August 2009 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to require notification of breaches of unsecured protected health information. Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA) that was enacted on February 17, 2009, requires HHS to issue interim final regulations within 180 days to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide notification in the case of breaches of unsecured protected health information. For purposes of determining what information is ``unsecured protected health information,'' in this document HHS is also issuing an update to its guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.

The Department of Homeland Security is issuing a final rule to amend its regulations to exempt portions of a Department-wide system of records entitled the ``Department of Homeland Security/ALL024 Facility and Perimeter Access Control and Visitor Management System of Records'' from certain provisions of the Privacy Act. Specifically, the Department exempts portions of the Department of Homeland Security/ ALL024 Facility and Perimeter Access Control and Visitor Management system from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

The Department of Homeland Security is issuing a final rule to amend its regulations to exempt portions of a Department-wide system of records entitled the ``Department of Homeland Security/ALL006 Accident Records System of Records'' from certain provisions of the Privacy Act. Specifically, the Department exempts portions of the Department of Homeland Security/ALL006 Accident Records system from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of proposed rulemaking to place the substance 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) and its salts into schedule I of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized as proposed, this action would impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribution, dispensing, importation, exportation, and possession of 5-MeO-DMT.

EPA is withdrawing two significant new use rules (SNURs) promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for chemical substances which were the subject of premanufacture notices (PMNs), i.e., multi-walled carbon nanotubes (PMN P-08-177) and single-walled carbon nanotubes (PMN P-08- 328). These chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. EPA published the SNURs using direct final rulemaking procedures. EPA received a notice of intent to submit adverse comments on these rules. Therefore, the Agency is withdrawing these SNURs, as required under the expedited SNUR rulemaking process. EPA also intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.

The Coast Guard proposes to establish a temporary safety zone for the Ocean City Beachfront Air Show, an aerial demonstration to be held over the waters of the Atlantic Ocean adjacent to Ocean City, New Jersey. This Safety Zone is necessary to provide for the safety of life on navigable waters during the event. This proposed action would temporarily restrict vessel traffic in portions of the Atlantic Ocean adjacent to Ocean City, New Jersey during the aerial demonstration.

The United States Department of Agriculture (USDA), through the Commodity Credit Corporation (CCC), published in the Federal Register of January 21, 2009, an interim final rule with request for comment amending the program regulations for the Grassland Reserve Program (GRP) to incorporate programmatic changes authorized by the Food, Conservation, and Energy Act of 2008 (2008 Act) using Regulation Identification Number (RIN) 0578-AA38. This amendment to the January 21, 2009, interim final rule corrects the RIN to read 0578-AA53, clarifies the nature of the contingent right of enforcement, expands its discussion regarding GRP policy for wind and solar power facilities, and requests comment on how GRP can be used to contribute to the Nation's efforts on energy, climate change, and carbon sequestration. Additionally, USDA seeks public input on the January 21, 2009, interim final rule, as amended. Therefore, USDA reopens the public comment period upon publication of this amendment until September 21, 2009.

The U.S. Office of Personnel Management is issuing a final rule to redefine the geographic boundaries of the Lake Charles- Alexandria and New Orleans, LA, appropriated fund Federal Wage System (FWS) wage areas. The final rule redefines Iberia and St. Martin Parishes, LA, from the New Orleans wage area to the Lake Charles- Alexandria wage area. These changes are based on consensus recommendations of the Federal Prevailing Rate Advisory Committee (FPRAC) to best match the counties proposed for redefinition to a nearby FWS survey area. FPRAC recommended no other changes in the geographic definitions of the Lake Charles-Alexandria and New Orleans wage areas.

The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting would improve the agency's process for collecting and analyzing postmarket medical device adverse event information. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. Elsewhere in this issue of the Federal Register, FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation. The proposal also includes modifications to the regulations specifying the content of required MDRs to better track information already solicited on the FDA Form 3500A.

This final rule revises the training, qualification, certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools. These changes are needed to clarify, update, and correct our existing regulations. These changes are intended to update and clarify the training and qualifications rules for pilots, flight instructors, ground instructors, and pilot schools to ensure a better understanding of these rules that relate to aircraft operations in the National Airspace System.

EPA is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Maryland on October 24, 2007 and June 30, 2008, except for the 2009 nitrogen oxides (NOX) ozone season and NOX annual allocations, the 2009 set-aside allocations and the Compliance Supplement Pool (CSP) allocations. These

The Commission has before it a petition for rulemaking filed by Louisiana Media Company, LLC (``Louisiana Media''), the licensee of station WVUE-DT, channel 8, New Orleans, Louisiana. Louisiana Media requests the substitution of its pre-transition digital channel 29 for its post-transition digital channel 8 at New Orleans.

