January 2014 – Federal Register Recent Federal Regulation Documents

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

This notice announces receipt of petitions for waiver from Samsung Electronics America, Inc. (Samsung) seeking an exemption from specified portions of the U.S. Department of Energy (DOE) test procedure for determining the energy consumption of electric refrigerators and refrigerator-freezers. Samsung asks that it be permitted to use an alternate test procedure that is intended to address difficulties in testing dual compressor systems using the currently applicable DOE test procedure. DOE solicits comments, data, and information concerning Samsung's petitions and the suggested alternate test procedure. Today's notice also grants Samsung an interim waiver from the electric refrigerator-freezer test procedure, subject to use of the alternative test procedure set forth in this notice. The waiver request pertains to the basic models set forth in Samsung's petitions that incorporate dual compressors.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health Clinical Center (CC) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 6, 2013, pp. 66750-66751, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health Clinical Center (CC), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

The U.S. Government Accountability Office (GAO) is extending the comment period for the proposed revisions to the Standards for Internal Control in the Federal Government, known as the ``Green Book,'' to February 18, 2014. We are requesting public comments on the proposed revisions in the exposure draft. The proposed changes contained in the 2013 Exposure Draft update to the Standards for Internal Control in the Federal Government reflect major developments in the accountability and financial management profession and emphasize specific considerations applicable to the government environment. The draft of the proposed changes to Standards for Internal Control in the Federal Government, 2013 Exposure Draft, is available and can be downloaded from GAO's Web page at www.gao.gov. All comments will be considered a matter of public record and will ultimately be posted on the GAO Web page.

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Masters of Fire: Copper Age Art in Israel,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Institute for the Study of the Ancient World at New York University, New York, NY, from on or about February 12, 2014, until on or about June 8, 2014, the Legion of Honor, Fine Arts Museums of San Francisco, San Francisco, CA, from on or about June 28, 2014, until on or about January 4, 2015, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

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.

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Degenerate Art: The Attack on Modern Art in Nazi Germany, 1937,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Neue Galerie, New York, New York, from on or about March 13, 2014, until on or about June 30, 2014, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

The Department of State and the Office of the United States Trade Representative (USTR) are providing notice that the United States and Panama intend to hold the first meeting of the Environmental Affairs Council (the ``Council'') and the first meeting of the Environmental Cooperation Commission (the ``Commission'') on January 29, 2014 in Panama City, Panama. The purpose of the Council meeting is to review implementation of Chapter 17 (Environment) of the United States-Panama Trade Promotion Agreement (TPA) and the purpose of the Commission meeting is to review implementation of the United States- Panama Environmental Cooperation Agreement (ECA) and approve a Work Program for implementing the ECA. The Department of State and USTR invite interested organizations and members of the public to attend the public session of the meetings and comment on any items that should be included on the meeting agendas. The Department of State also invites suggestions for items to be included in the Work Program. During the Council meeting, the United States and Panama (collectively the ``Parties'') will discuss their respective implementation of and progress under Chapter 17. During the Commission meeting, the Parties will provide an overview of environmental cooperation, and present and approve the inaugural 2014-2017 Environmental Cooperation Work Program.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requests for Feedback on Medical Device Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is establishing a public docket to receive input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements to FDA's Office of Generic Drugs (OGD). Specifically, FDA is interested in hearing about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help address, for example by providing more or better information to industry. This action is intended to solicit suggestions that will improve the completeness and quality of ANDA submissions to FDA. FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry. More complete, higher quality ANDA submissions will positively affect the availability of low-cost, high-quality generic drugs to the public.

The Food and Drug Administration (FDA) has determined the regulatory review period for GADAVIST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible. This guidance finalizes the draft guidance issued in November 2010.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the Federal Register of January 9, 2014 (79 FR 1645). The amendment is being made to reflect a change in the Date and Time and the Agenda portions of the document. There are no other changes.

This notice announces receipt of a petition for waiver from Samsung Electronics America, Inc. (Samsung) regarding specified portions of the U.S. Department of Energy (DOE) test procedure for determining the energy consumption of electric refrigerators and refrigerator-freezers. In its petition, Samsung provides an alternate test procedure identical to the test procedure DOE published in a final rule setting out testing requirements for manufacturers to follow starting in 2014. DOE solicits comments, data, and information concerning Samsung's petition and the suggested alternate test procedure. Today's notice also grants Samsung an interim waiver from the electric refrigerator and refrigerator-freezer test procedure, subject to use of the alternative test procedure set forth in this notice.

The U.S. Department of Energy (DOE) gives notice of the decision and order (Case No. CD-009) that grants to Indesit Company (Indesit) a waiver from the DOE clothes dryer test procedure. The waiver pertains to the models of condensing residential clothes dryer specified in Indesit's petition. Condensing clothes dryers cannot be tested using the currently applicable DOE test procedure. Under today's decision and order, Indesit shall not be required to test and rate its specified models of residential condensing clothes dryer pursuant to the current test procedure.

As required by the Privacy Act of 1974, 5 U.S.C. 552a(e)(4), notice is hereby given that the Department of Veterans Affairs (VA) proposes to modify its existing system of records ``Loan Guaranty Home, Condominium and Manufactured Home Loan Applicants Records, Specially Adapted Housing Applicant Records and Vendee Loan Applicant RecordsVA (55VA26).''

The Federal Trade Commission announces the revised thresholds for interlocking directorates required by the 1990 amendment of Section 8 of the Clayton Act. Section 8 prohibits, with certain exceptions, one person from serving as a director or officer of two competing corporations if two thresholds are met. Competitor corporations are covered by Section 8 if each one has capital, surplus, and undivided profits aggregating more than $10,000,000, with the exception that no corporation is covered if the competitive sales of either corporation are less than $1,000,000. Section 8(a)(5) requires the Federal Trade Commission to revise those thresholds annually, based on the change in gross national product. The new thresholds, which take effect immediately, are $29,945,000 for Section 8(a)(1), and $2,994,500 for Section 8(a)(2)(A).

The Bureau of Indian Affairs (BIA) owns, or has an interest in, irrigation projects located on or associated with various Indian reservations throughout the United States. We are required to establish irrigation assessment rates to recover the costs to administer, operate, maintain, and rehabilitate these projects. We are notifying you that we have adjusted the irrigation assessment rates at several of our irrigation projects and facilities to reflect current costs of administration, operation, maintenance, and rehabilitation.

The Bureau of Land Management (BLM) has examined and found suitable for classification for lease and conveyance under the Recreation and Public Purposes (R&PP) Act, as amended, 61.81 acres of public land in Inyo County, California. The public land contains a solid waste landfill that has been closed to public use. The County of Inyo proposes to use the land to implement a long-term monitoring and closure plan for the landfill.

The United States Forest Service (USFS) has filed an application with the Bureau of Land Management (BLM) requesting that the Secretary of the Interior extend the duration of Public Land Order (PLO) No. 7133 for an additional 20-year term. PLO No. 7133 withdrew approximately 496.22 acres of National Forest System land from location and entry under the mining laws in order to protect the Brown Mountain, Pal Moore Meadows, Teepee, Cedar Creek, and Flowery Trail Seed Orchards. The withdrawal created by PLO No. 7133 will expire on April 12, 2015, unless it is extended. This notice also gives the public an opportunity to comment on the proposed application and action and to request a public meeting.