Drawbridge Operation Regulations; Sacramento River, Sacramento, CA, 15878-15879 [2013-05712]
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15878
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Rules and Regulations
26 CFR Part 48
3. Paragraph (b)(2)(iv) Example 7.
4. The last sentence of paragraph
(b)(2)(iv) Example 8., Example 11., and
Example 13.
The revisions read as follows:
Example 8. * * * Accordingly, both the
single axis endoskeletal knee shin systems
manufactured by X and the prosthetic legs
made by Y are devices that are of a type that
are generally purchased by the general public
at retail for individual use.
[TD 9604]
§ 48.4191–2
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RIN 1545–BJ44
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
Taxable Medical Devices; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting Amendment.
AGENCY:
This document contains
corrections to final regulations (TD
9604) that were published in the
Federal Register on Friday, December 7,
2012 (77 FR 72924). The final
regulations provide guidance on the
excise tax imposed on the sale of certain
medical devices, enacted by the Health
Care and Education Reconciliation Act
of 2010 in conjunction with the Patient
Protection and Affordable Care Act.
DATES: This correction is effective on
March 13, 2013 and is applicable after
December 31, 2012.
FOR FURTHER INFORMATION CONTACT:
Natalie Payne, Michael Beker, or
Stephanie Bland, at (202) 622–3130 (not
a toll free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
The final regulations (TD 9604) that
are the subject of this correction is
under section 4191 of the Internal
Revenue Code.
Need for Correction
As published, the final regulations
(TD 9604) contain errors that may prove
to be misleading and are in need of
clarification.
List of Subjects in 26 CFR Part 48
Excise taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 48 is
corrected by making the following
correcting amendments:
PART 48—MANUFATURERS AND
RETAILERS EXCISE TAXES
Paragraph 1. The authority citation
for part 48 continues to read in part as
follows:
emcdonald on DSK67QTVN1PROD with RULES
■
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 48.4191–2 is amended
by revising:
■ 1. The second sentence of paragraph
(b)(2).
■ 2. The last sentence of paragraph
(b)(2)(iv) Example 5., and Example 6.
■
VerDate Mar<15>2010
14:47 Mar 12, 2013
Jkt 229001
Taxable medical device.
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(b) * * *
(2) * * * A device will be considered
to be of a type that is generally
purchased by the general public at retail
for individual use if it is regularly
available for purchase and use by
individual consumers who are not
medical professionals, and if the design
of the device demonstrates that it is not
primarily intended for use in a medical
institution or office or by a medical
professional. * * *
*
*
*
*
*
(iv) * * *
Example 5. * * * Based on the totality of
the facts and circumstances, the mobile x-ray
systems are not devices that are of a type that
are generally purchased by the general public
at retail for individual use.
Example 6. * * * Accordingly, the
pregnancy test kits are devices that are of a
type that are generally purchased by the
general public at retail for individual use.
Example 7. X manufactures blood glucose
monitors, blood glucose test strips, and
lancets. X sells the blood glucose monitors,
test strips, and lancets to distributors Y and
Z, which, in turn, sell the monitors, test
strips, and lancets to medical institutions and
offices, medical professionals, and retail
businesses. The FDA requires manufacturers
of blood glucose monitors, test strips, and
lancets to list the items as devices with the
FDA. The FDA classifies the blood glucose
monitors under 21 CFR part 862 (Clinical
Chemistry and Clinical Toxicology Devices)
and product code NBW. The FDA classifies
the test strips under 21 CFR part 862
(Clinical Chemistry and Clinical Toxicology
Devices) and product code NBW. The FDA
classifies the lancets under 21 CFR part 878
(General and Plastic Surgery Devices) and
product code FMK.
The blood glucose monitors and test strips
are included in the FDA’s online IVD Home
Use Lab Tests (Over-the-Counter Tests)
database. Therefore, the blood glucose
monitors and test strips fall within the safe
harbor set forth in paragraph (b)(2)(iii)(A) of
this section. Further, the FDA product code
name for NBW is ‘‘System, Test, Blood
Glucose, Over the Counter.’’ Therefore, the
blood glucose monitors and test strips also
fall within the safe harbor set forth in
paragraph (b)(2)(iii)(C) of this section.
In addition, the lancets are supplies
necessary for the effective use of DME as
described in section 110.3 of chapter 15 of
the Medicare Policy Benefit Manual.
Therefore, the lancets fall within the safe
harbor set forth in paragraph (b)(2)(iii)(D)(5)
of this section.
Accordingly, the blood glucose monitors,
test strips, and lancets are devices that are of
a type that are generally purchased by the
general public at retail for individual use.
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Example 11. * * * Accordingly, the
urinary ileostomy bags are devices that are of
a type that are generally purchased by the
general public at retail for individual use.
*
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Example 13. * * * Based on the totality of
the facts and circumstances, the NMRI
systems are not devices that are of a type that
are generally purchased by the general public
at retail for individual use.
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Par. 3. Section 48.4216(c)–1 is
amended by revising paragraph (e)(1) to
read as follows:
■
§ 48.4216(c)–1 Computation of tax on
leases and installment sales.
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(e) * * *
(1) General rule. Payments made on or
after January 1, 2013, pursuant to a
contract for the lease, installment sale,
or sale on credit of a taxable medical
device that was entered into on or after
March 30, 2010, are subject to tax under
section 4191. The provisions of sections
4216(c) and 4217, paragraphs (a), (b),
and (c) of this section, and § 48.4217–2
apply.
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LaNita VanDyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. 2013–05703 Filed 3–12–13; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–0044]
Drawbridge Operation Regulations;
Sacramento River, Sacramento, CA
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Tower
Drawbridge across Sacramento River,
mile 59.0, at Sacramento, CA. The
deviation is necessary to allow the
community to participate in the Ninth
Annual Shamrock footrace. This
deviation allows the bridge to remain in
SUMMARY:
E:\FR\FM\13MRR1.SGM
13MRR1
emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Rules and Regulations
the closed-to-navigation position during
the event.
DATES: This deviation is effective from
7:30 a.m. to 1:05 p.m. on March 17,
2013.
ADDRESSES: The docket for this
deviation, [USCG–2013–0044], is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District;
telephone 510–437–3516, email
David.H.Sulouff@uscg.mil. If you have
questions on viewing the docket, call
Barbara Hairston, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION: The
California Department of Transportation
has requested a temporary change to the
operation of the Tower Drawbridge,
mile 59.0, over Sacramento River, at
Sacramento, CA. The Tower Drawbridge
navigation span provides a vertical
clearance of 30 feet above Mean High
Water in the closed-to-navigation
position. As required by 33 CFR
117.189(a), the draw opens on signal
from May 1 through October 31 from 6
a.m. to 10 p.m. and, from November 1
through April 30 from 9 a.m. to 5 p.m.
At all other times the draw shall open
on signal if at least four hours notice is
given, Navigation on the waterway is
commercial and recreational.
The drawspan will be secured in the
closed-to-navigation position from 7:30
a.m. to 1:05 p.m. on March 17, 2013, to
allow the community to participate in
the Ninth Annual Shamrock footrace.
This temporary deviation has been
coordinated with waterway users. There
are no scheduled river boat cruises or
anticipated levee maintenance during
this deviation period. No objections to
the proposed temporary deviation were
raised. Vessels that can transit the
bridge, while in the closed-to-navigation
position, may continue to do so at any
time. In the event of an emergency the
drawspan can be opened without delay.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
VerDate Mar<15>2010
14:47 Mar 12, 2013
Jkt 229001
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: February 28, 2013.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard
District.
[FR Doc. 2013–05712 Filed 3–12–13; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–0038]
Drawbridge Operation Regulations;
Sacramento River, