Department of Health and Human Services February 2007 – Federal Register Recent Federal Regulation Documents
Results 251 - 269 of 269
Regulatory Site Visit Training Program
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
University of Arkansas/Food and Drug Administration Food Labeling Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled ``UA/FDA Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on April 10, 2007, from 8 a.m. to 5 p.m., and on April 11, 2007, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253- 4970, or e-mail: david.arvelo@fda.hhs.gov. For information on accommodation options, 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. Registration: You are encouraged to register by March 23, 2007. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. 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 following form 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.
Guidance for Industry; Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.'' The guidance document describes a means by which a cord blood processing system and storage container may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying a cord blood processing system and storage container into class II (special controls). This guidance document is immediately in effect as the special control for this device, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled ``Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.'' FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infectious Disease in Xenotransplantation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infectious Disease in Xenotransplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2008: Proposed Annual Payment Rate Updates, and Policy Changes; and Proposed Hospital Direct and Indirect Graduate Medical Education Policy Changes
This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed payment amounts and factors used to determine the updated Federal rates that are described in this proposed rule were determined based on the LTCH PPS rate year July 1, 2007 through June 30, 2008. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and would continue to be effective each October 1. The proposed outlier threshold for July 1, 2007, through June 30, 2008, would also be derived from the LTCH PPS rate year calculations. We are also proposing to make policy changes which include proposed revisions to the GME and IME policies. In addition, we are adding a technical amendment correcting the regulations text at Sec. 412.22.
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