September 2006 – Federal Register Recent Federal Regulation Documents

EPA is announcing the availability of a final report titled, ``Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment'' (EPA/600/R-05/043F), prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD).

EPA expressed environmental concerns about increased fugitive dust emissions, and suggested a mitigation strategy of moving the coal hopper, conveyor and coal loading area closer to the proposed project area. Also, EPA requested that the final EIS discuss the range of mercury concentrations found in Black Butte coal and compare this concentration with other coal mined in Wyoming and the United States. Rating EC2.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) has submitted the following proposal(s) for the collection of information to the Office of Management and Budget for review and approval.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 22, 2006, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Merck & Co., Inc. of Whitehouse Station, New Jersey. The complaint alleges violations of section 337 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain alendronate salts and products containing same by reason of infringement of U.S. Patent No. 4,922,007. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a permanent exclusion order and a permanent cease and desist order.

As part of an ongoing effort to improve the quality, objectivity, utility, and integrity of information collected and disseminated by the Federal Government, the Office of Management and Budget (OMB) is issuing revised Standards and Guidelines for Statistical Surveys. OMB proposed revised standards and requested public comment on July 14, 2005 (70 FR 40746-40747). The proposed standards were based on recommendations from the Federal Committee on Statistical Methodology's (FCSM) Subcommittee on Standards for Statistical Surveys whose charge was to update and revise OMB Statistical Policy Directive No. 1, Standards for Statistical Surveys, and OMB Statistical Policy Directive No. 2, Publication of Statistics. The guidance, which applies to all Federal agencies subject to the Paperwork Reduction Act of 1995, is intended to ensure that the results of statistical surveys sponsored by the Federal Government are as reliable and useful as possible. OMB received six public comments on the proposed standards and has made some modifications to the proposed standards and guidelines in response to these comments. OMB is now issuing these Standards and Guidelines for Statistical Surveys as final, and they are available in their entirety along with the public comments and OMB's summary of and response to the public comments on the OMB Web site at https://www.whitehouse.gov/omb/inforeg/ statpolicy.html.

The Department of the Navy is amending a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The Department of the Navy is deleting a system of records notice from its existing inventory of records systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

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 estimated reporting and recordkeeping burden associated with the Mammography Quality Standards Act requirements.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (71 FR 39686) published on July 13, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0002, ``Indian Health Service Contract Health Service Report.'' Type of Information Collection Request: Extension of a currently approved information collection, 0917-0002, ``Indian Health Service Contract Health Service Report.'' Form Number: IHS 843-1A. Need and Use of Information Collection: The purpose for the collection is to authorize contract health care providers to provide health care services to eligible IHS patients. The IHS form 843-1A ``Order for Health Services'' was developed specifically for this collection of information. Other than revising the title ``Purchase-Delivery Order for Health Services'' to read ``Order for Health Services'', acquisition terms on the front of the form, the contract clauses contained on the back of copy 3 of the form, the form has not been revised and there is no change in the substance or in the use of the form. A copy of the form is at Attachment 2. The majority of the information contained in this form is completed by IHS staff from existing IHS automated patient and vendor data files. Contract health care providers complete and sign the streamlined form and submit it, along with a completed standard Centers for Medicare & Medicaid Services (CMS) health claim form (CMS 1450 (UB 92) and CMS 1500), to the IHS for verification and payment. The CMS forms are used and accepted nation-wide by the health care industry and IHS is an approved user. The information collected is needed to administer and manage the contract health care services provided to eligible American Indian and Alaska Native patients. The form is used to: Authorize contract health care services for eligible patients; certify that the health care services requested and authorized have been performed by the contract provider(s); process payments for health care services performed by such providers; obtain program data; and, serve as a legal document for health and medical care authorized by the IHS and rendered by health care providers under contract with the IHS. The information collected is also used for: Planning for further care of the patient; for keeping an accurate record of the patient's health status and health services received and recommended; for planning future health care programs; for communicating among members of the health care team; for evaluating the health care rendered; for research and continuing education; and, for the provision of program health statistics. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides the estimated burden hours for this information collection:

Pursuant to the Federal Advisory Committee Act (Pub. L. 92-463 as amended by Pub. L. 94-409, Pub. L. 96-523, Pub. L. 97-375 and Pub. L. 105-153), we are announcing a meeting of the Bureau of Economic Analysis Advisory Committee. The meeting will discuss recent measurement issues relating to the personal consumption expenditures price index, compensation and employment, research and development, and the upcoming comprehensive revision of the NIPAs.

The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

The Nuclear Regulatory Commission (NRC) is issuing a regulatory information summary (RIS) to provide guidance for receiving enforcement discretion when concentrating uranium at drinking water facilities.

This proposed rule would implement a new provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that prohibits recouping Medicare overpayments when an appeal is received from a provider or supplier until a decision is rendered by a Qualified Independent Contractor (QIC). The QIC is the second level of appeal in the Medicare claims appeal process. This provision changes how interest is to be paid to a provider or supplier whose overpayment is reversed at subsequent administrative or judicial levels of appeal. This proposed rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in our obligation to pay interest to a provider or supplier whose appeal is successful at levels above the QIC.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Notice 2006-XX, Fuel Cell Motor Vehicle Credit.