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Voluntary reporting update

Executive Summary

Number of new submissions to FDA's Cosmetic Voluntary Reporting Program estimated at 1,920 annually, agency says in July 8 Federal Register notice. Additional 75 amendments and 20 notices of discontinuance also are anticipated, FDA notes. Larger cosmetic companies have resumed participation in CVRP program since it was discontinued due to lack of funding in 1998 and reinstated in 1999, but smaller companies are "lagging," agency says. Program's estimated 987-hour maintenance burden on FDA is 60% that reported in 1999, agency says. Under CVRP, FDA requests cosmetic manufacturers submit ingredient statements and reported adverse reactions for their products...
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