March 3, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved and misbranded oral drug products that are labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy and persons who manufacture or cause the manufacture of such products. These drug products are marketed without approved applications, and many are inappropriately labeled for use in infants and young children. These drug products must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA), or comply with an FDA over-the-counter (OTC) drug final monograph, before marketing.

The Federal Communications Commission has received Office of Management and Budget (OMB) approval for the following public information collection(s) pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid OMB control number.

The Commodity Futures Trading Commission (Commission or CFTC) is proposing to amend its regulations affecting the operations and activities of commodity pool operators (CPOs) and commodity trading advisors (CTAs) (Proposal) in order to have those regulations reflect changes made to the Commodity Exchange Act (CEA) by the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act).

The 1996 amendments to the Safe Drinking Water Act (SDWA) require that the United States Environmental Protection Agency (EPA or the Agency) establish criteria for a program to monitor unregulated contaminants and to publish a list of contaminants to be monitored every five years. This action meets the SDWA requirement by proposing the design for the third UCMR cycle (i.e., UCMR 3). EPA is proposing six EPA-developed analytical methods, and four equivalent consensus organization-developed methods to monitor for 28 new UCMR chemical contaminants. In addition, EPA proposes monitoring for two viruses, for a total of 30 UCMR 3 contaminants. As envisioned, virus analysis (along with related analysis for pathogen indicators) would be conducted in laboratories under EPA contract. UCMR 3 provides EPA and other interested parties with scientifically valid data on the occurrence of these contaminants in drinking water, permitting the assessment of the number of people potentially being exposed and the levels of that exposure. These data are the primary source of occurrence and exposure information the Agency uses to determine whether to regulate these contaminants. In addition, as part of an Expedited Methods Update, this proposed action also would amend regulations concerning inorganic chemical sampling and analytical requirements. A minor editorial correction to the table moves methods from the ``Other'' column to the ``ASTM'' column, as it applies to the inorganic chemical sampling and analytical requirements. The UCMR program is not affected by these changes.

This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.

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 PRA).

The U.S. Department of Agriculture (USDA) is amending its regulations implementing the Equal Access to Justice Act (EAJA) by raising the maximum hourly attorney fees rate from $125.00 to $150.00 for covered proceedings initiated on and after the effective date of this final rule.

NMFS proposes regulations to implement measures in Framework Adjustment (FW) 45 to the NE Multispecies Fishery Management Plan (FMP). FW 45 was developed by the New England Fishery Management Council (Council) to prevent overfishing, rebuild overfished stocks, achieve optimum yield (OY), and minimize the economic impact of management measures on affected vessels, pursuant to the Magnuson- Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). This action would revise the biological reference points and stock status for pollock, update annual catch limits (ACLs) for several stocks for fishing years (FYs) 2011-2012, adjust the rebuilding program for Georges Bank (GB) yellowtail flounder, increase scallop vessel access to the Great South Channel Exemption Area, approve five new sectors, modify the existing dockside and at-sea monitoring requirements, revise several sector administrative provisions, establish a Gulf of Maine (GOM) Cod Spawning Protection Area, and refine measures affecting the catch of limited access NE multispecies Handgear A vessels. This action would disapprove the Council's proposed catch limits for GB yellowtail flounder for FY 2011, and instead propose new catch limits for this stock through emergency action authority based on new flexibility provided by the International Fisheries Agreement Clarification Act. This action is necessary to ensure that the fishery is managed on the basis of the best available science, to comply with the acceptable biological catch (ABC) control rules adopted in Amendment 16 to the FMP, and to enhance the viability of the fishery following the transition to sector management in 2010.