Guidelines for determining probability of causation under the Energy Employees Occupational Illness Compensation Program Act of 2000; revision of guidelines on non-radiogenic cancers. Final rule

In a notice of proposed rulemaking published in the Federal Register on March 21, 2011, the Department of Health and Human Services (HHS) proposed to treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) (76 FR 15268). Under this final rule, CLL will be treated as being potentially caused by radiation and hence as potentially compensable under EEOICPA. HHS reverses its decision to exclude CLL from such treatment.     

Employee Retirement Income Security Act of 1974; rules and regulations for administration and enforcement; claims procedure--Department of Labor. Notice of proposed rulemaking

This document contains a proposed regulation revising the minimum requirements for benefit claims procedures of employee benefit plans covered by Title I of the Employee Retirement Income Security Act of 1974 (ERISA or the Act). This proposed regulation would establish new standards for the processing of group health disability, pension, and other employee benefit plan claims filed by participants and beneficiaries. In the case of group health plans, as well as certain plans providing disability benefits, the new standards are intended to ensure more timely benefit determinations, improved access to information on which a benefit determination is made, and greater assurance that participants and beneficiaries will be afforded a full and fair review of denied claims. If adopted as final, the proposed regulation would affect participants and beneficiaries of employee benefit plans, plan, fiduciaries, and others who assist in the provision of plan benefits, such as third-party benefits administrators and health service providers or health maintenance organizations that provide benefits to participants and beneficiaries of employee benefit plans.     

Respiratory protective devices--NIOSH. Notice of proposed rulemaking

This proposed rule addresses NIOSH's and the Department of Labor/Mine Safety and Health Administration's (MSHA) certification requirements for respiratory protective devices. Specifically, the proposal would replace existing MSHA regulations with new public health regulations, while also upgrading current testing requirements for particulate filters. This action is the first of a series of modulates which will, over the next several years, upgrade current respirator requirements. This modular approach will allow improvements to be implemented on a priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. Except for the particulate-filter requirements, most requirements of existing regulations would be incorporated into the new regulations without change. The proposed testing requirements for particulate filters would significantly improve the current approach to evaluating the effectiveness of an air-purifying respirator's filter to remove toxic particulates from the ambient air, updating existing provisions to be consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under these proposed requirements would also enable respirator users to select from a broader range of certified respirators that meet the current performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis, the infectious agent that causes tuberculosis (TB). This Notice also announces an informal public meeting on the proposed rule, as indicated below. Elsewhere in this issue of the Federal Register, MSHA is publishing a proposal to remove existing regulations at 30 CFR part 11, which would be made obsolete by a final rule resulting from this proposed rule.     

Use of multislice computed tomography in disaster victim identification--advantages and limitations

After a mass fatality incident (MFI), all victims have to be rapidly and accurately identified for juridical reasons as well as for the relatives' sake. Since MFIs are often international in scope, Interpol has proposed standard disaster victim identification (DVI) procedures, which have been widely adopted by authorities and forensic experts. This study investigates how postmortem multislice computed tomography (MSCT) can contribute to the DVI process as proposed by Interpol. The Interpol postmortem (PM) form has been analyzed, and a number of items in sections D and E thereof have been postulated to be suitable for documentation by CT data. CT scans have then been performed on forensic cases. Interpretation of the reconstructed images showed that indeed much of the postmortem information required for identification can be gathered from CT data. Further advantages of the proposed approach concern the observer independent documentation, the possibility to reconstruct a variety of images a long time after the event, the possibility to distribute the work by transmitting CT data digitally, and the reduction of time and specialists needed at the disaster site. We conclude that MSCT may be used as a valuable screening tool in DVI in the future.     

