December 4, 2013 – Federal Register Recent Federal Regulation Documents

Adequacy Status of the West Virginia Portion of the Steubenville-Weirton, WV-OH Nonattainment Area Submitted for the 2006 Fine Particulate Matter Standard Redesignation Request and Maintenance Plan for Transportation Conformity Purposes
Document Number: 2013-28984
Type: Notice
Date: 2013-12-04
Agency: Environmental Protection Agency
In this notice, EPA is notifying the public that we have made insignificance findings through the transportation conformity adequacy process, under the Clean Air Act (CAA), for directly emitted fine particulate matter (PM2.5) and nitrogen oxides (NOX) in the West Virginia portion of the Steubenville- Weirton, WV-OH 2006 PM2.5 national ambient air quality standard (NAAQS) nonattainment area. West Virginia submitted the insignificance findings with the redesignation request and maintenance plan submittal on June 8, 2012. As a result of EPA's findings, the West Virginia portion of the Steubenville-Weirton, WV-OH nonattainment area is no longer required to perform a regional emissions analysis for directly emitted PM2.5, or NOX, as part of future PM2.5 conformity determinations for the 2006 daily PM2.5 air quality standard.
Determination of Benchmark Compensation Amount for Certain Executives and Employees
Document Number: 2013-28982
Type: Notice
Date: 2013-12-04
Agency: Management and Budget Office, Executive Office of the President, Office of Federal Procurement Policy
The Office of Management and Budget is publishing the attached memorandum to the Heads of Executive Departments and Agencies announcing that $952,308 is the ``benchmark compensation amount'' for certain executives and employees in terms of costs allowable under Federal Government contracts during contractors' fiscal year 2012. This determination is required under Section 39 of the Office of Federal Procurement Policy Act, as amended (41 U.S.C. 1127). The benchmark compensation amount applies to both defense and civilian agencies.
Adequacy Status of the West Virginia Portion of the Steubenville-Weirton, WV-OH Nonattainment Area Submitted for the 1997 Fine Particulate Matter Standard Redesignation Request and Maintenance Plan for Transportation Conformity Purposes
Document Number: 2013-28981
Type: Notice
Date: 2013-12-04
Agency: Environmental Protection Agency
In this notice, EPA is notifying the public that we have made insignificance findings through the transportation conformity adequacy process, under the Clean Air Act (CAA), for directly emitted fine particulate matter (PM2.5) and nitrogen oxides (NOX) in the West Virginia portion of the Steubenville- Weirton, WV-OH 1997 PM2.5 national ambient air quality standard (NAAQS) nonattainment area. West Virginia submitted the insignificance findings with the redesignation request and maintenance plan submittal on April 13, 2012. As a result of EPA's findings, the West Virginia portion of the Steubenville-Weirton, WV-OH nonattainment area is no longer required to perform a regional emissions analysis for directly emitted PM2.5, or NOx, as part of future PM2.5 conformity determinations for the 1997 annual PM2.5 air quality standard.
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations
Document Number: 2013-28980
Type: Proposed Rule
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested groups and individuals to nominate specific drug products or categories of drug products and is describing the information that should be provided to the Agency in support of each nomination.
List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
Document Number: 2013-28979
Type: Proposed Rule
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing the proposed rule to list bulk drug substances used in pharmacy compounding and preparing to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products, although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA- approved drugs. To identify candidates for this bulk drugs list, interested groups and individuals may nominate specific bulk drug substances, and FDA is describing the information that should be provided to the Agency in support of each nomination.
Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Request for Nominations
Document Number: 2013-28978
Type: Proposed Rule
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products in accordance with section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), concerning outsourcing facilities. To identify candidates for this bulk drugs list, interested groups and individuals may nominate specific bulk drug substances, and FDA is describing the information that should be provided to the Agency in support of each nomination.
Proposed Collection; Comment Request
Document Number: 2013-28977
Type: Notice
Date: 2013-12-04
Agency: Securities and Exchange Commission, Agencies and Commissions
Adequacy Status of the Submitted Redesignation Requests and Maintenance Plans for the Charleston, West Virginia 1997 and 2006 Fine Particulate Matter National Ambient Air Quality Standards Nonattainment Area for Transportation Conformity Purposes
Document Number: 2013-28967
Type: Notice
Date: 2013-12-04
Agency: Environmental Protection Agency
In this notice, EPA is notifying the public that EPA has made insignificance findings through the transportation conformity adequacy process, under the Clean Air Act (CAA), for directly emitted fine particulate matter (PM2.5) and nitrogen oxides (NOX) in the Charleston, West Virginia 1997 and 2006 PM2.5 national ambient air quality standards (NAAQS) nonattainment area. West Virginia submitted the insignificance findings with the redesignation requests and maintenance plans submittal on December 6, 2012. As a result of EPA's findings, the Charleston, West Virginia nonattainment area is no longer required to perform a regional emissions analysis for directly emitted PM2.5, or NOX, as part of future PM2.5 conformity determinations for the 1997 and 2006 PM2.5 NAAQS.
