The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Validation of GrowthBased Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products,'' dated February 2008. The draft guidance document provides manufacturers of cellular and gene therapy

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Hemoglobin Based Oxygen Carriers: Current Status and Future Directions. The purpose of the public workshop is to discuss the safety of hemoglobinbased oxygen carriers (HBOCs) as related to a variety of potential uses of these investigational products. We are

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Risk Communication Advisory Committee

General Function of the Committee: To provide advice and recommendations to the agency on effective risk communication.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of the draft Compliance Policy Guide (CPG) Sec. 555.320 Listeria monocytogenes (the draft CPG). The draft CPG provides guidance for FDA staff on the agency's enforcement policy for Listeria monocytogenes in readytoeat (RTE) foods that support growth of the organism and RTE

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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 ReadyTo Eat Foods'' (the draft Listeria guidance). This draft guidance, when finalized, will complement FDA's current good manufacturing practices (CGMP)

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a public meeting to discuss a Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes (the draft CPG) that provides guidance for FDA staff on the agency's enforcement policy for L. monocytogenes in ready toeat (RTE) foods that support growth of the organism and RTE foods that do not

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the animal drug regulations to correct an error in the indications for use for spectinomycin oral solution in swine. FDA is also amending the regulations for other oral dosage forms of spectinomycin to reflect a current format. These actions are being taken to improve the accuracy and readability

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Information Program on Clinical Trials for Serious and LifeThreatening Diseases: Maintaining a Databank'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The meeting of the Pulmonary-Allergy Drugs Advisory Committee scheduled for February 20, 2008, is cancelled. This meeting was announced in the Federal Register of December 21, 2007 (72 FR 72737).

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of tulathromycin injectable solution for the treatment of infectious bovine keratoconjunctivitis and the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of zilpaterol, monensin, and tylosin in threeway combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the regulation that establishes conditions under which overthecounter (OTC) skin protectant drug products are generally recognized as safe and effective (GRASE) and not misbranded. This amendment revises labeling requirements for OTC skin protectant drug products formulated and marketed as lip

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee, Center for Biologics Evaluation and Research (CBER), notify FDA in writing. A nominee may either be selfnominated or nominated

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Vaccines and Related Biological Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA is issuing this guidance to recommend approaches for determining whether a laboratory test may be

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration