2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.

The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87) addresses notification procedures for designated officers, medical facilities, and State and community public health officers regarding exposure of emergency response employees (EREs) to potentially life-threatening infectious diseases. The Secretary of Health and Human Services (Secretary) has delegated authority to the Director of the Centers for Disease Control and Prevention (CDC) to issue a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which EREs may be exposed in responding to emergencies (including a specification of those infectious diseases that are routinely transmitted through airborne or aerosolized means); guidelines describing circumstances in which employees may be exposed to these diseases; and guidelines describing the manner in which medical facilities should make determinations about exposures. CDC is seeking comment on the list of diseases and guidelines contained in this notice.

Pursuant to Section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969, the Council on Environmental Quality Final Regulations (40 CFR Parts 1500 through 1508), and the United States Section`s Operational Procedures for Implementing Section 102 of NEPA, published in the Federal Register September 2, 1981, (46 FR 44083); the USIBWC hereby gives notice of availability of the Final Environmental Assessment and FONSI for Arroyo Colorado South Levee Rehabilitation Project located in Cameron and Hidalgo Counties, Texas are available. An environmental impact statement will not be prepared.

In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on a new information collection for the National Pipeline Registry. PHMSA is preparing to request Office of Management and Budget (OMB) approval for a new information collection.

Notice is hereby given that the U.S. International Trade Commission has determined to extend the deadline for filing submissions on remedy, the public interest, and bonding in the above-captioned investigation.

Currently, a security index futures contract traded on, or subject to the rules of, a foreign board of trade may be offered or sold to persons located within the United States pursuant to a staff no-action letter confirming that the contract satisfies the requirements enumerated in Section 2(a)(1)(C)(ii) of the Commodity Exchange Act (the ``CEA'' or ``Act''). The Commodity Futures Trading Commission (``Commission'') is hereby proposing new requirements which would establish a Commission certification procedure applicable to the offer or sale, to persons in the U.S., of a security index futures contract traded on a foreign board of trade; the new certification procedure will replace the existing staff no-action process. Additionally, this proposed rule would establish a procedure for a foreign board of trade to request and receive a Commission certification on an expedited basis. Under this expedited procedure, a security index futures contract of qualifying foreign boards of trade could be offered or sold in the U.S. forty-five (45) days after submission of such request, absent a contrary action (or an extension of time) by the Commission.

This document is issued under the joint authority of the Secretary of Defense, the Administrator of General Services and the Administrator of the National Aeronautics and Space Administration. This Small Entity Compliance Guide has been prepared in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of rules appearing in Federal Acquisition Circular (FAC) 2005-47, which amend the FAR. An asterisk (*) next to a rule indicates that a regulatory flexibility analysis has been performed. Interested parties may obtain further information regarding these rules by referring to FAC 2005-47, which precedes this document. These documents are also available via the Internet at http:/ /www.regulations.gov.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have adopted as final, with changes, the interim rule amending the Federal Acquisition Regulation (FAR) to implement section 866 of the Duncan Hunter National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2009, which applies to executive agencies other than DoD. DoD is subject to section 852 of the John Warner NDAA for FY 2007, which is also implemented in this final rule. Section 866 requires the Councils to amend the FAR, and section 852 requires the Secretary of Defense to prescribe regulations to minimize excessive pass-through charges by contractors from subcontractors, or from tiers of subcontractors, that add no or negligible value, and to ensure that neither a contractor nor a subcontractor receives indirect costs or profit/fee (i.e., pass-through charges) on work performed by a lower-tier subcontractor to which the higher-tier contractor or subcontractor adds no or negligible value.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) are issuing an interim rule amending the Federal Acquisition Regulation (FAR) to incorporate changes made by the Small Business Administration (SBA) to its Small Disadvantaged Business (SDB) Program.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) are issuing a final rule amending the Federal Acquisition Regulation (FAR) to implement revisions to the Small Business Administration's HUBZone Program. This case requires that, for award of a HUBZone contract, a HUBZone small business concern must be a HUBZone small business concern both at the time of its initial offer and at the time of contract award. In addition, for general construction or construction by special trade contractors, a HUBZone small business concern must spend at least 50 percent of the cost of contract performance incurred for personnel on its own employees or subcontract employees of other HUBZone small business concerns. The 50 percent requirement may be waived in some circumstances.

This document summarizes the Federal Acquisition Regulation (FAR) rules agreed to by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) in this Federal Acquisition Circular (FAC) 2005-47. A companion document, the Small Entity Compliance Guide (SECG), follows this FAC. The FAC, including the SECG, is available via the Internet at https://www.regulations.gov.

This document is a request for comments regarding the recently released PCAST report and its implications for the nation's health information technology (HIT) agenda and ONC's implementation of the Health Information Technology for Economic and Clinical Health Act (HITECH Act).