[Title 21 CFR 1303.34]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1303 - QUOTAS]
[Sec. 1303.34 - Request for hearing or appearance; waiver.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1303.34Sec. 1303.34FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEQUOTAS
Sec. 1303.34  Request for hearing or appearance; waiver.

    (a) Any applicant or registrant who desires a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota shall, within 30 days after the date of 
receipt of the issuance, adjustment, suspension, or denial of such 
quota, file with the Administrator a written request for a hearing in 
the form prescribed in Sec. 1316.47 of this chapter. Any interested 
person who desires a hearing on the determination of an aggregate 
production quota shall, within the time prescribed

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in Sec. 1303.11(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 a hearing.
    (b) Any interested person who desires to participate in a hearing on 
the determination or adjustment of an aggregate production quota, which 
hearing is ordered by the Administrator pursuant to Sec. 1303.11(c) or 
Sec. 1303.13(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 such 
hearing in the form prescribed in Sec. 1316.48 of this chapter.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to paragraph (b) of this section, may, within the period 
permitted for filing a request for a hearing of notice of appearance, 
file with the Administrator a waiver of an opportunity for a hearing or 
to participate in a hearing, together with a written statement regarding 
his position on the matters of fact and law involved in such hearing. 
Such 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 therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to paragraph (b) 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 or to participate in the hearing, unless he 
shows good cause for such failure.
    (e) 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 pursuant to 
Sec. 1303.37 without a hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]