Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Revision of the Salable Quantity and Allotment Percentage for Class 3 (Native) Spearmint Oil for the 2004-2005 Marketing Year
This rule further amends prior interim final rules that increased the quantity of Class 3 (Native) spearmint oil produced in the Far West that handlers may purchase from, or handle for, producers during the 2004-2005 marketing year. This rule increases the Native spearmint oil salable quantity by an additional 85,936 pounds from 1,267,562 pounds to 1,353,498 pounds, and the allotment percentage by an additional 4 percent from 59 percent to 63 percent. The Spearmint Oil Administrative Committee (Committee), the agency responsible for local administration of the marketing order for spearmint oil produced in the Far West, unanimously recommended this rule to avoid extreme fluctuations in supplies and prices and to help maintain stability in the Far West spearmint oil market.
Notice of Proposed Information Collection: Comment Request
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Registration of Claims to Copyright, Group Registration of Published Photographs
The Copyright Office of the Library of Congress is amending its final regulations concerning group registration of published photographs to limit to 750 the number of photographs that may be identified on continuation sheets submitted with a single application form and filing fee. The regulation continues to place no limit on the number of photographs that may be included in a single group registration when the applicant elects not to use continuation sheets and instead identifies the date of publication for each photograph on the deposited image and the applicant meets the other regulatory requirements for group registration of published photographs. The regulation also clarifies that the date of publication for each photograph may be identified in a text file on the CD-ROM or DVD that contains the photographic images or on a list that accompanies the deposit and provides the publication date for each image.
Revision and Clarification of Deemed Export Related Regulatory Requirements
The Bureau of Industry and Security (BIS) is reviewing the recommendations contained in the U.S. Department of Commerce Office of Inspector General Report entitled ``Deemed Export Controls May Not Stop the Transfer of Sensitive Technology to Foreign Nationals in the U.S.'' (Final Inspection Report No. IPE-16176-March 2004). Certain of these recommendations would require regulatory changes that would affect existing requirements and policies for deemed export licenses. BIS is seeking comments on how these revisions would affect industry, the academic community, and U.S. government agencies involved in research.
Privacy Act of 1974, as Amended; Computer Matching Program
In compliance with the Privacy Act of 1974, as amended by Pub. L. 100-503, the Computer Matching and Privacy Protection Act of 1988, we are publishing a notice of a computer matching program that OCSE will conduct on behalf of itself and the District of Columbia Department of Human Services, Income Maintenance Administration (IMA) for verification of continued eligibility for Public Assistance. The match will utilize National Directory of New Hire (NDNH) records and IMA records. The purpose of the computer matching program is to exchange personal data for purposes of identifying individuals who are employed and also are receiving payments pursuant to the Temporary Assistance for Needy Families (TANF) benefit program administered by IMA.
Environmental Literacy Grants
This notice announces that OESD is soliciting 1- to 3-year proposals for environmental literacy projects. Funded projects will further NOAA's education goals articulated in the NOAA Education Plan http://www.oesd.noaa.gov/NOAAEdPlan.pdf. Funding is available to encourage the development of partnerships and to support existing, or foster growth of new, environmental literacy projects. This program has two funding priorities for FY05: (1) Partnerships that promote systemic change in NOAA-related science education, and (2) Innovative presentation of NOAA science and earth observing data through educational data visualizations and other educational tools. Within priority two, NOAA has committed to funding the installation of up to four ``Science on a Sphere'' (SOS) data systems at informal education venues. These ``Science on a Sphere'' installations will be funded by way of one- to three-year cooperative agreements. It is anticipated that final recommendations for funding under this announcement will be made in mid Calendar Year 2005, and that projects funded under this announcement will have a start date no earlier than September 30, 2005.
Committee Management; Notice of Public Meeting; Advisory Committee on Acoustic Impacts on Marine Mammals
The Marine Mammal Commission (Commission) will hold the fifth meeting of its Advisory Committee on Acoustic Impacts on Marine Mammals (Committee) 19 to 21 April, 2005 in Silver Spring, Maryland.
