Medical Device Classification Procedures; Reclassification Petition: Content and Form; Technical Amendment, 77387-77388 [2014-30141]
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Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Rules and Regulations
constituent amino acids, phenylalanine
and aspartic acid, and a small amount
of methanol. By contrast, the primary
metabolite of advantame is the deesterified form of advantame, namely N[N-[3-(3-hydroxy-4methoxyphenyl)propyl]-a-aspartyl]-Lphenylalanine. Because chemically
these two sweeteners are different
compounds, FDA’s safety decision on
advantame was based solely on studies
conducted on advantame. Therefore, we
did not consider the health effects of
aspartame in our safety decision on
advantame.
Regarding concerns about possible
effects of advantame on the
hypothalamus, the hypothalamus is
involved with endocrine control via the
pituitary gland. Therefore, any longlasting hypothalamic changes would
affect the pituitary gland. For this
reason, we recommend in our guidance
‘‘Toxicological Principles for the Safety
Assessment of Direct Food Additives
and Color Additives Used in Food’’ that
the pituitary gland from subchronic and
long-term animal studies be assessed for
treatment-related changes. Consistent
with our guidance, the pituitary gland
was one of the organs evaluated in the
animal studies on advantame that were
considered in the final rule, and there
was no evidence of toxicologically
significant changes.
As previously noted, NRDC has
requested that we withdraw our
approval of advantame until we
examine the brain tissues from the key
advantame animal studies that were
preserved for alteration of the
hypothalamus and fully consider the
implications on a child’s developing
brain. NRDC has claimed that several
studies on a different substance showed
effects on the hypothalamus, but has not
provided any information to support its
view that additional histopathological
examination of brain tissue samples is
necessary to establish the safety of
advantame. During our evaluation of the
advantame petition, we thoroughly
reviewed all of the data provided by the
petitioner on the safety of advantame,
including the results from a twogeneration study in rats, a chronic (52week) dog study, a 104-week mouse
carcinogenicity study, and a combined
104-week rat carcinogenicity feeding
study with in utero and chronic (52week) phases, which included extensive
histological evaluations of the brain,
including the hypothalamus. In
evaluating these studies, we applied the
appropriate safety factors to extrapolate
the findings from these animal studies
to humans as required by section
409(c)(5) of the FD&C Act. We also
considered the potential intake of
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16:05 Dec 23, 2014
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advantame at both the mean and 90th
percentile of consumption for various
age groups, including children. Based
on this exposure and toxicological
information, the estimated levels of
daily intake for even high consumers of
advantame were far below
(approximately 200 times) the
acceptable daily intake level,
establishing that advantame is safe for
the general population, including
children.
NRDC’s objection to the advantame
final rule does not provide any new
evidence or identify any evidence that
we overlooked in our evaluation that
would call into question FDA’s
determination of safety for advantame.
Moreover, NRDC has not provided a
basis for concluding that the
information we evaluated is inadequate
to support a finding that the use of
advantame as a non-nutritive sweetener
in food is safe. Therefore, this objection
does not provide a basis for us to
reconsider our decision to issue the
final rule on advantame.
IV. Summary and Conclusion
Section 409 of the FD&C Act requires
that a food additive be shown to be safe
before marketing. Under 21 CFR
170.3(i), a food additive is ‘‘safe’’ if
‘‘there is a reasonable certainty in the
minds of competent scientists that the
substance is not harmful under the
intended conditions of use.’’ In our May
21, 2014, final rule approving the use of
advantame, we concluded that the data
presented by the petitioner to establish
safety of the additive demonstrate that
advantame is safe for its intended use in
food.
The petitioner has the burden to
demonstrate the safety of the additive to
gain FDA approval. However, once we
make a finding of safety, the burden
shifts to an objector, who must come
forward with evidence that calls into
question our conclusion (see section
409(f)(1) of the FD&C Act). After
evaluating the objection from NRDC, we
have concluded that the objection does
not provide any basis for us to
reconsider our decision to issue the
final rule permitting the use of
advantame as a non-nutritive sweetener
and flavor enhancer in foods generally,
except meat and poultry. Accordingly,
we are not making any changes in
response to the objection.
Therefore, we have determined that
the final rule should not be modified or
revoked based on the objections. Thus,
we are confirming May 21, 2014, as the
effective date of the regulation.
