Department of Health and Human Services October 30, 2006 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry; Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (181) entitled ``Draft Guidance for Industry: Blue Bird Medicated Feed Labels.'' This draft guidance is intended to provide new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's (CVM's) current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Guidance for Industry on Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components,'' dated October 2006. The guidance document provides blood establishments that collect blood and blood components intended for transfusion or for further manufacture with advice on reporting to FDA a manufacturing change consisting of the implementation of a standardized full-length donor history questionnaire and accompanying materials (DHQ documents). The guidance document addresses which DHQ documents are acceptable, and establishes the process for FDA to recognize other DHQ documents in the future. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components'' dated April 2004.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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 the procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act.
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