April 7, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that CHOLBAM (cholic acid), manufactured by Asklepion Pharmaceuticals, LLC, meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that UNITUXIN (dinutuximab), manufactured by United Therapeutics Corporation, meets the criteria for a priority review voucher.

NMFS published a proposed rule in the Federal Register on March 19, 2015, to amend the regulations implementing the Atlantic Large Whale Take Reduction Plan. This action proposed to change the minimum number of traps per trawl to allow fishing with a single trap in certain Massachusetts and Rhode Island state waters; and proposed to modify the requirement to use one endline on trawls within certain areas in Massachusetts state waters. NMFS also proposed a \1/4\ mile buffer in waters surrounding certain islands in Maine to allow fishing with a single trap. In addition, NMFS proposed additional gear marking requirements for those waters allowing single traps as well as two new high use areas for humpback whales (Megaptera novaeangliae) and North Atlantic right whales (Eubalaena glacialis). In that proposal, NMFS provided the wrong address for the submission of electronic comments. With this document, we correct our error by publishing the correct ADDRESSES section in its entirety.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, regarding the opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of Disease Prevention (ODP) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Paris Watson, Senior Advisor, NIH Office of Disease Prevention, 6100 Executive Blvd., Room 2B03, Bethesda, MD 20892 or call (301) 496-1508 or email your request, including your address to prevention@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The U.S. Nuclear Regulatory Commission will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on June 16, 2015, to discuss the ACMUI Radioactive Seed Localization subcommittee report and to hear a presentation from Spectrum Pharmaceuticals regarding the training and experience requirements for alpha and beta emitters. Meeting information, including a copy of the agenda and handouts, will be available at https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/ 2015.html. The agenda and handouts may also be obtained by contacting Ms. Sophie Holiday using the information below.

Notice is hereby given that the Department of State has forwarded the attached Notifications of Proposed Export Licenses to the Congress on the dates indicated on the attachments pursuant to sections 36(c) and 36(d), and in compliance with section 36(f), of the Arms Export Control Act.

ACF and HRSA announce the renewal of the Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation to provide advice to the Secretary of Health and Human Services (``the Secretary'') on the design, plan, progress, and findings of the evaluation required under the Act.

The Department of Commerce (``the Department'') finds that revocation of the antidumping duty (``AD'') order on certain oil country tubular goods (``OCTG'') from the People's Republic of China (``PRC'') would be likely to lead to continuation or recurrence of dumping at the levels indicated in the ``Final Results of Sunset Review'' section of this notice.

The Department of Commerce (the Department) is rescinding its administrative review of the antidumping duty order on lightweight thermal paper (LWTP) from Germany for the period of November 1, 2013, through November 23, 2013, based on the withdrawal of all requests for review.

NMFS implements accountability measures (AMs) for commercial blueline tilefish in the exclusive economic zone (EEZ) of the South Atlantic. Commercial landings for blueline tilefish, as estimated by the Science and Research Director, have reached the commercial annual catch limit (ACL). Therefore, NMFS is closing the commercial sector for blueline tilefish in the South Atlantic EEZ at 12:01 a.m., local time, April 7, 2015, and it will remain closed until the start of the next fishing season, January 1, 2016. This closure is necessary to protect the blueline tilefish resource.

NMFS is opening directed fishing for northern rockfish in the Bering Sea and Aleutian Islands Management Area (BSAI). This action is necessary to fully use the 2015 total allowable catch (TAC) of northern rockfish in the BSAI.

The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2016 Emerging Markets Program (EMP). The intended effect of this notice is to solicit applications from the private sector and from government agencies for fiscal year 2016 and to set out criteria for the award of funds under the program in October 2015. The EMP is administered by personnel of the Foreign Agricultural Service (FAS).

NMFS is prohibiting directed fishing for Pacific cod by catcher/processors using hook-and-line gear in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2015 Pacific cod total allowable catch apportioned to catcher/processors using hook-and-line gear in the Western Regulatory Area of the GOA.

OSHA solicits public comments concerning its proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Asbestos in Construction Standard (29 CFR 1926.1101).

The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2016 Technical Assistance for Specialty Crops (TASC) program. The intended effect of this notice is to solicit applications from the private sector and from government agencies for fiscal year 2016 and to set out criteria for the award of funds in October 2015. The TASC program is administered by personnel of the Foreign Agricultural Service (FAS).

The Federal Energy Regulatory Commission published a document in the Federal Register on Tuesday, January 20, 2015 (80 FR 2591), providing the annual update to the fee schedule in Appendix A to Part 11, which lists per-acre rental fees by county (or other geographic area) for use of government lands by hydropower licensees and updating Appendix A to Part 11 with the fee schedule of per-acre rental fees by county (or other geographic area) from October 1, 2014, through September 30, 2015 (Fiscal Year 2015).