January 16, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not ``provided in advance in appropriations Acts'' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery.

This notice announces meetings of the International Telecommunication Advisory Committee (ITAC) to prepare advice on U.S. positions for the April 2008 meeting of the Organization of American States (OAS) Inter-American Telecommunication Commission (CITEL) Permanent Consultative Committee II (Radiocommunication including broadcasting) (PCC.II) and on various matters associated with the Asia- Pacific Economic Cooperation (APEC). The ITAC will meet to prepare advice for the U.S. on positions for the April 2008 meeting of the OAS CITEL PCC.II on Tuesday February 5, 10 a.m.-noon EST in Room 6B516 at the Federal Communications Commission, 445 12th Street, SW., Washington DC. Meeting details and detailed agendas will be posted on the mailing list pcc.ii- citel@eblist.state.gov. People desiring to participate on this list may apply to the secretariat at minardje@state.gov. The ITAC will meet to elicit private sector and industry input on the Asia-Pacific Economic Cooperation (APEC) Telecommunications Ministerial in April 2008 and on the APEC Telecommunications Working Group future work goals and planning. The meeting will be held on Thursday February 7, 2-4 p.m. EST hosted by Verizon Communications, 1300 Eye Street, Washington, DC. Meeting details and detailed agendas will be posted on the mailing list iccp-ps@eblist.state.gov. People desiring to participate on this list may apply to the secretariat at minardje@state.gov. The meetings are open to the public.

Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

Modified Base (1% annual-chance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents.

The Bureau of Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Commercial Invoice. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments form the public and affected agencies. This proposed information collection was previously published in the Federal Register (72 FR 59103) on October 18, 2007, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis.

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Declaration of Ultimate Consignee for Articles That Were Exported for Temporary Scientific Purposes. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register (72 FR 59103) on October 18, 2007, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Cost Submission. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments form the public and affected agencies. This proposed information collection was previously published in the Federal Register (72 FR 59104) on October 18, 2007, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10.

Base (1% annual chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.

Notice is hereby given that NMFS has received two applications for scientific research permits from the California Department of Fish and Game (CDFG), one from CDFG Region 1 and one from CDFG Region 3. The permits would affect federally threatened Southern Oregon/Northern California Coast coho salmon, endangered Central California Coast coho, threatened California Coastal Chinook salmon, threatened Northern California steelhead, threatened Central California Coast steelhead, threatened South-Central California Coast steelhead, and endangered Southern California steelhead. This document serves to notify the public of the availability of the permit application for review and comment.

This regulation establishes tolerances for residues of acetamiprid in or on bushberry subgroup 13-07B; caneberry subgroup 13- 07A; low growing berry subgroup 13-07G; onion, bulb, subgroup 3-07A; and onion, green, subgroup 3-07B. Nippon Soda Co., Ltd. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This document proposes a clarification under which activated phosphors that are not on the Toxic Substances Control Act (TSCA) section 8(b) Chemical Substance Inventory (TSCA Inventory) would be considered to be new chemical substances under TSCA section 5, thus would be subject to the notification requirements under TSCA section 5(a) new chemical notification requirements. In certain letters and other interpretations issued by EPA from 1978 to 2003, it appears that the Agency erroneously indicated that activated phosphors constitute solid mixtures for purposes of the TSCA Inventory, and thus that they were not separately reportable as chemical substances under TSCA section 5(a) new chemical notification requirements. This proposed clarification is necessary because EPA's interpretations in this area have not been consistent. Given this past inconsistency, EPA is seeking comment on its proposed clarfication.

This regulation establishes a tolerance for residues of mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]- alpha-(2-propynyloxy)-benzeneacetamide in or on Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; okra; vegetable, leafy except brassica, group 4; vegetable, tuberous and corm, subgroup 1C; grape; grape, raisin; onion, dry bulb; onion, green; and potato, wet peel. Syngenta Crop Protection Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The Food and Drug Administration (FDA) is announcing the availability of a risk assessment on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed this risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of a risk management plan for animal clones and their progeny. The risk management plan takes into account the risks identified in the risk assessment and sets out measures that FDA will use to manage those risks. In addition, FDA is announcing availability of guidance for industry 179. This guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed.

