December 30, 2008 – Federal Register Recent Federal Regulation Documents

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This action extends a temporary final rule initially published on October 18, 2005. The regulations contained in the temporary rule, emergency action, published on October 18, 2005, and subsequently extended several times at the request of the U.S. Food and Drug Administration (FDA), will expire on December 31, 2008. This temporary rule extends a closure of Federal waters through December 31, 2009. The FDA has determined that current oceanographic conditions and alga sampling data suggest that the northern section of the Temporary Paralytic Shellfish Poison (PSP) Closure Area remain closed to the harvest of bivalve molluscan shellfish, with the exception of sea scallop adductor muscles harvested and shucked at sea, and that the southern area remain closed to the harvest of whole or roe-on scallops. NMFS is publishing the regulatory text associated with this closure in this temporary emergency rule in order to ensure that current regulations accurately reflect the codified text that has been modified and extended numerous times, so that the public is aware of the regulations being extended through December 31, 2009.

EPA is taking direct final action to approve a redesignation request and a State Implementation Plan (SIP) revision submitted by the State of Oregon. On August 9, 2007 the State of Oregon submitted a request to EPA that the Salem carbon monoxide (CO) nonattainment area be redesignated to attainment for the CO National Ambient Air Quality Standard (NAAQS) and concurrently submitted a maintenance plan that provides for continued attainment of the CO NAAQS. The Salem CO nonattainment area has not violated the 8-hour CO NAAQS since 1985.

Citizens and eligible nationals of participating Visa Waiver Program countries may apply for admission to the United States at U.S. ports of entry as nonimmigrant aliens for a period of 90 days or less for business or pleasure without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission under applicable statutory and regulatory requirements. This rule adds Malta to the list of countries authorized to participate in the Visa Waiver Program.

EPA is approving a January 30, 2007, request from the Illinois Environmental Protection Agency (IEPA) that EPA find that the Illinois portion of the Chicago-Gary-Lake County, Illinois-Indiana (IL-IN) nonattainment area, has attained the revoked 1-hour ozone National Ambient Air Quality Standard (NAAQS). EPA is also approving an October 25, 2007, request from the Indiana Department of Environmental Management (IDEM) that EPA find that the Indiana portion of the Chicago-Gary-Lake County, IL-IN nonattainment area, has attained the revoked 1-hour ozone NAAQS. EPA proposed to approve both requests on July 7, 2008. We received three comments on our proposed rulemaking, which are addressed below.

To comply with the Federal Civil Penalties Inflation Adjustment Act of 1990, FRA is adjusting the minimum civil monetary penalty that it will apply when it assesses a civil penalty for a violation of a railroad safety statute or regulation under its authority. FRA is also adjusting its ordinary maximum and aggravated maximum penalties to incorporate the new maximum civil penalty amounts authorized by the Rail Safety Improvement Act of 2008. In particular, FRA is increasing the minimum civil penalty per violation from $550 to $650, while the ordinary maximum civil penalty per violation will be increased from $16,000 to $25,000 and the aggravated maximum civil penalty per violation where a grossly negligent violation or pattern of repeated violations has created an imminent hazard of death or injury (``grossly negligent violation'') will be increased from $27,000 to $100,000.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2008 through September 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

The Postal Service proposes to amend its regulations relating to records and information management. The proposed revisions contain, in part, new provisions to comply with Executive Order (EO) 13,392, entitled ``Improving Agency Disclosure of Information.''