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77387
Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30144 Filed 12–23–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 860
[Docket No. FDA–2013–N–1529]
Medical Device Classification
Procedures; Reclassification Petition:
Content and Form; Technical
Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending its
regulations for petitioning for device
reclassification to update mailing
addresses for the petitions. This action
is being taken to improve the accuracy
of the regulations.
DATES: This rule is effective December
24, 2014.
FOR FURTHER INFORMATION CONTACT:
Nancy Pirt, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4438, Silver Spring,
MD 20993–0002, 301–796–6254.
SUPPLEMENTARY INFORMATION: FDA is
updating mailing addresses for device
reclassification petitions (21 CFR
860.123). For devices regulated by the
Center for Devices and Radiological
Health, the room number is now 4438.
In addition, the Center for Biologics
Evaluation and Research has moved to
a new location at FDA’s White Oak
Campus. The address remains the same
for the Center for Drug Evaluation and
Research. The regulations are being
amended to ensure clarity and to
improve the accuracy and readability of
the regulations.
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment and a
delayed effective date are unnecessary
because these corrections are
nonsubstantive.
SUMMARY:
List of Subjects in 21 CFR Part 860
Administrative practice and
procedure, Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
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77388
Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Rules and Regulations
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 860 is
amended as follows:
PART 860—MEDICAL DEVICE
CLASSIFICATION PROCEDURES
1. The authority citation for 21 CFR
part 860 continues to read as follows:
■
Authority: 21 U.S.C. 360c, 360d, 360e,
360i, 360j, 371, 374.
2. Revise § 860.123(b)(1) to read as
follows:
■
§ 860.123 Reclassification petition:
Content and form.
*
*
*
*
*
(b) * * *
(1) For devices regulated by the
Center for Devices and Radiological
Health, addressed to the Food and Drug
Administration, Center for Devices and
Radiological Health, Regulations Staff,
10903 New Hampshire Ave., Bldg. 66,
Rm. 4438, Silver Spring, MD 20993–
0002; for devices regulated by the
Center for Biologics Evaluation and
Research, addressed to the Food and
Drug Administration, Center for
Biologics Evaluation and Research,
Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G112,
Silver Spring, MD 20993–0002; for
devices regulated by the Center for Drug
Evaluation and Research, addressed to
the Food and Drug Administration,
Center for Drug Evaluation and
Research, Central Document Control
Room, 5901–B Ammendale Rd.,
Beltsville, MD 20705–1266, as
applicable.
*
*
*
*
*
Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30141 Filed 12–23–14; 8:45 am]
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9707]
RIN 1545–BM08
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Filing of Form 5472
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
This document contains final
regulations concerning the manner of
filing Form 5472, ‘‘Information Return
of a 25% Foreign-Owned U.S.
SUMMARY:
16:05 Dec 23, 2014
Background
On June 6, 2014, the Department of
the Treasury (Treasury Department) and
the IRS published a notice of proposed
rulemaking (REG–114942–14) in the
Federal Register (79 FR 32687, 2014–26
IRB 1117) under sections 6038A and
6038C of the Internal Revenue Code
(Code) (proposed regulations). The
proposed regulations proposed
removing a provision for timely filing
Form 5472 separately from an income
tax return that is untimely filed
(‘‘untimely filed return provision’’). As
a result, Form 5472 would be required
to be filed in all cases only with the
filer’s income tax return for the taxable
year by the due date (including
extensions) of that return. No public
hearing was requested or held. The
Treasury Department and the IRS
received two written comments on the
proposed regulations, which are
available at www.regulations.gov. After
consideration of the comments, this
Treasury decision adopts the proposed
regulations, without substantive change,
as final regulations.
Summary of Comments
BILLING CODE 4164–01–P
VerDate Sep<11>2014
Corporation or a Foreign Corporation
Engaged in a U.S. Trade or Business.’’
The final regulations affect certain 25percent foreign-owned domestic
corporations and certain foreign
corporations that are engaged in a trade
or business in the United States that are
required to file Form 5472.
DATES: Effective date: These regulations
are effective on December 24, 2014.
Applicability date: For dates of
applicability, see §§ 1.6038A–1(n)(2)
and (n)(3) and 1.6038A–2(g).
