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CFR › Title 21 › Chapter I › Subchapter A › Part 17 › Section 17.15

21 CFR 17.15 - Parties to the hearing.

§ 17.15
Parties to the hearing.
(a) The parties to the hearing shall be the respondent and the Center(s) with jurisdiction over the matter at issue. No other person may participate.
(b) The parties may at any time prior to a final decision by the entity deciding any appeal agree to a settlement of all or a part of the matter. The settlement agreement shall be filed in the docket and shall constitute complete or partial resolution of the administrative case as so designated by the settlement agreement. The settlement document shall be effective upon filing in the docket and need not be ratified by the presiding officer or the Commissioner of Food and Drugs.
(c) The parties may be represented by counsel, who may be present at the hearing.

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