Document ID: FDA-2017-N-0011-0004
Agency: fda
Document Type: Rule
Title: Civil Money Penalty Definitions; Technical Amendment
Posted Date: 2017-07-25T04:00Z

[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Rules and Regulations]
[Page 34402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15532]

[[Page 34402]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2017-N-0011]

Civil Money Penalty Definitions; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending a 
civil money penalty regulation to correct a statutory reference to 
align the regulations with the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) and to ensure accuracy and clarity in the Agency's 
regulations.

DATES: This rule is effective July 25, 2017.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248, 
Silver Spring, MD 20993-0002, 301-796-4830.

SUPPLEMENTARY INFORMATION: FDA is amending its regulation at 21 CFR 
17.3 to correct a statutory reference to reflect the current citation. 
FDA is revising Sec.  17.3(a)(1) through (4) by replacing section 
``333(g)'' with section ``333(f).'' On July 27, 1995, FDA published a 
final rule establishing hearing procedures for use when FDA proposes 
the imposition of administrative civil money penalties (60 FR 38612 at 
38626). The document was published with a citation to 21 U.S.C. 333(g) 
(303(g) of the FD&C Act) that subsequently was changed to 21 U.S.C. 
333(f) (303(f) of the FD&C Act) by section 226(b)(1) of the Food and 
Drug Administration Amendments Act of 2007 (Pub. L. 110-85).
    Publication of this document constitutes final action on the change 
under the Administrative Procedure Act (5 U.S.C. 553). This technical 
amendment is nonsubstantive and merely updates and corrects a statutory 
reference in the Code of Federal Regulations (CFR) that is no longer 
current. FDA therefore, for good cause, has determined that notice and 
public comment are unnecessary under 5 U.S.C. 553(b)(3)(B). Further, 
this rule places no burden on affected parties for which such parties 
would need a reasonable time to prepare for the effective date of the 
rule. Accordingly, FDA, for good cause, has determined this technical 
amendment to be exempt under 5 U.S.C. 553(d)(3) and that the rule can 
become effective upon publication.
    FDA has determined under 21 CFR 25.30(i) that this final rule is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required. In 
addition, FDA has determined that this final rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-20) is not required.

List of Subjects in 21 CFR Part 17

    Administrative practice and procedure, Penalties.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
17 is amended as follows:

PART 17--CIVIL MONEY PENALTIES HEARINGS

0
1. The authority citation for part 17 continues to read as follows:

    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.

0
2. In Sec.  17.3, paragraph (a) is revised to read as follows:

Sec.  17.3  Definitions.

* * * * *
    (a) For specific acts giving rise to civil money penalty actions 
brought under 21 U.S.C. 333(f)(1):
    (1) Significant departure, for the purpose of interpreting 21 
U.S.C. 333(f)(1)(B)(i), means a departure from requirements that is 
either a single major incident or a series of incidents that 
collectively are consequential.
    (2) Knowing departure, for the purposes of interpreting 21 U.S.C. 
333(f)(1)(B)(i), means a departure from a requirement taken:
    (i) With actual knowledge that the action is such a departure; or
    (ii) In deliberate ignorance of a requirement; or
    (ii) In reckless disregard of a requirement.
    (3) Minor violations, for the purposes of interpreting 21 U.S.C. 
333(f)(1)(B)(ii), means departures from requirements that do not rise 
to a level of a single major incident or a series of incidents that are 
collectively consequential.
    (4) Defective, for the purposes of interpreting 21 U.S.C. 
333(f)(1)(B)(iii), includes any defect in performance, manufacture, 
construction, components, materials, specifications, design, 
installation, maintenance, or service of a device, or any defect in 
mechanical, physical, or chemical properties of a device.
* * * * *

    Dated: July 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15532 Filed 7-24-17; 8:45 am]
 BILLING CODE 4164-01-P