The Securities and Exchange Commission is re-opening the comment period to the ``Amendments to Regulation SHO'' it proposed in Securities Exchange Act Release No. 59748 (Apr. 10, 2009), 74 FR 18042 (Apr. 20, 2009) (the ``Proposal''). As a supplement to our request for comment on the Proposal, we are soliciting additional feedback regarding an alternative price test, on which we solicited comment in the Proposal, that would allow short selling only at a price above the current national best bid (the ``alternative uptick rule''). We are publishing this supplemental request for comment and reopening the comment period to help ensure that the public has a full opportunity to provide comments on the alternative uptick rule.

The Coast Guard is withdrawing its notice of proposed rulemaking concerning the operation of the SR 23 bridge across the Gulf Intracoastal Waterway (Algiers Alternate Route), mile 3.8, at Belle Chasse, Plaquemines Parish, Louisiana. The notice of proposed rulemaking proposed to allow the bridge to remain closed-to-navigation for an additional 90 minutes during weekday afternoons to facilitate the movement of vehicular traffic.

In a proposed rule published in the Federal Register on July 2, 2009, the Federal Maritime Commission proposed to repeal the exemption from the 45-day waiting period requirement applicable to certain Marine Terminal Agreements. The Commission also proposed to correct a typographical error in its regulations. This document extends the comment period.

The staff grants a rulemaking petition filed by Sunburst Media-Louisiana, LLC, by substituting FM Channel 230A for vacant Channel 242A at Dulac, Louisiana. The reference coordinates for Channel 230A at Dulac are 29-20-37 NL and 90-45-16 WL.

The Commission has before it a petition for rulemaking filed by WLS Television, Inc. (``WLS''), the licensee of station WLS-TV, DTV channel 7, Chicago, Illinois. WLS-TV requests the substitution of transition DTV channel 44 for its post-transition DTV channel 7 at Chicago.

EPA is proposing to approve state implementation plan revisions submitted by the State of California on June 5, 2009 relating to the State's basic and enhanced vehicle inspection and maintenance (I/M) program. EPA is also proposing to find, with two exceptions, that California's program meets the requirements of the Clean Air Act and EPA regulations for basic and enhanced I/M programs. EPA is making the proposed approval contingent upon California's submittal of revisions

EPA is proposing a limited approval and limited disapproval of revisions to the San Joaquin Valley Unified Air Pollution Control District portion of the California State Implementation Plan. These revisions concern a local fee rule that applies to major sources of volatile organic compound and nitrogen oxide emissions within the San Joaquin Valley ozone nonattainment area. We are proposing action on a local rule that regulates these emission sources under the Clean Air Act as amended in 1990. We are taking comments on this proposal and plan to follow with a final action.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: It was reported that after commanding the landing gear lever to down the three green landing gear positioning indication was displayed followed by the LG/LEVER DISAGREE EICAS [engine indicating and crew alerting system] message. The crew decided to continue the approach and landing procedure. As soon as the crew identified that the landing gear was not extended properly, a go-around procedure was successfully performed. During maneuver, the airplane settled momentarily onto the flaps and belly.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: It has been found the occurrence of corrosion on the Auxiliary Power Unit (APU) mounting rods that could cause the APU rod to break, affecting the APU support structure integrity.

The Department of Homeland Security (DHS) proposes to amend its regulations by rescinding the amendments promulgated on August 15, 2007, and October 28, 2008, relating to procedures that employers may take to acquire a safe harbor from receipt of no-match letters. Implementation of the 2007 final rule was preliminarily enjoined by the United States District Court for the Northern District of California on October 10, 2007. After further review, DHS has determined to focus its enforcement efforts relating to the employment of aliens not authorized to work in the United States on increased compliance through improved verification, including participation in E-Verify, ICE Mutual Agreement Between Government and Employers (IMAGE), and other programs.

The Commander, Eighth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Chatsworth Road Bridge across the Franklin Canal, mile 4.8, at Franklin, St. Mary Parish, Louisiana. This deviation will test a change to the operating schedule to determine whether a permanent change to the schedule is needed. It will allow the bridge to remain unmanned during most of the day by requiring a one-hour notice for an opening of the draw.

The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Hamilton Avenue Bridge across the Gowanus Canal, mile 1.2, at Brooklyn, New York. Under this temporary deviation the bridge shall require a four-hour advance notice for bridge openings for three months to facilitate bridge maintenance. Vessels that can pass under the draw without a bridge opening may do so at all times.

This regulation establishes an exemption from the requirement of a tolerance under 40 CFR 180.920 for residues of 1,2-ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No. 31075-24-8) when used as an inert ingredient in pesticide formulations applied to cotton or wheat crops only. Buckman Laboratories International, Inc submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1,2- ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2- chloroethane].