Privacy Act Procedures; Corrections, 34402-34403 [2017-15499]
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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Regulations (CFR) that is no longer
current.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:
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16:31 Jul 24, 2017
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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),
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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
Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Rules and Regulations
Gaming Commission are necessary to
meet congressional concerns regarding
gaming and to protect such gaming as a
means of generating tribal revenue. 25
U.S.C. 2702.
II. Corrections
25 CFR Part 515—Privacy Act
Procedures
This document makes several
correcting amendments to the
Commission’s Privacy Act procedures.
First, this document amends 25 CFR
515.7(c) to reflect that the correct
timeframe for the Privacy Act Appeals
Officer to respond to an appeal is 20
working days rather than 30 working
days. In 25 CFR 515.7(c) sentence one,
the regulation correctly refers to the
twenty-working day period established
in the Commission’s final rule. Then, in
sentence two, the regulation incorrectly
refers to the same time period as a thirty
working-day period. The Commission
addressed this change in its preamble to
the final rule and explained that this
time period was being changed to reflect
the twenty working-day time period
established within the Freedom of
Information Act. The second reference
to this time period was overlooked in
the previous publication. This
document also amends 25 CFR 515.3 to
update the Commission’s physical
address. This document also corrects a
grammatical error in 25 CFR 515.7(c).
Finally, it amends a cross-reference
contained in 25 CFR 515.10.
III. Certain Findings
Under the Administrative Procedure
Act, a notice of proposed rulemaking is
not required when an agency, for good
cause, finds that notice and public
comments are impractical, unnecessary,
or contrary to the public interest.
Because the revisions here are technical
in nature and are not substantive, the
NIGC is publishing a technical
amendment.
IV. Regulatory Matters
asabaliauskas on DSKBBY8HB2PROD with NOTICES
Executive Order 13175
The National Indian Gaming
Commission is committed to fulfilling
its tribal consultation obligations—
whether directed by statute or
administrative action such as Executive
Order 13175 (Consultation and
Coordination with Indian Tribal
Governments)—by adhering to the
consultation framework described in its
Consultation Policy published on July
15, 2013. Due to the ministerial nature
of the action being taken here,
consultation is not required under the
NIGC’s Consultation Policy.
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34403
Regulatory Flexibility Act
List of Subjects in 25 CFR Part 515
This rule will not have a significant
economic effect on a substantial number
of small entities as defined by the
Regulatory Flexibility Act, 5 U.S.C. 601,
et seq. Indian tribes are not considered
to be small entities for purposes of the
Regulatory Flexibility Act.
Administrative practice and
procedure, Privacy, Reporting and
recordkeeping requirements.
Small Business Regulatory Enforcement
Fairness Act
PART 515—PRIVACY ACT
PROCEDURES
This rule is not a major rule under 5
U.S.C. 804(2), the Small Business
Regulatory Enforcement Fairness Act.
This rule will not result in an annual
effect on the economy of $100 million
per year or more. This rule will not
cause a major increase in costs or prices
for consumers, individual industries,
federal, state, or local government
agencies, or geographic regions and does
not have significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of U.S.-based enterprises to
compete with foreign-based enterprises.
■
Unfunded Mandates Reform Act
The Commission, as an independent
regulatory agency, is exempt from
compliance with the Unfunded
Mandates Reform Act, 2 U.S.C. 1502(1);
2 U.S.C. 658(1).
Takings
In accordance with Executive Order
12630, the Commission determined the
rule does not have significant takings
implications. A takings implication
assessment is not required.
Civil Justice Reform Act
In accordance with Executive Order
12988, the Commission determined the
rule does not unduly burden the judicial
system and meets the requirements of
sections 3(a) and 3(b)(2) of the Executive
Order.
National Environmental Policy Act
The Commission determined this rule
does not constitute a major federal
action significantly affecting the quality
of the human environment and that a
detailed statement is not required
pursuant to the National Environmental
Policy Act of 1969, 42 U.S.C. 4321, et
seq.
Paperwork Reduction Act
The rule does not contain any
information collection requirements for
which Office of Management and
Budget approval under the Paperwork
Reduction Act (44 U.S.C. 3501–3520) is
required.
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Fmt 4700
Sfmt 9990
For the reasons set forth in the
preamble, the NIGC amends 25 CFR part
515 as follows:
1. The authority citation for part 515
continues to read as follows:
Authority: 5 U.S.C. 552a.
2. Amend § 515.3 by revising the third
sentence of paragraph (a) to read as
follows:
■
§ 517.3
Request for access to records.
(a) * * * The request may be made
in person at 90 K Street NE., Suite 200,
Washington, DC 20002 during the hours
of 9 a.m. to 12 noon and 2 p.m. to 5 p.m.
Monday through Friday, in writing at
NIGC Attn: Privacy Act Office, 1849 C
Street NW., Mail Stop #1621,
Washington, DC 20240, or via electronic
mail addressed to PARequests@nigc.gov.
*
*
*
*
*
3. Amend § 515.7 by revising the
second and sixth sentences of paragraph
(c) to read as follows:
■
§ 515.7 Appeals of initial adverse agency
determination.
*
*
*
*
*
(c) * * * For good cause shown,
however, the Privacy Act Appeals
Officer may extend the 20 day working
period. * * * The response to the
appeal shall also advise of the right to
institute a civil action in a federal
district court for judicial review of the
decision.
*
*
*
*
*
4. Amend § 515.10 by revising the first
sentence to read as follows:
■
§ 515.10
Fees.
The Commission shall charge fees for
duplication of records under the Privacy
Act in the same way in which it charges
duplication fees under § 517.9 of this
chapter. * * *
Dated: July 14, 2017.
Jonodev O. Chaudhuri,
Chairman.
Kathryn Isom-Clause,
Vice Chair.
