August 7, 2013 – Federal Register Recent Federal Regulation Documents

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Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions; Amended Notice of Meeting
Document Number: 2013-19056
Type: Notice
Date: 2013-08-07
Agency: Department of Health and Human Services
On June 26, 2013, the Department of Health and Human Services (HHS) published in the Federal Register an announcement of a public meeting to be held on August 28, 2013, to discuss how certain provisions of the HHS protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context (78 FR 38343). In the June 26, 2013 meeting announcement, HHS stated that presenters will be scheduled to speak at the public meeting in the order in which they register. Notice is hereby provided that HHS may group presenters according to the topic of their presentation.
Pacific Gas and Electric Company, Humboldt Bay Power Plant, Unit 3, Notice of Public Meeting on the License Termination Plan
Document Number: 2013-19054
Type: Notice
Date: 2013-08-07
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is providing notice that the NRC staff will conduct a meeting to discuss and accept public comments on the Humboldt Bay Power Plant (HBPP), Unit 3 License Termination Plan (LTP) on Tuesday, August 20, 2013, at 6:00 p.m. in the Great Room at the Warfinger Building, Eureka Public Marina, 1 Marina Way, Eureka, California. The HBPP is located about four miles southwest of the city of Eureka, Humboldt County, California and consists of 143 acres of land. Unit 3, which is the NRC licensed reactor, is currently being decommissioned with the spent fuel now stored in the onsite Independent Spent Fuel Storage Installation. Unit 3 decommissioning commenced in May 2009. Following the start of a new power generation facility in 2010, the licensee commenced with the permanent shutdown of the fossil Units 1 and 2. Units 1 and 2 are being decommissioned in conjunction with Unit 3 decommissioning. In accordance with the NRC regulations at Sec. 50.82(a)(9) of Title 10 of the Code of Federal Regulations (10 CFR), all power reactor licensees must submit an application for termination of their license. The application for termination of license must be accompanied or preceded by an LTP to be submitted for NRC approval. Pacific Gas and Electric submitted the proposed LTP for HBPP with a license amendment application dated May 3, 2013. The LTP would be approved by license amendment if found acceptable by the NRC staff. The amendment would be subject to such conditions and limitations as the NRC staff deems appropriate and necessary. In accordance with 10 CFR 20.1405 and 10 CFR 50.82(a)(9)(iii), the NRC is providing notice to individuals in the vicinity of the site that the NRC: (1) Is in receipt of the HBPP LTP; (2) will hold a public meeting: and (3) will accept comments from affected parties. The HBPP LTP is available for public viewing at the NRC's Public Document Room (PDR) or electronically through the NRC Agencywide Documents Access and Management System (ADAMS) at accession numbers ML131300009 and ML131300160. Documents may be examined, and/or copied for a fee, at the PDR, located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the ADAMS Public Library component on the NRC Web site, https://www.nrc.gov. Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS should contact the NRC PDR Reference staff by telephone at 1-800-397-4209, or 301-415-4737, or by email at pdr@nrc.gov. Any meeting updates or changes will be made available on the NRC's Public Meeting Schedule Web site at https://www.nrc.gov/public-involve/ public-meetings/.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Clinical Laboratory Improvement Amendments Waiver Applications
Document Number: 2013-19053
Type: Notice
Date: 2013-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Clinical Laboratory Improvement Amendments Waiver Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Rocky Mountain Arsenal National Wildlife Refuge, Commerce City, CO; Comprehensive Conservation Plan and Environmental Impact Statement; Two Ponds National Wildlife Refuge, Arvada, CO; Comprehensive Conservation Plan and Environmental Assessment
Document Number: 2013-19052
Type: Notice
Date: 2013-08-07
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), intend to prepare a Comprehensive Conservation Plan (CCP) and an Environmental Impact Statement (EIS) for the Rocky Mountain Arsenal National Wildlife Refuge in Commerce City, Colorado. The Service also intends to prepare a CCP and an Environmental Assessment for the Two Ponds National Wildlife Refuge in Arvada, Colorado. These refuges are currently being managed under Comprehensive Management Plans developed in the mid-1990s and as part of the Rocky Mountain Arsenal National Wildlife Refuge Complex. We provide this notice in compliance with our CCP policy to advise other Federal and State agencies, Tribes, and the public of our intentions, and to obtain suggestions and information on the scope of issues to consider in the planning process of revising the management plans for these refuges.
Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances
Document Number: 2013-19051
Type: Notice
Date: 2013-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. Guidances that are no longer up to date, and for which more current information is available, will be withdrawn. Guidances that reflect CDER's current thinking, CDER will decide whether to revise or finalize. This notice describes CDER's initiative, announces the first group of guidances to be withdrawn, describes in general terms draft guidances under consideration for revision or finalization, and explains how CDER is making this process as transparent as possible.
