2009 – Federal Register Recent Federal Regulation Documents

The Eight Regional Fishery Management Councils will convene a meeting of representatives of their respective Scientific and Statistical Committee (SSCs) at the Wyndam Sugar Bay Resort, St. Thomas, United States Virgin Islands, November 10-13, 2009.

The Food and Drug Administration (FDA) is reopening until October 19, 2010, the comment period for the notice of public meeting published in the Federal Register of April 20, 2009 (74 FR 17967). In that notice, FDA announced a public meeting that took place on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. FDA is reopening the comment period in light of continued public interest in this topic and to provide an opportunity for all interested parties to provide information and share views on the matter.

The FAA assigned the Aviation Rulemaking Advisory Committee (ARAC) a new task to provide advice and recommendations to the FAA about the current ARAC process. This notice informs the public of the new ARAC activity.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled ``Labeling for Human Prescription Drug and Biological Products Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.'' This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. This guidance finalizes the draft guidance published in the Federal Register on May 16, 2007.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We propose to adopt a new airworthiness directive (AD) for certain Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes. This proposed AD would require inspections for scribe lines in the fuselage skin at lap joints, the splice strap at certain butt joints, the skin or doubler at certain approved repair doublers, and the skin at decal locations; and related investigative and corrective actions if necessary. This proposed AD results from reports of scribe line damage found adjacent to the skin lap joints, decals, and wing-to- body fairings. We are proposing this AD to detect and correct scribe lines, which can develop into fatigue cracks in the skin. Undetected fatigue cracks can grow and cause sudden decompression of the airplane.

On March 31, 2003, the National Science Foundation (NSF) issued a final rule that authorized the collection of meteorites in Antarctica for scientific purposes only. These regulations implement Article 7 of the Protocol on Environmental Protection to the Antarctic Treaty and are issued pursuant to Section 6 of the Antarctic Conservation Act, as amended by the Antarctic Science, Tourism and Conservation Act of 1996. The regulations require appropriate collection, handling, and curation of Antarctic meteorites to preserve their scientific value. Antarctic expeditions planning to collect meteorites in Antarctica are required to submit their plans for the collection, handling, and curation of the meteorites to the National Science Foundation. NSF is providing notice of availability of a meteorite collection plan and inviting comments on the plan.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the objects in the exhibition: ``The Lost World of Old Europe: The Danube Valley 5000-3500BC,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Institute for the Study of the Ancient World, New York University, New York, NY, from on or about November 11, 2009, until on or about April 25, 2010, and at possible additional exhibitions or venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.

This action modifies Class E airspace at Beckley, WV. Controlled airspace is being expanded to contain the Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) that have been developed for Raleigh County Memorial Airport. This action enhances the National Airspace System by providing controlled airspace in the vicinity of Beckley, WV.

The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. This information collection request pertains to the Human Reliability Program (HRP). This information collection request consists of forms that will certify to DOE that respondents were advised of the requirements for occupying or continuing to occupy a HRP position. The HRP is a security and safety reliability program for individuals who apply for or occupy certain positions that are critical to the national security. It requires an initial and annual supervisory review, medical assessment, management evaluation, and a DOE personnel security review of all applicants or incumbents. It is also used to ensure that employees assigned to nuclear explosive duties do not have emotional, mental, or physical conditions that could result in an accidental or unauthorized detonation of nuclear explosives.

Based on the content of comments received during scoping the Humboldt-Toiyabe National Forest will prepare an environmental impact statement (EIS) to disclose the impacts associated with the following proposed actions:

NMFS received an application from the U.S. Air Force (USAF), Eglin Air Force Base (Eglin AFB), for renewal of an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to conducting air-to-surface (A-S) gunnery missions in the Gulf of Mexico (GOM). The USAF's activities are considered military readiness activities. Pursuant to the MMPA, NMFS is requesting comments on its proposal to issue an IHA to Eglin AFB to take, by Level B harassment only, several species of marine mammal during the specified activity for a period of 1 year.