The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in foodproducing animals. We are issuing this order based on evidence that extralabel use of these drugs in foodproducing animals will likely cause an adverse event in humans and, as such, presents a risk to the public

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is seeking volunteers from pharmaceutical companies to participate in a pilot
[[Page 37973]]
program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, consistent with the principles of quality by design and risk

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is correcting a document announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6A3958) that appeared in the Federal Register of June 20, 2008. FDA is correcting the addresses of both Pfizer, Inc., and Danisco USA, Inc.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Designation as Country not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle'' has been approved by the Office of Management and Budget (OMB)

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 and to allow 60 days

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing [[Page 37466]]
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), Office of Regulatory Affairs (ORA), Division of FederalState Relations (DFSR) is announcing the availability of grant funds for the support of innovative food defense projects. These grants are available to State, local, and tribal levels and must have national implication or application that can enhance

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a Request for Application (RFA) Number RFAFD08004 and its intention to receive and consider a new sole source application for the award of a cooperative agreement in fiscal year 2008 (FY 2008) to establish and support the Western Center for Food Safety (WCFS). The WCFS will be located at the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

I. Research Objectives

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of FederalState Relations (DFSR) in collaboration with the Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), is announcing the availability of an Agreement of Limited Competition. Only States

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of the information technology (IT) Plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan'' to achieve the objectives defined in the PDUFA Performance Goals. This plan is intended to provide regulated industry and other stakeholders with

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 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 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 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 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

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: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.'' The guidance explains FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for

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 Fort Dodge Animal Health, A Division of Wyeth Holdings Corp. The supplemental NADA provides for a revised food safety warning statement for oral use of sulfachlorpyridazine in the milk or

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 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 amending its regulations to implement a nomenclature change and to ensure accuracy and clarity in the agency's regulations.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's drug labeler code for ADM Alliance Nutrition, Inc. This action is being taken to improve the accuracy of the regulations.

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) has determined the regulatory review period for ERAXIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a
[[Page 35143]]
future filing, of a food additive petition (FAP 6A3958) proposing that the food additive regulations be amended to provide for the safe use of alitame as a sweetening agent or flavoring in food.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration