Agency: Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013[FR Doc 02-32848] 1. Implantation or Injectable Dosage Form New Animal Drugs; Praziquantel
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 Phoenix Scientific, Inc. The ANADA provides for the veterinary prescription
[[Page 79853]]
use of an injectable praziquantel solution in dogs and cats for the
removal of various species of
Published: 2002-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32978] 2. Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA) is establishing January 1, 2006, as the uniform compliance date for food labeling regulations that are issued between January 1, 2003, and December 31, 2004. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 20,
Published: 2002-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32979] 3. International Conference on Harmonisation; Draft Guidance on Addendum to E2C
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of
Published: 2002-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32850] 4. 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: 2002-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32849] 5. Agency Information Collection Activities; Submission for OMB Review; Comment
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.
Published: 2002-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32852] 6. International Conference on Harmonisation; Draft Guidance on the M4 Common
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Common Technical Document Quality: Questions and Answers/Location Issues.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human
Published: 2002-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32851] 7. Determination That Diazepam Autoinjector Was Not Withdrawn From Sale for
The Food and Drug Administration (FDA) has determined that
Diazepam Autoinjector (diazepam for injection) 5 milligrams per milliliter
[[Page 79641]]
(mg/mL) was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for diazepam for injection 5 mg/mL.
Published: 2002-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32747] 8. Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of danofloxacin solution in cattle, by subcutaneous injection, for treatment of bovine respiratory disease associated with Mannheimia
Published: 2002-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32748] 9. New Animal Drugs; Neomycin Sulfate Soluble Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Alpharma, Inc. The supplemental ANADA provides for use of neomycin sulfate soluble powder in the drinking water of growing turkeys for the control of mortality associated with
Published: 2002-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32750] 10. Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate
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. The supplemental NADA provides for use of an implant containing 100 milligrams (mg) trenbolone acetate and 14 mg estradiol benzoate for increased rate of weight
Published: 2002-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32662] 11. 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 an
Published: 2002-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32749] 12. 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: 2002-12-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32613] 13. Draft Guidance for Industry on Labeling for Topically Applied Cosmetic
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 2, 2002 (67 FR 71577). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients.'' The document was
Published: 2002-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32442] 14. Ophthalmic and Topical Dosage Form New Animal Drugs; Imidacloprid and
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Bayer Corp., Agriculture Division, Animal Health. The NADA provides for veterinary prescription use in dogs of an imidacloprid and ivermectin topical solution for the prevention of heartworm disease
Published: 2002-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32440] 15. Oral Dosage Form New Animal Drugs; Clindamycin Liquid; Change of Sponsor's
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 Delmarva Laboratories, Inc., and a change of this sponsor's address. The ANADA provides for oral use of clindamycin hydrochloride liquid in dogs and cats for the treatment of various
Published: 2002-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32441] 16. Electronic Products; Performance Standard for Diagnostic X-Ray Systems and
The Food and Drug Administration is correcting a proposed rule that appeared in the Federal Register of December 10, 2002 (67 FR 76056). The document proposed to amend the performance standard for diagnostic xray systems and their major components. The document was published with some inadvertent errors. This document corrects those errors.
Published: 2002-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32443] 17. Agency Information Collection Activities; Announcement of OMB Approval;
The Food and Drug Administration is announcing that a collection of information entitled ``Export Certificates for FDA Regulated Products Under Sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2002-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32444] 18. Agency Information Collection Activities; Announcement of OMB Approval;
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices: Humanitarian Use Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2002-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32341] 19. Oral Dosage Form New Animal Drugs; Florfenicol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by ScheringPlough Animal Health Corp. The NADA provides for use of a florfenicol concentrate solution to make medicated drinking water for administration to swine for the treatment of respiratory disease.
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32343] 20. Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride Soluble Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Alpharma, Inc. The supplemental ANADA provides for reducing the preslaughter withdrawal time to zero days for use of lincomycin soluble powder in medicated drinking water for
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32276] 21. Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplemental ANADA provides for the administration of an oxytetracycline injectable solution to lactating dairy cattle.
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32345] 22. New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 25 approved new animal drug applications (NADAs) from American Cyanamid to Fort Dodge Animal Health.
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32346] 23. New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of address for Phoenix Scientific, Inc.
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32342] 24. Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and
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 subcutaneous use of an implant containing trenbolone acetate and estradiol for increased rate of weight gain
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 02-32344] 25. Trimethobenzamide Hydrochloride Injection and Capsules; Drug Efficacy Study
The Food and Drug Administration (FDA) announces the resolution of issues concerning trimethobenzamide hydrochloride injection and capsules. This notice announces the approval of a supplemental new drug application (NDA) for Tigan (trimethobenzamide hydrochloride) Capsules, 300 milligrams (mg), and states that continued marketing of unapproved
Published: 2002-12-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013