January 7, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 104
Back Bay National Wildlife Refuge, City of Virginia Beach, VA; Final Comprehensive Conservation Plan and Finding of No Significant Impact for Environmental Assessment
We, the U.S. Fish and Wildlife Service (Service), announce the availability of our final comprehensive conservation plan (CCP) and finding of no significant impact (FONSI) for the environmental assessment (EA) for Back Bay National Wildlife Refuge (NWR). In this final CCP, we describe how we will manage this refuge for the next 15 years.
New Postal Product
The Commission is noticing a recently-filed Postal Service request to add Priority Mail Contract 34 to the competitive product list. This notice addresses procedural steps associated with this filing.
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the draft guidance. This draft guidance is a revision of the draft guidance for industry of the same title published on December 16, 2008.
Security Zone; 23rd Annual North American International Auto Show, Detroit River, Detroit, MI
The Coast Guard is establishing a temporary security zone on the Detroit River, Detroit, Michigan. This zone is intended to restrict vessels from a portion of the Detroit River in order to ensure the safety of participants, visitors and public officials at the 23rd Annual North American International Auto Show (NAIAS) being held at Cobo Hall in downtown Detroit, MI.
Application for Recertification of Prince William Sound Regional Citizens' Advisory Council
The Coast Guard announces the availability of, and seeks comments on, the application for recertification submitted by the Prince William Sound Regional Citizen's Advisory Council (PWSRCAC) for March 1, 2011, through February 29, 2012. Under the Oil Terminal and Tanker Environmental Oversight Act of 1990, the Coast Guard may certify on an annual basis, an alternative voluntary advisory group in lieu of a Regional Citizens' Advisory Council for Prince William Sound, Alaska. This advisory group monitors the activities of terminal facilities and crude oil tankers under the Prince William Sound program established by the statute. The current certification for PWSRCAC will expire February 28, 2011.
Standard on Powered Platforms for Building Maintenance; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
OSHA solicits public comments concerning its proposal to extend OMB approval of the information collection requirements specified in its Standard on Powered Platforms for Building Maintenance (29 CFR 1910.66).
Modifications of Debt Instruments
This document contains final regulations relating to the modification of debt instruments. The regulations clarify the extent to which the deterioration in the financial condition of the issuer is taken into account to determine whether a modified debt instrument will be recharacterized as an instrument or property right that is not debt. The regulations provide needed guidance to issuers and holders of debt instruments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey
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 FDA's Health and Diet Survey.
Property Traded on an Established Market
This document contains proposed regulations relating to determining when property is traded on an established market (that is, publicly traded) for purposes of determining the issue price of a debt instrument. The regulations amend the current regulations to clarify the circumstances that cause property to be publicly traded. The regulations provide needed guidance to issuers and holders of debt instruments. This document also provides a notice of a public hearing on these proposed regulations.
Guidance on Reporting Interest Paid to Nonresident Aliens
This document contains proposed regulations that provide guidance on the reporting requirements for interest on deposits maintained at U.S. offices of certain financial institutions and paid to nonresident alien individuals. These proposed regulations affect persons making payments of interest with respect to such deposits. This document also provides a notice of public hearing on these proposed regulations and withdraws the notice of proposed rulemaking published on August 2, 2002 (67 FR 50386).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA's recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection.
Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Determination of System Attributes for the Tracking and Tracing of Prescription Drugs.'' This public workshop is intended to provide a forum for discussing potential approaches toward a track and trace system and obtaining input from supply chain partners on attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages, and to further the Agency's goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.
FDA Transparency Initiative: Improving Transparency to Regulated Industry
As part of the third phase of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The report includes 19 action items and 5 draft proposals to improve transparency to regulated industry. FDA is seeking public comment on the content of the draft proposals, as well as on which draft proposals should be given priority.
Proposed Information Collection; Comment Request; Monthly Retail Trade Survey
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Privacy Act System of Records Notice (11-001)
Each Federal agency is required by the Privacy Act of 1974 to publish a description of the systems of records it maintains containing personal information when a system is substantially revised, deleted, or created. In this notice, NASA provides the required information for a new Agency-wide Privacy Act system of records generated in the process of complying with NASA's anti-harassment procedural requirements governing the reporting, fact-finding and resolution of allegations of harassment reported to NASA by its employees and contractors. This new system of records will assist NASA in fulfilling its obligations pursuant to the Supreme Court cases of Burlington Industries v. Ellerth, 524 U.S. 742 (1998), and Faragher v. City of Boca Raton, 524 U.S. 775 (1998): (1) To prevent harassment before it becomes severe or pervasive; (2) to conduct a prompt, thorough, and impartial investigation into allegations of harassing conduct; and (3) to take immediate and appropriate corrective action when the Agency determines that harassing conduct has occurred.
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