Civil Money Penalties: Biologics, Drugs, and Medical Devices | 21 CFR Part 17 (FR Doc. 95-18325)
60 FR 38612 · Docket No. 91N-0447 · Effective August 28, 1995
Last Reviewed: August 21, 2026
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- William B. Schultz, Deputy Commissioner for Policy, FDA
- Edition
- Final Rule — 60 FR 38612, 1995
- Pages
- 22 pages
- Added to library
- Added August 21, 2026
Overview
This 22-page Federal Register final rule (Vol. 60, No. 144, July 27, 1995) establishes 21 CFR Part 17, which governs hearings for FDA administrative civil money penalty (CMP) proceedings. The rule implements CMP provisions in five statutes: the National Childhood Vaccine Injury Act of 1986 (NCVIA), the Prescription Drug Marketing Act of 1988 (PDMA), the Safe Medical Devices Act of 1990 (SMDA), the Generic Drug Enforcement Act of 1992 (GDEA), and the Mammography Quality Standards Act of 1992 (MQSA). For mammography, the MQSA authorizes civil money penalties under §354(h)(2) of the Public Health Service Act (42 U.S.C. 263b) for failure to obtain a certificate, failure to comply with established quality standards, and other specified violations. The rule revokes two temporary procedural mechanisms (21 CFR §5.99 and §10.50(c)(21)) that had been issued in 1993 as interim measures. Presiding officers are administrative law judges under 5 U.S.C. 3105. Appeals go initially to the Departmental Appeals Board (DAB) of HHS, designated by the Commissioner as the reviewing authority for at least an initial four-year period. Judicial review is available to respondents following DAB action. The rule was developed in response to 12 public comments received after the May 26, 1993 NPRM (58 FR 30680), with more than 25 changes made in the final rule addressing procedural safeguards, burden of proof, discovery, settlement, and appeals. Signed by William B. Schultz, Deputy Commissioner for Policy, July 12, 1995.
Key Contents
-Regulatory action: Final rule | Docket No. 91N-0447 | FR Doc. 95-18325 | RIN 0905-AD59
-Published: Federal Register Vol. 60, No. 144 (July 27, 1995), pages 38612–38633
-Effective date: August 28, 1995
-Signed: William B. Schultz, Deputy Commissioner for Policy, July 12, 1995
-Contact: Joseph M. Sheehan, CDRH (HFZ-84), FDA, 9200 Gaither Rd., Rockville MD 20850, 301-594-4765
-CFR sections created or amended: 21 CFR Parts 5, 10, 17, and 20
• 21 CFR Part 17 (NEW): Civil Money Penalties Hearings (§§17.1–17.54)
• 21 CFR §5.99: REMOVED (temporary CMP procedures revoked)
• 21 CFR §10.50: AMENDED (§10.50(c)(21) removed)
• 21 CFR §20.86: AMENDED (disclosure in administrative/court proceedings now includes Part 17)
-Statutes implementing CMP authority under Part 17:
(a) FD&C Act §303(b)(2) to (4): prescription drug marketing practices (PDMA)
(b) FD&C Act §303(g): medical devices (SMDA)
(c) FD&C Act §307: abbreviated new drug applications and debarred individuals (GDEA)
(d) PHS Act §351(d)(2)(B): biologic recall orders (NCVIA)
(e) PHS Act §354(h)(2), MQSA: failure to obtain certificate, failure to comply with standards
(f) PHS Act §2128: intentional destruction/falsification of vaccine records (NCVIA)
-Key provisions of 21 CFR Part 17:
§17.3, Definitions: significant departure (single major incident or series of collectively consequential incidents); knowing departure (actual knowledge, deliberate ignorance, or reckless disregard); minor violations (departures not rising to a single major incident or collectively consequential series); defective (any defect in performance, manufacture, construction, components, materials, specifications, design, installation, maintenance, service, or chemical properties)
§17.5, Complaint: filed by Office of Chief Counsel attorney; must state allegations of liability, statutory basis, identification of violations, and reasons respondent is responsible
§17.9, Answer: filed within 30 days of service; failure to deny = deemed admitted; default imposes maximum statutory penalty
§17.11, Default: presiding officer may issue initial decision for failure to answer; extraordinary circumstances standard for relief
§17.13, Notice of hearing: served after answer is filed
§17.15, Parties: respondent and FDA Center(s) with jurisdiction; no other persons may participate
§17.17, Summary decisions: available when no genuine issue of material fact; 30-day response time to motion
§17.18, Interlocutory appeal: available when presiding officer certifies immediate review needed to prevent exceptional delay, expense, prejudice, or substantial harm to public interest
§17.19, Presiding officer authority: set hearing dates; administer oaths; issue subpoenas; rule on motions; regulate scope and timing of discovery; exclude parties for misconduct; waive rules to prevent prejudice
§17.20, Ex parte contacts: prohibited for any party or person except scheduling communications with presiding officer's office
