May 2014 – Federal Register Recent Federal Regulation Documents

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Department of the Navy announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed 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 information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

Pursuant to the provisions of the Privacy Act of 1974, as amended, the Department of the Interior is issuing a public notice of its intent to create the National Park Service ``Planning, Environment and Public Comment (PEPC) SystemNPS-23'' system of records. The system is an online collaborative tool designed to facilitate the project management process in conservation planning and environmental impact analysis. The system assists the National Park Service in making informed decisions with regard to a number of compliance issues throughout the planning, design, and construction process.

The Food and Drug Administration (FDA) has determined the regulatory review period for RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) is announcing a pilot project to evaluate its current systems for receiving postmarketing safety reports involving vaccine products electronically for processing into the Vaccine Adverse Event Reporting System (VAERS). As part of this pilot project, CBER also plans to assess the updated International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B(R3) specification for electronic transmission of vaccine Individual Case Safety Reports (ICSRs). Participation in the pilot project is open to firms that submit postmarketing reports into VAERS. CBER plans to accept participation from up to six applicants. The pilot project is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate current system capabilities for sending and receiving postmarketing safety reports for vaccine products using FDA's Electronic Submissions Gateway (ESG), including the use of the updated ICH E2B(R3) specification.

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.

This rule changes the minimum grade requirements currently prescribed under the marketing order for oranges, grapefruit, tangerines, and tangelos grown in Florida (order). The order is administered locally by the Citrus Administrative Committee (Committee). This rule reduces the minimum grade requirement for Valencia and other late type oranges shipped to interstate markets from a U.S. No. 1 to a U.S. No. 1 Golden from May 15 through June 14 each season and to a U.S. No. 2 external/U.S. No. 1 internal from June 15 through August 31 each season. This rule will provide additional Valencia and other late type oranges for late season markets, helping to maximize fresh shipments.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Defense Security Service (DSS) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed 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 information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the DFAS announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed 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 information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

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 Food and Drug Administration (FDA) has determined the regulatory review period for ADCETRIS based on biologics license application (BLA) 125399 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product, ADCETRIS.

The Food and Drug Administration (FDA) has determined the regulatory review period for ADCETRIS based on biologics license application (BLA) 125388 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product, ADCETRIS.

This notice announces that the FHWA and the Utah Department of Transportation (State) plan to renew and amend an existing MOU established pursuant to 23 U.S.C. 326 under which the FHWA has assigned to the State the FHWA's responsibility for determining whether a project is categorically excluded from preparation of an environmental assessment or an environmental impact statement under the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq. (NEPA) and for carrying out certain other responsibilities for conducting environmental reviews, consultations, and related activities for Federal-aid highway projects. The proposed amendments include removal of language referring to existing programmatic agreements between the State and FHWA concerning categorical exclusions. This change is proposed to make the processing of these documents more clearly defined. The public is invited to comment on any aspect of the proposed MOU, including the scope of environmental review, consultation, and other activities which are assigned.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics/Defense Technical Information Center (DTIC) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed 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 information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Defense Threat Reduction Agency (DTRA) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed 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 information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priorities List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA, as amended, also requires that the Priority List of Hazardous Substances be revised periodically. This announcement provides notice that a revised Priority List of 275 Hazardous Substances has been developed and is now available. CERCLA, as amended, also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list. Thus, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP). Address for Printed Copy: Requests for a printed copy of the 2013 Priority List of Hazardous Substances and Support Document, including the CEP report, should be submitted to Ms. Nickolette Roney, Division of Toxicology and Human Health Sciences, ATSDR, Mail Stop F-57, 1600 Clifton Road, NE., Atlanta, GA 30333. Electronic Availability: The 2013 Priority List of Hazardous Substances and Support Document are posted on ATSDR's Web site located at www.atsdr.cdc.gov/SPL. The CEP Report is posted at www.atsdr.cdc.gov/CEP.

We propose to supersede Airworthiness Directive (AD) 2010-03- 05, which applies to all The Boeing Company Model 747-200C and -200F series airplanes. AD 2010-03-05 currently requires, for section 41 upper deck floor beam upper chords, an inspection for cracks of certain fastener holes, and corrective action if necessary; and repetitive replacements of the upper chords, straps (or angles), and radius fillers of certain upper deck floor beams and, for any replacement that is done, inspections for cracks, and corrective actions if necessary. Since we issued AD 2010-03-05, we have determined that the upper deck floor beams are subject to widespread fatigue damage (WFD), the existing inspection program is not sufficient to maintain an acceptable level of safety, and section 42 upper deck floor beam upper chords are subject to the unsafe condition. This proposed AD would add post- replacement inspections for section 41 and reduce certain compliance times. This proposed AD would also require repetitive inspections of section 42 upper deck floor beam upper chords, repetitive replacements of the upper chords, post-replacement inspections, and corrective action if necessary. We are proposing this AD to detect and correct cracking of the upper chords and straps (or angles) of the floor beams, which could lead to failure of the floor beams and consequent loss of controllability, rapid decompression, and loss of structural integrity of the airplane.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-100, 737-200, 737-200C, 737-300, 737-400, and 737-500 series airplanes. This proposed AD was prompted by reports of cracking in the lower corners of the forward entry doorway and the upper corners of the airstairs cutout. This proposed AD would require inspections for cracking of the forward entry doorway and airstairs cutout, and corrective actions if necessary. This proposed AD also provides terminating action for the repetitive inspections. We are proposing this AD to detect and correct cracks in the lower corners of the forward entry door cutout and the upper corners of the airstairs cutout, which could progress and result in an inability to maintain cabin pressurization.

We, the U.S. Fish and Wildlife Service (Service), have prepared a draft environmental impact statement (EIS) under the National Environmental Policy Act of 1969, as amended (NEPA), in response to an application from Maricopa Sun, LLC (the applicant), for an incidental take permit (ITP) pursuant to the Endangered Species Act of 1973, as amended (Act). The applicant has prepared the draft Maricopa Sun Solar Complex Habitat Conservation Plan (HCP) for review. We announce a public comment period on the permit application, including the draft EIS and the proposed HCP. We request data, comments, new information, or suggestions from the public, other concerned governmental agencies, the scientific community, Tribes, industry, or any other interested party.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-600 and -700 series airplanes. This proposed AD was prompted by reports of cracking in a bulkhead lower frame. This proposed AD would require a detailed and open hole high frequency eddy current (HFEC) inspection of the left- and right- side lower frame webs and inner chords for cracking, if necessary, and corrective actions and preventative modifications, if necessary. This proposed AD would also provide for optional terminating action for the repetitive inspections under certain conditions. We are proposing this AD to detect and correct cracking in a bulkhead lower frame web and inner chord, which could result in a severed frame and induced skin cracks, and lead to rapid decompression of the fuselage.