Freedom of Information Act Administration
Document Number: 2013-19050
Type: Proposed Rule
Date: 2013-08-07
Agency: Peace Corps, Agencies and Commissions
The proposed rule updates Peace Corps regulations on the Freedom of Information Act (FOIA) to implement guidance given by the President and the Attorney General regarding discretionary disclosures of records or information exempt from disclosure under the FOIA, whenever disclosure would not foreseeably harm an interest protected by a FOIA exemption. The proposed rule is based on language used by Department of Justice in its FOIA regulations. Additionally, the proposed rule deletes unnecessary and superfluous language and ensures the rule is consistent with current law.
Extension of Public Comment Period for the Environmental Impact Statement on the Proposed Relocation of 18th Aggressor Squadron to Joint Base Elmendorf-Richardson, Alaska
Document Number: 2013-19048
Type: Notice
Date: 2013-08-07
Agency: Department of Defense, Department of the Air Force
The U.S. Air Force is issuing this notice to advise the public of an extension to the public comment period on the environmental impact statement on the proposed relocation of the 18th Aggressor Squadron to Joint Base Elmendord-Richardson, Alaska. The initial Notice of Availability published in the Federal Register on May 31, 2013 (78 FR 32645), and established a public comment period from May 31 through August 2, 2013. The Air Force has extended the deadline for submitting public comments to August 30, 2013. All substantive comments received by August 30, 2013 will be addressed in the Public Comment Section of the Final EIS. FOR FURTHER INFORMATION CONTACT: Please direct any written comments or requests for information to Mr. Allen Richmond, AFCEC/CZN, 2261 Hughes Ave, Ste 155, Lackland AFB, TX 78236-9853.
Notice of New Recreation Fee
Document Number: 2013-19047
Type: Notice
Date: 2013-08-07
Agency: Department of Agriculture, Forest Service
The Prescott National Forest is proposing to charge a fee at the new Eagle Ridge Group Campground near Prescott, Arizona, constructed in 2011. Eagle Ridge Group Campground has two sites with the following proposed fees: (1) Osprey recreation fee is proposed at $75/night for up to 50 persons or $125/night for up to 75 persons; (2) Peregrine recreation fee is proposed at $50/night for 1-25 persons. Rental of other facilities on the Prescott National Forest and other Arizona National Forests has shown that publics appreciate and enjoy the availability of group rental facilities. Funds from the fee revenue will be used for the continued operation and maintenance of Eagle Ridge Group Campground.
Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2013
Document Number: 2013-19046
Type: Notice
Date: 2013-08-07
Agency: Drug Enforcement Administration, Department of Justice
This notice establishes final adjusted 2013 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA) and assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as well as the 2013 aggregate production quotas for three recently temporarily controlled substances.
Notice
Document Number: 2013-19043
Type: Notice
Date: 2013-08-07
Agency: Department of Commerce, Bureau of Industry and Security
Notice of Proposed Information Collection; Request for Comments
Document Number: 2013-19042
Type: Notice
Date: 2013-08-07
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request approval for the collection of information for General Reclamation Requirements.
Proposed Collection; Comment Request
Document Number: 2013-19041
Type: Notice
Date: 2013-08-07
Agency: Securities and Exchange Commission, Agencies and Commissions
Ranger Alternative Management, L.P. and Ranger Funds Investment Trust; Notice of Application
Document Number: 2013-19039
Type: Notice
Date: 2013-08-07
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request
Document Number: 2013-19038
Type: Notice
Date: 2013-08-07
Agency: Securities and Exchange Commission, Agencies and Commissions
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-19036
Type: Notice
Date: 2013-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 (Pub. L. 95-541)
Document Number: 2013-19035
Type: Notice
Date: 2013-08-07
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 671 of the Code of Federal Regulations. This is the required notice of permit applications received.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 (Pub. L. 95-541)
Document Number: 2013-19034
Type: Notice
Date: 2013-08-07
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 670 of the Code of Federal Regulations. This is the required notice of permit applications received.
Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance
Document Number: 2013-19033
Type: Notice
Date: 2013-08-07
Agency: Department of Commerce, Economic Development Administration
Steens Mountain Advisory Council; Public Meeting Date Change
Document Number: 2013-19032
Type: Notice
Date: 2013-08-07
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, and the U.S. Department of the Interior, Bureau of Land Management (BLM), the Steens Mountain Advisory Council (SMAC) will meet as indicated below:
Tallgrass Interstate Gas Transmission, LLC; Notice of Application
Document Number: 2013-19031
Type: Notice
Date: 2013-08-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Transcontinental Gas Pipe Line Company, LLC; Notice of Application
Document Number: 2013-19030
Type: Notice
Date: 2013-08-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972
Document Number: 2013-19026
Type: Rule
Date: 2013-08-07
Agency: Department of Defense, Department of the Navy
The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG)(Admiralty and Maritime Law) has determined that USS INDEPENDENCE (LCS 2) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.
Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-19018
Type: Notice
Date: 2013-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final nor is it in effect at this time.
Conservation Reserve Program, Re-Enrollment
Document Number: 2013-19017
Type: Rule
Date: 2013-08-07
Agency: Department of Agriculture, Commodity Credit Corporation
This rule makes a technical correction to the Commodity Credit Corporation (CCC) Conservation Reserve Program (CRP) regulations to clarify that land with use restrictions that prohibit the production of agricultural commodities, typically through an easement or other deed restrictions, is not eligible for re-enrollment in CRP. This is not a new policy and would not have affected any program determinations for recent CRP sign ups, had this change been specified in the regulations at the time. This amendment will improve the regulations by maintaining consistency with longstanding policy. This rule corrects a provision in the current regulations that allows re-enrollment in CRP of land with easements or other deed restrictions that restrict the production of agricultural commodities. A 2003 interim rule inadvertently added that provision through an incorrect cross-reference, but clearly stated in the preamble that the intent was to exclude land with such easements or deed restrictions from re-enrollment. The purpose of CRP is to cost- effectively assist producers in conserving and improving soil, water, wildlife, and other natural resources by converting environmentally- sensitive acreage from the production of agricultural commodities to a long-term vegetative cover.
Information Collection; Guaranteed Farm Loan Program
Document Number: 2013-19015
Type: Notice
Date: 2013-08-07
Agency: Department of Agriculture, Farm Service Agency
In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) is seeking comments from all interested individuals and organizations on the extension and revision of a currently approved information collection associated with the Guaranteed Farm Loan Program. This information collection is used to make and service loans guaranteed by FSA to eligible farmers and ranchers.
Privacy Act of 1974; CMS Computer Match No. 2013-12; HHS Computer Match No. 1307; SSA Computer Match No. 1097-1899
Document Number: 2013-19014
Type: Notice
Date: 2013-08-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Social Security Administration (SSA).
Privacy Act of 1974; CMS Computer Match No. 2013-02; HHS Computer Match No. 1306; DoD-DMDC Match No. 12
Document Number: 2013-19013
Type: Notice
Date: 2013-08-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a CMP that CMS plans to conduct with the Department of Defense (DoD).
Proposed Information Collection; Comment Request; Report of Requests for Restrictive Trade Practice or Boycott
Document Number: 2013-19007
Type: Notice
Date: 2013-08-07
Agency: Department of Commerce, Bureau of Industry and Security
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Statement of Financial Interests, Regional Fishery Management Councils
Document Number: 2013-19006
Type: Notice
Date: 2013-08-07
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring; Availability
Document Number: 2013-19004
Type: Notice
Date: 2013-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring.'' This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance makes clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies.
Notice of Request To Release Airport Property
Document Number: 2013-19003
Type: Notice
Date: 2013-08-07
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to rule and invites public comment on the release of land at the Ottumwa Regional Airport, Ottumwa, Iowa, under the provisions of 49 U.S.C. 47107(h)(2).
Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee
Document Number: 2013-19002
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
An open meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee
Document Number: 2013-19001
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
An open meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
Proposed Collection; Comment Request for Regulation Project
Document Number: 2013-19000
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Qualified State Tuition Programs.
Proposed Collection; Comment Request for Regulation Project
Document Number: 2013-18999
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing regulation, TD 9353, Section 1045 Application to Partnerships.
Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee
Document Number: 2013-18998
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
An open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
Open Meeting of the Taxpayer Advocacy Panel Joint Committee
Document Number: 2013-18997
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
An open meeting of the Taxpayer Advocacy Panel Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
Open Meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee
Document Number: 2013-18996
Type: Notice
Date: 2013-08-07
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
An open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
Notice of Commissioner and Staff Attendance at North American Electric Reliability Corporation Meetings
Document Number: 2013-18995
Type: Notice
Date: 2013-08-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Internal Revenue Service
Document Number: 2013-18993
Type: Notice
Date: 2013-08-07
Agency: Department of the Treasury
An open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
60-Day Notice of Proposed Information Collection: Promise Zones
Document Number: 2013-18992
Type: Notice
Date: 2013-08-07
Agency: Department of Housing and Urban Development
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Proposed Collection; Comment Request
Document Number: 2013-18991
Type: Notice
Date: 2013-08-07
Agency: Department of Defense, Office of the Secretary
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2013-18990
Type: Notice
Date: 2013-08-07
Agency: Department of Health and Human Services, National Institutes of Health
Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA
Document Number: 2013-18986
Type: Rule
Date: 2013-08-07
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a safety zone on the navigable waters of the San Diego Bay in support of the Kuoni Destination Management Fireworks Display on August 6, 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.