Compliance and Enforcement, 4323-4324 [2013-00946]
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Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Rules and Regulations
(4) In addition to being shown to
comply with the other applicable
current good manufacturing practice
requirements listed under § 4.3, if the
combination product includes an HCT/
P, the current good manufacturing
practice operating system must also be
shown to implement and comply with
all current good tissue practice
requirements identified under § 4.3(d)
that would apply to that HCT/P if it
were not part of a combination product.
(c) During any period in which the
manufacture of a constituent part to be
included in a co-packaged or single
entity combination product occurs at a
separate facility from the other
constituent part(s) to be included in that
single-entity or co-packaged
combination product, the current good
manufacturing practice operating
system for that constituent part at that
facility must be demonstrated to comply
with all current good manufacturing
practice requirements applicable to that
type of constituent part.
(d) When two or more types of
constituent parts to be included in a
single-entity or co-packaged
combination product have arrived at the
same facility, or the manufacture of
these constituent parts is proceeding at
the same facility, application of a
current good manufacturing process
operating system that complies with
paragraph (b) of this section may begin.
(e) The requirements set forth in this
subpart and in parts 210, 211, 820, 600
through 680, and 1271 of this chapter
listed in § 4.3, supplement, and do not
supersede, each other unless the
regulations explicitly provide otherwise.
In the event of a conflict between
regulations applicable under this
subpart to combination products,
including their constituent parts, the
regulations most specifically applicable
to the constituent part in question shall
supersede the more general.
Subpart B [Reserved]
Dated: January 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–01068 Filed 1–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE INTERIOR
tkelley on DSK3SPTVN1PROD with
National Indian Gaming Commission
25 CFR Part 573
Compliance and Enforcement
National Indian Gaming
Commission, Interior.
AGENCY:
VerDate Mar<15>2010
17:36 Jan 18, 2013
Jkt 229001
ACTION:
Correcting amendments.
On August 9, 2012, the
National Indian Gaming Commission
(NIGC) published a final rule amending
its enforcement regulation to include a
graduated pre-enforcement process for
voluntary compliance. That rule
referenced a rule that was later
withdrawn and also incorrectly
referenced an internal citation. This
publication corrects the error and makes
technical amendments to reference the
Commission’s recently finalized appeal
rules contained in a new subchapter.
DATES: Effective: February 6, 2013.
FOR FURTHER INFORMATION CONTACT:
Maria Getoff, National Indian Gaming
Commission, 1441 L Street NW., Suite
9100, Washington, DC 20005. Email:
maria_getoff@nigc.gov; telephone: (202)
632–7003.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Indian Gaming Regulatory Act
(IGRA or Act), Public Law 100–497, 25
U.S.C. 2701 et seq., was signed into law
on October 17, 1988. The Act
establishes the National Indian Gaming
Commission (‘‘Commission’’) and sets
out a comprehensive framework for the
regulation of gaming on Indian lands.
The purposes of IGRA includes
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
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.
On August 9, 2012, the Commission
published a final rule amending part
573 (Compliance and Enforcement) to
include a graduated pre-enforcement
process through which a tribe may come
into voluntary compliance. 77 FR
47517, Aug. 9, 2012. The part also sets
forth general rules governing the
Commission’s enforcement of the IGRA,
NIGC regulations, and tribal ordinances
and resolutions approved by the Chair
under 25 CFR part 522.
On September 25, 2012, the
Commission published a final rule
consolidating all appeal proceedings
before the Commission into a new
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
4323
subchapter H (Appeal Proceedings
Before the Commission), thereby
removing former parts 524, 539, and
577. 77 FR 58941, Sept. 25, 2012. Thus,
any reference in part 573 to appeal
rights in former part 577 is obsolete and
must be revised to reference the new
subchapter H.
This document amends the final rule
by making two technical amendments
and a correction to the final rule to
accurately identify referenced
regulations. Specifically, this technical
amendment amends § 573.4(c)(3) and
§ 573.5(a) to accurately reference the
new subchapter H in place of part 577.
Also, this document corrects an error in
§ 573.2(c) by replacing a cross reference
to paragraph ‘‘(b)’’ with paragraph ‘‘(a).’’
Regulatory Matters
Regulatory Flexibility Act
The rule will not have a significant
impact on a substantial number of small
entities as defined under the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.
Moreover, Indian Tribes are not
considered to be small entities for the
purposes of the Regulatory Flexibility
Act.
Small Business Regulatory Enforcement
Fairness Act
The rule is not a major rule under 5
U.S.C. 804(2), the Small Business
Regulatory Enforcement Fairness Act.
The rule does not have an effect on the
economy of $100 million or more. The
rule will not cause a major increase in
costs or prices for consumers,
individual industries, Federal, State,
local government agencies or geographic
regions. Nor will the rule have a
significant adverse effect on
competition, employment, investment,
productivity, innovation, or the ability
of the enterprises, to compete with
foreign based enterprises.
Unfunded Mandate 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 has determined
that the rule does not have significant
takings implications. A takings
implication assessment is not required.
Civil Justice Reform
In accordance with Executive Order
12988, the Commission has determined
that the rule does not unduly burden the
judicial system and meets the
E:\FR\FM\22JAR1.SGM
22JAR1
4324
Federal Register / Vol. 78, No. 14 / Tuesday, January 22, 2013 / Rules and Regulations
requirements of sections 3(a) and 3(b)(2)
of the Order.
National Environmental Policy Act
The Commission has determined that
the rule does not constitute a major
federal action significantly affecting the
quality of the human environment and
that no detailed statement is required
pursuant to the National Environmental
Policy Act of 1969, 42 U.S.C. 4321, et
seq.
Paperwork Reduction Act
This rule does not require information
collection under the Paperwork
Reduction Act of 1995, 44 U.S.C. 2501,
et seq., and is therefore not subject to
review by the Office of Management and
Budget.
For the reasons discussed in the
Preamble, the Commission corrects its
regulations at 25 CFR part 573 as
follows:
1. The authority citation for part 573
continues to read as follows:
■
Occupational Safety and Health
Administration
29 CFR Part 1910
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Technical amendment.
AGENCY:
Authority: 25 U.S.C. 2706(b)(1); 2713; E.O.
13175, 65 FR 67249, 3 CFR 2000 Comp., p.
304.
2. In § 573.2, revise paragraph (c) to
read as follows:
■
§ 573.2 When may a letter of concern be
issued?
*
*
*
*
*
(c) A letter of concern issued under
paragraph (a) of this section must
provide a time period for the respondent
to respond. If the letter of concern is
resolved without enforcement action,
NIGC staff may send an investigation
completion letter pursuant to § 571.4 of
this chapter.
*
*
*
*
*
■ 3. In § 573.4, revise paragraph (c)(3) to
read as follows:
§ 573.4 When may the Chair issue an order
of temporary closure?
tkelley on DSK3SPTVN1PROD with
Dated: January 14, 2013, Washington, DC.
Tracie L. Stevens,
Chairwoman.
Daniel J. Little,
Associate Commissioner.
Occupational Exposure to Hazardous
Chemicals in Laboratories (NonMandatory Appendix); Technical
Amendment
PART 573—COMPLIANCE AND
ENFORCEMENT
*
*
*
*
(c) * * *
(3) Whether or not a respondent seeks
informal expedited review under this
paragraph, within thirty (30) days after
the Chair serves an order of temporary
closure the respondent may appeal the
order to the Commission under
subchapter H of this chapter. Otherwise,
Jkt 229001
*
*
*
*
(a) A respondent fails to appeal the
enforcement action as provided for in
subchapter H of this chapter and does
not enter into a settlement agreement
resolving the matter in its entirety; or
*
*
*
*
*
DEPARTMENT OF LABOR
Text of the Rules
17:36 Jan 18, 2013
*
BILLING CODE 7565–01–P
Enforcement, Enforcement actions,
Gambling, Gaming, Indians, Indian
gaming.
VerDate Mar<15>2010
§ 573.5 When does and enforcement
action become final agency action?
[FR Doc. 2013–00946 Filed 1–18–13; 8:45 am]
List of Subjects in 25 CFR Part 573
*
the order shall remain in effect unless
rescinded by the Chair for good cause.
■ 4. In § 573.5, revise paragraph (a) to
read as follows:
This document updates a
non-mandatory appendix in OSHA’s
Occupational Exposure to Hazardous
Chemicals in Laboratories Standard.
The non-mandatory appendix is being
updated to include the contents of the
latest National Academy of Sciences
publication entitled, ‘‘Prudent Practices
in the Laboratory: Handling and
Management of Chemical Hazards,’’
2011 edition. All revisions being made
are minor and non-substantive.
