August 14, 2014 – Federal Register Recent Federal Regulation Documents

Pursuant to the provisions of the ``Government in the Sunshine Act'' (5 U.S.C. 552b), and as authorized by 42 U.S.C. 2286b, notice is hereby given of the Defense Nuclear Facilities Safety Board's (Board) public meeting and hearing described below. The Board invites any interested persons or groups to present any comments, technical information, or data concerning safety issues related to the matters to be considered.

This notice announces a closed meeting of the Defense Programs Advisory Committee (DPAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) (the Act) requires that public notice of these meetings be announced in the Federal Register. Due to national security considerations, under section 10(d) of the Act and 5 U.S.C. 552b(c), the meeting will be closed to the public and matters to be discussed are exempt from public disclosure under Executive Order 13526 and the Atomic Energy Act of 1954, 42 U.S.C. 2161 and 2162, as amended.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

The U.S. Department of Energy (DOE) invites public comment on its Request for Information (RFI) to help inform DOE's research and development activities related to Distributed Generation from Wind Energy Systems.

The Assistant Secretary for Special Education and Rehabilitative Services announces two priorities under the Capacity Building Program for Traditionally Underserved Populations administered by the Rehabilitation Services Administration (RSA). The Assistant Secretary may use one or more of these priorities for competitions in fiscal year (FY) 2014 and later years. Priority 1 establishes a new vocational rehabilitation (VR) training institute for the preparation of personnel in American Indian Vocational Rehabilitation Services (AIVRS) projects (the Institute). Priority 2 requires a partnership between a four-year institution of higher education (IHE) and a two- year community college or tribal college. This partnership is designed to successfully implement the VR training Institute established in Priority 1. In addition, the partnership agreement required under Priority 2 provides a brief description of how the partnership will be managed, the partners' roles and responsibilities and a strategy for sustaining the partnership after the Federal investment ends.

As required by the Privacy Act of 1974, 5 U.S.C. 552a(e), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records currently entitled ``Patient Medical Record-VA'' (24VA10P2) as set forth in the Federal Register 77 FR 65938. VA is amending the system by revising the Routine Uses of Records Maintained in the System, Storage, and Safeguard. VA is republishing the system notice in its entirety.

The U.S. Nuclear Regulatory Commission (NRC) is considering an amendment to License No. 42-23539-01AF (Docket No. 030-28641) which authorizes the unrestricted release of Radioactive Waste Site RW-06 at Kirtland Air Force Base. The NRC has reviewed the Department of the Air Force's final status survey report and conducted an independent confirmatory survey of the site. The NRC concludes that the site meets the radiological criteria established in regulations for unrestricted use. The NRC plans to approve the final status survey report and issue an amendment to the license which allows Site RW-06 to be released for unrestricted use.

The Environmental Protection Agency (EPA or Agency) Office of External Affairs and Environmental Education (OEAEE) is issuing this notice to cancel the August 8, 2014 NEEAC Teleconference and reschedule it for August 21, 2014 from 3:00 p.m.-4:00 p.m. Eastern Time. Notice of the August 8, 2014 meeting was previously published on July 1, 2014: FR Doc 2014-15397 Filed 6-30-2014. The purpose of these teleconference(s), is to discuss specific topics of relevance for consideration by the council in order to provide advice and insights to the Agency on environmental education.

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 ``Faces of Impressionism: Portraits from the Mus[eacute]e d'Orsay,'' 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 Kimbell Art Museum, Fort Worth, Texas, from on or about October 19, 2014, until on or about January 25, 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.

The Environmental Protection Agency (EPA) Region 6 is issuing a Notice of Intent to Delete the Monroe Auto Equipment (Paragould Pit) Superfund Site (Site) located in Paragould, Greene County, Arkansas, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Arkansas, through the Arkansas Department of Environmental Quality have determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Immunogenicity Assessment for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, which may lead to serious or life-threatening adverse events for the patient or loss of efficacy of the product. This guidance is intended to assist manufacturers and clinical investigators in developing a risk-based approach in both the nonclinical and clinical phases of product development that will allow them to evaluate and reduce the likelihood that the immunogenicity of the product will cause harm to patients. This guidance finalizes the draft guidance issued in February 2013.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological ProductsConsiderations, Content, and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the Clinical Pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This revised draft guidance replaces the 2009 draft guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.''

The Food and Drug Administration (FDA) is announcing a public workshop regarding the clinical development of drugs for the prevention of serious infections caused by Staphylococcus aureus in the health care setting. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of clinical development of drugs to prevent Staphylococcus aureus infections including the design of clinical trials. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on September 5, 2014, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at the DoubleTree by Hilton Hotel Washington DC, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel's phone number is 301-589-5200. Contact Persons: Carole Miller or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6217, Silver Spring, MD 20993-0002, 301- 796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating is limited and will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to FDASTAPHWORKSHOP@fda.hhs.gov. Onsite registration the day of the workshop will be available, but advanced registration is preferred. Persons without access to the Internet can call 301-796-1300 to register. If you need a sign language interpreter or other special accommodations, please notify Carole Miller or Lori Benner (see Contact Persons) at least 7 days in advance.

The Food and Drug Administration (FDA) is correcting a final rule entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements'' that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with incorrect information regarding the availability of the International Conference on Harmonization's (ICH) data elements for postmarketing safety reports. The document also published with an incorrect statement regarding the impact of the final rule on small entities. This document corrects those errors.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide FDA's proposals for guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Evaluation of Automatic Class III Designation section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process. FDA is issuing this draft guidance to provide proposed updated recommendations for efficient interaction with FDA, including what information to submit when seeking a path to market for a novel device via the de novo process. This draft guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act to provide for the submission of de novos without a preceding premarket notification (510(k)) submission. This draft guidance is not final nor is it in effect at this time.

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of 3 individuals whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''

We propose to adopt a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 2000 and FALCON 2000EX airplanes. This proposed AD was prompted by a design review, which revealed that the forward servicing compartment (FSC) is configured with tie-down points. This proposed AD would require inspecting the FSC for installed tie-down points, and removing those tie-down points. We are proposing this AD to detect and correct installed tie-down points, which could lead to inadvertent use of the FSC as a cargo compartment, which could result in damage to the structure of the airplane or potential risk of fire.

FMCSA announces receipt of applications from 56 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will allow these individuals with ITDM to operate CMVs in interstate commerce.