Privacy Act of 1974; Implementation of Exemptions; Correction
The Department of Homeland Security (DHS) is correcting a notice of proposed rulemaking that was published in the Federal Register on March 22, 2005, at 70 FR 14427 which gives notice that DHS is concurrently establishing a new system of records pursuant to the Privacy Act of 1974 for the Bureau of Immigration and Customs Enforcement, Student and Exchange Visitor Program. In that proposed rulemaking, the Department proposes to exempt portions of this system of records from one or more provisions of the Privacy Act because of criminal, civil and administrative enforcement requirements. In the Heading of the proposed rulemaking, DHS inadvertently mislabeled the DHS docket number associated with the rulemaking. DHS would like to announce that the DHS docket number for submitting comments via to this notice is DHS-2005-0016. Directions for submitting comments using this method are outlined within 70 FR 14427.
Privacy Act of 1974; System of Records; Correction
The Department of Homeland Security (DHS) is correcting a notice that was published in the Federal Register on March 22, 2005, at 70 FR 14477 which gives notice that the Bureau of Immigration and Customs Enforcement (ICE) proposes to add a new system of records to the Department's inventory of record systems. The system of records is the Student and Exchange Visitor Information System. In the Heading of the notice, DHS inadvertently mislabeled the DHS docket number associated with the notice. DHS would like to announce that the DHS docket number for submitting comments to this notice is DHS-2005-0015. Directions for submitting comments using this method are outlined within 70 FR 14477.
Endangered Species; File No. 1514
Notice is hereby given that the NMFS Pacific Islands Regional Office (PIRO), 1601 Kapiolani Blvd., Ste. 1110, Honolulu, HI 96814, has been issued a permit to take green (Chelonia mydas), leatherback (Dermochelys coriacea), loggerhead (Caretta caretta), olive ridley (Lepidochelys olivacea), and hawksbill (Eretmochelys imbricata) sea turtles for purposes of scientific research.
Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska
NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the first seasonal apportionment of the 2005 Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA has been reached.
Notice of Availability of the Proposed Notice of Sale for Outer Continental Shelf (OCS) Oil and Gas Lease Sale 196 in the Western Gulf of Mexico (GOM)
The MMS announces the availability of the proposed Notice of Sale for proposed Sale 196 in the Central GOM OCS. This Notice is published pursuant to 30 CFR 256.29(c) as a matter of information to the public. With regard to oil and gas leasing on the OCS, the Secretary of the Interior, pursuant to section 19 of the OCS Lands Act, provides the affected States the opportunity to review the proposed Notice. The proposed Notice sets forth the proposed terms and conditions of the sale, including minimum bids, royalty rates, and rentals.
Iranian Transactions Regulations
The Office of Foreign Assets Control (``OFAC'') of the U.S. Department of the Treasury is revising the Iranian Transactions Regulations to clarify the applicability of certain general licenses to brokers and dealers in securities.
Approval and Promulgation of Implementation Plans; Texas; Post 1996 Rate-of-Progress Plan, Adjustments to the 1990 Base Year Emissions Inventory, and Motor Vehicle Emissions Budgets for the Dallas/Fort Worth Ozone Nonattainment Area
EPA is approving a State Implementation Plan (SIP) revision for the State of Texas. This revision includes the Post 1996 Rate-of- Progress (ROP) plan, adjustments to the 1990 base year emissions inventory, and ROP Motor Vehicle Emissions Budgets for the Dallas/Fort Worth (DFW) ozone nonattainment area. This plan shows planned emission reductions required by the Clean Air Act (Act) from 1996 to 1999 to improve air quality in the Dallas/Fort Worth Area. The reductions are from the 1990 base year emissions inventory. The adjustments to the 1990 base year emissions inventory improve that inventory. The Motor Vehicle Emissions Budgets are used for determining conformity of transportation projects to the SIP. This action satisfies the Act's requirements for a serious ozone nonattainment area's Post 1996 Rate- of-Progress requirements and approves the Motor Vehicle Emissions Budgets under the Rate-of-Progress Plan.
