December 4, 2013 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.

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.

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.