August 21, 2009 – Federal Register Recent Federal Regulation Documents

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.