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e-CFR data is current as of October 26, 2020

Title 21Chapter IIPart 1309 → Subject Group


Title 21: Food and Drugs
PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS


Hearings

§1309.51   Hearings generally.

(a) In any case where the Administrator shall hold a hearing on any registration or application therefore, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by sections 303 and 304 of the Act (21 U.S.C. 823-824), by §§1309.52 through 1309.55, and by the procedures for administrative hearings under the Act set forth in §§1316.41 through 1316.67 of this chapter.

(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act or any other law of the United States.

[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]

§1309.52   Purpose of hearing.

If requested by a person entitled to a hearing, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration. 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.

§1309.53   Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to §§1309.42 and 1309.43 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause, file with the Administrator a written request for a hearing in the form prescribed in §1316.47 of this chapter.

(b) Any person entitled to a hearing pursuant to §§1309.42 and 1309.43 may, within the period permitted for filing a request for a hearing, 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. 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.

(c) If any person entitled to a hearing pursuant to §§1309.42 and 1309.43 fails to file a request for a hearing, 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.

(d) If any person entitled to a hearing waives or is deemed to waive his or her opportunity for the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to §1309.57 without a hearing.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

§1309.54   Burden of proof.

(a) At any hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 of the Act (21 U.S.C. 823) are not satisfied.

(b) At any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) are satisfied.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

§1309.55   Time and place of hearing.

The hearing will commence at the place and time designated in the order to show cause or notice of hearing published in the Federal Register (unless expedited pursuant to Section 1309.44(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 thereof by the presiding officer at the hearing.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

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