DATES: The effective date of this
technical amendment to the standard is
January 22, 2013.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Frank Meilinger,
Director, Office of Communications,
OSHA, U.S. Department of Labor, Room
N–3647, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone: (202)
693–1999.
General and technical information:
Andrew Levinson, OSHA Directorate of
Standards and Guidance, Office of
Biological Hazards, Room N–3718, U.S.
Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone: (202) 693–1950.
SUMMARY:
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Frm 00020
Fmt 4700
Sfmt 4700
SUPPLEMENTARY INFORMATION:
Background
When the OSHA Laboratory Standard
was published in 1990, the nonmandatory Appendix A was based on
the 1981 edition of ‘‘Prudent Practices
for Handling Hazardous Chemicals in
Laboratories’’ and the 1983 edition of
‘‘Prudent Practices for Disposal of
Chemicals from Laboratories,’’ both
published by National Academy Press.
Since then, there have been many
changes in the culture of safety in
laboratories. The National Academies of
Science (NAS) recognized these changes
and has revised and updated its earlier
‘‘Prudent Practices,’’ reflected in the
2011 edition of ‘‘Prudent Practices in
the Laboratory: Handling and
Management of Chemical Hazards’’
(National Academies Press). The 2011
edition of ‘‘Prudent Practices’’ is being
used by OSHA as the basis for nonmandatory Appendix A because of its
wide distribution and acceptance and
because of its preparation by recognized
authorities in the laboratory community.
OSHA has reviewed the 2011 edition
and collaborated with the NAS to revise
non-mandatory Appendix A. This new
revision addresses current laboratory
practices, security, and emergency
response, as well as promoting safe
handling of highly toxic and explosive
chemicals and their waste products.
Inapplicability of Public Notice and
Delayed Effective Date Requirements
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(3)(B), provides that, when an
Agency for good cause finds that notice
and public procedure are impracticable,
unnecessary or contrary to the public
interest, the Agency may issue a final
rule without providing notice and an
opportunity for public comment. OSHA
has determined that there is good cause,
pursuant to 5 U.S.C. 553(b)(3)(B),
Section 6(b) of the Occupational Safety
and Health Act of 1970 (29 U.S.C.
655(b)), and 29 CFR 1911.5, for making
this technical amendment final without
prior proposal and opportunity for
comment because the amendment does
not modify or revoke existing rights or
obligations, and does not establish new
rights or obligations. Its revisions are
non-mandatory and disseminated for
informational purposes only. For the
same reasons, the Agency finds good
cause under 5 U.S.C. 553(d)(3) to make
the amendments effective upon
publication.
List of Subjects in 29 CFR Part 1910
Occupational safety and health,
Laboratories.
E:\FR\FM\22JAR1.SGM
22JAR1
]]>Agencies
[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Rules and Regulations]
[Pages 4323-4324]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00946]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Part 573
Compliance and Enforcement
AGENCY: National Indian Gaming Commission, Interior.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: On August 9, 2012, the National Indian Gaming Commission
(NIGC) published a final rule amending its enforcement regulation to
include a graduated pre-enforcement process for voluntary compliance.
That rule referenced a rule that was later withdrawn and also
incorrectly referenced an internal citation. This publication corrects
the error and makes technical amendments to reference the Commission's
recently finalized appeal rules contained in a new subchapter.
DATES: Effective: February 6, 2013.
FOR FURTHER INFORMATION CONTACT: Maria Getoff, National Indian Gaming
Commission, 1441 L Street NW., Suite 9100, Washington, DC 20005. Email:
maria_getoff@nigc.gov; telephone: (202) 632-7003.
SUPPLEMENTARY INFORMATION:
I. Background
The Indian Gaming Regulatory Act (IGRA or Act), Public Law 100-497,
25 U.S.C. 2701 et seq., was signed into law on October 17, 1988. The
Act establishes the National Indian Gaming Commission (``Commission'')
and sets out a comprehensive framework for the regulation of gaming on
Indian lands. The purposes of IGRA includes 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 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.
On August 9, 2012, the Commission published a final rule amending
part 573 (Compliance and Enforcement) to include a graduated pre-
enforcement process through which a tribe may come into voluntary
compliance. 77 FR 47517, Aug. 9, 2012. The part also sets forth general
rules governing the Commission's enforcement of the IGRA, NIGC
regulations, and tribal ordinances and resolutions approved by the
Chair under 25 CFR part 522.
On September 25, 2012, the Commission published a final rule
consolidating all appeal proceedings before the Commission into a new
subchapter H (Appeal Proceedings Before the Commission), thereby
removing former parts 524, 539, and 577. 77 FR 58941, Sept. 25, 2012.
Thus, any reference in part 573 to appeal rights in former part 577 is
obsolete and must be revised to reference the new subchapter H.
This document amends the final rule by making two technical
amendments and a correction to the final rule to accurately identify
referenced regulations. Specifically, this technical amendment amends
Sec. 573.4(c)(3) and Sec. 573.5(a) to accurately reference the new
subchapter H in place of part 577. Also, this document corrects an
error in Sec. 573.2(c) by replacing a cross reference to paragraph
``(b)'' with paragraph ``(a).''
Regulatory Matters
Regulatory Flexibility Act
The rule will not have a significant impact on a substantial number
of small entities as defined under the Regulatory Flexibility Act, 5
U.S.C. 601, et seq. Moreover, Indian Tribes are not considered to be
small entities for the purposes of the Regulatory Flexibility Act.
Small Business Regulatory Enforcement Fairness Act
The rule is not a major rule under 5 U.S.C. 804(2), the Small
Business Regulatory Enforcement Fairness Act. The rule does not have an
effect on the economy of $100 million or more. The rule will not cause
a major increase in costs or prices for consumers, individual
industries, Federal, State, local government agencies or geographic
regions. Nor will the rule have a significant adverse effect on
competition, employment, investment, productivity, innovation, or the
ability of the enterprises, to compete with foreign based enterprises.
Unfunded Mandate 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 has
determined that the rule does not have significant takings
implications. A takings implication assessment is not required.
Civil Justice Reform
In accordance with Executive Order 12988, the Commission has
determined that the rule does not unduly burden the judicial system and
meets the
[[Page 4324]]
requirements of sections 3(a) and 3(b)(2) of the Order.
National Environmental Policy Act
The Commission has determined that the rule does not constitute a
major federal action significantly affecting the quality of the human
environment and that no detailed statement is required pursuant to the
National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.
Paperwork Reduction Act
This rule does not require information collection under the
Paperwork Reduction Act of 1995, 44 U.S.C. 2501, et seq., and is
therefore not subject to review by the Office of Management and Budget.
List of Subjects in 25 CFR Part 573
Enforcement, Enforcement actions, Gambling, Gaming, Indians, Indian
gaming.
Text of the Rules
For the reasons discussed in the Preamble, the Commission corrects
its regulations at 25 CFR part 573 as follows:
PART 573--COMPLIANCE AND ENFORCEMENT
0
1. The authority citation for part 573 continues to read as follows:
Authority: 25 U.S.C. 2706(b)(1); 2713; E.O. 13175, 65 FR 67249,
3 CFR 2000 Comp., p. 304.
0
2. In Sec. 573.2, revise paragraph (c) to read as follows:
Sec. 573.2 When may a letter of concern be issued?
* * * * *
(c) A letter of concern issued under paragraph (a) of this section
must provide a time period for the respondent to respond. If the letter
of concern is resolved without enforcement action, NIGC staff may send
an investigation completion letter pursuant to Sec. 571.4 of this
chapter.
* * * * *
0
3. In Sec. 573.4, revise paragraph (c)(3) to read as follows:
Sec. 573.4 When may the Chair issue an order of temporary closure?
* * * * *
(c) * * *
(3) Whether or not a respondent seeks informal expedited review
under this paragraph, within thirty (30) days after the Chair serves an
order of temporary closure the respondent may appeal the order to the
Commission under subchapter H of this chapter. Otherwise, the order
shall remain in effect unless rescinded by the Chair for good cause.
0
4. In Sec. 573.5, revise paragraph (a) to read as follows:
Sec. 573.5 When does and enforcement action become final agency
action?
* * * * *
(a) A respondent fails to appeal the enforcement action as provided
for in subchapter H of this chapter and does not enter into a
settlement agreement resolving the matter in its entirety; or
* * * * *
Dated: January 14, 2013, Washington, DC.
Tracie L. Stevens,
Chairwoman.
Daniel J. Little,
Associate Commissioner.
[FR Doc. 2013-00946 Filed 1-18-13; 8:45 am]
BILLING CODE 7565-01-P
