November 28, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

Pursuant to applicable provisions of the Federal Lands Recreation Enhancement Act (REA), the Bureau of Land Management (BLM) La Jara Field Office is proposing to collect fees at the Zapata Falls Campground in Alamosa County, Colorado (Township 28S, Range 73W, Section 17). Under Section 2(2) of the REA, Zapata Falls Campground qualifies as a site wherein visitors can be charged an ``Expanded Amenity Recreation Fee'' authorized under section 3(g). In accordance with the REA, and the BLM's implementing regulations, the La Jara Field Office is proposing to charge $11 per night for individual sites and $20 per night for group-site fees for overnight camping within the developed campground.

This notice amends the notice of a major disaster declaration for the Commonwealth of Pennsylvania (FEMA-4030-DR), dated September 12, 2011, and related determinations.

This notice amends the notice of a major disaster declaration for State of Missouri (FEMA-4012-DR), dated August 12, 2011, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Virginia (FEMA-4042-DR), dated November 4, 2011, and related determinations.

The Mid-Atlantic Fishery Management Council (Council) and its Mid-Atlantic Monkfish Subcommittee will hold public meetings.

The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: NRC Form 396, ``Certification of Medical Examination by Facility Licensee.'' 2. Current OMB approval number: 3150-0024. 3. How often the collection is required: Upon application for an initial or upgrade operator license or, every six years for the renewal of operator or senior operator license, and upon notices of disability. 4. Who is required or asked to report: Facility licensees who are tasked with certifying the medical fitness of an applicant or licensee. 5. The number of annual respondents: 136 Facilities submitting initial and upgrade applications, renewals and disability forms. 6. The number of hours needed annually to complete the requirement or request: 1,224 hours (1,020 hours for reporting, and 204 hours for recordkeeping). 7. Abstract: NRC Form 396 is used to transmit information to the NRC regarding the medical condition of applicants for initial operator licenses or renewal of operator licenses and for the maintenance of medical records for all licensed operators. The information is used to determine whether the physical condition and general health of applicants for operator licensees is such that the applicant would not be expected to cause operational errors and endanger public health and safety. Submit, by January 27, 2012, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site: https://www.nrc.gov/public-involve/doc- omment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC- 2011-0250. Public comments and supporting materials related to this document can be found at https://www.regulations.gov by searching on Docket No. NRC-2011-0250. Mail comments to NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555- 0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at (301) 415-6258, or by e-mail to INFOCOLLECTS.Resource@NRC.GOV.

The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR Part 20, ``Standards for Protection Against Radiation.'' 2. Current OMB approval number: 3150-0014. 3. How often the collection is required: Most reports are collected annually, but decommissioning reports are collected at license termination. 4. Who is required or asked to report: NRC licensees, including those requesting license terminations. Types of licensees include civilian commercial, industrial, academic, and medical users of nuclear materials. Licenses are issued for, among other things, the possession, use, processing, handling, and importing and exporting of nuclear materials, and for the operation of nuclear reactors. 5. The number of annual respondents: 3,000. 6. The number of hours needed annually to complete the requirement or request: 91,503 hours (5,476 hours reporting + 342 hours third-party disclosure + 85,685 hours recordkeeping). 7. Abstract: 10 CFR part 20 establishes standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the NRC. These standards require the establishment of radiation protection programs, maintenance of radiation protection programs, maintenance of radiation records recording of radiation received by workers, reporting of incidents which could cause exposure to radiation, submittal of an annual report to NRC of the results of individual monitoring, and submittal of license termination information. These mandatory requirements are needed to protect occupationally exposed individuals from undue risks of excessive exposure to ionizing radiation and to protect the health and safety of the public. Submit, by January 27, 2012, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. OMB clearance requests are available at the NRC Web site: https://www.nrc.gov/public-involve/doc- comment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC- 2011-0271. Public comments and supporting materials related to this document can be found at https://www.regulations.gov by searching on Docket No. NRC-2011-0271. Mail comments to NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555- 0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at (301) 415-6258, or by email to INFOCOLLECTS.Resource@NRC.GOV.

This notice amends the notice of a major disaster declaration for State of Missouri (FEMA-1980-DR), dated May 9, 2011, and related determinations.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,'' dated November 2011. The draft guidance document provides recommendations on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, the draft guidance provides notification that FDA considers the use of an FDA- licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. The guidance is intended for blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. The draft guidance, when finalized, is intended to supplement previous memoranda and guidance from FDA concerning the testing of donations for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc), and the management of donors and units mentioned in those documents.

The Secretary of the Interior is publishing this notice as required by section 10(a) of the Soboba Band of Luise[ntilde]o Indians Settlement Act of 2008, Public Law 110-297, 122 Stat. 2975, 2983 (Settlement Act). The publication of this notice causes certain waivers and releases of claims to become effective as required by the Settlement Act.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.

As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: (a) 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; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) 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 (e) ways to further reduce the information burden for 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 Paperwork Reduction Act (PRA) that does not display a valid OMB control number.

This document informs the public that an appeal of the closing of the Witten, South Dakota post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioners, and others to take appropriate action.

In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request renewed approval for the collection of information for surface and underground mining permit applications minimum requirements for information on environmental resources.

EPA is taking direct final action to approve several State Implementation Plan (SIP) revisions submitted by the South Carolina Department of Health and Environmental Control (SC DHEC). These revisions establish reasonably available control technology (RACT) requirements for the three major sources located in the portion of York County, South Carolina that is within the bi-state Charlotte-Gastonia-Rock Hill, North Carolina-South Carolina 1997 8-hour ozone nonattainment area that either emit volatile organic compounds (VOC), nitrogen oxides (NOX) or both. The bi-state Charlotte-Gastonia-Rock Hill 1997 8-hour ozone nonattainment area is hereinafter referred to as the ``bi-state Charlotte Area.'' In addition, South Carolina's SIP revisions include negative declarations for certain source categories for which EPA has control technique guidelines (CTG), meaning that SC DHEC has concluded that no such sources are located in that portion of the nonattainment area. EPA has evaluated the proposed revisions to South Carolina's SIP, and has concluded that they are consistent with statutory and regulatory requirements and EPA guidance.