July 15, 2008 – Federal Register Recent Federal Regulation Documents

The Department of Energy (DOE) Office of Environmental Management (EM), and the National Nuclear Security Administration (NNSA), will co-sponsor a Suppliers Outreach event for suppliers interested in providing service and products in the nuclear sector.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 9) issued by the presiding administrative law judge (``ALJ'') extending the target date in the above-captioned investigation to September 14, 2009.

This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 3 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacturer of products distributed within the United States.

This document amends the Department of Veterans Affairs (VA) adjudication regulations regarding eligibility verification reports for certain parents receiving dependency and indemnity compensation. This amendment is necessary to conform the regulation to statutory provisions.

In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an IHA to BP Exploration (Alaska), Inc. (BPXA) to take, by harassment, small numbers of six species of marine mammals incidental to a 3D, ocean bottom cable (OBC) seismic survey in the Liberty Prospect, Beaufort Sea, Alaska during July and August, 2008.