82 FR 34402 - Civil Money Penalty Definitions; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 141 (July 25, 2017)

Page Range		34402-34402
FR Document		2017-15532

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.

Federal Register, Volume 82 Issue 141 (Tuesday, July 25, 2017)

[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Rules and Regulations]
[Page 34402]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

34402 Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Rules and Regulations

DEPARTMENT OF HEALTH AND this technical amendment to be exempt includes any defect in performance,
HUMAN SERVICES under 5 U.S.C. 553(d)(3) and that the manufacture, construction, components,
rule can become effective upon materials, specifications, design,
Food and Drug Administration publication. installation, maintenance, or service of
FDA has determined under 21 CFR a device, or any defect in mechanical,
21 CFR Part 17 25.30(i) that this final rule is of a type physical, or chemical properties of a
[Docket No. FDA–2017–N–0011]
that does not individually or device.
cumulatively have a significant effect on * * * * *
Civil Money Penalty Definitions; the human environment. Therefore,
Dated: July 18, 2017.
Technical Amendment neither an environmental assessment
nor an environmental impact statement Anna K. Abram,
AGENCY: Food and Drug Administration, is required. In addition, FDA has Deputy Commissioner for Policy, Planning,
HHS. determined that this final rule contains Legislation, and Analysis.
Final rule; technical
ACTION: no collections of information. Therefore, [FR Doc. 2017–15532 Filed 7–24–17; 8:45 am]
amendment. clearance by the Office of Management BILLING CODE 4164–01–P
and Budget under the Paperwork
SUMMARY: The Food and Drug
Reduction Act of 1995 (44 U.S.C. 3501–
Administration (FDA or Agency) is
20) is not required. DEPARTMENT OF INTERIOR
amending a civil money penalty
regulation to correct a statutory List of Subjects in 21 CFR Part 17 National Indian Gaming Commission
reference to align the regulations with Administrative practice and
the Federal Food, Drug, and Cosmetic procedure, Penalties. 25 CFR Part 515
Act (the FD&C Act) and to ensure
Therefore, under the Federal Food,
accuracy and clarity in the Agency’s RIN 3141–AA65
Drug, and Cosmetic Act and under
regulations.
authority delegated to the Commissioner Privacy Act Procedures; Corrections
DATES: This rule is effective July 25, of Food and Drugs, 21 CFR part 17 is
2017. amended as follows: AGENCY: National Indian Gaming
FOR FURTHER INFORMATION CONTACT: Commission, Department of Interior.
Jarilyn Dupont, Office of Policy, Food PART 17—CIVIL MONEY PENALTIES ACTION: Correcting amendments.
and Drug Administration, 10903 New HEARINGS
Hampshire Ave., Bldg. 32, Rm. 4248, SUMMARY: On January 24, 2017, the
■ 1. The authority citation for part 17 National Indian Gaming Commission
Silver Spring, MD 20993–0002, 301– continues to read as follows:
796–4830. (NIGC) revised its Privacy Act
Authority: 21 U.S.C. 331, 333, 337, 351, regulations. That document included
SUPPLEMENTARY INFORMATION: FDA is
352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 incorrect information regarding the
amending its regulation at 21 CFR 17.3 U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554, NIGC’s address and contained
to correct a statutory reference to reflect 555, 556, 557. conflicting timelines for resolving
the current citation. FDA is revising appeals. This document corrects the
■ 2. In § 17.3, paragraph (a) is revised to
§ 17.3(a)(1) through (4) by replacing final regulations.
read as follows:
section ‘‘333(g)’’ with section ‘‘333(f).’’
On July 27, 1995, FDA published a final DATES: Effective July 25, 2017 and
§ 17.3 Definitions.
rule establishing hearing procedures for applicable beginning January 24, 2017.
* * * * *
use when FDA proposes the imposition FOR FURTHER INFORMATION CONTACT:
(a) For specific acts giving rise to civil
of administrative civil money penalties Andrew Mendoza, Staff Attorney, (202)
money penalty actions brought under 21
(60 FR 38612 at 38626). The document 632–7003.
U.S.C. 333(f)(1):
was published with a citation to 21 (1) Significant departure, for the SUPPLEMENTARY INFORMATION:
U.S.C. 333(g) (303(g) of the FD&C Act) purpose of interpreting 21 U.S.C. I. Background
that subsequently was changed to 21 333(f)(1)(B)(i), means a departure from
U.S.C. 333(f) (303(f) of the FD&C Act) by requirements that is either a single The Indian Gaming Regulatory Act
section 226(b)(1) of the Food and Drug major incident or a series of incidents (IGRA or the Act), Public Law 100–497,
Administration Amendments Act of that collectively are consequential. 25 U.S.C. 2701 et seq., was signed into
2007 (Pub. L. 110–85). (2) Knowing departure, for the law October 17, 1988. The Act
Publication of this document purposes of interpreting 21 U.S.C. established the NIGC and set out a
constitutes final action on the change 333(f)(1)(B)(i), means a departure from a comprehensive framework for the
under the Administrative Procedure Act requirement taken: regulation of gaming on Indian lands.
(5 U.S.C. 553). This technical (i) With actual knowledge that the The purposes of the Act include:
amendment is nonsubstantive and action is such a departure; or Providing a statutory basis for the
merely updates and corrects a statutory (ii) In deliberate ignorance of a operation of gaming by Indian tribes as
reference in the Code of Federal requirement; or a means of promoting tribal economic
Regulations (CFR) that is no longer (ii) In reckless disregard of a development, self-sufficiency, and
current. FDA therefore, for good cause, strong tribal governments; ensuring that
asabaliauskas on DSKBBY8HB2PROD with NOTICES

requirement.
has determined that notice and public (3) Minor violations, for the purposes the Indian tribe is the primary
comment are unnecessary under 5 of interpreting 21 U.S.C. 333(f)(1)(B)(ii), beneficiary of the gaming operation; and
U.S.C. 553(b)(3)(B). Further, this rule means departures from requirements declaring that the establishment of
places no burden on affected parties for that do not rise to a level of a single independent federal regulatory
which such parties would need a major incident or a series of incidents authority for gaming on Indian lands,
reasonable time to prepare for the that are collectively consequential. the establishment of federal standards
effective date of the rule. Accordingly, (4) Defective, for the purposes of for gaming on Indian lands, and the
FDA, for good cause, has determined interpreting 21 U.S.C. 333(f)(1)(B)(iii), establishment of a National Indian

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Document Created: 2018-10-24 11:20:21
Document Modified: 2018-10-24 11:20:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		This rule is effective July 25, 2017.
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.
FR Citation		82 FR 34402
CFR Associated		Administrative Practice and Procedure and Penalties

82 FR 34402 - Civil Money Penalty Definitions; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 141 (July 25, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration