Department of Health and Human Services January 13, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
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 sponsor's address for Alstoe, Ltd.
Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling OTC Human Drug ProductsQuestions and Answers.'' This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products to implement the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This draft guidance discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors in implementing the new requirements. The labeling examples in this draft guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Registration and Listing
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.
Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution
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 use of levamisole hydrochloride soluble powder to make a drench solution for oral administration to cattle and sheep which is effective against various internal parasites.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements contained in existing FDA regulations governing State petitions for exemption from preemption.
Alltech, Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Alltech, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.
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