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Comments Sought on Notice of Participation with FDA

09/09/2011

Federal Register Notice: FDA is seeking comment on reporting requirements for filing a notice of participation with FDA (21 CFR 12.45). Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a public board of inquiry, on disclosure of data and information by participants. Comments should be submitted by 11/8. To view this notice, click here.

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