Designation of medically underserved populations and health professional shortage areas--HRSA. Proposed rules

The rules proposed below would consolidate the processes for designating medically underserved populations (MUPs) and health professional shortage areas (HPSAs), designations that are used in several DHHS programs. The purpose is to improve the way underserved areas are designated by incorporating up-to-date measures of health status and access barriers and eliminating inconsistencies and duplication of effort. The intended effect is to reduce the effort and data burden on States and communities by simplifying and automating the design process as much as possible, while maximizing the use of technology. The proposed rules involve major changes to both the MUP and the primary care HPSA designation criteria, which have the effect of making primary care HPSAs a subset of the MUPs. No changes are proposed with respect to the criteria for designating dental and mental health HPSAs. Podiatric, vision care, pharmacy, and veterinary care HPSA designations would be abolished under the rules proposed below.     

方孝孺“民本法治”思想初探

方孝孺的＂民本法治＂思想是黄宗羲等晚近思想家提出民主法治理念的基础,他结合儒家＂仁政＂理论,主张＂君职＂、＂立法利民＂,这在中国法律思想的发展过程中具有十分重要的意义,是我国当代民主法治建设重要的传统法律文化资源。     

Medical devices; establishment registration and device listing for manufacturers and distributors of devices; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing establishment registration and device listing by domestic distributors. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.     

Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule

The Food and Drug administration (FDA) is issuing a final rule stating that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this final rule after considering the reports and recommendations of various OTC drug advisory review panels and public comments on proposed agency regulations, which were issued in the form of a tentative final monograph (proposed rule). Based on the absence of substantive comments in opposition to the agency's proposed nonmonograph status for these ingredients, as well as the failure of interested parties to submit new data or information to FDA under the regulation, the agency has determined that the presence of these ingredients in an OTC drug product would result in that drug product not being generally recognized as safe and effective or would result in misbranding. This final rule is part of the ongoing review of OTC drug products conducted by FDA.     

Medical devices; humanitarian use of devices; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing humanitarian use devices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.     

Medical devices; device tracking--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is issuing a final rule to establish a device tracking requirement for certain categories of medical devices as required by the Safe Medical Devices Act of 1990 (the SMDA). In a proposed rule issued on May 27, 1992, and published elsewhere in this issue of the Federal Register, FDA discussed the agency's initial review of certain comments received in response to an earlier proposed rule that published in the Federal Register of March 27, 1992 (57 FR 10702), that has been withdrawn. In issuing this final rule, FDA is providing notice that the proposed rule published elsewhere in this issue of the Federal Register now has the status of a final rule by operation of section 3(c)(2) of the SMDA. FDA is also confirming that the effective date of this rule is March 1, 1993. This rule applies to all devices subject to tracking under the SMDA that are initially introduced into interstate commerce or presented for importation into the United States on or after March 1, 1993. In the proposed rule published elsewhere in this issue of the Federal Register, FDA requests comments on that proposal. Upon closure of the comment period for that proposed rule and consideration of comments responding to both the original March 27, 1992, proposed rule and the new proposed rule, FDA will, if necessary, take further actions to revise the rule.     

Privacy Act of 1974; notice of new system of records--HHS. Notice of new system of records

In accordance with the Privacy Act of 1974 (Pub. L. 93-5790, as amended, the Office of Human Development Services is proposing to establish a new system of records, Records Maintained on Individuals for Program Evaluation Purposes Under Contracts, HHS, HDS No. 09-80-0100. We have provided background information about the proposed system in the "SUPPLEMENTARY INFORMATION" section below. HDS invites public comments by April 19, 1984 on the proposed routine uses of the system.     

Blind Detection of Region Duplication Forgery Using Fractal Coding and Feature Matching

Digital image forgery detection is important because of its wide use in applications such as medical diagnosis, legal investigations, and entertainment. Copy–move forgery is one of the famous techniques, which is used in region duplication. Many of the existing copy–move detection algorithms cannot effectively blind detect duplicated regions that are made by powerful image manipulation software like Photoshop. In this study, a new method is proposed for blind detecting manipulations in digital images based on modified fractal coding and feature vector matching. The proposed method not only detects typical copy–move forgery, but also finds multiple copied forgery regions for images that are subjected to rotation, scaling, reflection, and a mixture of these postprocessing operations. The proposed method is robust against tampered images undergoing attacks such as Gaussian blurring, contrast scaling, and brightness adjustment. The experimental results demonstrated the validity and efficiency of the method.     

