December 9, 2009 – Federal Register Recent Federal Regulation Documents
Results 101 - 134 of 134
Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.'' This guidance describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. This guidance finalizes the draft guidance published on February 3, 2006.
Draft Principles and Standards Sections of the “Economic and Environmental Principles and Guidelines for Water and Related Land Resources Implementation Studies”; Initiation of Revision and Request for Comments
Section 2031 of the Water Resources Development Act of 2007 (Pub. L. 110-114) directs the Secretary of the Army to revise the ``Economic and Environmental Principles and Guidelines for Water and Related Land Resources Implementation Studies,'' (P&G) dated March 10, 1983, consistent with a number of considerations enumerated in the statute. The Administration has initiated the development of uniform planning standards for the development of water resources that would apply to water resources development programs and activities government-wide, to agencies in addition to the traditional water resources development agencies covered under the current Principles and Guidelines: the Army Corps of Engineers, Bureau of Reclamation (Interior), Natural Resources Conservation Service (USDA), and Tennessee Valley Authority. Therefore, the Council on Environmental Quality (CEQ), in coordination with the Office of Management and Budget, has implemented a two phase interagency process revising the planning guidance. The first phase focused on facilitating interagency revisions to the ``Principles and Standards'' (Chapter I of the existing P&G) of Principles and Guidelines for planning water resources
Notice of Inquiry Regarding Passenger Vessel Financial Responsibility
The Federal Maritime Commission is issuing this Inquiry to solicit information and comments concerning the benefits and burdens of the current Commission requirements by which passenger vessel operators establish proof of financial responsibility in the event of nonperformance of a contracted cruise from a U.S. port. Comments received from the public and interested segments of the passenger cruise industry will assist in determining whether or not the Commission should amend its regulations at 46 CFR Part 540, Subpart A.
Swine Health Protection; Feeding of Processed Product to Swine
We are adopting as a final rule, without change, an interim rule that amended the swine health protection regulations to clarify the applicability of the regulations regarding the treatment of garbage that consists of industrially processed materials. The interim rule made clear that such materials are subject to the same treatment requirements as other regulated garbage, except for materials that meet the definition of processed product that we added to the regulations in the interim rule. The interim rule was necessary to ensure that garbage fed to swine has been treated to inactivate disease organisms that pose a risk to the U.S. swine industry.
Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Corn Genetically Engineered for Tolerance to Glyphosate and Acetolactate Synthase-Inhibiting Herbicides
We are advising the public of our determination that a corn line developed by Pioneer Hi-Bred International, designated as transformation event 98140, which has been genetically engineered for tolerance to glyphosate and acetolactate synthase-inhibiting herbicides, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by the Pioneer Hi-Bred International in its petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition for nonregulated status and its associated environmental assessment. This notice also announces the availability of our written determination and finding of no significant impact.
National Veterinary Accreditation Program
We are amending the regulations regarding the National Veterinary Accreditation Program to establish two accreditation categories in place of the former single category, to add requirements for supplemental training and renewal of accreditation, and to offer program certifications. We are making these changes in order to support the Agency's animal health safeguarding initiatives, to involve accredited veterinarians in integrated surveillance activities, and to make the provisions governing our National Veterinary Accreditation Program more uniform and consistent. These changes will increase the level of training and skill of accredited veterinarians in the areas of disease prevention and preparedness for animal health emergencies in the United States.
Notice of Proposed New Fee Site; Federal Lands Recreation Enhancement Act, (Title VIII, Pub. L. 108-447)
The Arapaho-Roosevelt National Forest is proposing to charge a $90 expanded amenity recreation fee for the overnight rental of the historic Squaw Mountain Fire Lookout. Fees are assessed based on the level of amenities and services provided, cost of operations and maintenance, market assessment and public comment. The fee is proposed and will be determined upon further analysis and public comment. Funds from fees would be used for the continued operation, maintenance and improvements of this lookout. An analysis of the lookout shows that the proposed fees are reasonable and typical of comparable sites.
Small Business Size Regulations; 8(a) Business Development/Small Disadvantaged Business Status Determinations
On October 28, 2009, the U.S. Small Business Administration (SBA or Agency) proposed changes to its 8(a) Business Development (8(a) BD) and Small Disadvantaged Business (SDB) programs as well as its size regulations. The rule proposes to make a number of changes to the regulations governing the 8(a) BD and SDB programs, and several changes to SBA's size regulations. Some of the changes involve technical issues. Other changes are more substantive and result from SBA's experience in implementing the current regulations. SBA requested comments on the various approaches for the proposed changes in the proposed rulemaking. The proposed rule provided a 60-day comment period closing on December 28, 2009.
