December 9, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.'' The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.

The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls Technical Sections'' that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Environmental Protection Agency (EPA) is proposing to determine that the South Coast air quality planning area in California has attained the 1997 annual and 24-hour fine particle (PM2.5) National Ambient Air Quality Standards. This proposed determination is based upon complete (or otherwise validated), quality-assured, and certified ambient air monitoring data showing that the area has monitored attainment of the 1997 annual and 24-hour PM2.5 standards based on the 2011-2013 monitoring period. The EPA is further proposing that, if the EPA finalizes this determination of attainment, the requirements for the area to submit certain State implementation plan revisions shall be suspended for so long as the area continues to attain the 1997 annual and 24-hour PM2.5 standards.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from November 13, 2014 to November 26, 2014. The last biweekly notice was published on November 25, 2014.

This Notice announces the availability of the Finding of No Significant Impact (FONSI) for the America's Marine Highway Program, which designates criteria, eligibility requirements, and information for applicants seeking to establish services on a ``short sea'' marine highway (America's Marine Highway). The objective of the America's Marine Highway (AMH) Program is to identify opportunities to reduce landside congestion and to optimize the transportation of goods and passengers through use of the waterway network. MARAD previously made available for public review a programmatic environmental assessment (PEA) that analyzed the potential environmental impacts of continuing to execute the AMH Program (Program). Based on the PEA, MARAD determined that the proposed action will not significantly affect the human or natural environment and therefore does not require the preparation of an environmental impact statement. For actions not described in the PEA, or for specific projects associated with an AMH, MARAD may prepare or oversee the preparation of a supplemental environmental assessment or other appropriate documentation.

The Environmental Protection Agency (EPA) is proposing revisions and confidentiality determinations for the petroleum and natural gas systems source category of the Greenhouse Gas Reporting Program. In particular, the EPA is proposing to add calculation methods and reporting requirements for greenhouse gas emissions from gathering and boosting facilities, completions and workovers of oil wells with hydraulic fracturing, and blowdowns of natural gas transmission pipelines between compressor stations. The EPA is also proposing well identification reporting requirements to improve the EPA's ability to verify reported data and enhance transparency. This action also proposes confidentiality determinations for new data elements contained in these proposed amendments.

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model MD-90-30 airplanes. This AD was prompted by reports of cracks emanating from the aft-most barrel nut holes of the left and right upper rear spar caps of the horizontal stabilizer. This AD requires repetitive high frequency eddy current (ETHF) inspections for cracks in the areas around the two aft-most barrel nut holes of the upper rear spar caps, and corrective action if necessary; and repetitive ETHF inspections for cracks in the areas around the two aft- most barrel nut holes of any repaired or replaced upper rear spar cap, and corrective actions if necessary. We are issuing this AD to detect and correct such cracks, which could propagate until the upper rear spar cap severs, and result in failure of the horizontal stabilizer upper center or aft skin panel and adversely affect the structural integrity of the airplane.