[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.24]
[Page 116-117]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart B Initiation of Proceedings
Sec. 12.24 Ruling on objections and requests for hearing.
(a) As soon as possible the Commissioner will review all objections
and requests for hearing filed under Sec. 12.22 and determine--
(1) Whether the regulation should be modified or revoked under Sec.
12.26;
(2) Whether a hearing has been justified; and
(3) Whether, if requested, a hearing before a Public Board of
Inquiry under part 13 or before a public advisory committee under part
14 or before the Commissioner under part 15 has been justified.
(b) A request for a hearing will be granted if the material
submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution
at a hearing. A hearing will not be granted on issues of policy or law.
(2) The factual issue can be resolved by available and specifically
identified reliable evidence. A hearing will not be granted on the basis
of mere allegations or denials or general descriptions of positions and
contentions.
(3) The data and information submitted, if established at a hearing,
would be adequate to justify resolution of the factual issue in the way
sought by the person. A hearing will be denied if the Commissioner
concludes that the
[[Page 117]]
data and information submitted are insufficient to justify the factual
determination urged, even if accurate.
(4) Resolution of the factual issue in the way sought by the person
is adequate to justify the action requested. A hearing will not be
granted on factual issues that are not determinative with respect to the
action requested, e.g., if the Commissioner concludes that the action
would be the same even if the factual issue were resolved in the way
sought, or if a request is made that a final regulation include a
provision not reasonably encompassed by the proposal. A hearing will be
granted upon proper objection and request when a food standard or other
regulation is shown to have the effect of excluding or otherwise
affecting a product or ingredient.
(5) The action requested is not inconsistent with any provision in
the act or any regulation in this chapter particularizing statutory
standards. The proper procedure in those circumstances is for the person
requesting the hearing to petition for an amendment or waiver of the
regulation involved.
(6) The requirements in other applicable regulations, e.g.,
Sec. Sec. 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in
the notice promulgating the final regulation or the notice of
opportunity for hearing are met.
(c) In making the determination in paragraph (a) of this section,
the Commissioner may use any of the optional procedures specified in
Sec. 10.30(h) or in other applicable regulations, e.g., Sec. Sec.
314.200, 514.200, and 601.7(a).
(d) If it is uncertain whether a hearing has been justified under
the principles in paragraph (b) of this section, and the Commissioner
concludes that summary decision against the person requesting a hearing
should be considered, the Commissioner may serve upon the person by
registered mail a proposed order denying a hearing. The person has 30
days after receipt of the proposed order to demonstrate that the
submission justifies a hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 399, Jan. 5, 1999]
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