shipping casks for transportation away from Skull Valley. At the option of the Band, non-radiological decommissioning and restoration of the facility may include the removal of structures and reasonably returning the land to its original condition. The future of the buildings and other improvements to be constructed by PFS on the Reservation is to be determined by the Band and the BIA. PFS is obligated to remove the buildings and other improvements at the request of the Band. PFS will collect sufficient advanced funding or provide other financial assurances to accomplish any or all of the non-radiological decommissioning. If the Band chooses to retain any or all of the buildings and other improvements once the radiological decommissioning is complete, it has the right to receive a transfer from PFS in an “intact” condition. The future use of any buildings and other improvements not removed by PFS, including the soil-concrete mixture below the pads, would be at the discretion of the Band. Any impacts associated with such use would be evaluated by a separate NEPA review. The proposed lease requires that the SNF be removed from the Reservation before the end of the lease term. Alternative 2 involves constructing the proposed PFS facility at an alternative location (Site B) on the Reservation. This site is located about 800 m (0.5 mile) south of the proposed Site A and is similar in terms of its environmental characteristics to the proposed site. Under this alternative, a new rail line would be constructed across BLM lands from Skunk Ridge. The rail corridor through Skull Valley would be essentially identical to the one for the proposed action, but it would be about 1.6 km (1 mile) longer due to the slightly greater distance of Site B from the existing main rail line. From BLM's perspective, Alternative 2 would require amendment of the Pony Express RMP and the authorization of a right-of-way across public lands for the construction and operation of a new rail line. Amendment of the Pony Express RMP would involve the Defense Department's compliance with section 2815(b) of the National Defense Authorization Act for FY 2000. Because the rail line is essentially the same as that involved in Alternative 1, designation of the Cedar Mountain Wilderness Area in Pub. L. 109-163 appears to preclude the grant of a right-of-way for the rail line in Alternative 2. Alternative 3 involves constructing the proposed PFS facility at Site A, but transportation of SNF from the existing Union Pacific main rail line to the site would be accomplished by heavy-haul tractor/trailers. An ITF and rail siding would be built on land managed by BLM at the existing main rail line near Timpie, Utah, to transfer SNF shipping casks from rail cars to the heavy-haul vehicles, which would then transport the SNF along the existing Skull Valley Road to the site. No rail line would be built under this alternative. The ITF would occupy 9-11 acres of BLM land approximately 2 miles west of the intersection of I-80 and Skull Valley Road and outside of the lands designated in Pub. L. 109-163 as the Cedar Mountain Wilderness Area. It would consist of three rail sidings, a new access road for heavy-haul vehicles, and a building with a crane for transferring SNF shipping casks from rail cars onto heavy-haul tractor/trailers. PFS has filed an application for a right-of-way from BLM to use this land. The ITF would not require an amendment to the Pony Express RMP. The ITF would occupy previously disturbed land lying between the existing Union Pacific Railroad and Interstate 80. SNF would arrive at the ITF by rail using the Union Pacific rail line. The crane would load the fuel from the rail cars onto heavy-haul tractor/trailers, which would use the existing Skull Valley road to carry the fuel south to the PFS facility on the Goshute Reservation, a distance of approximately 26 miles. From BLM's perspective, Alternative 3 involves the authorization of a right-of-way to occupy public lands for the ITF; no RMP amendment would be necessary. Alternative 4 involves constructing the PFS facility at Site B on reservation lands and transportation of SNF by heavy-haul tractor/trailers. As in alternative 3, PFS would seek a right-of-way to authorize use of an ITF on BLM lands. No rail corridor would be constructed under this alternative, and no amendment of BLM's RMP would be necessary. Under the no action alternative, no PFS facility or transportation facilities would be built in Skull Valley. Under this alternative, NRC would deny the application for a license for the proposed PFS facility, and no certification by the Secretary of lease conditions would occur. From BLM's perspective, the right-of-way applications filed by PFS would be denied. The Band would be free to pursue alternative uses for the land in the northwest corner of the Reservation. Jim Hughes, Deputy Director. [FR Doc. E6-1595 Filed 2-6-06; 8:45 am] BILLING CODE 4310-22-P DEPARTMENT OF THE INTERIOR Meeting of the California Desert District Advisory Council AGENCY: Bureau of Land Management, Interior. ACTION: Notice of public meeting. SUMMARY: Notice is hereby given, in accordance with Public Laws 92-463 and 94-579, that the California Desert District Advisory Council to the Bureau of Land Management, U.S. Department of the Interior, will participate in a field tour of BLM-administered public lands on Friday, March 31, 2006, from 8 a.m. to 5 p.m., and meet in formal session on Saturday, April 1 from 8 a.m. to 1 p.m. in Conference Rooms A, B and C in the CalWorks Building within the Imperial County Center II Complex, located at 2895 South 4th Street, in El Centro, California. The Council and interested members of the public will depart for a field tour of the Imperial Sand Dunes Recreation Area (ISDRA) at 8 a.m. from the parking lot of the Best Western John Jay Inn, located at 2352 South 4th Street in El Centro. The public is welcome to participate in the tour, but should plan on providing their own transportation, drinks, and lunch. Tour stops and presentations/updates will focus on BLM management of the ISDRA, including monitoring and fee collection. SUPPLEMENTARY INFORMATION: All Desert District Advisory Council meetings are open to the public. Public comment for items not on the agenda is scheduled at the beginning of the meeting Saturday morning. Time for public comment may be made available by the Council Chairman during the presentation of various agenda items, and is scheduled at the end of the meeting. Although the Saturday meeting is tentatively scheduled from 8 a.m. to 1 p.m., the meeting could conclude prior to 1 p.m. should the Council conclude its discussions. Therefore, members of the public interested in a particular agenda item or discussion should schedule their arrival accordingly. Written comments may be filed in advance of the meeting for the California Desert District Advisory Council, c/o Bureau of Land Management, Public Affairs Office, 22835 Calle San Juan De Los Lagos, Moreno Valley, California 92553. Written comments also are accepted at the time of the meeting and, if copies are provided to the recorder, will be incorporated into the minutes. FOR FURTHER INFORMATION CONTACT: Doran Sanchez, BLM California Desert District Public Affairs Specialist,

