Advisory Committee; Food Advisory Committee; Termination, 58553-58554 [2017-26829]
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Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
any report containing information
which is determined to be necessary to
carry out the surveys and studies
provided for by the Act; and
(c) Persons not notified in writing of
their filing obligation by the Bureau of
Economic Analysis are not required to
complete the survey.
■ 3. Add § 801.10 to read as follows:
sradovich on DSK3GMQ082PROD with RULES
§ 801.10 Rules and regulations for BE–12,
Benchmark Survey of Foreign Direct
Investment in the United States—2017.
A BE–12, Benchmark Survey of
Foreign Direct Investment in the United
States, will be conducted covering 2017.
All legal authorities, provisions,
definitions, and requirements contained
in §§ 801.1 through 801.2 and §§ 801.4
through 801.6 are applicable to this
survey. Specific additional rules and
regulations for the BE–12 survey are
given in paragraphs (a) through (e) of
this section. More detailed instructions
are given on the report forms and
instructions.
(a) Response required. A response is
required from persons subject to the
reporting requirements of the BE–12,
Benchmark Survey of Foreign Direct
Investment in the United States—2017,
contained in this section, whether or not
they are contacted by BEA. Also, a
person, or their agent, contacted by BEA
about reporting in this survey, either by
sending them a report form or a written
inquiry, must respond in writing
pursuant to this section. This may be
accomplished by filing a properly
completed BE–12 report (BE–12A, BE–
12B, BE–12C, or BE–12 Claim for Not
Filing);
(b) Who must report. A BE–12 report
is required for each U.S. affiliate (except
certain private funds as described
below), that is, for each U.S. business
enterprise in which a foreign person
(foreign parent) owned or controlled,
directly or indirectly, 10 percent or
more of the voting securities in an
incorporated U.S. business enterprise,
or an equivalent interest in an
unincorporated U.S. business
enterprise, at the end of the business
enterprise’s fiscal year that ended in
calendar year 2017. Certain private
funds are exempt from reporting on the
BE–12 survey. If a U.S. business meets
ALL of the following 3 criteria, it is not
required to file any BE–12 report except
to indicate exemption from the survey if
contacted by BEA: (1) The U.S. business
enterprise is a private fund; (2) the
private fund does not own, directly or
indirectly through another business
enterprise, an ‘‘operating company’’—
i.e., a business enterprise that is not a
private fund or a holding company—in
which the foreign parent owns at least
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15:49 Dec 12, 2017
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10 percent of the voting interest; AND
(3) if the foreign parent owns the private
fund indirectly (through one or more
other U.S. business enterprises), there
are no U.S. ‘‘operating companies’’
between the foreign parent and the
indirectly-owned private fund.
(c) Forms to be filed. (1) Form BE–12A
must be completed by a U.S. affiliate
that was majority-owned by one or more
foreign parents (for purposes of this
survey, a ‘‘majority-owned’’ U.S.
affiliate is one in which the combined
direct and indirect ownership interest of
all foreign parents of the U.S. affiliate
exceeds 50 percent) if, on a fully
consolidated basis, or, in the case of real
estate investment, on an aggregated
basis, any one of the following three
items for the U.S. affiliate (not just the
foreign parent’s share) was greater than
$300 million (positive or negative) at the
end of, or for, its fiscal year that ended
in calendar year 2017:
(i) Total assets (do not net out
liabilities);
(ii) Sales or gross operating revenues,
excluding sales taxes; or
(iii) Net income after provision for
U.S. income taxes.
(2) Form BE–12B must be completed
by:
(i) A majority-owned U.S. affiliate if,
on a fully consolidated basis, or, in the
case of real estate investment, on an
aggregated basis, any one of the three
items listed in paragraph (c)(1) of this
section (not just the foreign parent’s
share), was greater than $60 million
(positive or negative) but none of these
items was greater than $300 million
(positive or negative) at the end of, or
for, its fiscal year that ended in calendar
year 2017.