The Department of Commerce (``Department'') is currently conducting the aligned semi-annual 2005-2006 new shipper review and 2005-2006 administrative review of the antidumping duty order on honey from the People's Republic of China (``PRC''). The period of review (``POR'') for both the new shipper review and administrative review is December 1, 2005, through November 30, 2006. Five respondents reported that they had no exports or sales of the subject merchandise during the POR; therefore, we are preliminarily rescinding our review of these companies. We preliminarily determine that Wuhu Qinshi Tangye Co., Ltd. (``Wuhu Qinshi''); Jiangsu Light Industry Products Imp & Exp (Group) Corp. (``Jiangsu Light''); Qinhuangdao Municipal Dafeng Industrial Co., Ltd. (``QMD''); and Inner Mongolia Altin Bee-Keeping (``IMA'') have failed to cooperate by not acting to the best of their ability to comply with our requests for information and, as a result, should be assigned a rate based on adverse facts available. Additionally, we have preliminarily determined that, because the Department has not calculated antidumping duty margins in this segment of the proceeding, the two separate rate companies in the administrative review will be assigned the separate rate margin from the most recent segment of this proceeding in which such a rate was calculated, which in this case is the less than fair value (``LTFV'') investigation. Finally, we have preliminarily determined that QHD Sanhai Honey Co., Ltd. (``QHD Sanhai''), the new shipper respondent, did not make sales of subject merchandise to the United States below normal value. If these preliminary results are adopted in our final results of this review, we will instruct U.S. Customs and Border Protection (``CBP'') to assess antidumping duties on all appropriate entries of subject merchandise during the POR. Interested parties are invited to comment on these preliminary results. We will issue the final results no later than 120 days from the date of publication of this notice.

Notice is hereby given that the USDA Forest Service, Lake Tahoe Basin Management Unit (LTBMU), together with the Lahontan Regional Water Quality Control Board will prepare a joint Environmental Impact Statement (EIS/EIR) and Environmental Inpact Report (EIR) to disclose the impacts associated with the following proposed action: Reduction of hazardous fuels and restoration of healthy forest conditions on approximately 12,500 acres within the South Shore area of the LTBMU, extending from the southeast shore of Cascade Lake eastward to the border between the States of California and Nevada and extending from the southern shore of Lake Tahoe southward to include the California State Highway 89 corridor. This project is proposed under authority of the Healthy Forest Restoration Act of 2003. The Forest Service is the lead Federal agency for the preparation of this EIS/EIR in compliance with the National Environmental Policy Act (NEPA) and all other applicable laws, executive orders, regulations, and direction. The Lahontan Regional Water Quality Control Board (LRWQCB) is the lead State of California agency for the preparation of the EIS/EIR in compliance with the California Environmental Quality Act (CEQA), and all other applicable laws and regulations. Both agencies have determined an EIS/EIR is needed to effectively analyze the proposal and evaluate impacts. Reduction of hazardous fuels would be accomplished by thinning to remove ladder fuels and reduce over-crowding in forest stands, removal of excessive fuel loads on the ground, mastication, chipping, and prescribed burning. Resoration of Healthy forest conditions would be accomplished by removal of conifer encroachement from meadows and aspen stands, retention of Jeffrey and sugar pine species to restore a historic species mix more resistant to fire, and thinning to improve resistance to crown fire, drought, insects, and disease.

In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this notice announces 26 grant awards totaling $27,484,189 from the Department's FY2006 Housing Opportunities for Persons With AIDS (HOPWA) program. The notice announces the selection of 16 permanent supportive housing renewal grants and 10 new projects. This notice makes available the names of the award recipients and grant amounts.

The Department of Agriculture, in consultation with the Department of the Interior, intends to renew the Provincial Advisory Committees (PACs) for the five provinces in California, Oregon, and Washington. This renewal is in response to the continued need for the PACs to provide advice on coordinating the implementation of the Record of Decision (ROD) of April 13, 1994, for Management of Habitat for Late-Successional and Old-Growth Forest Related Species Within the Range of the Northern Spotted Owl. The PACs also provide advice and recommendations to promote integration and coordination of forest management activities between Federal and non-Federal entities.