2011 – Federal Register Recent Federal Regulation Documents

This document informs the public that an appeal of the closing of the East Vassalboro, Maine 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.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register Notice with a 60-day comment period on this information collection on July 7, 2011 (76 FR 39907). 1. Type of submission, new, revision, or extension: Revision. 2. The title of the information collection: 10 CFR part 74 Material Control and Accounting of Special Nuclear Material. 3. Current OMB approval number: 3150-0123. 4. The form number if applicable: N/A. 5. How often the collection is required: Submission is a one-time requirement which has been completed by all current licensees. However, licensees may submit amendments or revisions to the plans as necessary. In addition, specified inventory and material status reports are required annually or semi-annually. Other reports are submitted as events occur. 6. Who will be required or asked to report: Persons licensed under 10 CFR part 70 who possess and use certain forms and quantities of Special Nuclear Material (SNM). 7. An estimate of the number of annual responses: 131. 8. The estimated number of annual respondents: 19. 9. An estimate of the total number of hours needed annually to complete the requirement or request: An annual total of 8,589 hours (989 hours for reporting and 7,600 hours for recordkeeping). The average annual burden per respondent for reporting is 47 hours. The average annual burden per recordkeeping for the 110 record keepers is 61 hours. 10. Abstract: 10 CFR part 74 establishes requirements for material control and accounting of SNM, and specific performance-based regulations for licensees authorized to possess, use and produce strategic special nuclear material, and special nuclear material of moderate strategic significance and low strategic significance. The information is used by the NRC to make licensing and regulatory determinations concerning material control and accounting of special nuclear material and to satisfy obligations of the United States to the International Atomic Energy Agency (IAEA). Submission or retention of the information is mandatory for persons subject to the requirements. The public may examine and have copied for a fee publicly available documents, including the final supporting statement, at the NRC's Public Document Room, Room O-1F21, 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 and questions should be directed to the OMB reviewer listed below by December 7, 2011. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. Chad Whiteman, Desk Officer, Office of Information and Regulatory Affairs (3150-0123), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be emailed to CWhiteman@omb.eop.gov or submitted by telephone at (202) 395-4718. The NRC Clearance Officer is Tremaine Donnell, (301) 415-6258.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines'' dated October 2011. The guidance document provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine with recommendations on critical clinical considerations for investigational studies of these products. The guidance also provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to support a subsequent biologics license application (BLA) for marketing approval. The guidance applies to therapeutic cancer vaccines that are intended for the treatment of patients with an existing diagnosis of cancer. The guidance does not apply to vaccines for preventative and therapeutic infectious disease indications, to products intended to induce or augment a non-specific immune response, or to products intended to prevent or decrease the incidence of cancer in individuals without a prior history of that cancer. Furthermore, the guidance does not apply to adoptive immunotherapeutic products which may mediate their therapeutic effect by targeting the tumor directly, such as T cell or NK cell products. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2009.

The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Yersinia species (spp.) detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the recommendation(s) of the panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device.

The Indian Arts and Crafts Board (IACB) collects information to identify and revise listings for the Source Directory of American Indian and Alaska Native Owned and Operated Arts and Crafts Businesses (Source Directory). In compliance with the Paperwork Reduction Act of 1995, the IACB has submitted a request for renewal of approval of this information collection to the Office of Management and Budget (OMB), and requests public comments on this submission.

This notice opens lands for selection by the State of Alaska (State), subject to Section 24 of the Federal Power Act (FPA). The lands include approximately 1,355 acres of National Forest System lands withdrawn for Power Site Classification No. 221 by the Secretarial Order dated May 14, 1929, and approximately 948 acres of public land withdrawn for the Federal Energy Regulatory Commission (FERC) Power Project No. 13234. This action will permit conveyance of the land to the State, if such land is otherwise available, and retain the power rights to the United States. Any land described herein that is not conveyed to the State will remain subject to the terms and conditions of the Tongass National Forest reservation and any other withdrawal of record.

The purpose of this notice is to request public nominations to fill three positions for the Bureau of Land Management's (BLM) Wyoming's 10-member Resource Advisory Council (RAC). The RAC provides advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within the State of Wyoming.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of New York (FEMA-4031-DR), dated 09/23/2011. Incident: Remnants of Tropical Storm Lee. Incident Period: 09/07/2011 through 09/11/2011.

This is an amendment of the Presidential declaration of a major disaster for the State of New York (FEMA-4031-DR), dated 09/13/ 2011. Incident: Remnants of Tropical Storm Lee. Incident Period: 09/07/2011 through 09/11/2011.

This is a notice of an Administrative declaration of a disaster for the State of FLORIDA dated 10/27/2011. Incident: Severe Storms and Tornadoes. Incident Period: 10/18/2011. Effective Date: 10/27/2011. Physical Loan Application Deadline Date: 12/27/2011. Economic Injury (EIDL) Loan Application Deadline Date: 07/27/2012.

This is an amendment of the Presidential declaration of a major disaster for the Commonwealth of Pennsylvania (FEMA-4030-DR), dated 09/12/2011. Incident: Tropical Storm Lee. Incident Period: 09/03/2011 through 10/15/2011. Effective Date: 10/27/2011. Physical Loan Application Deadline Date: 11/14/2011. EIDL Loan Application Deadline Date: 06/12/2012.

The purpose of this notice is to inform the public and interested State and local government officials of the filing of Plats of Survey in Nevada.

This notice invites comments from the public regarding the New Markets Tax Credit (NMTC) Program, which is jointly administered by the Community Development Financial Institutions Fund (CDFI Fund) and the Internal Revenue Service (IRS). All materials submitted will be available for public inspection and copying.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled In Re Certain Communications Equipment, Components Thereof, and Products Containing the Same, Including Power Over Ethernet Telephones, Switches, Wireless Access Points, Routers and Other Devices Used in WLANs and Cameras, DN 2853; the Commission is soliciting comments on any public interest issues raised by the complaint.

The Enforcement Bureau (the ``Bureau'') gives notice of Mr. Jeremy R. Sheets's suspension from the schools and libraries universal service support mechanism (or ``E-Rate Program''). Additionally, the Bureau gives notice that debarment proceedings are commencing against him. Mr. Sheets, or any person who has an existing contract with or intends to contract with him to provide or receive services in matters arising out of activities associated with or related to the schools and libraries support mechanism, may respond by filing an opposition, supported by documentation to Joy Ragsdale, Federal Communications Commission, Enforcement Bureau, Investigations and Hearings Division, Room 4-A236, 445 12th Street SW., Washington, DC 20554.