Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction, 89848-89849 [2016-29774]
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Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Rules and Regulations
specifically authorized to do so by the
General Counsel, the employee must
not:
(1) Disclose classified, confidential or
privileged information; or
(2) For a current USTR employee,
testify as an expert or opinion witness
with regard to any matter arising out of
the employee’s official duties or USTR’s
mission or functions, unless testimony
is provided on behalf of the United
States. A former employee can provide
expert or opinion testimony where the
testimony involves only general
expertise gained while employed as a
USTR employee.
§ 2004.35 Processing demands and
requests.
§ 2004.37 Restrictions that apply to
released records and information.
(a) The General Counsel will review a
request or demand to produce or
disclose records, information or
testimony and determine whether, or
under what conditions, to authorize the
employee to testify regarding USTR
matters or produce records and
information. The General Counsel will
notify the requester of the final
determination, the reasons for the grant
or denial of the demand or request, and
any conditions on disclosure.
(b) When necessary, the General
Counsel will coordinate with the U.S.
Department of Justice to file appropriate
motions, including motions to remove
the matter to Federal court, to quash, or
to obtain a protective order.
(c) The General Counsel will process
demands and requests in the order in
which they are received. Absent
unusual circumstances and depending
on the scope of the demand or request,
the General Counsel will respond
within 45 calendar days of the date
USTR receives all information necessary
to evaluate the demand or request.
(a) The General Counsel may impose
conditions or restrictions on the release
of records and information, including
requiring the parties to the legal
proceeding to obtain a protective order
or to execute a confidentiality
agreement to limit access and further
disclosure. The terms of a protective
order or confidentiality agreement must
be acceptable to the General Counsel. In
cases where protective orders or
confidentiality agreements already have
been executed, USTR may condition the
release of records and information on an
amendment to the existing protective
order or confidentiality agreement.
(b) If the General Counsel so
determines, USTR may present original
records for examination in response to
a demand or request, but the records
cannot be marked or altered or
presented as evidence or otherwise used
in a manner by which they could lose
their status as original records. In lieu
of original records, certified copies will
be presented for evidentiary purposes.
(See 28 U.S.C. 1733).
§ 2004.36 Restrictions that apply to
testimony.
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(d) Limits. The General Counsel will
limit any authorization for testimony to
the scope of the demand, and the scope
of permissible production of records
and information to that set forth in the
written authorization.
(e) Failure to meet requirements and
exceptions. USTR may oppose any
demand or request that does not meet
the requirements set forth in this
subpart. The General Counsel may grant
exceptions to the requirements in this
subpart upon a showing of compelling
need, to promote a significant interest of
USTR or the United States, or for other
good cause.
§ 2004.38
(a) The General Counsel may impose
conditions or restrictions on the
testimony of USTR employees
including, for example, limiting the
scope of testimony or requiring the
requester and other parties to the legal
proceeding to agree that the testimony
transcript will be kept under seal or will
only be used or made available in the
particular legal proceeding for which
testimony was requested. The General
Counsel also may require a copy of the
testimony transcript at the requester’s
expense.
(b) USTR may offer the employee’s
written declaration in lieu of testimony.
(c) If authorized to testify pursuant to
this subpart, an employee may testify as
to relevant facts within his or her
personal knowledge, but, unless
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§ 2004.39
Fees.
(a) USTR may condition the
production of records, information or an
employee’s appearance on advance
payment of reasonable costs, which may
include but are not limited to those
associated with employee search time,
copying, computer usage, and
certifications.
(b) Witness fees will include fees,
expenses and allowances prescribed by
the rules applicable to the particular
legal proceeding. If no fees are
prescribed, USTR will base fees on the
rule of the federal district court closest
to the location where the witness will
appear. Such fees may include but are
not limited to time for preparation,
travel and attendance at the legal
proceeding.
Janice Kaye,
Chief Counsel for Administrative Law, Office
of the U.S. Trade Representative.
[FR Doc. 2016–29875 Filed 12–12–16; 8:45 am]
BILLING CODE 3290–F7–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 20, 201, 207, 314, 514,
515, 601, 607, and 1271
[Docket No. FDA–2005–N–0464 (Formerly
Docket No. 2005N–0403)]
In the event of an adverse ruling.
(a) Notwithstanding USTR’s rejection
of a demand or request for records,
information or testimony, if a court or
other competent authority orders a
USTR employee to comply with the
demand, the employee promptly must
notify the General Counsel of the order,
and must respectfully decline to
comply, citing United States ex rel.
Touhy v. Ragen, 340 U.S. 462 (1951).
(b) To seek reconsideration of USTR’s
rejection of a demand or request, or of
any restrictions on receiving records,
information or testimony, a requester
must send a petition for reconsideration
in accordance with § 2004.34(a) within
10 days of the date of the determination.
The petition must contain a clear and
concise statement of the basis for the
reconsideration with supporting
authorities. Determinations about
PO 00000
petitions for reconsideration are within
the discretion of the United States Trade
Representative or his/her designee, and
are final.
(c) Pursuant to section 704 of the
Administrative Procedure Act, 5 U.S.C.
704, a petition for reconsideration of a
final determination under this section is
a prerequisite to judicial review.
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Requirements for Foreign and
Domestic Establishment Registration
and Listing for Human Drugs,
Including Drugs That Are Regulated
Under a Biologics License Application,
and Animal Drugs; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule; correction.
The Food and Drug
Administration (FDA) is correcting a
final rule entitled ‘‘Requirements for
Foreign and Domestic Establishment
Registration and Listing for Human
Drugs, Including Drugs That Are
Regulated Under a Biologics License
Application, and Animal Drugs’’ that
appeared in the Federal Register of
August 31, 2016 (81 FR 60169). That
final rule amended current regulations
SUMMARY:
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Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Rules and Regulations
concerning who must register
establishments and list human drugs,
human drugs that are also biological
products, and animal drugs. The final
rule was published with an incorrect
statement in the preamble about the
rule’s effect on establishments at which
investigational drugs are manufactured.
This document corrects that error.
DATES:
Effective December 13, 2016.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6254, Silver Spring,
MD 20993–0002, 301–796–2242.
In the
Federal Register of August 31, 2016 (81
FR 60169), FDA published the final rule
‘‘Requirements for Foreign and
Domestic Establishment Registration
and Listing for Human Drugs, Including
Drugs That Are Regulated Under a
Biologics License Application, and
Animal Drugs.’’ The final rule published
with an incorrect statement in the
preamble about the rule’s effect on
establishments at which investigational
drugs are manufactured. Under the
amended regulations, manufacturers,
repackers, relabelers, or salvagers who
manufacture, repack, relabel, or salvage
drugs solely for use in research,
teaching, or chemical analysis and not
for sale are exempt from the
establishment registration requirement
under 21 CFR 207.13(e) if they do not
engage in other activities that require
them to register.
In the Federal Register of August 31,
2016, in FR Doc. 2016–20471, the
following correction is made: On page
60185, in the first column, in the third
paragraph under ‘‘2. When must initial
registration information be provided?
(§ 207.21),’’ the following sentence is
removed: ‘‘Accordingly, an
establishment at which an
investigational drug is manufactured is
subject to the establishment registration
requirement.’’
SUPPLEMENTARY INFORMATION:
Dated: December 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–29774 Filed 12–12–16; 8:45 am]
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BILLING CODE 4164–01–P
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 301
[TD 9796]
RIN 1545–BM94
Treatment of Certain Domestic Entities
Disregarded as Separate From Their
Owners as Corporations for Purposes
of Section 6038A
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
This document contains final
regulations that treat a domestic
disregarded entity wholly owned by a
foreign person as a domestic corporation
separate from its owner for the limited
purposes of the reporting, record
maintenance and associated compliance
requirements that apply to 25 percent
foreign-owned domestic corporations
under section 6038A of the Internal
Revenue Code.
DATES: Effective date: These regulations
are effective December 13, 2016.
Applicability date: For dates of
applicability, see §§ 1.6038A–1(n)(1)
and (2) and 301.7701–2(e)(9).
FOR FURTHER INFORMATION CONTACT:
Ronald M. Gootzeit, (202) 317–6937 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Paperwork Reduction Act
The collection of information
contained in these final regulations has
been previously reviewed and approved
by the Office of Management and
Budget in accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)) under control number
1545–1191. The estimated average
annual recordkeeping burden per
recordkeeper is 10 hours. The estimated
reporting burden is being reported
under Form 5472 (OMB #1545–0123).
The collection of information in these
final regulations is in §§ 1.6038A–2 and
1.6038A–3. This information will
enhance the United States’ compliance
with international standards of
transparency and exchange of
information for tax purposes and will
strengthen the enforcement of U.S. tax
laws. The likely respondents are
foreign-owned domestic entities that are
disregarded as separate from their
owners.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
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89849
number assigned by the Office of
Management and Budget.
Books or records relating to a
collection of information must be
retained as long as their contents may
become material in the administration
of any internal revenue law. Generally,
tax returns and tax return information
are confidential, as required by 26
U.S.C. 6103.
Background and Explanation of
Provisions
On May 10, 2016, the Department of
the Treasury (Treasury Department) and
the Internal Revenue Service (IRS)
published in the Federal Register a
notice of proposed rulemaking (REG–
127199–15; 81 FR 28784) under sections
6038A and 7701 (the proposed
regulations). The proposed regulations
would treat a domestic disregarded
entity wholly owned by a foreign person
as a domestic corporation separate from
its owner for the limited purposes of the
reporting, record maintenance and
associated compliance requirements
that apply to 25 percent foreign-owned
domestic corporations under section
6038A of the Internal Revenue Code.
The proposed regulations would have
applied to taxable years of the entities
described in § 301.7701–2(c)(2)(vi)
ending on or after the date that is 12
months after the date of publication of
the Treasury decision adopting the
proposed rules as final regulations in
the Federal Register.
In addition to generally soliciting
comments on all aspects of the proposed
rules, the preamble to the proposed
regulations specifically requested
comments on possible alternative
methods for reporting a domestic
disregarded entity’s transactions in
cases in which the foreign owner of the
domestic disregarded entity already has
an obligation to report the income
resulting from those transactions—for
example, transactions resulting in
income effectively connected with the
conduct of a U.S. trade or business.
No written comments on the proposed
regulations were received, and no
public hearing was requested or held.
However, these final regulations reflect
a limited number of changes by the
Treasury Department and the IRS to the
proposed regulations.
First, it was and remains the intent of
the Treasury Department and the IRS
that the generally applicable exceptions
to the requirements of section 6038A
should not apply to a domestic
disregarded entity that is wholly owned
by a foreign person. Accordingly, the
proposed regulations provided that the
exceptions to the record maintenance
requirements in § 1.6038A–1(h) and (i)
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]]>Agencies
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Rules and Regulations]
[Pages 89848-89849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29774]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271
[Docket No. FDA-2005-N-0464 (Formerly Docket No. 2005N-0403)]
Requirements for Foreign and Domestic Establishment Registration
and Listing for Human Drugs, Including Drugs That Are Regulated Under a
Biologics License Application, and Animal Drugs; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule entitled ``Requirements for Foreign and Domestic Establishment
Registration and Listing for Human Drugs, Including Drugs That Are
Regulated Under a Biologics License Application, and Animal Drugs''
that appeared in the Federal Register of August 31, 2016 (81 FR 60169).
That final rule amended current regulations
[[Page 89849]]
concerning who must register establishments and list human drugs, human
drugs that are also biological products, and animal drugs. The final
rule was published with an incorrect statement in the preamble about
the rule's effect on establishments at which investigational drugs are
manufactured. This document corrects that error.
DATES: Effective December 13, 2016.
FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-2242.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 31, 2016
(81 FR 60169), FDA published the final rule ``Requirements for Foreign
and Domestic Establishment Registration and Listing for Human Drugs,
Including Drugs That Are Regulated Under a Biologics License
Application, and Animal Drugs.'' The final rule published with an
incorrect statement in the preamble about the rule's effect on
establishments at which investigational drugs are manufactured. Under
the amended regulations, manufacturers, repackers, relabelers, or
salvagers who manufacture, repack, relabel, or salvage drugs solely for
use in research, teaching, or chemical analysis and not for sale are
exempt from the establishment registration requirement under 21 CFR
207.13(e) if they do not engage in other activities that require them
to register.
In the Federal Register of August 31, 2016, in FR Doc. 2016-20471,
the following correction is made: On page 60185, in the first column,
in the third paragraph under ``2. When must initial registration
information be provided? (Sec. 207.21),'' the following sentence is
removed: ``Accordingly, an establishment at which an investigational
drug is manufactured is subject to the establishment registration
requirement.''
Dated: December 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29774 Filed 12-12-16; 8:45 am]
BILLING CODE 4164-01-P
