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21 CFR 17.18 - Interlocutory appeal from ruling of presiding officer.

§ 17.18
Interlocutory appeal from ruling of presiding officer.
(a) Except as provided in paragraph (b) of this section, rulings of the presiding officer may not be appealed before consideration on appeal of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory appeal to the entity deciding the appeal (currently the DAB) if the presiding officer certifies on the record or in writing that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest.
(c) When an interlocutory appeal is made, a participant may file a brief on the appeal only if specifically authorized by the presiding officer or the entity deciding the appeal (currently the DAB), and if such authorization is granted, only within the period allowed by the presiding officer or the entity deciding the appeal. If a participant is authorized to file a brief, any other participant may file a brief in opposition, within the period allowed by the entity deciding the appeal (currently the DAB). The deadline for filing an interlocutory appeal is subject to the discretion of the presiding officer.

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