Export Trade Certificate of Review
Document Number: 2013-28966
Type: Notice
Date: 2013-12-04
Agency: Department of Commerce, International Trade Administration
The Office of Trade and Economic Analysis (``OTEA'') of the International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (``Certificate''). This notice summarizes the proposed amendment and requests comments relevant to whether the amended Certificate should be issued.
Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances
Document Number: 2013-28963
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled ``Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act''. The draft guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act. When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance. The Agency is also announcing the withdrawal of a guidance entitled, ``Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act,'' which was issued in November 1998, and the withdrawal of CPG Section 460.200 of the Compliance Program Guidance (CPG) Manual entitled, ``Pharmacy Compounding,'' which was issued in May 2002. These guidances are being withdrawn because they are no longer consistent with the Agency's current thinking on the issues they address.
Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2013-28962
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance is intended to assist human drug compounders that choose to register as outsourcing facilities (outsourcing facilities) in registering with FDA. The draft guidance provides information on how an outsourcing facility should submit facility registration information electronically.
Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability
Document Number: 2013-28961
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.'' This guidance provides information in response to questions that FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products in retail outlets.
Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2013-28960
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA), and sets forth an interim electronic submission method for human drug compounders that choose to register as outsourcing facilities (outsourcing facilities).
Availability of 2014-2018 Draft Strategic Plan and Request for Public Comment
Document Number: 2013-28959
Type: Notice
Date: 2013-12-04
Agency: Department of Energy
The Department of Energy (DOE) invites the public to comment on the draft DOE 2014-2018 Strategic Plan. The Government Performance and Results Act (GPRA) Modernization Act of 2010 requires that federal agencies revise and update their strategic plan at least every four years and, in doing so, solicit the views of interested members of the public during this process.
Production of Nonpublic Records and Testimony of OPIC Employees in Legal Proceedings
Document Number: 2013-28954
Type: Proposed Rule
Date: 2013-12-04
Agency: Overseas Private Investment Corporation, Agencies and Commissions
This rule proposes revisions to the Overseas Private Investment Corporation's (``OPIC'') regulations governing the production of nonpublic testimony or records for court proceedings, commonly known as Touhy regulations after Touhy v. Ragen, 340 U.S. 462 (1951).
Definitions of Transmittal of Funds and Funds Transfer
Document Number: 2013-28951
Type: Rule
Date: 2013-12-04
Agency: Department of the Treasury, Financial Crimes Enforcement Network
The Financial Crimes Enforcement Network, a bureau of the Department of the Treasury, and the Board of Governors of the Federal Reserve System are issuing this Final Rule amending the regulatory definitions of ``funds transfer'' and ``transmittal of funds'' under the regulations implementing the Bank Secrecy Act (``BSA''). We are amending the definitions to maintain their current scope in light of changes to the Electronic Fund Transfer Act, which will avoid certain currently covered transactions being excluded from BSA requirements.
Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations
Document Number: 2013-28941
Type: Notice
Date: 2013-12-04
Agency: Environmental Protection Agency
In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by registrants to voluntarily cancel certain pesticide registrations. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw their requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registration has been cancelled only if such sale, distribution, or use is consistent with the terms as described in the final order.
Notice of Availability of the Proposed Notice of Sale (NOS) for Eastern Gulf of Mexico Planning Area (EPA) Outer Continental Shelf (OCS) Oil and Gas Lease Sale 225 (EPA Sale 225)
Document Number: 2013-28934
Type: Notice
Date: 2013-12-04
Agency: Department of the Interior, Bureau of Ocean Energy Management
BOEM announces the availability of the Proposed NOS for proposed EPA Sale 225. This Notice is published pursuant to 30 CFR 556.29(c) as a matter of information to the public. With regard to oil and gas leasing on the OCS, the Secretary of the Interior, pursuant to section 19 of the OCS Lands Act, provides affected States the opportunity to review the Proposed NOS. The Proposed NOS sets forth the proposed terms and conditions of the sale, including minimum bids, royalty rates, and rental rates.
