[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.1]

[Page 202-203]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17_CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
Sec. 17.1  Scope.




Sec.
17.1 Scope.
17.3 Definitions.
17.5 Complaint.
17.7 Service of complaint.
17.9 Answer.
17.11 Default upon failure to file an answer.
17.13 Notice of hearing.
17.15 Parties to the hearing.
17.17 Summary decisions.
17.18 Interlocutory appeal from ruling of presiding officer.
17.19 Authority of the presiding officer.
17.20 Ex parte contacts.
17.21 Prehearing conferences.
17.23 Discovery.
17.25 Exchange of witness lists, witness statements, and exhibits.
17.27 Hearing subpoenas.
17.28 Protective order.
17.29 Fees.
17.30 Computation of time.
17.31 Form, filing, and service of papers.
17.32 Motions.
17.33 The hearing and burden of proof.
17.34 Determining the amount of penalties and assessments.
17.35 Sanctions.
17.37 Witnesses.
17.39 Evidence.
17.41 The administrative record.
17.43 Posthearing briefs.
17.45 Initial decision.
17.47 Appeals.
17.48 Harmless error.
17.51 Judicial review.
17.54 Deposit in the Treasury of the United States.

    Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 
360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554, 555, 556, 
557.

    Source: 60 FR 38626, July 27, 1995, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 17 appear at 68 FR 
24879, May 9, 2003.


    This part sets forth practices and procedures for hearings 
concerning the administrative imposition of civil money penalties by 
FDA. Listed below are the statutory provisions that as of August 28, 
1995, authorize civil money penalties that are governed by these 
procedures.
    (a) Section 303 (b)(2) through (b)(4) of the Federal Food, Drug, and 
Cosmetic Act (the act) authorizing civil money penalties for certain 
violations of the act that relate to prescription drug marketing 
practices.
    (b) Section 303(g) of the act authorizing civil money penalties for 
certain violations of the act that relate to medical devices.
    (c) Section 307 of the act authorizing civil money penalties for 
certain actions in connection with an abbreviated new drug application 
or certain actions in connection with a person or individual debarred 
under section 306 of the act.

[[Page 203]]

    (d) Section 351(d)(2)(B) of the Public Health Service Act (the PHS 
Act) authorizing civil money penalties for violations of biologic recall 
orders.
    (e) Section 354(h)(2) of the PHS Act, as amended by the Mammography 
Quality Standards Act of 1992, authorizing civil money penalties for 
failure to obtain a certificate, failure to comply with established 
standards, among other things.
    (f) Section 2128 of the PHS Act authorizing civil money penalties 
for intentionally destroying, altering, falsifying, or concealing any 
record or report required to be prepared, maintained, or submitted by 
vaccine manufacturers pursuant to that section of the PHS Act.