Department of Health and Human Services October 3, 2011 – Federal Register Recent Federal Regulation Documents
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Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is proposing to amend and republish the list as required by the Bioterrorism Response Act. Further, on July 2, 2010, the President signed Executive Order 13546, ``Optimizing the Security of Biological Select Agents and Toxins in the United States'' that directed the Secretaries of HHS and Agriculture (USDA) to designate a subset of the select agents and toxins list (Tier 1) that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence; explore options for graded protection for these Tier 1 agents and toxins to permit tailored risk management practices based upon relevant contextual factors; and consider reducing the overall number of agents and toxins on the select agents and toxins list. E.O. 13546 also established the Federal Experts Security Advisory Panel (FESAP) to advise the HHS and USDA Secretaries on the designation of Tier 1 agents and toxins, reduction in the number of agents on the Select Agent List, establishment of suitability standards for those having access to Tier 1 select agents and toxins, and establishment of physical security and information security standards for Tier 1 select agents and toxins. The tiering of the select agents and toxins list will allow the application of more optimized security measures for those select agents or toxins which pose a higher risk to public health and safety should they be stolen or otherwise misused. In addition to addressing the FESAP recommendations in this Notice of Proposed Rulemaking (NPRM), we are also proposing to add two agents, Lujo and Chapare viruses to the list; adding definitions; and clarifying language concerning security, training, biosafety, and incident response. These changes will increase the usability of the select agents and toxins regulations as well as providing for enhanced program oversight.
Notice of Intent To Prepare an Environmental Impact Statement
In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (HHS), is issuing this notice to advise the public that an environmental impact statement will be prepared for the NIH Animal Center at Poolesville Master Plan, Poolesville, Montgomery County, Maryland. For Further Information Contact: Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775; fax 301-480-8056; or e-mail nihnepa@mail.nih.gov. Supplementary Information: The NIH Animal Center is located on 513 acres 4 miles southwest of the City of Poolesville, a small agricultural community located in western Maryland. The campus is a component of the National Institutes of Health (NIH), one of the world's largest biomedical research facilities and the Federal government's focal point for medical and behavioral research. The NIH Animal Center at Poolesville is a major extension of animal holding and production facilities at Bethesda and consists of a number of buildings used to house, quarantine, and study the behavior and immunological conduct of a variety of animal models. The NIH Animal Center at Poolesville conducts and supports research protocols for various Institutes and Centers, which includes the studies of animal behavior, conduct of immunologic procedures and sampling, and surgical investigation. Total building space on the campus amounts to approximately 364,507 gsf. Approximately 199 people work at the NIH Animal Center site. A Master Plan is an integrated series of documents that present in graphic, narrative, and tabular form the current composition of NIH campuses and the plan for their orderly and comprehensive development over a 20-year period. The plan provides guidance in coordinating the physical development of NIH campuses, including building locations, utility capacities, road alignments, parking facilities, and the treatment of open spaces. General design guidelines are also used to provide detailed guidance for the placement and design of physical improvements. The proposed action is to develop a long-range physical master plan for the NIH Animal Center. The plan will cover a 20-year planning period and address the future development of the NIH Animal Center site, including placement of future construction; vehicular and pedestrian circulation on- and off-campus; parking within the property boundaries; open space in and around the campus; required setbacks; historic properties; natural and scenic resources; noise; and lighting. The plan will examine potential growth in the NIH Animal Center personnel, and consequent construction of space over the planning period. Future construction on the site could include such facilities as: new animal holding, research laboratories, and support facilities. In accordance with 40 CFR 1500-1508 and DHHS environmental procedures, NIH will prepare an Environmental Impact Statement (EIS) for the proposed master plan. The EIS will evaluate the impacts of the master plan should development occur as proposed. Among the items the EIS will examine are the implications of the master plan on community infrastructure, including, but not limited to, utilities, storm water management, traffic and transportation, and other public services. To ensure that the public is afforded the greatest opportunity to participate in the planning and environmental review process, the NIH is inviting oral and written comments on the master plan and related environmental issues. The NIH will be sponsoring a public Scoping Meeting to provide individuals an opportunity to share their ideas on the master planning effort, including recommended alternatives and environmental issues the EIS should consider. The meeting is planned for 6:30 p.m. to 9 p.m. on October 25, 2011 at the Town Hall Building at 19721 Beall Street, Poolesville, Maryland 20837. All interested parties are encouraged to attend. The NIH has established a 30-day public comment period for the scoping process. Scoping comments must be postmarked no later than November 18, 2011 to ensure they are considered. All comments and questions on the EIS should be directed to Valerie Nottingham at the address listed above, telephone 301-496-7775; fax 301-480-8056; or e- mail nihnepa@mail.nih.gov.
Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA is issuing this draft guidance to provide updated recommendations for efficient interaction with FDA, including what information to submit, when seeking a path to market for a novel device via the de novo process. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Comprehensive Primary Care Initiative
This notice announces a solicitation for health care payer organizations to participate in the Comprehensive Primary Care initiative (CPC), a multipayer model designed to improve primary care.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
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