South Carolina: Final Authorization of State Hazardous Waste Management Program Revisions
South Carolina has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to South Carolina. In the ``Rules and Regulations'' section of this Federal Register, EPA is authorizing the changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we get comments that oppose this action, we will withdraw the immediate final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time.
South Carolina: Final Authorization of State Hazardous Waste Management Program Revision
South Carolina has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for Final authorization, and is authorizing the State's changes through this immediate final action. EPA is publishing this rule to authorize the changes without a prior proposal because we believe this action is not controversial and do not expect comments that oppose it. Unless we get written comments which oppose this authorization during the comment period, the decision to authorize South Carolina's changes to their hazardous waste program will take effect. If we get comments that oppose this action, we will publish a document in the Federal Register withdrawing this rule before it takes effect and a separate document in the proposed rules section of this Federal Register will serve as a proposal to authorize the changes.
Proposed Consent Decree, Clean Air Act Citizen Suit
In accordance with section 113(g) of the Clean Air Act, as amended (``Act'' or ``CAA''), 42 U.S.C. 7413(g), notice is hereby given of a proposed consent decree, to address a lawsuit filed by Environmental Defense and American Lung Association (jointly referred to as the ``Plaintiffs''): Environmental Defense and American Lung Association v. Johnson, No. 1:05CV00493 (D.D.C.). On March 10, 2005, the Plaintiffs filed a complaint to compel EPA to make a determination as to whether each state has submitted state implementation plans (``SIPs'') required by section 110(a) of the CAA for the national ambient air quality standards for fine particles (``PM-2.5 NAAQS'') and for ozone (``8-hour ozone NAAQS'') (jointly referred to as the ``1997 NAAQS'').
Notice of Availability: Draft NPDES Permit for Concentrated Animal Feeding Operations for Puerto Rico
Today's notice makes available for public comment the draft NPDES Permit for Concentrated Animal Feeding Operations for Puerto Rico for public review and comment. This draft permit is being published to meet one of EPA's key action items in the Concentrated Animal Feeding Operations Regulationsto issue NPDES permits to reduce risk to water quality and human health from animal feeding operations by December 2006. Please note that this Draft Permit for CAFOs in Puerto Rico has been sent to Public Notice in both an English and a Spanish Newspaper in Puerto Rico for a period of 60 days. The Concentrated Animal Feeding Operation (CAFO) General Permit is a single permit which covers all CAFOs that apply for coverage in the Commonwealth of Puerto Rico. Consequently, those CAFOs which are covered by the General Permit will have identical permit language and requirements. Unique facility-specific requirements will be similarly referenced in the permit. The facility-specific requirements are found in the Puerto Rico Environmental Quality Board's regulations for Animal Feeding Operations and detailed in an Agricultural Waste Management Plan (AWMP). The AWMP is a requirement for all CAFOs. For Puerto Rico the AWMP is synonymous with a Residuals Management System. Only Animal Feeding Operations (AFOs) which meet the definition of a CAFO are eligible to apply for coverage under the General Permit. AFOs which do not meet the definition are not eligible to be covered under the General Permit. To determine if your operation is a CAFO, see 40 CFR 122.23 (4) and (6) as well as Part VII of the Definitions section of the General Permit. In addition, facilities can be designated as CAFOs on a case by case basis. EPA believes that comments from a wide range of interested stakeholders is important to produce a final permit that will help EPA achieve the goal of reducing risk to water quality and human health from animal feeding operations. EPA is interested in receiving comments from reviewers of the draft NPDES Permit for Concentrated Animal Feeding Operations for Puerto Rico, and will carefully consider this input as it prepares a final permit.
Privacy Act of 1974; Notice of Amendment to an Existing System of Records
As required by the Privacy Act of 1974, 5 U.S.C. 552a, and the Office of Management and Budget (OMB) Circular A-130, the Department of Energy (DOE) is publishing a notice of a proposed amendment to an existing system of records and the deletion of a system that will no longer be maintained. DOE has acquired a new financial system that requires new hardware and software. This notice proposes to combine DOE-18 ``Accounts Payable Financial System'' and DOE-19 ``Accounts Receivable Financial System'' into a single system of records, eliminate DOE-19 ``Accounts Receivable Financial System'' from the Department's inventory of systems of records, rename DOE-18 to ``Financial Accounting System,'' expand the categories of records maintained in the system, and establish a new routine use provision for DOE-18.
