April 2015 – Federal Register Recent Federal Regulation Documents

Notice is hereby given of a meeting of the Marine Protected Areas Federal Advisory Committee (Committee) in Tacoma, Washington.

The plat of survey of the following described lands is scheduled to be officially filed in the Bureau of Land Management Alaska State Office, Anchorage, Alaska, 30 days from the date of publication. Survey Desription: The plat represents the survey of U.S. Survey No. 14187, Alaska, located approximately 72 miles northeast of Bethel, within unsurveyed T. 13 N., R. 59 W., Seward Meridian, Alaska.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications for the treatment of non- small cell lung cancer. This guidance focuses on endpoints specifically for lung cancer trials to support drug approval or labeling claims. This guidance should speed the development and improve the quality of protocols submitted to FDA to support anticancer effectiveness claims. This guidance finalizes the draft guidance issued on June 17, 2011.

The Food and Drug Administration (FDA) is correcting a final rule entitled ``Administrative Detention of Drugs Intended for Human or Animal Use'' that appeared in the Federal Register of May 29, 2014 (79 FR 30716). The rule sets forth the procedures for detention of drugs believed to be adulterated or misbranded and amends the scope of FDA's part 16 regulatory hearing procedures to include the administrative detention of drugs. The rule published with incorrect statements regarding the impact of the final rule on small entities. This document corrects those errors.

The Food and Drug Administration (FDA or Agency) has determined that OXYTOCIN 5 United States Pharmacopeia (USP) Units in Dextrose 5% (oxytocin), injectable, injection, 5 USP Units in 500 milliliters (mL), (1 USP Unit/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 500 mL, (2 USP Units/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 1000 mL, (1 USP Unit/100 mL); and OXYTOCIN 20 USP Units in Dextrose 5% (oxytocin), injectable, injection, 20 USP Units in 1000 mL, (2 USP Units/100 mL), (hereinafter ``these oxytocin drug products'') were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve an abbreviated new drug application (ANDA) for these oxytocin drug products, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs.'' This draft guidance explains how manufacturers, packers, and distributors (firms) that may either be the applicant or acting on behalf of the applicant, should make submissions pertaining to promotional materials for human prescription drugs and biologic products (``drugs'') to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This draft guidance describes the various types of submissions of promotional materials and general considerations for submissions. In addition, this draft guidance discusses the specific aspects of submission of promotional materials using module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file. This guidance does not address the more general requirements for a valid electronic submission using eCTD or the specifications for module 1 of the eCTD. This guidance contains both binding and nonbinding provisions.

The SBA, Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Spokane, WA Regulatory Fairness Hearing. This hearing is open to the public.

This rule amends the Honey Packers and Importers Research, Promotion, Consumer Education and Information Order (Order) to increase the assessment rate from $0.01 per pound to $0.015 per pound on honey and honey products, over a two-year period. The Order limits an increase in the assessment rate to no more than one-quarter cent per pound per year. Thus, the rate will increase to $0.0125 per pound for the period January 1 through December 31, 2015, and to $0.015 per pound on and after January 1, 2016. This increase was unanimously recommended by the Honey Packers and Importers Board (Board) which administers the Order with oversight by the U.S. Department of Agriculture (USDA). Under the program, assessments are collected from first handlers (packers) and importers and used for research and promotion projects designed to maintain and expand the market for honey and honey products in the United States and abroad. Additional funds will allow the Board to expand its production research activities and promotional efforts. The Board's production research focuses on maintaining the health of honey bee colonies. Increasing demand for honey and honey products will benefit the honey industry as a whole. This action also makes three additional changes to: Clarify that the assessment rate applies not only to the Harmonized Tariff Schedule numbers but to any other numbers used to identify honey; change the length of time that books and records are to be held; and change the exemption requirements.

This rule revises the minimum quantity exception for potatoes handled under the Colorado potato marketing order, Area No. 2 (order). The order regulates the handling of Irish potatoes grown in Colorado and is administered locally by the Colorado Potato Administrative Committee, Area No. 2 (Committee). This action increases the quantity of potatoes that may be handled under the order without regard to the order's handling regulation requirements from 1,000 to 2,000 pounds. The change in the import regulation is required under section 8e of the Agricultural Marketing Agreement Act of 1937. This action allows for the importation which, in the aggregate, does not exceed 2,000 pounds for all other round type potatoes, except red skinned, round type or long type potatoes that continue to remain at a 500 pound limit, to be imported without regard to the import regulations. This action is expected to benefit producers, handlers, and importers.

We, the U.S. Fish and Wildlife Service (Service), published a proposed rule in the Federal Register on April 1, 2015, to propose permit regulations to govern the use of captive-bred, trained raptors to control or take birds or other wildlife to mitigate damage or other problems, including risks to human health and safety. In that proposed rule, we provided a partially incorrect address for the submission of hard-copy comments and some incorrect information regarding information collection requirements. With this document, we correct these errors.