Department of Health and Human Services February 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not include medical device data systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be exempt from the premarket notification requirements when it is indicated for use only by a healthcare professional and does not perform irreversible data compression.

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing colchicine for injection (hereinafter ``colchicine for injection products''), and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce. All colchicine for injection products are administered intravenously. Colchicine is associated with a variety of serious adverse events, some of them potentially fatal. Furthermore, a narrow margin of safety exists between a therapeutic dose of colchicine and a toxic dose of the drug. Colchicine for injection products are new drugs that require approved applications because they are not generally recognized as safe and effective. Manufacturers who wish to market a colchicine for injection product must obtain FDA approval of a new drug application (NDA).

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To- Eat Foods'' (the draft Listeria guidance). This draft guidance, when finalized, will complement FDA's current good manufacturing practices (CGMP) regulations by providing specific guidance on the control of L. monocytogenes in the processing of refrigerated or frozen ready-to-eat foods (RF-RTE foods). The draft Listeria guidance and the CGMP regulations are intended to assist processors in controlling L. monocytogenes in the food processing environment during the manufacture of RF-RTE foods.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Fish and Fisheries Products Hazards and Controls Guidance, Third Edition June 2001: Letter to Seafood Processors that Purchase Grouper, Amberjack and Related Predatory Reef Species Captured in the Northern Gulf of Mexico.'' The guidance sets forth the agency's recommendations for ensuring the safety of grouper, amberjack, and related predatory reef species captured in the northern Gulf of Mexico with respect to ciguatera fish poisoning (CFP). The guidance is in response to recent cases of CFP that have occurred in the United States.

This notice announces a solicitation for up to six additional hospitals to participate in the Rural Community Hospital Demonstration Program for the remainder of the 5-year time period allowed by section 410A of the MMA that is currently scheduled to end in 2010.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Institutes of Health (NIH). This MOU establishes the terms of collaboration between the two Federal agencies to develop a unified Federal approach to adverse event (AE) reporting. Specifically, FDA and NIH will collaborate in development of a project that will result in a web-based method for consumers, health professionals, investigators, sponsors, and other parties to electronically submit AE reports. The project includes the development of at least two products: (1) A Rational Questionnaire, an interactive help system that will assist reporters of information in determining what specific data need to be submitted and to whom, and (2) a prototype to test the feasibility of a central, Federal web-based portal to provide direct, seamless, online submission of adverse event reports to appropriate agencies.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 26, 2007 (Vol. 72, No. 226, p. 65969) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Questionnaire Cognitive Interview and Pretesting. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of the data collection is to conduct cognitive interviews, focus groups, Pilot household interviews, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common evaluation method is the cognitive interview, in which a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews. When possible, cognitive interviews are conducted in the survey's intended mode of administration. Cognitive interviewing provides useful information on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. There are no costs to respondents other than their time. Frequency of Response: Once. Affected Public: Individuals or households.