Agency: Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013[FR Doc 05-22069] 101. Guidance for Industry and Food and Drug Administration Staff; Class II
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.'' This guidance document has been developed as a special control guidance document to support the classification of the low energy ultrasound wound cleaner into class II
Published: 2005-11-07 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21973] 102. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2005-11-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21974] 103. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of October 24, 2005 (70 FR 61455). The document announced an approval by the Office of Management and Budget. The document was published with an incorrect expiration date for OMB control number 09100345. This document corrects that error.
Published: 2005-11-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-22012] 104. Determination of Regulatory Review Period for Purposes of Patent Extension;
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 28, 2003 (68 FR 9690). The document announced that FDA had determined the regulatory review period for ZOMETA. A Request for Revision of Regulatory Review Period was filed for the product on May 4, 2005. FDA reviewed its records and
Published: 2005-11-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-22014] 105. Pediatric Advisory Committee; Notice of Meeting
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: Pediatric Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. The committee
Published: 2005-11-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-22013] 106. Advisory Committee on Special Studies Relating to the Possible Long-Term
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: Advisory Committee on Special Studies Relating
to the Possible LongTerm Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee).
Published: 2005-11-04 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21807] 107. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2005-11-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21808] 108. New Animal Drugs for Use in Animal Feeds; Melengestrol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of a melengestrol acetate Type A medicated article with monensin and tylosin Type A medicated articles to
Published: 2005-11-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21641] 109. Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel Paste
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 Virbac AH, Inc. The supplemental NADA provides revised labeling for ivermectin and praziquantel oral paste used in horses for the treatment and control of various internal parasites.
Published: 2005-11-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21774] 110. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2005-11-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21642] 111. Guidance for Industry: A Notice from the Food and Drug Administration to
The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``A Notice from the
Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on
Decontamination of Transport Vehicles.'' This guidance is intended to
provide information and
Published: 2005-11-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21493] 112. Oncologic Drugs Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 14, 2005 (70 FR 60094). The amendment is being made to reflect changes in the Agenda portion of the document. There are no other changes.
Published: 2005-10-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21525] 113. Prescription Drug User Fee Act; Public Meeting; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of October 18, 2005 (70 FR 60536). The document announced a public meeting on the Prescription Drug User Fee Act (PDUFA). The document was published with typographical errors in the DATES and FOR FURTHER INFORMATION CONTACT sections of the document. This
Published: 2005-10-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21524] 114. Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
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: Psychopharmacologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Published: 2005-10-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21348] 115. Medical Devices; Immunology and Microbiology Devices; Classification of
The Food and Drug Administration (FDA) is classifying the
cystic fibrosis transmembrane conductance regulator (CFTR) gene [[Page 61737]]
mutation detection systems into class II (special controls). The
special control that will apply to the device is the guidance document
entitled ``Class II Special Controls Guidance Document: CFTR Gene
Mutation
Published: 2005-10-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21350] 116. Vaccines and Related Biological Products Advisory Committee; Notice of
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: Vaccines and Related Biological Products Advisory Committee.
General Function of the Committee: To provide advice and recommendations
Published: 2005-10-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21349] 117. Guidance for Industry and Food and Drug Administration Staff; Class II
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with
Published: 2005-10-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21347] 118. Guidance for Industry on Potassium Chloride Modified-Release Tablets and
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Potassium Chloride ModifiedRelease Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of
Published: 2005-10-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21240] 119. Agency Information Collection Activities; Proposed Collection; Comment
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
Published: 2005-10-25 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21241] 120. Clinical Pharmacology Subcommittee of the Advisory Committee for
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: Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science.
General Function of the Committee: To provide advice and recommendations
Published: 2005-10-25 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21157] 121. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``2005 Food Safety Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2005-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21158] 122. Agency Information Collection Activities; Submission for Office of Management
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the [[Page 61456]]
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Published: 2005-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21152] 123. MicroArray Quality Control Project Meeting on MicroArray Quality Control;
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``MicroArray Quality Control (MAQC) Project Meeting on MicroArray Quality Control.'' The focus of the 2day meeting will be to review the datasets generated by the MAQC study.
Date and Time: The meeting will be held on Thursday, December 1, 2005, from 8 a.m. to 5 p.m.
Published: 2005-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21151] 124. Agency Information Collection Activities: Proposed Collection; Comment
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
Published: 2005-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 05-21153] 125. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2005-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013