Desert Southwest Customer Service Region-Rate Order No. WAPA-121
This action is to extend the existing Rate Schedules PD-NTS1, INT-NTS1, DSW-SD1, DSW-RS1, DSW-FR1, DSW-EI1, DSW-SPR1, and DSW-SUR1 for the Desert Southwest Customer Service Region (DSW) network integration transmission services (NTS) for the Parker-Davis Project (P-DP) and the Pacific Northwest-Pacific Southwest Intertie Project (Intertie) and ancillary services for the Western Area Lower Colorado control area through March 31, 2006. The additional time is needed to accommodate the extension of the Multi-System Transmission Rate (MSTR) Public Process.
Montana: Filing of Plats of Amended Protraction Diagrams
The Bureau of Land Management (BLM) will file the plats of the amended protraction diagrams of the lands described below in the BLM Montana State Office, Billings, Montana, (30) days from the date of publication in the Federal Register.
Notice of Intent To Prepare a Comprehensive Conservation Plan and Environmental Assessment for the Long Island National Wildlife Refuge Complex
This notice advises the public that the U.S. Fish and Wildlife Service (Service) intends to prepare a Comprehensive Conservation Plan (CCP) and Environmental Assessment (EA) pursuant to the National Environmental Policy Act and its implementing regulations, for the Long Island National Wildlife Refuge (NWR) Complex refuges located in the State of New York. The Long Island NWR Complex is a diverse group of eight refuges totaling over 6,200 acres, and contains most of the habitat types found on Long Island which are important to migratory birds and other wildlife. These refuges include Amagansett, Conscience Point, Lido Beach, Morton, Oyster Bay, Seatuck, Target Rock, and Wertheim NWRs. The refuges are in Suffolk and Nassau Counties, New York. This notice also advises the public that the Service is withdrawing a previous notice, published on May 30, 2000, stating that an Environmental Impact Statement (EIS) would be developed for the refuge complex. Comments already received under the previous notice will be considered during preparation of the subject CCP/EA. The Service is furnishing this notice in compliance with the National Wildlife Refuge System Administration Act of 1966, as amended (16 U.S.C. 668dd et seq.): (1) To advise other agencies and the public of our intentions, and (2) to obtain suggestions and information on the scope of issues to include in the environmental documents.
Karnal Bunt; Regulated Areas
We are amending the Karnal bunt regulations to make changes to the list of areas or fields regulated because of Karnal bunt, a fungal disease of wheat. We are adding certain areas in La Paz, Maricopa, and Pinal Counties, AZ, and Riverside County, CA, to the list of regulated areas either because they were found during surveys to contain a bunted wheat kernel, or because they are within the 3-mile-wide buffer zone around fields or areas affected with Karnal bunt. We are also removing certain areas or fields in Maricopa and Pinal Counties, AZ, and Imperial County, CA, from the list of regulated areas based on our determination that those fields or areas meet our criteria for release from regulation. These actions are necessary to prevent the spread of Karnal bunt to noninfected areas of the United States and to relieve restrictions on certain areas that are no longer necessary.
Classical Swine Fever Status of Mexican States of Campeche, Quintana Roo, Sonora, and Yucatan
We are amending the regulations by adding the Mexican States of Campeche, Quintana Roo, Sonora, and Yucatan to the lists of regions considered free of classical swine fever (CSF). We have conducted a series of risk evaluations and have determined that these four States have met our requirements for being recognized as free of this disease. This action allows the importation into the United States of pork, pork products, live swine, and swine semen from these regions. In addition, this rule requires live swine, pork, and pork products imported into the United States from the four Mexican States to be certified as having originated in one of those States or in another region recognized by the Animal and Plant Health Inspection Service as free of CSF and as not having been commingled, prior to export to the United States, with animals and animal products from regions where CSF exists.
