Department of Health and Human Services May 10, 2006 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry; Process for Handling Pediatric Referrals to FDA: Additional Safeguards for Children in Clinical Investigations.'' This guidance is intended to assist clinical investigators, institutional review boards (IRBs), sponsors, and other interested parties in understanding FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. The draft guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under these regulations and in reaching final determinations in accordance with these regulations.
Food Safety and Defense Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas and the Mid-Continental Association of Food and Drug Officials, is announcing a public workshop entitled ``Food Safety and Defense Workshop.'' This public workshop is intended to provide information about current Good Manufacturing Practice regulations for foods, Hazard Analysis Critical Control Point (HACCP), food defense awareness, and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on June 6 and 7, 2006, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Continuing Education Center in Fayetteville, AR, located downtown (2 East Center St.). Accommodations: There are many lodging choices in the area, but the Radisson Hotel in Fayetteville (479-442-5555) is immediately adjacent to the Continuing Education Center. Contact: Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-4221, FAX: 479-575-2165, or e-mail: seideman@uark.edu. You may also contact David Arvelo, Food and Drug Administration, 4040 N Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: david.arvelo@fda.hhs.gov. Registration: Registration by May 28, 2006, is encouraged. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Please submit your registration as soon as possible. Those accepted into the course will receive confirmation. Registration at the site is not guaranteed, but may be possible on a space-available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200, payable to ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the form available online at https://www.mcafdo.org/ or the registration form in this document and submit along with a check or money order for $150 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
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