The Federal Register

Supplements and Other Changes to Approved New Animal Drug Applications

Wed, Dec 13 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug. The final rule sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report.

Food Labeling: Nutrition Labeling of Dietary Supplements on a ``Per Day'' Basis

Wed, Dec 13 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its nutrition labeling regulations for dietary supplements to provide that the quantitative amount and the percent of Daily Value of a dietary ingredient may be voluntarily presented on a ``per day'' basis in addition to the required ``per serving'' basis when a recommendation is made on the label that the dietary supplement be consumed more than once per day. This final rule responds to a citizen petition requesting that FDA amend our dietary supplement nutrition labeling regulations to include this provision. FDA is taking this action to give manufacturers of dietary supplements the option to present nutrition information on a ``per day'' basis to consumers.
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Dec 13 2006 11:00:00 GMT

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.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Dec 13 2006 11:00:00 GMT

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop

Wed, Dec 13 2006 11:00:00 GMT

The Food and Drug Administration (FDA) Los Angeles District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDAregulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA.

Date and Time: The public workshop is scheduled for Wednesday, February 7, 2007, from 8:30 a.m. to 5 p.m. and Thursday, February 8, 2007, from 8:30 a.m. to 4:30 p.m.

Location: The public workshop will be held at the Wyndham San Diego at Emerald Plaza, 400 West Broadway, San Diego, CA 92101, 6192394500,