November 2011 – Federal Register Recent Federal Regulation Documents

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to assure that on the job training establishments are providing veterans with the appropriate rehabilitation training.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

This action corrects a final rule published by the FAA in the Federal Register on September 19, 2011, that amends and establishes nine Air Traffic Service Routes (ATS) in the Northeast United States. This action provides more accurate latitude/longitude coordinates for one waypoint (WP) in the description of area navigation (RNAV) route Q- 480.

The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 223, Airport Surface Wireless Communications Eleventh Meeting

This action proposes to establish restricted area airspace within the Devils Lake Military Operations Area (MOA), overlying Camp Grafton Range, in the vicinity of Devils Lake, ND. The new restricted areas would permit realistic training in modern tactics to be conducted at Camp Grafton Range while ensuring the safe and efficient use of the National Airspace System (NAS) in the Devils Lake, ND, area. Unlike restricted areas which are designated under Title 14 Code of Federal Regulations (14 CFR) part 73, MOAs are not rulemaking airspace actions. However, since the proposed restricted areas overlap the Devils Lake East MOA, the FAA is including a description of the Devils Lake East MOA change in this NPRM. The MOA change described herein will also be published in the National Flight Data Digest (NFDD).

The purpose of this notice is to request public nominations to fill one position on the Utah Resource Advisory Council (RAC) in category three (representatives of state, county, or local elected office; employees of a state agency responsible for management of natural resources; representatives of Indian tribes within or adjacent to the area for which the council is organized; representatives of academia who are employed in natural sciences; or the public-at-large).

The Bureau of Land Management (BLM), Hollister Field Office, proposes to sell a parcel of public land totaling approximately 23.42 acres, more or less, in Santa Clara County, California. The public land would be sold for appraised fair market value. The appraised value of the public land is $135,000.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the 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 the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through January 31, 2012. DoD proposes that OMB extend its approval for three additional years.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the 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 the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through November 30, 2012. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.

Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the following meeting notice is announced:

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.