(ii) A minority-owned U.S. affiliate
(for purposes of this survey, a
‘‘minority-owned’’ U.S. affiliate is one
in which the combined direct and
indirect ownership interest of all foreign
parents of the U.S. affiliate is 50 percent
or less) if, on a fully consolidated basis,
or, in the case of real estate investment,
on an aggregated basis, any one of the
three items listed in paragraph (c)(1) of
this section (not just the foreign parent’s
share), was greater than $60 million
(positive or negative) at the end of, or
for, its fiscal year that ended in calendar
year 2017.
(3) Form BE–12C must be completed
by a U.S. affiliate if, on a fully
consolidated basis, or, in the case of real
estate investment, on an aggregated
basis, none of the three items listed in
paragraph (c)(1) of this section for a U.S.
affiliate (not just the foreign parent’s
share), was greater than $60 million
(positive or negative) at the end of, or
PO 00000
Frm 00021
Fmt 4700
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58553
for, its fiscal year that ended in calendar
year 2017.
(4) BE–12 Claim for Not Filing will be
provided for response by persons that
are not subject to the reporting
requirements of the BE–12 survey but
have been contacted by BEA concerning
their reporting status.
(d) Aggregation of real estate
investments. All real estate investments
of a foreign person must be aggregated
for the purpose of applying the
reporting criteria. A single report form
must be filed to report the aggregate
holdings, unless written permission has
been received from BEA to do
otherwise. Those holdings not
aggregated must be reported separately
on the same type of report that would
have been required if the real estate
holdings were aggregated.
(e) Due date. A fully completed and
certified Form BE–12A, BE–12B, BE–
12C, or BE–12 Claim for Not Filing is
due to be filed with BEA not later than
May 31, 2018 (or by June 30, 2018 for
reporting companies that use BEA’s
eFile system).
[FR Doc. 2017–26887 Filed 12–12–17; 8:45 am]
BILLING CODE 3510–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA–2017–N–6379]
Advisory Committee; Food Advisory
Committee; Termination
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is announcing the
termination of the Food Advisory
Committee. This document removes the
Food Advisory Committee from the
Agency’s list of standing advisory
committees.
DATES: This rule is effective December
13, 2017.
FOR FURTHER INFORMATION CONTACT:
Karen Strambler, Center for Food Safety
and Applied Nutrition (CFSAN), Food
and Drug Administration, 5001 Campus
Dr., Rm. 1C–008, College Park, MD
20740, 240–402–2589, Fax: 301–436–
2637, karen.strambler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Food
Advisory Committee (the Committee)
was established on March 6, 1992 (57
FR 8064). The Committee provides
advice to the Commissioner of Food and
SUMMARY:
E:\FR\FM\13DER1.SGM
13DER1
58554
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Rules and Regulations
Drugs and other appropriate officials on
emerging food and cosmetic safety, food
science, nutrition, and other foodrelated health issues that FDA considers
of primary importance for its food and
cosmetics programs. The Committee
may also be asked to provide advice and
make recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
The Committee is no longer needed
and will be terminated on December 12,
2017. Over the past several years, the
Committee has met very infrequently,
and the effort and expense of
maintaining the Committee are no
longer justified. Any relevant food
issues in the future could be addressed
by FDA’s Science Board and/or FDA’s
Risk Communication Advisory
Committee, with additional
augmentation of expertise by
appropriate subject matter experts
serving as temporary members on either
of those committees. In addition,
CFSAN will continue to hold
workshops, meetings, conferences, and
webinars to engage with its
stakeholders.
Under 5 U.S.C. 553(b)(3)(B) and (d)
and 21 CFR 10.40(d) and (e), the Agency
finds good cause to dispense with notice
and public comment procedures and to
proceed to an immediate effective date
on this rule. Notice and public comment
and a delayed effective date are
unnecessary because the Committee is
not being adequately used, and the final
rule merely removes the name of the
Food Advisory Committee from the list
of standing advisory committees in
§ 14.100 (21 CFR 14.100).
Therefore, the Agency is amending
§ 14.100(f) as set forth in the regulatory
text of the document.
List of Subjects in 21 CFR Part 14
Administrative practice and
procedure, Advisory committee, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
of the availability of summaries of the
basis of approval and of environmental
review documents, where applicable.
The animal drug regulations are also
being amended to make technical
amendments to improve the accuracy of
the regulations.
This rule is effective December
13, 2017.
DATES:
1. The authority citation for part 14
continues to read as follows:
FOR FURTHER INFORMATION CONTACT:
Authority: 5 U.S.C. App. 2; 15 U.S.C 1451–
1461, 21 U.S.C. 41–50, 141–149, 321–394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155; Pub. L. 113–54.
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
■
§ 14.100
[Amended]
SUPPLEMENTARY INFORMATION:
2. Section 14.100 is amended by
removing paragraph (f).
■
I. Approval Actions
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26829 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
and 558
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for a
new animal drug application (NADA)
and abbreviated new animal drug
applications (ANADAs) during May and
June 2017. FDA is informing the public
SUMMARY:
FDA is amending the animal drug
regulations to reflect approval actions
for a NADA and ANADAs during May
and June 2017, as listed in table 1. In
addition, FDA is informing the public of
the availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents may be
seen in the Dockets Management Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday. Persons with access to the
internet may obtain these documents at
the CVM FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/ApprovedAnimalDrug
Products/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2017
Approval date
File No.
055–099
June 21, 2017 ...........
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May 23, 2017 ............
141–338
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15:49 Dec 12, 2017
Sponsor
Product name
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Jkt 244001
PO 00000
Species
CLAVAMOX (amoxicillin
Dogs and cats ......
and clavulanate potassium tablets) Chewables.
INTERCEPTOR SPECDogs .....................
TRUM (milbemycin
oxime/ praziquantel)
Chewable Tablets.
Frm 00022
Fmt 4700
Sfmt 4700
E:\FR\FM\13DER1.SGM
Effect of the action
Supplemental approval of
a chewable tablet form
of the approved tablet.
Supplemental approval for
the treatment and control of adult tapeworm
(Dipylidium caninum) infections in dogs and
puppies 2 pounds of
body weight or greater
and 6 weeks of age and
older.
13DER1
Public
documents
FOI Summary.
FOI Summary.
]]>Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58553-58554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26829]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2017-N-6379]
Advisory Committee; Food Advisory Committee; Termination
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
termination of the Food Advisory Committee. This document removes the
Food Advisory Committee from the Agency's list of standing advisory
committees.
DATES: This rule is effective December 13, 2017.
FOR FURTHER INFORMATION CONTACT: Karen Strambler, Center for Food
Safety and Applied Nutrition (CFSAN), Food and Drug Administration,
5001 Campus Dr., Rm. 1C-008, College Park, MD 20740, 240-402-2589, Fax:
301-436-2637, [email protected].
SUPPLEMENTARY INFORMATION: The Food Advisory Committee (the Committee)
was established on March 6, 1992 (57 FR 8064). The Committee provides
advice to the Commissioner of Food and
[[Page 58554]]
Drugs and other appropriate officials on emerging food and cosmetic
safety, food science, nutrition, and other food-related health issues
that FDA considers of primary importance for its food and cosmetics
programs. The Committee may also be asked to provide advice and make
recommendations on ways of communicating to the public the potential
risks associated with these issues and on approaches that might be
considered for addressing the issues.
The Committee is no longer needed and will be terminated on
December 12, 2017. Over the past several years, the Committee has met
very infrequently, and the effort and expense of maintaining the
Committee are no longer justified. Any relevant food issues in the
future could be addressed by FDA's Science Board and/or FDA's Risk
Communication Advisory Committee, with additional augmentation of
expertise by appropriate subject matter experts serving as temporary
members on either of those committees. In addition, CFSAN will continue
to hold workshops, meetings, conferences, and webinars to engage with
its stakeholders.
Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e),
the Agency finds good cause to dispense with notice and public comment
procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary
because the Committee is not being adequately used, and the final rule
merely removes the name of the Food Advisory Committee from the list of
standing advisory committees in Sec. 14.100 (21 CFR 14.100).
Therefore, the Agency is amending Sec. 14.100(f) as set forth in
the regulatory text of the document.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committee, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
1. The authority citation for part 14 continues to read as follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C 1451-1461, 21 U.S.C. 41-50,
141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C.
201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. L. 113-
54.
Sec. 14.100 [Amended]
0
2. Section 14.100 is amended by removing paragraph (f).
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26829 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P