§17.21, Prehearing conferences: presiding officer may schedule; at least one required upon motion of any party
§17.23, Discovery: document production requests ≥60 days before hearing; response ≤30 days; no depositions, interrogatories, or admissions; written direct testimony substitutes; presiding officer may order oral depositions upon showing information unavailable by alternative means
§17.25, Witness lists and exhibits: exchanged ≥30 days before hearing; failure to exchange = exclusion of witness testimony
§17.33, Burden of proof: Center must prove respondent's liability and appropriateness of penalty by preponderance of evidence; respondent bears burden on affirmative defenses and mitigating factors
§17.34, Penalty amount: presiding officer and DAB evaluate mitigating/aggravating circumstances; refer to statutory factors for the applicable statute
§17.35, Sanctions: presiding officer may sanction parties for failing to comply with orders, subpoenas, rules, or procedures; failing to prosecute/defend; or engaging in misconduct, including striking pleadings, drawing adverse inferences, excluding parties or counsel, or entering judgment
§17.45, Initial decision: issued within 90 days of posthearing briefing; must contain findings of fact, conclusions of law, and amount of any penalties
§17.47, Appeals: either party may appeal initial decision to DAB within 30 days; DAB decision within 60 days if practicable; standard of review, questions of fact: substantial evidence on whole record; questions of law: whether initial decision is erroneous
§17.51, Judicial review: DAB decision constitutes final agency action; respondent may petition Court of Appeals; exhaustion of DAB appeal is jurisdictional prerequisite
§17.54, Deposit: amounts assessed under Part 17 delivered to Director, Division of Financial Management (HFA-100) and deposited in U.S. Treasury
-Procedural safeguards: written direct testimony under penalty of perjury (§17.37(b)); presiding officer applies Federal Rules of Evidence when appropriate (§17.39(b)); presiding officer may issue protective orders for trade secrets and confidential commercial information (§17.19(b)(18)); settlement agreements filed in docket, effective upon filing without ratification by presiding officer or Commissioner (§17.15(b))
-Hearing venue: FDA headquarters, Rockville MD (presiding officer has discretion to change venue upon showing of significant hardship to respondent)
-No private right of action created (§17.1, revised to remove reference to future statutory authority)
How This Applies to Your Practice
21 CFR Part 17 is the procedural backbone of every MQSA civil money penalty action. When FDA proposes to impose a civil money penalty on a mammography facility (whether for operating without a valid certificate, for substantive quality standard violations following an inspection, or for other MQSA violations), the facility's rights and FDA's obligations are governed entirely by Part 17. Compliance officers and facility administrators who receive a Notice of Intent to Impose Civil Money Penalties or a formal Complaint under the MQSA should immediately consult Part 17 (specifically §§17.5, 17.9, 17.11, 17.13, 17.19, 17.23, 17.33, 17.45, 17.47, and 17.51) to understand the timeline, the burden of proof, discovery limitations, the presiding officer's authority, and the appellate process. The 30-day answer deadline in §17.9 is critical: failure to answer within 30 days waives all rights to contest the penalty amount and results in default imposition of the maximum statutory penalty. Legal counsel should be retained immediately upon receipt of a complaint.
Practitioner Implications
Key operational facts for mammography facilities receiving MQSA civil money penalty actions: (1) 30 days from complaint service to file an answer; missing this deadline results in default imposition of maximum statutory CMP (§17.11); (2) Request for extension of time must be filed before the 30-day deadline expires and must show good cause (§17.9(c)); (3) Discovery is limited, no depositions or interrogatories; document requests must be made ≥60 days before hearing; (4) All witness testimony is submitted in writing under penalty of perjury before the hearing; oral testimony is the exception (§17.37); (5) Burden of proof is preponderance of evidence on the government; respondent bears burden on affirmative defenses (§17.33); (6) DAB appeal is a jurisdictional prerequisite to seeking judicial review; a respondent who does not exhaust the DAB process cannot petition the Court of Appeals (§17.51(c)); (7) Settlement agreements are effective upon filing in the docket without need for presiding officer or Commissioner ratification (§17.15(b)).
Didn't find what you were looking for?
Our team has supported breast imaging centers since 1995. If it's not here, we probably know the answer.