June 2006 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') granting complainant's motion to amend the complaint and notice of investigation in the above-captioned investigation to substitute respondent Toyota Motor Manufacturing North America, Inc. with Toyota Motor Engineering & Manufacturing North America, Inc. and Toyota Motor Manufacturing Kentucky, Inc.

Notice is hereby given that the U.S. International Trade Commission has instituted a formal enforcement proceeding relating to a limited exclusion order issued at the conclusion of the above-captioned investigation.

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 Form FDA 3601 entitled ``Medical Device User Fee Cover Sheet'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.

The Food and Drug Administration (FDA) is announcing the following public meeting: The Use of Bayesian Statistics in Medical Device Clinical Trials. The draft guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials'' provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials.

We are adopting as a final rule, without change, an interim rule that amended the brucellosis regulations concerning interstate movement of cattle by changing the classification of Idaho from Class Free to Class A. That action was necessary to prevent the interstate spread of brucellosis.

The Office of Personnel Management (OPM) is issuing proposed changes in eligibility requirements and public accountability standards, and to several other parts of the regulations, for the Combined Federal Campaign (CFC). These proposed changes are intended to streamline the significant eligibility requirements and public accountability standards and other administrative areas to reduce the burden on applicant charitable organizations seeking to qualify for the CFC, simplify the administrative process of determining whether charitable organizations are eligible to participate in the CFC and facilitate modernization of the CFC program.

This notice provides further clarification as to the jurisdiction and enforcement responsibilities of the Occupational Safety and Health Administration and 14 of its approved State Plans at various Department of Energy (DOE) sites which are not subject to the Atomic Energy Act (AEA). OSHA's regulations in 29 CFR 1952 are amended to reflect this jurisdiction, as appropriate.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (the Task Force). The Task Force, a standing, independent panel of private-sector experts in prevention and primary care, is composed of members appointed to serve for four year terms with an option for reappointment. New members are selected each year to replace (approximately) one fourth of the Task Force members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. Task Force members meet three times a year for two days in the Washington, DC area. Member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals and organizations may nominate one or more persons qualified for membership on the Task Force. Qualification Requirements: The mission of the Task Force is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the Task Force, an applicant or nominee MUST demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some Task Force members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Strongest consideration will be given to individuals who are recognized nationally or internationally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair in the scientific integrity of the work of the Task Force including financial, intellectual, or other conflicts.

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.

Pursuant to sections 254(a)(11)(A) and 255(b) of the Help America Vote Act (HAVA), Public Law 107-252, the U.S. Election Assistance Commission (EAC) hereby causes to be published in the Federal Register material changes to the HAVA State plan previously submitted by American Samoa.

This proposed notice sets forth proposed revisions to work relative value units (RVUs) affecting payment for physicians' services. The statute requires that we review RVUs no less often than every 5 years. This is our third review of work RVUs since we implemented the physician fee schedule (PFS) on January 1, 1992. These revisions to work RVUs are proposed to be effective for services furnished beginning January 1, 2007. These revisions reflect changes in medical practice, coding changes, new data on relative value components, and the addition of new procedures that affect the relative amount of physician work required to perform each service as required by the statute. In addition, we are proposing revisions to our methodology for calculating practice expense (PE) RVUs, including changes based on supplemental survey data for PE. This revised methodology would be used to establish payment for services beginning January 1, 2007.

In this document, the Commission notifies the public, state Telecommunications Relay Services (TRS) programs, and interstate TRS providers that the annual consumer complaint log summaries are due. To assist the Commission in monitoring the service quality of TRS providers, the Commission requires state TRS programs and TRS providers that provide interstate TRS, interstate STS, interstate Spanish relay, interstate captioned telephone relay, VRS, and IP Relay to maintain and submit consumer complaints that allege violations of the federal TRS mandatory minimum standards. Complaint log summaries shall include, at a minimum, the number of complaints received that allege a violation of the federal TRS mandatory minimum standards, the date of the complaint, the nature of the complaint, the date of its resolution, and an explanation of the resolution.

To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted to OMB an information collection request (ICR) to renew approval of the paperwork requirements in the regulations under ``30 CFR Part 251, Geological and Geophysical (G&G) Explorations of the OCS,'' and related documents. This notice also provides the public a second opportunity to comment on the paperwork burden of these regulatory requirements.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.