Combined Notice of Filings
Document Number: 2013-28925
Type: Notice
Date: 2013-12-04
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2013-28924
Type: Notice
Date: 2013-12-04
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #2
Document Number: 2013-28923
Type: Notice
Date: 2013-12-04
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2013-28922
Type: Notice
Date: 2013-12-04
Agency: Department of Energy, Federal Energy Regulatory Commission
Freedom of Information
Document Number: 2013-28914
Type: Proposed Rule
Date: 2013-12-04
Agency: Overseas Private Investment Corporation, Agencies and Commissions
This rule proposes revisions to the Overseas Private Investment Corporation's (``OPIC'') Freedom of Information Act (FOIA) regulations by making substantive and administrative changes. These revisions are intended to supersede OPIC's current FOIA regulations, located at this Part. The proposed rule incorporates the FOIA revisions contained in the Openness Promotes Effectiveness in our National Government Act of 2007 (``OPEN Government Act''), makes administrative changes to reflect OPIC's cost, and organizes the regulations to more closely match those of other agencies for ease of reference. The proposed rule also reflects the disclosure principles established by President Barack Obama and Attorney General Eric Holder in their FOIA Policy Memoranda issued on January 12, 2009 and March 19, 2009, respectively.
Collection of Information Under Review by Office of Management and Budget
Document Number: 2013-28906
Type: Notice
Date: 2013-12-04
Agency: Coast Guard, Department of Homeland Security
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding Information Collection Requests (ICRs), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of an extension to the following collections of information: 1625-0007, Characteristics of Liquid Chemicals Proposed for Bulk Water Movement and 1625-0100, Advance Notice of Vessel Arrival. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Mandatory Civil Rights Data Collection
Document Number: 2013-28904
Type: Notice
Date: 2013-12-04
Agency: Department of Education
In accordance with the Paperwork Reduction Act, ED is proposing a new information collection.
Revision of a Currently Approved Information Collection for the Energy Efficiency and Conservation Block Grant Program Status Report
Document Number: 2013-28902
Type: Notice
Date: 2013-12-04
Agency: Department of Energy
A 60-day notice and request for comments was published in the Federal Register on July 6, 2013 (78 FR 34089). No comments were received in response to this Notice. A 30-day notice and request for comments was published in the Federal Register on August 15, 2013 (78 FR 49736). No comments were received in response to this Notice. This subsequent 30-day notice represents a further reduction in the burden estimation to reflect the ongoing collection of information from only a more limited number of awardees; and allows public comment on the final version of the information collection request. The Department of Energy (DOE) invites public comment on a revision of a currently approved collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. Comments are invited on: (a) Whether the revision of the currently approved collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the reduced burden pertaining to the approved collection of information, including the validity of the methodology and assumptions used; (c) ways to further enhance the quality, utility, and clarity of the information being collected; and (d) ways to further minimize the burden regarding the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Application of Ultimate JETCHARTERS, LLC for Commuter Air Carrier Authority
Document Number: 2013-28900
Type: Notice
Date: 2013-12-04
Agency: Department of Transportation, Office of the Secretary
The Department of Transportation is directing all interested persons to show cause why it should not issue an order finding Ultimate JETCHARTERS, LLC, fit, willing, and able, and awarding it commuter air carrier authority to conduct scheduled commuter service.
Findings of Research Misconduct
Document Number: 2013-28887
Type: Notice
Date: 2013-12-04
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Timothy Sheehy, B.A., BSc., SAIC-Frederick, Inc.
Proposed Priority-Promise Zones
Document Number: 2013-28799
Type: Proposed Rule
Date: 2013-12-04
Agency: Department of Education
On October 25, 2013, the Secretary of Education (Secretary) published in the Federal Register (78 FR 63913) a notice of proposed priority regarding the expansion of Department of Education (Department) programs and projects that support activities in designated Promise Zones. This notice established a November 25, 2013, deadline for the submission of written comments. We are reopening the public comment period until December 13, 2013.
Migratory Bird Permits; Delegating Falconry Permitting Authority to 17 States
Document Number: 2013-28709
Type: Rule
Date: 2013-12-04
Agency: Fish and Wildlife Service, Department of the Interior
The States of Alabama, California, Connecticut, Delaware, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, Nevada, New York, Rhode Island, South Carolina, Vermont, West Virginia, and Wisconsin have requested that we delegate permitting for falconry to the State, as provided under our regulations. We have reviewed regulations and supporting materials provided by these States, and have concluded that their regulations comply with the Federal regulations. We change the falconry regulations accordingly. We make additional changes to the regulations to remove parts that will no longer be relevant after December 31, 2013, and, in one case, to remove contradictory language, and to correct errors.
