Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for Information; Availability

• Date: May 04, 2010
• Source: www.fda.gov

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.’’ This draft guidance describes the user fees associated with 513(g) requests for information.

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 28, 2010. Submit written or electronic comments on the collection of information June 28, 2010.

 

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