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[FR Doc 04-28578] 1. New Animal Drugs for Use in Animal Feeds; Chlortetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to add the approved withdrawal time to the limitations to conditions of use for chlortetracycline Type C medicated feeds for chickens when fed at the 500 gram per ton level. This change is being made to improve the accuracy of the regulations.
Published: 2004-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28576] 2. New Animal Drugs for Use in Animal Feeds; Tilmicosin
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 Elanco Animal Health which provides for revised reproductive safety labeling of tilmicosin Type A medicated article used in medicated swine feeds.
Published: 2004-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28577] 3. Secondary Direct Food Additives Permitted in Food for Human Consumption
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acidified sodium chlorite solutions as an antimicrobial agent on finfish and crustaceans. This action is in response to a petition filed by Alcide Corp.
Published: 2004-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28579] 4. Nonclinical and Clinical Datasets; Notice of Pilot Project
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is seeking volunteers to participate in a pilot project involving the evaluation of various analysis tools to facilitate the use of electronic datasets for analysis of animal and human data submitted to FDA by applicants of biologics license applications
Published: 2004-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28580] 5. Universal Reagents, Inc.; Revocation of U.S. License No. 0887
The Food and Drug Administration (FDA) is announcing the revocation of the biologics license (U.S. License No. 0887) issued to Universal Reagents, Inc., (URI) for the manufacture of Source Plasma. A notice of opportunity for a hearing on a proposal to revoke the license was published in the Federal Register of July 10, 2003. URI requested a
Published: 2004-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28438] 6. Guidance for Industry and FDA Staff; Class II Special Controls Guidance
The Food and Drug Administration (FDA) is announcing the
availability of the guidance document entitled ``Class II Special
Controls Guidance Document: Vascular and Neurovascular Embolization
Devices.'' Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to change the names, revise the
identifications, and reclassify the
Published: 2004-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28461] 7. New Animal Drugs; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Pharmacia & Upjohn Co. to Pharmacia & Upjohn Co., a Division of Pfizer, Inc., and to correct the sponsor's mailing address.
Published: 2004-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-55521] 8. Indirect Food Additives: Paper and Paperboard Components
CFR Correction
In Title 21 of the Code of Federal Regulations, Parts 170 to 199,
revised as of April 1, 2004, on page 207, in Sec. 176.170,
alphabetically add the following entry to the table in paragraph (b)(2):
Sec. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.
* * * * *
(b) * * *
(2) * * *
Published: 2004-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28437] 9. Cardiovascular and Neurological Devices; Reclassification of Two Embolization
The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is
Published: 2004-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28573] 10. Proposed Referral Program from the Food and Drug Administration to the
The Food and Drug Administration (FDA) is extending to January 25, 2005, the comment period for the notice that appeared in the Federal Register of November 26, 2004 (69 FR 68948). In the notice, FDA announced the availability and requested comments on the draft guidance entitled ``Proposed Referral Program from the Food and Drug Administration to
Published: 2004-12-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28252] 11. Gastroenterology-Urology Devices; Classification for External Penile Rigidity
The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing
Published: 2004-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28251] 12. Medical Devices; Obstetrical and Gynecological Devices; Classification of the
The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system 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: Assisted Reproduction Laser Systems.'' The agency is classifying this device into class II
Published: 2004-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28254] 13. Guidance for Industry and FDA Staff on Class II Special Controls Guidance
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.'' This guidance document describes a means by which assisted reproduction laser systems may comply with the requirement of special controls for class II devices.
Published: 2004-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28255] 14. 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: External Penile Rigidity Devices.'' This guidance document describes a means by which external penile rigidity devices may comply with the requirement of special controls for class II devices. Elsewhere in
Published: 2004-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28134] 15.Agency Information Collection Activities; Announcement of Office of Management
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Pharmacogenomics Data Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2004-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28136] 16.Agency Information Collection Activities; Announcement of Office of Management
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Feeding Practices Study II'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2004-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28137] 17.Agency Information Collection Activities; Proposed Collection; Comment Request;
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
Published: 2004-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28138] 18.Agency Information Collection Activities; Proposed Collection; Comment Request;
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
Published: 2004-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28135] 19.Dietary Supplements; Premarket Notification for New Dietary Ingredient
The Food and Drug Administration (FDA) is reopening to February 1, 2005, the comment period for a notice that appeared in the Federal Register of October 20, 2004 (69 FR 61680). In the notice, FDA solicited comments on FDA's premarket notification program for new dietary ingredients (NDIs) and announced a public meeting on that topic. The comment
Published: 2004-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-28043] 20. Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is amending the food additive regulations by establishing a new maximum permitted energy level of x rays for treating food of 7.5 million electron volts (MeV) provided that the x rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted
Published: 2004-12-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-27868] 21. Irradiation in the Production, Processing, and Handling of Food
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a source of fast (high energy) neutrons to inspect containers that may contain food. This action is in response to a petition filed by Science Applications International Corp. (SAIC).
Published: 2004-12-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-27737] 22. Advisory Committees; Tentative Schedule of Meetings for 2005
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2005. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one
Published: 2004-12-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-27736] 23. Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism;
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information.'' The draft guidance is intended to assist applicants with the submission of abbreviated new drug applications (ANDAs) when a drug substance
Published: 2004-12-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-27387] 24.[Docket Nos. 2003M-0172, 2004M-0309, 2004M-0433, 2004M-0341, 2004M- 0356,
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Published: 2004-12-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 04-27292] 25. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled `` Presubmission Conference'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2004-12-14 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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