November 7, 2011 – Federal Register Recent Federal Regulation Documents
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Letters of Authorization To Take Marine Mammals
In accordance with the Marine Mammal Protection Act of 1972, as amended (MMPA), we, the Fish and Wildlife Service, have issued letters of authorization for the nonlethal take of polar bears and Pacific walrus incidental to oil and gas industry exploration, development, and production activities in the Beaufort Sea and the adjacent northern coast of Alaska and incidental to oil and gas industry exploration activities in the Chukchi Sea and the adjacent western coast of Alaska.
Post Office Closing
This document informs the public that an appeal of the closing of the Rembrandt, Iowa 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.
Request for Information and Recommendations on Resolutions, Decisions, and Agenda Items for Consideration at the Sixteenth Regular Meeting of the Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora
To implement the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES or the Convention), the Parties to the Convention meet periodically to review what species in international trade should be regulated and other aspects of the implementation of CITES. The sixteenth regular meeting of the Conference of the Parties to CITES (CoP16) is tentatively scheduled to be held in March 2013 in Thailand. This is our second in a series of Federal Register notices that, together with an announced public meeting, provide you with an opportunity to participate in the development of the U.S. negotiating positions for CoP16. We published our first CoP16-related Federal Register notice on June 14, 2011, in which we requested information and recommendations on species proposals for the United States to consider submitting for consideration at CoP16. Further input from the public on species proposals will be sought in a future notice. With this notice we are soliciting and invite you to provide us with information and recommendations on resolutions, decisions, and agenda items that the United States might consider submitting for discussion at CoP16. In addition, with this notice we provide preliminary information on how to request approved observer status for nongovernmental organizations that wish to attend the meeting.
Post Office Closing
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.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
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 August 9, 2011 (76 FR 48908). 1. Type of submission, new, revision, or extension: New. 2. The title of the information collection: Employment Application System for Entry-Level Legal Positions. 3. Current OMB approval number: 3150-XXXX. 4. The form number if applicable: n/a. How often the collection is required: On occasion. 5. Who will be required or asked to report: Applicants seeking employment through the NRC Office of the General Counsel Honor Law Graduate Program or Summer Internship Program. 6. An estimate of the number of annual responses: 1,500. 7. The estimated number of annual respondents: 1,500. 8. An estimate of the total number of hours needed annually to complete the requirement or request: 1,500. 9. Abstract: The NRC is seeking to implement a Web-based job application system that will allow the NRC Office of the General Counsel to track, manage, and interact with applicants seeking entry- level attorney positions through the Honor Law Graduate program or temporary, summer legal positions through the Summer Internship Program. Applicants seeking employment consideration will submit application materials, including cover letters, resumes, school transcripts, lists of references, and writing samples, via a Web-based interface. These application materials may contain names, addresses, phone numbers, email addresses, school information/grades, employment information/histories, and works of writing. The public may examine and have copied for a fee publicly available documents, including the final supporting statement, at the NRC's PDR, 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 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.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
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.
Notice of Availability for Public Comment on the Interagency Ocean Observing Committee Draft Certification Criteria for Non-Federal Asset Integration Into IOOS
The National Science Foundation publishes this notice on behalf of the Interagency Ocean Observation Committee (IOOC) to announce a 60-day public comment period for non-federal asset certification criteria. This draft certification criteria will be used to establish eligibility for non-federal assets to be integrated into the U.S. Integrated Ocean Observation System (IOOS) and to ensure compliance with all applicable standards and protocols. This criteria was developed in response to a requirement in the Integrated Coastal Ocean Observation System Act of 2009 (33 U.S.C. 3601-3610) and is applicable to all non-federal assets as defined in the Act, including Regional Information Coordination Entities (RICEs).
Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability
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.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the requirement of special controls for class II devices. This draft guidance is not final nor is it in effect at this time.
Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection
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.
Product Shortage Report; Availability; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of a medical product shortage report entitled ``A Review of FDA's Approach to Medical Product Shortages.'' The Agency is making the report available by placing it in the docket opened for a previous public workshop on drug shortages. The report discusses the Agency's approach to product shortages, particularly those products regulated by the FDA Center for Drug Evaluation and Research (CDER). FDA requests comments, until December 23, 2011, on the report and its recommendations, including whether there are additional suggestions for recommendations and how we should prioritize work on these recommendations.
Information Collection Requests to Office of Management and Budget
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit Information Collection Requests (ICRs) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collections of information: 1625-0028, Course Approval and Records for Merchant Marine Training Schools and 1625-0069, Ballast Water Management for Vessels with Ballast Tanks Entering U.S. Waters. Our ICRs describe the information we seek to collect from the public. Before submitting these ICRs to OIRA, the Coast Guard is inviting comments as described below.
Renewal of Information Collection for Source Directory Publication
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.
Order Providing for Opening of Lands Subject to Section 24 of the Federal Power Act; Alaska
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.
Notice of Realty Action: Direct (Non-Competitive) Sale of Reversionary Interest in Benton County, WA
The reversionary interest held by the United States in the land described in SUPPLEMENTARY INFORMATION below has been determined suitable for direct sale and release to the City of West Richland, Washington, under the authority of Section 203 of the Federal Land Policy and Management Act of 1976 (FLPMA). The parcel is currently patented to the City of West Richland, Washington, pursuant to the Recreation and Public Purposes Act of 1926, as amended and supplemented; however, the purpose for which the parcel can be used is restricted by the reversionary clause.
Call for Nominations for the Wyoming Resource Advisory Council
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.
New York Disaster Number NY-00113
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.
New York Disaster Number NY-00108
This is an amendment of the Presidential declaration of a major disaster for the State of New York (FEMA-4020-DR), dated 08/31/ 2011. Incident: Hurricane Irene. Incident Period: 08/26/2011 through 09/05/2011.
New York Disaster Number NY-00110
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.
Louisiana Disaster #LA-00043
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Louisiana (FEMA- 4041-DR), dated 10/28/2011. Incident: Tropical Storm Lee. Incident Period: 09/01/2011 through 09/05/2011. Effective Date: 10/28/2011. Physical Loan Application Deadline Date: 12/27/2011. Economic Injury (EIDL) Loan Application Deadline Date: 07/30/2012.
Florida Disaster #FL-00064
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.
Texas Disaster Number TX-00382
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Texas (FEMA- 4029-DR), dated 09/21/2011. Incident: Wildfires. >Incident Period: 08/30/2011 and continuing. Effective Date: 10/25/2011. Physical Loan Application Deadline Date: 11/21/2011. Economic Injury (EIDL) Loan Application Deadline Date: 06/21/2012.
GSA Approves Renewal of North American Numbering Council Charter Through September 23, 2013
On October 18, 2011, the Commission released a public notice announcing GSA's approval of the renewal of the North American Numbering Council charter through September 23, 2013. The intended effect of this action is to make the public aware of the renewal of the North American Numbering Council charter.
Pennsylvania Disaster Number PA-00044
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.
Shasta County Resource Advisory Committee
The Shasta County Resource Advisory Committee was scheduled to meet Wednesday, November 30, 2011 in Redding, California. The committee is authorized under the Secure Rural Schools and Community Self- Determination Act (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The committee's charter expired in October 2011 and its renewal is under review by the Secretary of Agriculture. In compliance with the Federal Advisory Committee Act, the committee will not be meeting until the charter is renewed.
Filing of Plats of Survey; Nevada
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.
New Markets Tax Credit Program
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.
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