April 22, 2016 – Federal Register Recent Federal Regulation Documents

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA 95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. This notice utilizes standard clearance procedures in accordance with the Paperwork Reduction Act of 1995 and 5 CFR 1320.12.

NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this reinstatement of a previously approved collection, as required by Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). The purpose of this notice is to allow for 60 days of public comment. NCUA is soliciting comments on the reinstatement of the information collection described below.

The Food and Drug Administration (FDA) has determined the regulatory review period for LUZU 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). FDA had announced a 1-day public hearing for April 13, 2016, to obtain input on the guidances, but on February 29, 2016, announced that due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, the hearing was postponed. FDA also stated its intent to extend the comment period for the four draft guidance documents and to schedule a scientific workshop to identify and discuss the scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell-based products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the HHS Secretary declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements for firms that intend to export certain unapproved medical devices.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance documents entitled ``Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry''; ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff''; ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry''; and ''Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' The Agency is taking this action to allow interested persons additional time to submit comments and any new information.

The North Pacific Fishery Management Council (Council) Crab Plan Team (CPT) will meet May 9, 2016 through May 12, 2016.

The Fishlake Resource Advisory Committee (RAC) will meet in Richfield, Utah. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: https://cloudapps-usda-gov.force.com/ FSSRS/RAC_Page?id=001t0000002JcvHAAS.

NASA is proposing to amend the NASA Federal Acquisition Regulation Supplement (NFS) to clarify NASA's award fee process by incorporating terms used in award fee contracting; guidance relative to final award fee evaluations; release of source selection information; and the calculation of the provisional award fee payment percentage in NASA end-item award fee contracts.

The Fishlake Resource Advisory Committee (RAC) will meet in Richfield, Utah. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: https://cloudapps-usda-gov.force.com/ FSSRS/RAC_Page?id=001t0000002JcvHAAS.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Arthur Kill (AK) Railroad Bridge across Arthur Kill, mile 11.6, between Staten Island, New York and Elizabeth, New Jersey. This deviation allows the bridge to remain in the closed position to facilitate bridge inspection.

U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Regulations Relating to Recordation and Enforcement of Trademarks and Copyrights (Part 133 of the CBP Regulations). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.

Notice is hereby given that the U.S. International Trade Commission has determined to extend the target date for completion of the above-captioned investigation until June 1, 2016. The Commission also requests briefing from the parties on the issues indicated in this notice.

These special conditions are issued for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. These airplanes will have a digital-systems network architecture composed of several connected networks that may allow access to or by external computer systems and networks, and may result in airplane electronic system- security vulnerabilities. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are issued for the Dassault Aviation (Dassault) Model Falcon 5X airplane. This airplane will have a novel or unusual design feature associated with go-around performance credit when using an automatic takeoff thrust-control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.