July 2, 2013 – Federal Register Recent Federal Regulation Documents

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

The Coast Guard is establishing a temporary safety zone on the waters of Green Bay near Menominee, MI. This safety zone is intended to restrict vessels from a portion of Green Bay due to a fireworks display. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with the fireworks display.

This is a Notice of the Presidential declaration of a major disaster for the State of Alaska (FEMA-4122-DR), dated 06/25/2013. Incident: Flooding. Incident Period: 05/17/2013 through 06/11/2013. Effective Date: 06/25/2013. Physical Loan Application Deadline Date: 08/26/2013. Economic Injury (EIDL) Loan Application Deadline Date: 03/25/2014.

This is a notice of an Administrative declaration of a disaster for the State of California dated 06/25/2013. Incident: Powerhouse Fire. Incident Period: 05/30/2013 through 06/11/2013. Effective Date: 06/25/2013. Physical Loan Application Deadline Date: 08/26/2013. Economic Injury (EIDL) Loan Application Deadline Date: 03/25/2014.

The U.S. Integrated Ocean Observing System Program Office, which the National Oceanic and Atmospheric Administration (NOAA) is the lead agency for, proposes rules to implement provisions of the Integrated Coastal and Ocean Observation System Act of 2009 (ICOOS Act). Among other things, the ICOOS Act directs the Interagency Ocean Observation Committee (IOOC) to develop and approve certification criteria and procedures for integrating regional information coordination entities (RICEs) into the National Integrated Coastal and Ocean Observation System (System). This proposed rule would accomplish that goal. This rule also implements the provisions of the ICOOS Act establishing that certified entities integrated into the System are, for the purposes of determining liability arising from the dissemination and use of observation data, considered part of NOAA and therefore their employees engaged in the collection, management, and dissemination, of observation data in the System receive the same tort protections for use of that data as Federal employees.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS intends to conduct with State-based Administering Entities (AEs). Under this CMP CMS will disclose certain information to the State-based AEs within the Health Insurance Exchanges Program. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed matching program, CMS invites comments on all portions of this notice. See ``Effective Dates'' section below for comment period.

The Coast Guard is establishing a temporary safety zone on the navigable waters of the Chesapeake Bay in Hampton, VA to support the Fort Monroe Fireworks. This action is intended to restrict vessel traffic movement in the specified area in order to protect the life and property of the maritime public and spectators from the hazards associated with fireworks displays.

The Coast Guard will enforce the safety zone for the Independence Day Fireworks, Kings Beach, CA in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).

The Coast Guard will enforce the safety zone for the ``Lights on the Lake'' Fourth of July Fireworks display, South Lake Tahoe, CA in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).

The Coast Guard will enforce the safety zone for the Hilton Fourth of July Fireworks in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).

The Coast Guard has issued a temporary deviation from the operating schedule that governs three Seattle Department of Transportation (SDOT) bridges: The Ballard Bridge, mile 1.1, the Fremont Bridge, mile 2.6, and the University Bridge, mile 4.3, all crossing the Lake Washington Ship Canal at Seattle, WA. The deviation is necessary to accommodate heavier than normal roadway traffic associated with a fireworks display over Lake Union. This deviation allows the bridges to remain in the closed position immediately prior to until immediately after the fireworks display.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' dated July 2013. The draft guidance document provides sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Interstate Shellfish Dealer's Certificate'' 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 announcing that a collection of information entitled ``Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the responses to public comments and decisions of the National Institutes of Health (NIH) regarding the use of chimpanzees in research. In February 2012, the NIH charged a working group of the Council of Councils, a federal advisory committee, to provide advice on implementing recommendations made by the Institute of Medicine (IOM) Committee on the Use of Chimpanzees in Biomedical and Behavioral Research in its 2011 report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity. On January 22, 2013, the NIH Council of Councils (Council) accepted recommendations presented by the Working Group on the Use of Chimpanzees in NIH-Supported Research and provided these recommendations to the NIH. The NIH subsequently issued a request for comments to obtain broad public input on the 28 Council recommendations that the NIH is considering as it determines how to implement the IOM Committee's recommendations. This notice summarizes the comments received in response to the request for comments and announces the agency's decisions with respect to the Council recommendations. The NIH plans to prepare subsequent procedural guidance and technical assistance, as appropriate, to implement some of these decisions. Investigators should continue to follow existing guidance (see NOT-OD-12-025 at https://grants.nih.gov/grants/guide/ notice-files/NOT-OD-12-025.html) regarding the submission of applications, proposals, or protocols for research involving chimpanzees until the NIH announces the procedural guidance.

The Food and Drug Administration (FDA) is correcting a proposed order that appeared in the Federal Register of June 12, 2013 (78 FR 35173). The document proposed to reclassify stair-climbing wheelchairs. The document was published with typographical errors in the DATES section of the document. This document corrects those errors.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a revision of a currently approved collection for State agency Supplemental Nutrition Assistance Program (SNAP), administrative matters. FNS plans to develop and launch an electronic workflow system, SNAP Workflow Information Management (SWIM), to streamline FNS waiver processing, the current waiver request form will be transposed to an online waiver request form. The online version of the request form does not modify the currently approved burden hours in any way, but changes the method of collection for this information.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria).