Participation of a Person Described in Section 6103(n) in a Summons Interview Under Section 7602(a)(2) of the Internal Revenue Code, 34625-34626 [2014-14265]
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Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations
and the collections of information under
21 CFR part 801 have been approved
under OMB control number 0910–0485.
VII. Codification of Orders
Prior to the amendments by FDASIA,
section 513(e) of the FD&C Act provided
for FDA to issue regulations to reclassify
devices. Although section 513(e) of the
FD&C Act as amended requires FDA to
issue final orders rather than
regulations, FDASIA also provides for
FDA to revoke previously issued
regulations by order. FDA will continue
to codify classifications and
reclassifications in the Code of Federal
Regulations (CFR). Changes resulting
from final orders will appear in the CFR
as changes to codified classification
determinations or as newly codified
orders. Therefore, under section
513(e)(1)(A)(i) of the FD&C Act, as
amended by FDASIA, in this final order,
we are revoking the requirements in 21
CFR 872.3640 related to the
classification of blade-form endosseous
implants as class III devices and
codifying the reclassification of bladeform endosseous into class II.
List of Subjects in 21 CFR Part 872
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 872 is
amended as follows:
PART 872—DENTAL DEVICES
1. The authority citation for 21 CFR
part 872 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 872.3640 is amended by
revising paragraph (a) and (b)(2) to read
as follows:
■
ehiers on DSK2VPTVN1PROD with RULES
§ 872.3640
15:22 Jun 17, 2014
Jkt 232001
Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14216 Filed 6–17–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Endosseous dental implant.
(a) Identification. An endosseous
dental implant is a prescription device
made of a material such as titanium or
titanium alloy that is intended to be
surgically placed in the bone of the
upper or lower jaw arches to provide
support for prosthetic devices, such as
artificial teeth, in order to restore a
patient’s chewing function.
(b) * * *
(2) Classification. Class II (special
controls). The device is classified as
class II if it is a blade-form endosseous
dental implant. The special controls for
this device are:
(i) The design characteristics of the
device must ensure that the geometry
and material composition are consistent
with the intended use;
VerDate Mar<15>2010
(ii) Mechanical performance (fatigue)
testing under simulated physiological
conditions to demonstrate maximum
load (endurance limit) when the device
is subjected to compressive and shear
loads;
(iii) Corrosion testing under simulated
physiological conditions to demonstrate
corrosion potential of each metal or
alloy, couple potential for an assembled
dissimilar metal implant system, and
corrosion rate for an assembled
dissimilar metal implant system;
(iv) The device must be demonstrated
to be biocompatible;
(v) Sterility testing must demonstrate
the sterility of the device;
(vi) Performance testing to evaluate
the compatibility of the device in a
magnetic resonance (MR) environment;
(vii) Labeling must include a clear
description of the technological
features, how the device should be used
in patients, detailed surgical protocol
and restoration procedures, relevant
precautions and warnings based on the
clinical use of the device, and
qualifications and training requirements
for device users including technicians
and clinicians;
(viii) Patient labeling must contain a
description of how the device works,
how the device is placed, how the
patient needs to care for the implant,
possible adverse events and how to
report any complications; and
(ix) Documented clinical experience
must demonstrate safe and effective use
and capture any adverse events
observed during clinical use.
Internal Revenue Service
26 CFR Part 301
[TD 9669]
RIN 1545–BM25
Participation of a Person Described in
Section 6103(n) in a Summons
Interview Under Section 7602(a)(2) of
the Internal Revenue Code
Internal Revenue Service (IRS),
Treasury.
ACTION: Temporary regulations.
AGENCY:
This document contains
temporary regulations modifying
regulations promulgated under section
SUMMARY:
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34625
7602(a) of the Internal Revenue Code
relating to administrative summonses.
Specifically, these temporary
regulations clarify that persons with
whom the IRS or the Office of Chief
Counsel (Chief Counsel) contracts for
services described in section 6103(n)
and its implementing regulations may
be included as persons designated to
receive summoned books, papers,
records, or other data and to take
summoned testimony under oath. These
temporary regulations may affect
taxpayers, a taxpayer’s officers or
employees, and any third party who is
served with a summons, as well as any
other person entitled to notice of a
summons. The text of these temporary
regulations serves as the text of the
proposed regulations (REG–121542–14)
set forth in the notice of proposed
rulemaking on this subject in the
Proposed Rules section in this issue of
the Federal Register.
DATES: Effective Date: These regulations
are effective on June 18, 2014.
Applicability Date: For date of
applicability, see paragraph (d) of this
temporary regulation.
FOR FURTHER INFORMATION CONTACT: A M
Gulas at (202) 317–6834 (not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background and Explanation of
Provisions
These temporary regulations amend
Procedure and Administration
Regulations (26 CFR part 301)
promulgated under section 7602 of the
Internal Revenue Code. These
temporary regulations make clear that
persons described in section 6103(n)
and Treas. Reg. § 301.6103(n)–1(a) with
whom the IRS or Chief Counsel
contracts for services may receive books,
papers, records, or other data
summoned by the IRS and take
testimony of a person who the IRS has
summoned as a witness to provide
testimony under oath. While IRS
officers and employees remain
responsible for issuing summonses and
developing and conducting
examinations, the temporary regulations
clarify that contractors are permitted to
participate fully in a summons
interview. Full participation includes,
but is not limited to, receipt, review,
and use of summoned books, papers,
records, or other data, being present
during summons interviews,
questioning the person providing
testimony under oath, and asking a
summoned person’s representative to
clarify an objection or an assertion of
privilege.
E:\FR\FM\18JNR1.SGM
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ehiers on DSK2VPTVN1PROD with RULES
34626
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations
The assistance of persons from
outside the IRS or Chief Counsel
promotes efficient administration and
enforcement of laws administered by
the IRS, by providing specialized
knowledge, skills, or abilities that the
IRS officers or employees assigned to
the case may not possess. For example,
outside persons often assist the IRS in
matters involving transfer pricing. To
clarify the role of these outside persons,
these temporary regulations expressly
provide that when an IRS officer or
employee summons a taxpayer or other
witness to produce books, papers,
records, or other data and/or to give
testimony, an outside person hired by
the IRS or Chief Counsel authorized to
receive returns or return information
pursuant to section 6103(n) may receive
the summoned books, papers, records,
or other data and take the testimony of
the witness under oath.
When the IRS hires an outside person
to assist an IRS officer or employee to
review books and papers, analyze data,
or take testimony from a summoned
witness, the IRS will ensure that the
inherently governmental functions
associated with section 7602, for
example, deciding whether to issue a
summons, deciding whom to summon,
what information must be produced or
who will be required to testify, and
issuing the summons, will still be
performed by an IRS officer or
employee. The contractors’ role will be
limited to functions that are not
inherently governmental, such as taking
testimony by asking questions,
reviewing books or papers, or analyzing
other data. As a further safeguard, the
temporary regulations expressly provide
that any contractor that the IRS
authorizes to ask questions of a
summoned witness testifying under
oath must do so in the presence and
under the guidance of an IRS officer or
employee.
The conclusion that contractors may
receive summoned books and papers,
analyze data, and question summoned
witnesses is consistent with Treas. Reg.
§ 301.7602–2(c)(1)(i)(B) and (c)(1)(ii)
Example 2. Under those rules, which
implement the provision requiring
notice to the taxpayer of contacts by IRS
officers or employees with third parties,
contractors (in this case appraisers) are
treated in the same manner as IRS
officers or employees when they contact
industry experts to discuss a taxpayer’s
business.
The temporary regulations are
effective for summons interviews
conducted on or after June 18, 2014. The
applicability of the temporary
regulations will expire on June 16, 2017.
VerDate Mar<15>2010
15:22 Jun 17, 2014
Jkt 232001
Special Analyses
It has been determined that this
Treasury Decision is not a significant
regulatory action as defined in
Executive Order 12866, as
supplemented by Executive Order
13563. Therefore, a regulatory
assessment is not required. The IRS has
determined that sections 553(b) and (d)
of the Administrative Procedure Act (5
U.S.C. chapter 5) do not apply to these
regulations and because the regulations
do not impose a collection of
information on small entities, the
Regulatory Flexibility Act (5 U.S.C.
chapter 6) does not apply. Pursuant to
section 7805(f) of the Internal Revenue
Code, the IRS will submit these
temporary regulations to the Chief
Counsel for Advocacy of the Small
Business Administration for comments
about the regulations’ impact on small
business.
Drafting Information
The principal author of these
regulations is A M Gulas of the Office
of Associate Chief Counsel (Procedure
and Administration).
an IRS officer or employee, participate
fully in the interview of the witness
summoned by the IRS to provide
testimony under oath. Fully
participating in an interview includes,
but is not limited to, receipt, review,
and use of summoned books, papers,
records, or other data; being present
during summons interviews;
questioning the person providing
testimony under oath; and asking a
summoned person’s representative to
clarify an objection or assertion of
privilege.
(c) [Reserved]. For further guidance,
see § 301.7602–1(c).
(d) Effective/applicability date. This
section applies to summons interviews
conducted on or after June 18, 2014.
(e) Expiration date. The applicability
of this section expires on or before June
16, 2017.
Heather C. Maloy,
Acting Deputy Commissioner for Services and
Enforcement.
Approved: June 9, 2014
Mark J. Mazur,
Assistant Secretary of the Treasury (Tax
Policy).
List of Subjects in 26 CFR Part 301
[FR Doc. 2014–14265 Filed 6–17–14; 8:45 am]
Employment taxes, Estate taxes,
Excise taxes, Gift taxes, Income taxes,
Penalties, Reporting and recordkeeping
requirements.
BILLING CODE 4830–01–P
Adoption of Amendments to the
Regulations
Accordingly, 26 CFR part 301 is
amended as follows:
PART 301—PROCEDURE AND
ADMINISTRATION
Paragraph 1.
The authority citation for part 301
continues to read in part as follows:
■
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 301.7602–1T is added
to read as follows:
■
§ 301.7602–1T Examination of books and
witnesses (temporary).
(a) [Reserved]. For further guidance,
see § 301.7602–1(a).
(b) through (b)(2) [Reserved]. For
further guidance, see § 301.7602–1(b)
through (b)(2).
(b)(3) Participation of a person
described in section 6103(n). For
purposes of this paragraph (b), a person
authorized to receive returns or return
information under section 6103(n) and
§ 301.6103(n)–1(a) of the regulations
may receive and examine books, papers,
records, or other data produced in
compliance with the summons and, in
the presence and under the guidance of
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2013–0214]
Safety Zones; Recurring Events in
Captain of the Port Duluth Zone—Point
to LaPointe Swim
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the safety zone in 33 CFR 165.943 for
the Point to LaPointe Swim in LaPointe,
WI from 7:20 a.m. through 10 a.m. on
August 2, 2014. This action is necessary
to protect participants and spectators
during the Point to LaPointe swim.
During the enforcement period, entry
into, transiting, or anchoring within the
safety zone is prohibited unless
authorized by the Captain of the Port
Duluth or his designated on-scene
representative.
SUMMARY:
The regulations in 33 CFR
165.943(b) will be enforced from 7:20
a.m. through 10 a.m. on August 2, 2014,
for the Point to LaPointe Swim safety
zone, § 165.943(a)(7).
DATES:
E:\FR\FM\18JNR1.SGM
18JNR1
Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Rules and Regulations]
[Pages 34625-34626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14265]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 301
[TD 9669]
RIN 1545-BM25
Participation of a Person Described in Section 6103(n) in a
Summons Interview Under Section 7602(a)(2) of the Internal Revenue Code
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Temporary regulations.
-----------------------------------------------------------------------
SUMMARY: This document contains temporary regulations modifying
regulations promulgated under section 7602(a) of the Internal Revenue
Code relating to administrative summonses. Specifically, these
temporary regulations clarify that persons with whom the IRS or the
Office of Chief Counsel (Chief Counsel) contracts for services
described in section 6103(n) and its implementing regulations may be
included as persons designated to receive summoned books, papers,
records, or other data and to take summoned testimony under oath. These
temporary regulations may affect taxpayers, a taxpayer's officers or
employees, and any third party who is served with a summons, as well as
any other person entitled to notice of a summons. The text of these
temporary regulations serves as the text of the proposed regulations
(REG-121542-14) set forth in the notice of proposed rulemaking on this
subject in the Proposed Rules section in this issue of the Federal
Register.
DATES: Effective Date: These regulations are effective on June 18,
2014.
Applicability Date: For date of applicability, see paragraph (d) of
this temporary regulation.
FOR FURTHER INFORMATION CONTACT: A M Gulas at (202) 317-6834 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Background and Explanation of Provisions
These temporary regulations amend Procedure and Administration
Regulations (26 CFR part 301) promulgated under section 7602 of the
Internal Revenue Code. These temporary regulations make clear that
persons described in section 6103(n) and Treas. Reg. Sec. 301.6103(n)-
1(a) with whom the IRS or Chief Counsel contracts for services may
receive books, papers, records, or other data summoned by the IRS and
take testimony of a person who the IRS has summoned as a witness to
provide testimony under oath. While IRS officers and employees remain
responsible for issuing summonses and developing and conducting
examinations, the temporary regulations clarify that contractors are
permitted to participate fully in a summons interview. Full
participation includes, but is not limited to, receipt, review, and use
of summoned books, papers, records, or other data, being present during
summons interviews, questioning the person providing testimony under
oath, and asking a summoned person's representative to clarify an
objection or an assertion of privilege.
