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HHS - 21 CFR PART 15

PUBLIC HEARING BEFORE THE COMMISSIONER

active, Most Current
Organization: HHS
Publication Date: 1 April 2019
Status: active
Page Count: 3
scope:

The procedures in this part apply when:

(a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administation.

(b) The act or regulation specifically provides for a public hearing before the Commissioner on a matter, e.g., § 330.10(a)(8) relating to over-thecounter drugs and sections 520 (b) and (f)(1)(B), and 521 of the act relating to proposals to allow persons to order custom devices, to proposed device good manufacturing practice regulations, and to proposed exemptions from preemption of State and local device requirements under § 808.25(e).

(c) A person who has right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead requests under § 12.32 a public hearing before the Commissioner, and the Commissioner, as a matter of discretion, accepts the request.

Document History

April 1, 2020
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...
21 CFR PART 15
April 1, 2019
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...
April 1, 2018
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...
April 1, 2017
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...
April 1, 2016
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...
April 1, 2015
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...
April 1, 2014
PUBLIC HEARING BEFORE THE COMMISSIONER
The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public...

References

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