FOR FURTHER INFORMATION CONTACT:
Anand Desai at (202) 317–6939 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Jkt 235001
One comment recommended that the
‘‘untimely filed return provision’’ be
retained because the IRS may not timely
receive the information required by
Form 5472 if the untimely filed return
provision is removed. The comment
also recommended conforming changes
to permit the filing of Form 5471,
‘‘Information Return of U.S. Persons
With Respect to Certain Foreign
Corporations,’’ and Form 8865, ‘‘Return
of U.S. Persons With Respect to Certain
Foreign Partnerships,’’ separately from
an income tax return that is untimely
filed.
The Treasury Department and the IRS
decline to adopt this comment. The
Treasury Department and the IRS have
determined that tax administration
generally is more efficient when forms
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(for example, Form 5471, Form 5472,
and Form 8865) are filed with the filer’s
timely filed income tax return.
The second comment addressed
issues unrelated to the proposed
regulatory change. The final regulations
do not incorporate the suggestions
contained in this comment, which are
outside the scope of the proposed
regulations.
Special Analyses
It has been determined that these
regulations are not a significant
regulatory action as defined in
Executive Order 12866, as
supplemented by Executive Order
13563. Therefore, a regulatory
assessment is not required. It has also
been determined that section 553(b) of
the Administrative Procedure Act (5
U.S.C. chapter 5) does not apply to these
regulations, and because the regulations
do not impose a collection of
information, the Regulatory Flexibility
Act (5 U.S.C. chapter 6) does not apply.
Pursuant to section 7805(f) of the Code,
the notice of proposed rulemaking
preceding this regulation was submitted
to the Chief Counsel for Advocacy of the
Small Business Administration for
comment on its impact on small
business.
Drafting Information
The principal author of these
regulations is Anand Desai, Office of
Associate Chief Counsel (International).
However, other personnel from the
Treasury Department and the IRS
participated in their development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Adoption of Amendments to the
Regulations
Accordingly, 26 CFR part 1 is
amended as follows:
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
■
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 1.6038A–1 is amended
by revising the third sentence of, and
adding a new fourth sentence to,
paragraph (n)(2), and adding a third
sentence to paragraph (n)(3), to read as
follows:
■
§ 1.6038A–1
definitions.
*
*
*
(n) * * *
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General requirements and
*
*
]]>Agencies
[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Rules and Regulations]
[Pages 77387-77388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30141]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 860
[Docket No. FDA-2013-N-1529]
Medical Device Classification Procedures; Reclassification
Petition: Content and Form; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations for petitioning for device reclassification to update
mailing addresses for the petitions. This action is being taken to
improve the accuracy of the regulations.
DATES: This rule is effective December 24, 2014.
FOR FURTHER INFORMATION CONTACT: Nancy Pirt, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4438, Silver Spring, MD 20993-0002, 301-796-6254.
SUPPLEMENTARY INFORMATION: FDA is updating mailing addresses for device
reclassification petitions (21 CFR 860.123). For devices regulated by
the Center for Devices and Radiological Health, the room number is now
4438. In addition, the Center for Biologics Evaluation and Research has
moved to a new location at FDA's White Oak Campus. The address remains
the same for the Center for Drug Evaluation and Research. The
regulations are being amended to ensure clarity and to improve the
accuracy and readability of the regulations.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment and a delayed effective date
are unnecessary because these corrections are nonsubstantive.
List of Subjects in 21 CFR Part 860
Administrative practice and procedure, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
[[Page 77388]]
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
860 is amended as follows:
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
0
1. The authority citation for 21 CFR part 860 continues to read as
follows:
Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
0
2. Revise Sec. 860.123(b)(1) to read as follows:
Sec. 860.123 Reclassification petition: Content and form.
* * * * *
(b) * * *
(1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Regulations Staff, 10903
New Hampshire Ave., Bldg. 66, Rm. 4438, Silver Spring, MD 20993-0002;
for devices regulated by the Center for Biologics Evaluation and
Research, addressed to the Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for
devices regulated by the Center for Drug Evaluation and Research,
addressed to the Food and Drug Administration, Center for Drug
Evaluation and Research, Central Document Control Room, 5901-B
Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
* * * * *
Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30141 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P