[[Page 34626]]
The assistance of persons from outside the IRS or Chief Counsel
promotes efficient administration and enforcement of laws administered
by the IRS, by providing specialized knowledge, skills, or abilities
that the IRS officers or employees assigned to the case may not
possess. For example, outside persons often assist the IRS in matters
involving transfer pricing. To clarify the role of these outside
persons, these temporary regulations expressly provide that when an IRS
officer or employee summons a taxpayer or other witness to produce
books, papers, records, or other data and/or to give testimony, an
outside person hired by the IRS or Chief Counsel authorized to receive
returns or return information pursuant to section 6103(n) may receive
the summoned books, papers, records, or other data and take the
testimony of the witness under oath.
When the IRS hires an outside person to assist an IRS officer or
employee to review books and papers, analyze data, or take testimony
from a summoned witness, the IRS will ensure that the inherently
governmental functions associated with section 7602, for example,
deciding whether to issue a summons, deciding whom to summon, what
information must be produced or who will be required to testify, and
issuing the summons, will still be performed by an IRS officer or
employee. The contractors' role will be limited to functions that are
not inherently governmental, such as taking testimony by asking
questions, reviewing books or papers, or analyzing other data. As a
further safeguard, the temporary regulations expressly provide that any
contractor that the IRS authorizes to ask questions of a summoned
witness testifying under oath must do so in the presence and under the
guidance of an IRS officer or employee.
The conclusion that contractors may receive summoned books and
papers, analyze data, and question summoned witnesses is consistent
with Treas. Reg. Sec. 301.7602-2(c)(1)(i)(B) and (c)(1)(ii) Example 2.
Under those rules, which implement the provision requiring notice to
the taxpayer of contacts by IRS officers or employees with third
parties, contractors (in this case appraisers) are treated in the same
manner as IRS officers or employees when they contact industry experts
to discuss a taxpayer's business.
The temporary regulations are effective for summons interviews
conducted on or after June 18, 2014. The applicability of the temporary
regulations will expire on June 16, 2017.
Special Analyses
It has been determined that this Treasury Decision is not a
significant regulatory action as defined in Executive Order 12866, as
supplemented by Executive Order 13563. Therefore, a regulatory
assessment is not required. The IRS has determined that sections 553(b)
and (d) of the Administrative Procedure Act (5 U.S.C. chapter 5) do not
apply to these regulations and because the regulations do not impose a
collection of information on small entities, the Regulatory Flexibility
Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of
the Internal Revenue Code, the IRS will submit these temporary
regulations to the Chief Counsel for Advocacy of the Small Business
Administration for comments about the regulations' impact on small
business.
Drafting Information
The principal author of these regulations is A M Gulas of the
Office of Associate Chief Counsel (Procedure and Administration).
List of Subjects in 26 CFR Part 301
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income
taxes, Penalties, Reporting and recordkeeping requirements.
Adoption of Amendments to the Regulations
Accordingly, 26 CFR part 301 is amended as follows:
PART 301--PROCEDURE AND ADMINISTRATION
0
Paragraph 1.
The authority citation for part 301 continues to read in part as
follows:
Authority: 26 U.S.C. 7805 * * *
0
Par. 2. Section 301.7602-1T is added to read as follows:
Sec. 301.7602-1T Examination of books and witnesses (temporary).
(a) [Reserved]. For further guidance, see Sec. 301.7602-1(a).
(b) through (b)(2) [Reserved]. For further guidance, see Sec.
301.7602-1(b) through (b)(2).
(b)(3) Participation of a person described in section 6103(n). For
purposes of this paragraph (b), a person authorized to receive returns
or return information under section 6103(n) and Sec. 301.6103(n)-1(a)
of the regulations may receive and examine books, papers, records, or
other data produced in compliance with the summons and, in the presence
and under the guidance of an IRS officer or employee, participate fully
in the interview of the witness summoned by the IRS to provide
testimony under oath. Fully participating in an interview includes, but
is not limited to, receipt, review, and use of summoned books, papers,
records, or other data; being present during summons interviews;
questioning the person providing testimony under oath; and asking a
summoned person's representative to clarify an objection or assertion
of privilege.
(c) [Reserved]. For further guidance, see Sec. 301.7602-1(c).
(d) Effective/applicability date. This section applies to summons
interviews conducted on or after June 18, 2014.
(e) Expiration date. The applicability of this section expires on
or before June 16, 2017.
Heather C. Maloy,
Acting Deputy Commissioner for Services and Enforcement.
Approved: June 9, 2014
Mark J. Mazur,
Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. 2014-14265 Filed 6-17-14; 8:45 am]
BILLING CODE 4830-01-P