Civil Money Penalty Definitions; Technical Amendment, 34402 [2017-15532]
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34402
Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Rules and Regulations
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.
Final rule; technical
amendment.
ACTION:
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
§ 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Regulations (CFR) that is no longer
current.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
asabaliauskas on DSKBBY8HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:31 Jul 24, 2017
Jkt 241001
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
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.
2. In § 17.3, paragraph (a) is revised to
read as follows:
■
§ 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),
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
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
DEPARTMENT OF INTERIOR
National Indian Gaming Commission
25 CFR Part 515
RIN 3141–AA65
Privacy Act Procedures; Corrections
National Indian Gaming
Commission, Department of Interior.
ACTION: Correcting amendments.
AGENCY:
On January 24, 2017, the
National Indian Gaming Commission
(NIGC) revised its Privacy Act
regulations. That document included
incorrect information regarding the
NIGC’s address and contained
conflicting timelines for resolving
appeals. This document corrects the
final regulations.
DATES: Effective July 25, 2017 and
applicable beginning January 24, 2017.
FOR FURTHER INFORMATION CONTACT:
Andrew Mendoza, Staff Attorney, (202)
632–7003.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Indian Gaming Regulatory Act
(IGRA or the Act), Public Law 100–497,
25 U.S.C. 2701 et seq., was signed into
law October 17, 1988. The Act
established the NIGC and set out a
comprehensive framework for the
regulation of gaming on Indian lands.
The purposes of the Act include:
Providing a statutory basis for the
operation of gaming by Indian tribes as
a means of promoting tribal economic
development, self-sufficiency, and
strong tribal governments; ensuring that
the Indian tribe is the primary
beneficiary of the gaming operation; and
declaring that the establishment of
independent federal regulatory
authority for gaming on Indian lands,
the establishment of federal standards
for gaming on Indian lands, and the
establishment of a National Indian
E:\FR\FM\25JYR1.SGM
25JYR1
Agencies
[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.
-----------------------------------------------------------------------
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