The Food and Drug Administration (FDA) is staying the final monograph for overthecounter (OTC) sunscreen drug products that published in the Federal Register of May 21, 1999 (64 FR 27666). The final monograph established conditions under which OTC sunscreen drug products are generally recognized as safe and effective and not misbranded. This stay

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration is announcing a public meeting entitled ``Preparation for ICH Meetings in Brussels, Belgium, Including Progress on Implementation of the Common Technical Document (CTD)'' to solicit information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Brussels,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is correcting an extension of comment period for an advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of December 7, 2001 (66 FR 63519). The document gave notice that FDA is extending the comment period for the ANPRM that appeared in the Federal Register of August 10, 2001

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: Cardiovascular and Renal Drugs Advisory Committee.

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

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: PulmonaryAllergy Drugs Advisory Committee.

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

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 address for Phibro Animal Health.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending its regulations to remove references to certain room numbers that no longer are valid because the address of the Center for Food Safety and Applied Nutrition (CFSAN) changed to 5100 Paint Branch Pkwy., College Park, MD, on December 14, 2001. FDA also is amending its regulations to remove a

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability for comment of draft guidance for industry entitled ``Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora.'' This draft guidance is a revision of the guidance document no. 52 entitled ``Microbiological Testing of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is providing notice of a cooperative arrangement between the Department of Health and Human Services and the Department of Agriculture of the United States of America and the Secretariat of Health and the Secretariat of Agriculture, Livestock, Rural Development, Fish, and Food of the United Mexican States.

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: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA), Southwest Regional Small Business Program (Small Business Program), Office of Regulatory Affairs, in collaboration with FDA's Center for Food Safety and Applied Nutrition, the State of Missouri Department of Public Health, the Kansas City Department of Health and the Missouri Milk, Food and Environmental

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 ``Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications.'' This guidance is a second revision of the guidance entitled ``Major, Minor, FAX, and Telephone Amendments to Original Abbreviated New Drug Applications.'' FDA's

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Exemptions from the Warning Label Requirement for JuiceRecommendations for Effectively Achieving a 5Log Reduction.'' This draft document is intended to provide guidance to fruit and vegetable juice producers about FDA's revised

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below 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 providing an opportunity for interested persons to submit comments and suggestions on the contents of a guidance document that FDA is considering drafting on the labeling of reprocessed single use devices (SUDs) with respect to the name of the original equipment manufacturer (OEM) and the remanufacturer

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is issuing a final rule that establishes the notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States. These regulations implement recent changes in the statutory

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: Oncologic Drugs Advisory Committee.

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

Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) currently entitled ``Filth from Insects, Rodents, and Other Pests in Food.'' The purpose of this draft CPG is to revise, clarify, and redefine existing guidance on the interpretation of filth in foods within the context of current

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 9B4680) proposing that the food additive regulations be amended to provide for the expanded safe use of 5,7bis(1,1
dimethylethyl)3hydroxy2(3H)benzofuranone, reaction products with o xylene as an antioxidant

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#142) entitled ``Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)'' (VICH GL29). This draft guidance has been developed by the International Cooperation on Harmonisation of Technical

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Integration of DoseCounting Mechanisms into MDI Drug Products.'' This draft guidance makes recommendations to manufacturers to incorporate dosecounters into metereddose inhalers (MDIs) being developed for the treatment of lung

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies.'' This guidance updates a notice of availability entitled ``Potassium Iodide as a Thyroid Blocking Agent in a Radiation Emergency: Final Recommendations on Use'' published in the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is seeking volunteers to participate in a pilot project involving the testing of the Patient Profile Viewer (PPV). The PPV is computer software that allows a reviewer to display data collected from case report tabulations (CRTs) submitted in electronic format.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration