July 15, 2013 – Federal Register Recent Federal Regulation Documents

This action creates new certification and qualification requirements for pilots in air carrier operations. As a result of this action, a second in command (first officer) in domestic, flag, and supplemental operations must now hold an airline transport pilot certificate and an airplane type rating for the aircraft to be flown. An airline transport pilot certificate requires that a pilot be 23 years of age and have 1,500 hours total time as a pilot. Pilots with fewer than 1,500 flight hours may qualify for a restricted privileges airline transport pilot certificate beginning at 21 years of age if they are a military-trained pilot, have a bachelor's degree with an aviation major, or have an associate's degree with an aviation major. The restricted privileges airline transport pilot certificate will also be available to pilots with 1,500 flight hours who are at least 21 years of age. This restricted privileges airline transport pilot certificate allows a pilot to serve as second in command in domestic, flag, and supplemental operations not requiring more than two pilot flightcrew members. This rule also retains the second-class medical certification requirement for a second in command in part 121 operations. Pilots serving as an air carrier pilot in command (captain) must have, in addition to an airline transport pilot certificate, at least 1,000 flight hours in air carrier operations. This rule also adds to the eligibility requirements for an airline transport pilot certificate with an airplane category multiengine class rating or an airline transport pilot certificate obtained concurrently with a type rating. To receive an airline transport pilot certificate with a multiengine class rating a pilot must have 50 hours of multiengine flight experience and must have completed a new FAA-approved Airline Transport Pilot Certification Training Program. This new training program will include academic coursework and training in a flight simulation training device. These requirements will ensure that a pilot has the proper qualifications, training, and experience before entering an air carrier environment as a pilot flightcrew member.

The Food and Drug Administration (FDA) is proposing a regulation to implement administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Specifically, FDA will be able to administratively detain drugs encountered during an inspection that an officer or employee conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C Act) concerning inspections that would make a drug adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.

This is an amendment of the Presidential declaration of a major disaster for the State of Illinois (FEMA-4116-DR), dated 05/10/ 2013. Incident: Severe Storms, Straight-line Winds and Flooding. Incident Period: 04/16/2013 through 05/05/2013. Effective Date: 07/03/2013. Physical Loan Application Deadline Date: 07/09/2013. EIDL Loan Application Deadline Date: 02/10/2014.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance only for the State of Iowa (FEMA-4126- DR), dated 07/02/2013. Incident: Severe storms, tornadoes, and flooding. Incident Period: 05/19/2013 through 06/14/2013. Effective Date: 07/02/2013. Physical Loan Application Deadline Date: 09/03/2013. Economic Injury (EIDL) Loan Application Deadline Date: 04/02/2014.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.'' This draft guidance is intended to provide information to industry on how to submit initial and amended pediatric study plans (PSPs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

The meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for July 17, 2013, is cancelled. This meeting was announced in the Federal Register of May 17, 2013 (78 FR 29142 to 29143). This meeting has been canceled due to new information submitted to the application. The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register.

The United States Department of Commerce, International Trade Administration, U.S. and Foreign Commercial Service published a document in the Federal Register of May 30, 2013 regarding the U.S. Healthcare Trade Mission to Russia, October 21-25, 2013. This mission has been cancelled. Please update the existing notice with a note that this mission is cancelled as of July 8, 2013.

The Commander Fifth Coast Guard District has issued a temporary deviation from the regulations governing the operation of the US 50 Bridge, over Isle of Wight (Sinepuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate the 10th annual ``Island 2 Island'' Half Marathon. This deviation allows the drawbridge to remain in the closed position to vessels during the race.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the swing of the Route 70/Harkers Island Bridge, across The Straights, mile 0.6, Harkers Island, NC. This deviation is necessary to facilitate coupling repair on the Route 70/ Harkers Island Bridge. This temporary deviation allows the swing bridge to remain in the closed to navigation position.

The Coast Guard is establishing a temporary safety zone within Milwaukee Harbor, Milwaukee, Wisconsin. This zone is intended to restrict vessels from a portion of Milwaukee Harbor due to 4 fireworks displays at Discovery World Pier. This safety zone is necessary to protect the surrounding public and vessels from the hazards associated with these fireworks displays.

The Coast Guard is issuing this Interim Rule to address two omissions from the regulatory text of the Safety zone and Regulated Navigation Area in the Chicago Sanitary and Ship Canal, Romeoville, IL. These omissions include requirements for the regulated navigation area that vessels must be greater than twenty feet in length and must not be a personal or human powered watercraft of any kind (e.g. jet skis, wave runners, kayaks, row boats, etc.). This revision is intended to make the regulatory text consistent with the discussion of the rule as originally published in the Federal Register on December 12, 2011.

The United States Coast Guard is announcing that it will no longer maintain a watch on 2182 kHz, will no longer guard the Digital Selective Calling (DSC) channel 2187.5 kHz, and will no longer transmit Marine Information Broadcasts on 2670 kHz. The minimal use of these channels by mariners for distress and safety coupled with antenna site deterioration, costly upkeep, and extensive maintenance required to support the medium frequency (MF) system have led to a Coast Guard decision to terminate the MF services and direct the public mariner to use more modern safety and distress services which can be more reliably received by the Coast Guard.

The National Science Foundation published a Notice of Meeting for the July 18 Advisory Committee for Mathematical and Physical Sciences in the Federal Register on June 21, 2013. This notice corrects the operated assistance teleconference telephone number and the password.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of a previously approved information collection.

This document announces decisions by NHTSA that certain motor vehicles not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS) are eligible for importation into the United States because they are substantially similar to vehicles originally manufactured for sale in the United States and certified by their manufacturers as complying with the safety standards, and they are capable of being readily altered to conform to the standards or because they have safety features that comply with, or are capable of being altered to comply with, all applicable FMVSS.

EPA is taking final action to determine that the Sacramento nonattainment area in California has attained the 2006 24-hour fine particle (PM2.5) National Ambient Air Quality Standard (NAAQS or standard). This determination is based upon complete, quality-assured, and certified ambient air monitoring data showing that this area has monitored attainment of the 2006 24-hour PM2.5 NAAQS based on the 2010-2012 monitoring period. Based on the above determination, the requirements for this area to submit an attainment demonstration, together with reasonably available control measures, a reasonable further progress (RFP) plan, and contingency measures for failure to meet RFP and attainment deadlines are suspended for so long as the area continues to attain the 2006 24-hour PM2.5 NAAQS.