(951)697-5220. Dated: January 30, 2006. Steven J. Borchard, District Manager. [FR Doc. E6-1640 Filed 2-6-06; 8:45 am] BILLING CODE 4310-40-P DEPARTMENT OF THE INTERIOR [WYW153578] Notice of Proposed Reinstatement of Terminated Oil and Gas Lease AGENCY: Bureau of Land Management, Interior. ACTION: Notice. SUMMARY: Under the provisions of Section 371(a) of the Energy Policy Act of 2005, the lessee, Charles A. Einarsen, timely filed a petition for reinstatement of competitive oil and gas lease WYW153578 in Natrona County, Wyoming. The lessee paid the required rental accruing from the date of termination, September 1, 2002, and submitted a signed agreement, specifying future rental and royalty rates for this lease would be at $10.00 per acre or fraction of an acre and 16 2/3 percent respectively. In accordance with 43 CFR 3103.4-1 and 43 CFR 3108.2-3(f) the lessee petitioned to reduce the rental and royalty rates for the subject lease to the rates specified in Sections 1 and 2 of the original lease agreement and submitted justification and rationalization for the request. After thoroughly reviewing the lessee's petition and taking into consideration the information submitted, we have granted the request to reduce the rental rates to those in Section 1 of the original lease agreement but have denied the request for a reduced royalty rate. The purpose of granting a reduced royalty rate is to extend the productive life of an existing well. Normally it cannot be determined whether a lease can be successfully operated at the higher royalty rate required for reinstated leases until the lease has been fully developed. Because the productivity of the leasehold has not been fully determined, the request for a reduced royalty rate is premature. No leases were issued that affect these lands. The lessee had paid the required $500 administrative fee for lease reinstatement and $166 cost for publishing this Notice. The lessee has met all the requirements for reinstatement of the lease per Sec. 31(e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188(e)). We are proposing to reinstate the lease, effective the date of termination subject to: • The original terms and conditions of the lease; • The rental rates specified in Section 1 of the original lease agreement; and • The increased royalty of 16 2/3 percent or 4 percentages above the existing competitive royalty rate. FOR FURTHER INFORMATION CONTACT: Bureau of Land Management, Pamela J. Lewis, Chief, Branch of Fluid Minerals Adjudication, at

(307)775-6176. Pamela J. Lewis, Chief, Branch of Fluid Minerals Adjudication. [FR Doc. E6-1638 Filed 2-6-06; 8:45 am] BILLING CODE 4310-22-P INTERNATIONAL TRADE COMMISSION [Investigation Nos. 731-TA-457-A-D (Second Review)] Heavy Forged Hand Tools From China Determinations On the basis of the record 1 developed in the subject five-year reviews, the United States International Trade Commission (Commission) determines, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)) (the Act), that revocation of the antidumping duty orders on heavy forged hand tools from China would be likely to lead to continuation or recurrence of material injury to industries in the United States within a reasonably foreseeable time. 1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)). Background The Commission instituted these reviews on July 1, 2005 (70 FR 38197) and determined on October 4, 2005 that it would conduct expedited reviews (70 FR 61156, October 20, 2005). The Commission transmitted its determinations in these reviews to the Secretary of Commerce on January 31, 2006. The views of the Commission are contained in USITC Publication 3836 (January 2006), entitled *Heavy Forged Hand Tools from China: Investigation Nos. 731-TA-457 (Second Review).* By order of the Commission. Issued: February 1, 2006. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E6-1637 Filed 2-6-06; 8:45 am] BILLING CODE 7020-02-P INTERNATIONAL TRADE COMMISSION [USITC SE-06-011] Sunshine Act Meeting Notice Agency Holding the Meeting: International Trade Commission. Time and Date: February 23, 2006 at 11 a.m. Place: Room 101, 500 E Street SW., Washington, DC 20436. Telephone:

(202)205-2000. Status: Open to the public. Matters to Be Considered: 1. Agenda for future meetings: none. 2. Minutes. 3. Ratification List. 4. Inv. Nos. 701-TA-401 and 731-TA-853 and 854 (Second Review) (Structural Steel Beams from Japan and Korea)—briefing and vote. (The Commission is currently scheduled to transmit its determination and Commissioners' opinions to the Secretary of Commerce on or before March 8, 2006.). 5. *Outstanding action jackets* : none. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. By order of the Commission: Issued: February 3, 2006. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. 06-1176 Filed 2-3-06; 2:00 pm]

Connectionstraces to 9

Traces to 9 documents

U.S. Code