Novaluron; Pesticide Tolerances
This regulation establishes tolerances for residues of novaluron in or on bushberry subgroup 13-07B; Brassica, leafy greens, subgroup 5B; turnip, greens; fruit, stone, group 12, except cherry; cherry; and plum, prune, dried. This regulation additionally revises an existing tolerance in or on egg and revises terminology for an existing tolerance. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Policy Paper on Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses; Notice of Availability
EPA is making available for comment a policy paper entitled ``Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses,'' that describes how the Agency will assess pesticide risks not governed by the Federal Food, Drug and Cosmetic Act. To provide comprehensive and consistent evaluation of potential risks of food use pesticides, non-food use pesticides, and related occupational exposures, EPA intends to apply risk assessment techniques developed in implementing the Food Quality Protection Act of 1996 to any pesticide risk assessment, whether it falls under FQPA or not, as long as applying the risk assessment technique is consistent with good scientific practice and is not otherwise prohibited by law. Specifically, this will include using an additional safety/uncertainty factor to protect children, considering aggregate exposures to pesticides from multiple sources, and considering cumulative effects which may occur from exposure to multiple pesticides with a common mechanism of toxicity. Moreover, risks will be explicitly reported for individuals who had not been explicitly considered, specifically workers age 12-17 and children taken into agricultural fields. Taking this step at this time has important environmental justice ramifications. EPA anticipates that implementing this policy will increase protections, especially for agricultural workers and children of workers in agricultural fields.
Pesticides; Draft Guidance for Pesticide Registrants on Pesticide Drift Labeling and Petition to Protect Children from Pesticide Drift; Notices of Availability; Extension of Comment Period
EPA issued two related notices in the Federal Register of November 4, 2009, one concerning draft guidance on pesticide drift labeling, and one on a petition submitted to the Agency for protecting children from pesticide drift. Both notices announced the availability of the source documents and opened public comment periods of 60 days (until January 4, 2010). Today's notice extends the comment period on both notices for an additional 60 days, from January 4, 2010 to March 5, 2010.
Endangered and Threatened Wildlife and Plants; Revised Critical Habitat for the Santa Ana Sucker (Catostomus santaanae
We, the U.S. Fish and Wildlife Service (Service), propose to revise the designated critical habitat for the Santa Ana sucker (Catostomus santaanae). The areas identified in this proposed rule constitute a revision of the areas designated as critical habitat for the Santa Ana sucker on January 4, 2005. In the 2005 final rule, we designated 8,305 ac (3,361 ha) of critical habitat in Los Angeles County. Approximately 9,605 acres (ac) (3,887 hectares (ha)) of habitat in the Santa Ana River (San Bernardino, Riverside, and Orange Counties) and the San Gabriel River and Big Tujunga Creek (Los Angeles County) in southern California fall within the boundaries of the proposed revised critical habitat designation.
Endangered and Threatened Wildlife and Plants; Establishment of a Nonessential Experimental Population of Bull Trout in the Clackamas River Subbasin, Oregon
We, the U.S. Fish and Wildlife Service (Service), in cooperation with the U.S. Forest Service (USFS) and the State of Oregon, propose to establish a nonessential experimental population (NEP) of bull trout (Salvelinus confluentus) in the Clackamas River and its tributaries in Clackamas County, Oregon, under section 10(j) of the Endangered Species Act of 1973, as amended (Act). The geographic boundaries of the NEP would include the entire Clackamas River subbasin as well as the mainstem Willamette River, from Willamette Falls to its points of confluence with the Columbia River, including Multnomah Channel. The best available data indicate that reintroduction of bull trout to the Clackamas subbasin is biologically feasible and will promote the conservation of the species. We are seeking comments on this proposal and on our draft environmental assessment (EA), prepared pursuant to the National Environmental Policy Act of 1969, as amended (NEPA), which analyzes the potential environmental impacts associated with the proposed reintroduction.
Medicare Program; Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process
This final rule will implement the procedures that the Department of Health and Human Services will follow at the Administrative Law Judge and Medicare Appeals Council levels in deciding appeals brought by individuals who have enrolled in the Medicare prescription drug benefit program. In addition, it will implement the reopening procedures that will be followed at all levels of appeal.
Medicare Program: Changes to the Medicare Claims Appeal Procedures
Under the procedures in this final rule, Medicare beneficiaries and, under certain circumstances, providers and suppliers of health care services can appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B pursuant to sections 1869 and 1879 of the Social Security Act (the Act). Section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) amended section 1869 of the Act to provide for significant changes to the Medicare claims appeal procedures. After publication of a proposed rule implementing the section 521 changes, additional new statutory requirements for the appeals process were enacted in Title IX of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In March 2005, we published an interim final rule with comment period to implement these statutory changes. This final rule responds to comments on the interim final rule regarding changes to these appeal procedures, makes revisions where warranted, establishes the final implementing regulations, and explains how the new procedures will be put into practice.
Corporate Credit Unions
NCUA is issuing proposed amendments to its rule governing corporate credit unions contained in part 704. The major revisions involve corporate credit union capital, investments, asset-liability management, governance, and credit union service organization (CUSO) activities. The amendments would establish a new capital scheme, including risk-based capital requirements; impose new prompt corrective action requirements; place various new limits on corporate investments; impose new asset-liability management controls; amend some corporate governance provisions; and limit a corporate CUSO to categories of services preapproved by NCUA. In addition, this proposal contains conforming amendments to part 702, Prompt Corrective Action (for natural person credit unions); part 703, Investments and Deposit Activities (for federal credit unions); part 747, Administrative Actions, Adjudicative Hearings, Rules of Practice and Procedure, and Investigations; and part 709, Involuntary Liquidation of Federal Credit Unions and Adjudication of Creditor Claims Involving Federally Insured Credit Unions. These amendments will strengthen individual corporates and the corporate credit union system as a whole.
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