Notice of Intent To Seek Approval To Collect Information
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR part 1320 (60 FR 44978, August 29, 1995), this notice announces the National Agricultural Library's intent to request approval for new information collection relating to the information needs of Library customers and potential customers, and customers' satisfaction with current Library services. This voluntary survey gives current and potential customers the opportunity to provide feedback that will assist Library staff in revising current services or creating new ones to meet customers' information needs more effectively.
Irradiation in the Production, Processing, and Handling of Food; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of December 23, 2004 (69 FR 76844). The document amended the food additive regulations by establishing a new maximum permitted energy level of x rays for treating food of 7.5 million electron volts provided the x rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. The document was published with two errors in the preamble section. This document corrects those errors.
Workforce Investment Act-Grants for Workforce Investment Boards
The U.S. Department of Labor (USDOL), Employment and Training Administration (ETA), announces the availability up to $5 million for grants to eligible Workforce Investment Boards (WIBs) that have demonstrated successfully the ability to form working partnerships with grassroots faith-based and community organizations (FBCOs). Grassroots FBCOs may include faith-based and community organizations, minority-led or immigrant-led non-profit or community development organizations and/ or other small non-profit organizations. This grant will build upon successful ETA grants from program years (PY) 2001 to 2004 that focused on the use of intermediaries and WIBs to build partnerships between FBCOs and local One-Stop systems. The WIB will develop and implement an 18-month project to encourage the formation of long-term contractual and non-contractual partnerships with FBCOs that meet an unmet community need related to hard-to-serve populations (e.g., ex-offenders, limited-English, welfare-to work, etc.). This investment supports and complements the President's High- Growth Job Training Initiative. The foundation of this initiative is the creation of partnerships to work collaboratively in the development of solutions to the human resource challenges facing our growth industries, while developing maximum access for American workers to gain the competencies they need to obtain good jobs. These partnerships include the public workforce system, business and industry, education and training providers and economic development principals. ETA is investing in demonstration projects in twelve high growth/high demand sectors that include advanced manufacturing, automotive services, biotechnology, construction, energy, financial services, geospatial technology, healthcare, hospitality, information technology (IT) & IT business-related services, retail, and transportation. This solicitation is designed to extend the partnership invitation to FBCOs through the direct involvement of our nation's Workforce Investment Boards. This grant also complements ETA's ongoing sectoral employment research and evaluationsi.e., identifying workforce needs and opportunities within a local or regional industry or cross-industry occupational group while retaining a focus on economic performance and competitiveness. FBCOs can discharge a significant community role in assisting Boards by bringing new entrants to the job market that can be trained and equipped to meet emerging and evolving industry needs. Each applicant Board will identify up to three businesses or industry sectors to collaborate with the Board and FBCOs within the local One- Stop system to provide jobs for qualified employees from the identified geographic areas.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its seventh meeting. The meeting will be open to the public.
Dried Prunes Produced in California; Increased Assessment Rate
This rule increases the assessment rate established for the Prune Marketing Committee (committee) under Marketing Order No. 993 for the 2004-05 and subsequent crop years from $4.00 to $6.00 per ton of salable dried prunes. The committee locally administers the marketing order which regulates the handling of dried prunes grown in California. Authorization to assess dried prune handlers enables the committee to incur expenses that are reasonable and necessary to administer the program. The committee recommended a higher assessment rate because the 2004-05 crop is very small, and the higher assessment rate is needed to generate funds to meet program expenses and provide an adequate financial reserve. The crop year began August 1 and ends July 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Community Reinvestment Act Regulations
The OCC, Board, FDIC, and OTS (collectively, ``we'' or ``the agencies'') are adopting, in final form, without change, the joint interim rule that was published for comment in the Federal Register on July 8, 2004. This joint final rule conforms our regulations implementing the Community Reinvestment Act (CRA) to changes in: the Standards for Defining Metropolitan and Micropolitan Statistical Areas published by the U.S. Office of Management and Budget (OMB) in December 2000; census tracts designated by the U.S. Census Bureau (Census); and the Board's Regulation C, which implements the Home Mortgage Disclosure Act (HMDA). The joint final rule also makes a technical correction to a cross-reference within our CRA regulations. This joint final rule does not make substantive changes to the requirements of the CRA regulations, and it is identical to the joint interim final rule adopted by the agencies.
