PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE - Subpart E--Hearings
This page includes changes
to the Code of Federal Regulations since April 1, 2007. View
Key.
Sec. 1315.50 Hearings generally.
The procedures for the hearing related to assessment of annual needs or to
the issuance, adjustment, suspension, or denial of a manufacturing,
procurement, or import quota are governed generally by the adjudication
procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559)
and specifically by section 1002 of the Act (21 U.S.C. 952), by Sec. Sec.
1315.52 through 1315.62 of this part, and by the procedures for administrative
hearings under the Act set forth in Sec. Sec. 1316.41 through 1316.67 of this
chapter.
Sec. 1315.52 Purpose of hearing.
(a) The Administrator may, in his sole discretion, hold a hearing for the
purpose of receiving factual evidence regarding any one or more issues (to be
specified by him) involved in the determination or adjustment of any
assessment of national needs.
(b) If requested by a person applying for or holding a procurement, import,
or individual manufacturing quota, the Administrator shall hold a hearing for
the purpose of receiving factual evidence regarding the issues involved in the
issuance, adjustment, suspension, or denial of the quota to the person, but
the Administrator need not hold a hearing on suspension of a quota under Sec.
1301.36 or Sec. 1309.43 of this chapter separate from a hearing on the
suspension of registration under that section.
(c) Extensive argument should not be offered into evidence, but rather
presented in opening or closing statements of counsel or in memoranda or
proposed findings of fact and conclusions of law.
Sec. 1315.54 Waiver or modification of rules.
The Administrator or the presiding officer (with respect to matters pending
before him) may modify or waive any rule in this part by notice in advance of
the hearing, if he determines that no party in the hearing will be unduly
prejudiced and the ends of justice will thereby be served. Such notice of
modification or waiver shall be made a part of the record of the hearing.
Sec. 1315.56 Request for hearing or appearance; waiver.
(a) Any applicant or registrant entitled to a hearing under Sec. 1315.52
and who desires a hearing on the issuance, adjustment, suspension or denial of
a procurement, import, or individual manufacturing quota must, within 30 days
after the date of receipt of the issuance, adjustment, suspension or denial of
the application, file with the Administrator a written request for a hearing
in the form prescribed in Sec. 1316.47 of this chapter.
(b) Any interested person who desires a hearing on the determination of an
assessment of annual needs must, within the time prescribed in Sec.
1315.11(c), file with the Administrator a written request for a hearing in the
form prescribed in Sec. 1316.47 of this chapter, including in the request a
statement of the grounds for the hearing.
(c) Any interested person who desires to participate in a hearing on the
determination or adjustment of an assessment of annual needs, which hearing is
ordered by the Administrator under Sec. 1315.11(c) or
Sec. 1315.13(c), may do
so by filing with the Administrator, within 30 days of the date of publication
of notice of the hearing in the Federal Register, a written notice of his
intention to participate in the hearing in the form prescribed in Sec. 1316.48
of this chapter.
(d) Any person entitled to a hearing under Sec. 1315.52 or entitled to
participate in a hearing under paragraph (c) of this section may, within the
period permitted for filing a request for a hearing or notice of appearance,
file with the Administrator a waiver of an opportunity for a hearing, together
with a written statement regarding his position on the matters of fact and law
involved in such hearing. The statement, if admissible, shall be made a part
of the record and shall be considered in light of the lack of opportunity for
cross-examination in determining the weight to be attached to matters of fact
asserted.
(e) If any person entitled to a hearing under Sec. 1315.52 or entitled to
participate in a hearing under paragraph (c) of this section fails to file a
request for a hearing or notice of appearance or if he so files and fails to
appear at the hearing, he shall be deemed to have waived his opportunity for
the hearing unless he shows good cause for such failure.
(f) If all persons entitled to a hearing or to participate in a hearing
waive or are deemed to waive their opportunity for the hearing or to
participate in the hearing, the Administrator may cancel the hearing, if
scheduled, and issue his final order under Sec. 1315.62 without a hearing.
Sec. 1315.58 Burden of proof.
(a) At any hearing regarding the determination or adjustment of an
assessment of annual needs each interested person participating in the hearing
shall have the burden of proving any propositions of fact or law asserted by
him in the hearing.
(b) At any hearing regarding the issuance, adjustment, suspension, or
denial of a procurement, import, or individual manufacturing quota, the
Administration shall have the burden of proving that the requirements of this
part for such issuance, adjustment, suspension, or denial are satisfied.
Sec. 1315.60 Time and place of hearing.
(a) If any applicant or registrant requests a hearing on the issuance,
adjustment, suspension, or denial of his procurement, import, or individual
manufacturing quota under Sec. 1315.54, the Administrator shall hold a
hearing.
(b) Notice of the hearing shall be given to the applicant or registrant of
the time and place at least 30 days prior to the hearing, unless the applicant
or registrant waives such notice and requests the hearing be held at an
earlier time, in which case the Administrator shall fix a date for such
hearing as early as reasonably possible.
(c) The hearing shall commence at the place and time designated in the
notice given under paragraph (b) of this section or in the notice of hearing
published in the Federal Register pursuant to Sec. 1315.11(c) or
Sec. 1315.13(c), but thereafter it may be moved to a different place and may be
continued from day to day or recessed to a later day without notice other than
announcement by the presiding officer at the hearing.
Sec. 1315.62 Final order.
As soon as practicable after the presiding officer has certified the record
to the Administrator, the Administrator shall issue his order on the
determination or adjustment of the assessment of annual needs or on the
issuance, adjustment, suspension, or denial of the procurement, import, or
individual manufacturing quota, as the case may be. The order shall include
the findings of fact and conclusions of law upon which the order is based. The
order shall specify the date on which it shall take effect. The Administrator
shall serve one copy of his order upon each party in the hearing.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
