Changes to the Federal Register for May 9, 2007

Animal Drugs, Feed and Related Products 21 CFR 500-599
Part 510 - The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from American Pharmaceutical Partners, Inc., to Abraxis Pharmaceuticals Products and to change the sponsor's mailing address. [72 FR 26288]

Animal Drugs, Feed and Related Products 21 CFR 500-599
Part 529 - The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of oxytetracycline hydrochloride soluble powder for skeletal marking of finfish fry and fingerlings by immersion. [72 FR 26289]

Biologics, Cosmetics, Medical Devices, Mammography, Radiological Health 21 CFR 600-1299
Part 866 - The Food and Drug Administration (FDA) is classifying gene expression profiling test systems for breast cancer prognosis into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. [72 FR 26290]

Mineral Resources 30 CFR 700-END
Part 935 - We are approving an amendment to the Ohio regulatory program (the "Ohio program") under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). This amendment is intended to remove certain Conflict of Interest provisions from the approved Ohio program that were previously approved by OSM but have not been promulgated by Ohio through their rulemaking process. [72 FR 26291]

Navigation and Navigable Waters 33 CFR 125-199
Part 165 - The Coast Guard is establishing a temporary safety zone in the navigable waters of San Francisco Bay for the loading, transport, inactive period, and launching of fireworks used during the KFOG "KaBoom" Fireworks Display to be held on May 12, 2007. This safety zone is intended to prohibit vessels and people from entering into or remaining within the regulated areas in order to ensure the safety of participants and spectators. [72 FR 26296]

Navigation and Navigable Waters 33 CFR 125-199
Part 165 - The Coast Guard is establishing a temporary safety zone during the "Washington Summer Festival and the Washington 4th of July Fireworks" displays to be held on the waters of the Pamlico River, Washington, North Carolina. This action is necessary to provide for the safety of life on navigable waters during the event. This action will restrict vessel traffic in portions of the Pamlico River adjacent to Washington, North Carolina during the fireworks display. [72 FR 26298]

Pesticides Programs 40 CFR 150-189
Part 174 - This regulation establishes an extension of the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied/used as a plant-incorporated protectant (PIP). Syngenta Seeds, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied/used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2008. [72 FR 26300]

Pesticides Programs 40 CFR 150-189
Part 180 - This regulation establishes pesticide tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) for combined residues of flufenacet and its metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in or on grass (forage, hay), sweet corn (forage, kernel plus cob with husk removed, stover), wheat (bran, forage, grain, hay, straw), cattle kidney, goat kidney, hog kidney, horse kidney, and sheep kidney. Bayer Cropscience petitioned EPA to establish these tolerances. [72 FR 26304]

Pesticides Programs 40 CFR 150-189
Part 180 - This regulation establishes tolerances for combined residues of clethodim and certain of its metabolites in or on asparagus; flax, seed; herb, subgroup 19A; hop, dried cones; leafy greens subgroup 4A; safflower, meal; safflower, seed; sesame, seed; and vegetable, legume, group 6, except soybean. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). [72 FR 26310]

Pesticides Programs 40 CFR 150-189
Part 180 - This regulation establishes a time-limited tolerance for combined residues of fenpyroximate in or on honey. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide in managed beehives. This regulation establishes a maximum permissible level for residues of fenpyroximate in this food commodity. The tolerance expires and is revoked on December 31, 2010. [72 FR 26317]

Pesticides Programs 40 CFR 150-189
Part 180 - This regulation establishes an exemption from the requirement of a tolerance for residues of foramsulfuron on corn, sweet (K+CWHR); corn, sweet, forage; corn, sweet, stover; corn, pop grain; and corn, pop, stover when applied/used as a herbicide. The Interregional Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of foramsulfuron. [72 FR 26322]

Wildlife And Fisheries 50 CFR 600-END
Part 648 - This final rule implements the Georges Bank (GB) Cod Hook Sector Fishing Year (FY) 2007 Operations Plan and Agreement, approved by the Administrator, Northeast Region, NMFS (Regional Administrator). Amendment 13 to the Northeast (NE) Multispecies Fishery Management Plan (FMP) (Amendment 13) authorized allocation of up to 20 percent of the annual GB cod total allowable catch (TAC) to the GB Cod Hook Sector (Sector). Pursuant to that authorization, the Sector submitted an Operations Plan and Sector Contract entitled, "Georges Bank Cod Hook Sector Fishing Year 2007-2008 Operations Plan and Agreement" (together referred to as the Sector Agreement) and requested an allocation of GB cod, consistent with regulations implementing Amendment 13. This action results in authorization of the Sector Operations Plan during the 2007 fishing year and allocation of 675 mt of GB cod to the Sector. [72 FR 26325]