Interagency Proposal on the Classification of Commercial Credit Exposures
The OCC, Board, FDIC, and OTS (the agencies) request comment on their proposal to revise the classification system for commercial credit exposures. The proposal will replace the current commercial loan classification system categories ``special mention,'' ``substandard,'' and ``doubtful'' with a two-dimensional based framework. The proposed framework would be used by institutions and supervisors for the uniform classification of commercial and industrial loans; leases; receivables; mortgages; and other extensions of credit made for business purposes by federally insured depository institutions and their subsidiaries (institutions), based on an assessment of borrower creditworthiness and estimated loss severity. The proposed framework would not modify the interagency classification of retail credit as stated in the ``Uniform Retail Credit Classification and Account Management Policy Statement,'' issued in February 2000. However, by creating a new treatment for commercial loan exposures, the proposed framework would modify Part I of the ``Revised Uniform Agreement on the Classification of Assets and Appraisal of Securities Held by Banks and Thrifts' issued in June 2004. This proposal is intended to enhance the methodology used to systematically assess the level of credit risk posed by individual commercial extensions of credit and the level of an institution's aggregate commercial credit risk.
Food and Drug Administration/Drug Information Association Cross Labeling; Public Meeting; Combination Products and Mutually Conforming Labeling
The Food and Drug Administration (FDA), in cooperation with the Drug Information Association (DIA), is announcing a public meeting to solicit views and provide an interactive forum for discussion of stakeholders' perspectives about, and experiences with, the legal and public health issues that arise when sponsors seek to develop or market a product of one type (device, drug, or biological product) that would be labeled for use with an already approved product of a different type, and the approved product's labeling would not be changed. The input received at the meeting and comments made to the docket after the meeting will be considered in developing draft guidance on this topic.
Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Using a Centralized IRB Process in Multicenter Clinical Trials.'' The draft guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA's regulations by facilitating the use of a centralized IRB review process.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Determination That ACIPHEX (Rabeprazole Sodium) Delayed-Release Tablets, 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ACIPHEX (rabeprazole sodium) delayed-release tablets, 10 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for rabeprazole sodium delayed-release tablets, 10 mg.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for PARAPLATIN (carboplatin), TRUSOPT (dorzolamide), CAMPTOSAR (irinotecan), PREVACID (lansoprazole), TAMIFLU (oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate), IMITREX (sumatriptan), DETROL and DETROL LA (tolterodine). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. In addition, the agency is also announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies for the following antidepressants: CELAXA (citalopram), REMERON (mirtazapine), SERZONE (nefazodone), PAXIL (paroxetine), and ZOLOFT (sertraline). Studies for these drugs were submitted before the BPCA was implemented. Therefore, they are not subject to its requirements. However, due to the public's interest in these pediatric studies, FDA asked the sponsors to consent to the public disclosure of a summary of the medical and clinical pharmacology reviews for these studies. Based on sponsors' consent, FDA is making the summaries publicly available.
Exclusions From Income and Net Worth Computations
This document amends the Department of Veterans Affairs (VA) adjudication regulations to exclude from income and net worth computations in the pension and parents' dependency and indemnity compensation programs benefits or payments received pursuant to the Medicare Prescription Drug Discount Card and Transitional Assistance Program in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This amendment is necessary to conform the regulations to statutory provisions.
Escort Vessels for Certain Tankers-Crash Stop Criteria
The Coast Guard proposes to make permanent the 1994 suspension of the crash stop requirements in our tanker escort rules.
Terms Imposed by States on Numbering of Vessels
The Coast Guard is correcting the preamble to a final rule that appeared in the Federal Register of March 18, 2005 (70 FR 13102). The final rule expands the number of conditions that a State may require in order for owners to obtain vessel numbering certificates in that State. The preamble to the final rule contains an error in the regulatory evaluation.