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21 CFR 17.11 - Default upon failure to file an answer.

§ 17.11
Default upon failure to file an answer.
(a) If the respondent does not file an answer within the time prescribed in § 17.9 and if service has been effected as provided in § 17.7, the presiding officer shall assume the facts alleged in the complaint to be true, and, if such facts establish liability under the relevant statute, the presiding officer shall issue an initial decision within 30 days of the time the answer was due, imposing:
(1) The maximum amount of penalties provided for by law for the violations alleged; or
(2) The amount asked for in the complaint, whichever amount is smaller.
(b) Except as otherwise provided in this section, by failing to file a timely answer, the respondent waives any right to a hearing and to contest the amount of the penalties and assessments imposed under paragraph (a) of this section, and the initial decision shall become final and binding upon the parties 30 days after it is issued.
(c) If, before such a decision becomes final, the respondent files a motion seeking to reopen on the grounds that extraordinary circumstances prevented the respondent from filing an answer, the initial decision shall be stayed pending a decision on the motion.
(d) If, on such motion, the respondent can demonstrate extraordinary circumstances excusing the failure to file an answer in a timely manner, the presiding officer may withdraw the decision under paragraph (a) of this section, if such a decision has been issued, and shall grant the respondent an opportunity to answer the complaint as provided in § 17.9(a).
(e) If the presiding officer decides that the respondent's failure to file an answer in a timely manner is not excused, he or she shall affirm the decision under paragraph (a) of this section, and the decision shall become final and binding upon the parties 30 days after the presiding officer issues the decision on the respondent's motion filed under paragraph (c) of this section.

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 554 - Adjudications

§ 555 - Ancillary matters

§ 556 - Hearings; presiding employees; powers and duties; burden of proof; evidence; record as basis of decision

§ 557 - Initial decisions; conclusiveness; review by agency; submissions by parties; contents of decisions; record

USC : Title 21 - FOOD AND DRUGS

§ 331 - Prohibited acts

§ 333 - Penalties

§ 337 - Proceedings in name of United States; provision as to subpoenas

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360c - Classification of devices intended for human use

§ 360f - Banned devices

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 371 - Regulations and hearings

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 262 - Regulation of biological products

§ 263b - Certification of mammography facilities

42 USC § 300aa–28 - Manufacturer recordkeeping and reporting