Revisions to Auxiliary Installations, Replacement Facilities, and Siting and Maintenance Regulations
Document Number: 2013-28548
Type: Rule
Date: 2013-12-04
Agency: Department of Energy, Federal Energy Regulatory Commission
The Federal Energy Regulatory Commission (Commission) is issuing this Final Rule to amend its regulations to clarify that auxiliary installations added to existing or proposed interstate transmission facilities under the Commission's regulations must be located within the authorized right-of-way or facility site for the existing or proposed facilities and use only the same temporary work space that was or will be used to construct the existing or proposed facilities; and to codify the common industry practice of notifying landowners prior to coming onto their property to install auxiliary or replacement facilities, certain replacements, or conduct maintenance activities.
Electronic Reporting Under the Toxic Substances Control Act
Document Number: 2013-28510
Type: Rule
Date: 2013-12-04
Agency: Environmental Protection Agency
EPA is amending certain reporting requirements that were promulgated under the Toxic Substances Control Act (TSCA) to require the use electronic reporting. EPA is requiring the use of electronic reporting in order to minimize the paperwork burden associated with the underlying regulatory requirements and to minimize the cost to the Federal Government of the creation, collection, maintenance, use, dissemination, and disposition of information. This action will also improve the quality and use of information to strengthen decisionmaking, accountability, and openness in government and society, as well as provide for the timely dissemination of public information and in a manner that promotes the utility of the information to the public and makes effective use of information technology.
Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy
Document Number: 2013-28338
Type: Notice
Date: 2013-12-04
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public of our preliminary concurrence with the World Organization for Animal Health's (OIE) bovine spongiform encephalopathy (BSE) risk designations for 14 regions. The OIE recognizes these regions as being of either negligible risk for BSE or of controlled risk for BSE. We are taking this action based on our review of information supporting the OIE's risk designations for these regions.
Commission Seeks Comment on Licensing Models and Technical Requirements in the 3550-3650 MHz Band
Document Number: 2013-28254
Type: Proposed Rule
Date: 2013-12-04
Agency: Federal Communications Commission, Agencies and Commissions
In this notice of proposed rulemaking, the Commission seeks comment on some specific variations of the licensing and technical proposals for the 3550-3650 MHz band (3.5 GHz Band) originally set forth in Amendment of the Commission's rules with Regard to Commercial Operations in the 3550-3650 MHz Band.
Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products
Document Number: 2013-28228
Type: Rule
Date: 2013-12-04
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are amending the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy (BSE). We are basing importation conditions on the inherent risk of BSE infectivity in specified commodities, as well as on the BSE risk status of the region in which the commodities originate. We are establishing a system for classifying regions as to BSE risk that is consistent with the system employed by the World Organization for Animal Health (OIE), the international standard-setting organization for guidelines related to animal health. The conditions we are adopting for the importation of specified commodities are based on internationally accepted scientific literature, and are, in general, consistent with guidelines set out in the OIE's Terrestrial Animal Health Code. We are also classifying certain specified countries as to BSE risk and are removing BSE restrictions on the importation of cervids and camelids and products derived from such animals. We are making these amendments after conducting a thorough review of relevant scientific literature and a comprehensive evaluation of the issues and concluding that the changes to the regulations will continue to guard against the introduction of BSE into the United States, while allowing the importation of additional animals and animal products into this country.
Takes of Marine Mammals Incidental to Specified Activities; U.S. Navy Training and Testing Activities in the Atlantic Fleet Training and Testing Study Area
Document Number: 2013-27846
Type: Rule
Date: 2013-12-04
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Upon application from the U.S. Navy (Navy), we (the National Marine Fisheries Service) are issuing regulations under the Marine Mammal Protection Act to govern the unintentional taking of marine mammals incidental to training and testing activities conducted in the Atlantic Fleet Training and Testing (AFTT) Study Area from November 2013 through November 2018. These regulations allow us to issue Letters of Authorization (LOA) for the incidental take of marine mammals during the Navy's specified activities and timeframes, set forth the permissible methods of taking, set forth other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, and set forth requirements pertaining to the monitoring and reporting of the incidental take.