E. Sequoyah Simermeyer,
Commissioner.
[FR Doc. 2017–15499 Filed 7–24–17; 8:45 am]
BILLING CODE 7565–01–P
E:\FR\FM\25JYR1.SGM
25JYR1
]]>Agencies
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Rules and Regulations]
[Pages 34402-34403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15499]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF INTERIOR
National Indian Gaming Commission
25 CFR Part 515
RIN 3141-AA65
Privacy Act Procedures; Corrections
AGENCY: National Indian Gaming Commission, Department of Interior.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: 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:
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
[[Page 34403]]
Gaming Commission are necessary to meet congressional concerns
regarding gaming and to protect such gaming as a means of generating
tribal revenue. 25 U.S.C. 2702.
II. Corrections
25 CFR Part 515--Privacy Act Procedures
This document makes several correcting amendments to the
Commission's Privacy Act procedures. First, this document amends 25 CFR
515.7(c) to reflect that the correct timeframe for the Privacy Act
Appeals Officer to respond to an appeal is 20 working days rather than
30 working days. In 25 CFR 515.7(c) sentence one, the regulation
correctly refers to the twenty-working day period established in the
Commission's final rule. Then, in sentence two, the regulation
incorrectly refers to the same time period as a thirty working-day
period. The Commission addressed this change in its preamble to the
final rule and explained that this time period was being changed to
reflect the twenty working-day time period established within the
Freedom of Information Act. The second reference to this time period
was overlooked in the previous publication. This document also amends
25 CFR 515.3 to update the Commission's physical address. This document
also corrects a grammatical error in 25 CFR 515.7(c). Finally, it
amends a cross-reference contained in 25 CFR 515.10.
III. Certain Findings
Under the Administrative Procedure Act, a notice of proposed
rulemaking is not required when an agency, for good cause, finds that
notice and public comments are impractical, unnecessary, or contrary to
the public interest. Because the revisions here are technical in nature
and are not substantive, the NIGC is publishing a technical amendment.
IV. Regulatory Matters
Executive Order 13175
The National Indian Gaming Commission is committed to fulfilling
its tribal consultation obligations--whether directed by statute or
administrative action such as Executive Order 13175 (Consultation and
Coordination with Indian Tribal Governments)--by adhering to the
consultation framework described in its Consultation Policy published
on July 15, 2013. Due to the ministerial nature of the action being
taken here, consultation is not required under the NIGC's Consultation
Policy.
Regulatory Flexibility Act
This rule will not have a significant economic effect on a
substantial number of small entities as defined by the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq. Indian tribes are not considered
to be small entities for purposes of the Regulatory Flexibility Act.
Small Business Regulatory Enforcement Fairness Act
This rule is not a major rule under 5 U.S.C. 804(2), the Small
Business Regulatory Enforcement Fairness Act. This rule will not result
in an annual effect on the economy of $100 million per year or more.
This rule will not cause a major increase in costs or prices for
consumers, individual industries, federal, state, or local government
agencies, or geographic regions and does not have significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of U.S.-based enterprises to compete with
foreign-based enterprises.
Unfunded Mandates Reform Act
The Commission, as an independent regulatory agency, is exempt from
compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2
U.S.C. 658(1).
Takings
In accordance with Executive Order 12630, the Commission determined
the rule does not have significant takings implications. A takings
implication assessment is not required.
Civil Justice Reform Act
In accordance with Executive Order 12988, the Commission determined
the rule does not unduly burden the judicial system and meets the
requirements of sections 3(a) and 3(b)(2) of the Executive Order.
National Environmental Policy Act
The Commission determined this rule does not constitute a major
federal action significantly affecting the quality of the human
environment and that a detailed statement is not required pursuant to
the National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.
Paperwork Reduction Act
The rule does not contain any information collection requirements
for which Office of Management and Budget approval under the Paperwork
Reduction Act (44 U.S.C. 3501-3520) is required.
List of Subjects in 25 CFR Part 515
Administrative practice and procedure, Privacy, Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the NIGC amends 25 CFR
part 515 as follows:
PART 515--PRIVACY ACT PROCEDURES
0
1. The authority citation for part 515 continues to read as follows:
Authority: 5 U.S.C. 552a.
0
2. Amend Sec. 515.3 by revising the third sentence of paragraph (a) to
read as follows:
Sec. 517.3 Request for access to records.
(a) * * * The request may be made in person at 90 K Street NE.,
Suite 200, Washington, DC 20002 during the hours of 9 a.m. to 12 noon
and 2 p.m. to 5 p.m. Monday through Friday, in writing at NIGC Attn:
Privacy Act Office, 1849 C Street NW., Mail Stop #1621, Washington, DC
20240, or via electronic mail addressed to PARequests@nigc.gov.
* * * * *
0
3. Amend Sec. 515.7 by revising the second and sixth sentences of
paragraph (c) to read as follows:
Sec. 515.7 Appeals of initial adverse agency determination.
* * * * *
(c) * * * For good cause shown, however, the Privacy Act Appeals
Officer may extend the 20 day working period. * * * The response to the
appeal shall also advise of the right to institute a civil action in a
federal district court for judicial review of the decision.
* * * * *
0
4. Amend Sec. 515.10 by revising the first sentence to read as
follows:
Sec. 515.10 Fees.
The Commission shall charge fees for duplication of records under
the Privacy Act in the same way in which it charges duplication fees
under Sec. 517.9 of this chapter. * * *
Dated: July 14, 2017.
Jonodev O. Chaudhuri,
Chairman.
Kathryn Isom-Clause,
Vice Chair.
E. Sequoyah Simermeyer,
Commissioner.
[FR Doc. 2017-15499 Filed 7-24-17; 8:45 am]
BILLING CODE 7565-01-P