The Proposal for a Directive on the Patentability of Computer-implemented Inventions

The European Commission Proposal for a Directive on the Patentability of Computer-implemented Inventions is an important step towards harmonising and clarifying the patent protection available for such inventions in European Member States. This paper discusses the proposed Directive, its potential impact and some initial reactions from those in the software industry. It outlines the background to the Proposal, discussing briefly the exclusion of computer programs 'as such' from patent protection under the European Patent Convention (EPC). The paper observes that, in its current form, the proposed Directive will narrow the protection currently available to patentees and that some thought should be given to transitional provisions. It concludes that, whatever balance is struck as the Directive progresses to adoption, the Directive will have the benefit of providing a mechanism for aligning the approach of European Member States to patenting computer-implemented inventions. 'Educational initiatives' may, however, be required if European companies, in particular Small and Mediumsized Enterprises (SMEs), are, as intended by the Commission, to view the harmonization and greater transparency provided by the proposed Directive as an incentive to use patents to exploit their computer-implemented inventions.     

Sanctions applicable to letter of credit administration--Office of the Secretary, HHS. Proposed rule

We are proposing regulations that would govern the imposition of sanctions against recipient organizations holding letters of credit under programs administered by the Department of Health and Human Services. The regulations would describe the conditions which may prompt the imposition of sanctions and would establish uniform procedures for providing affected recipient organizations: (1) Adequate notice of the grounds upon which proposed sanctions are based, (2) an opportunity to respond to the factual and legal bases of the proposed sanctions, and (3) a reasoned decision that articulates the factual and legal bases of the Department's final decision. We believe that these uniform procedures would be useful both as a sound management tool for the Department and as a guide to grantees and contractors.     

Medical devices; reports of corrections and removals; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removal of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is issued under FDAMA and the act as amended.     

The Norwegian Barents Sea Management Plan and the EC Marine Strategy Directive: Some Political and Legal Challenges with an Ecosystem-Based Approach to the Protection of the European Marine Environment

This article addresses some of the implications of the EU's proposed Marine Strategy Directive for ongoing work in the regional seas conventions and for national work on regional marine strategies. The starting point is the proposed directive's focus on the ecosystem approach to the protection of the marine environment. Key elements within this approach are analysed, such as integration of environmental considerations into other policy areas; introduction of ecological quality objectives; and establishment of holistic monitoring and assessment programmes. Is it possible to transform these concepts into legally binding obligations? What will the implications of the proposed directive be for the rights and obligations of EU Member States under international law? A Management Plan for the Norwegian Part of the Barents Sea ('Barents Plan') was adopted by the Norwegian Government in March 2006 and approved by the Norwegian Storting (Parliament) in June 2006. It provides an example of a concrete application of the concepts in the proposed directive. Based on an analysis of the proposed Marine Strategy Directive and the Barents Plan, some key political and legal challenges are discussed in this article.     

Automated comparison of firearm bullets

Fired bullets bear striation marks that can be thought of as a "fingerprint" left by the firearm. This new comparison approach is based on an automated extraction of a "signature" encompassing the relevant marks from an image. To this end, multiple pictures of the bullet are recorded first by using different illumination patterns, and a high quality image is generated by means of fusion techniques. After a preprocessing, the image intensities are filtered along the striations direction, yielding a compact representation of the marks. A non-linear filter selects the striae of interest. The actual comparison takes place by cross-correlating the signatures obtained this way. Finally, an assessment strategy is proposed to objectively evaluate the performance of the system. As demonstrated with an image database of real bullets, the proposed approach outperforms a state-of-the-art commercial system.     

Medicare program; prospective payment system for hospital outpatient services; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on September 8, 1998, (63 FR 47552). In that rule, as required by sections 4521, 4522, and 4523 of the Balanced Budget Act of 1997, we proposed to eliminate the formula-driven overpayment for certain outpatient hospital services, extend reductions in payment for costs of hospital outpatient services, and establish in regulations a prospective payment system for hospital outpatient services (and for Medicare Part B services furnished to inpatients who have no Part A coverage.) The comment period is extended for 60 days.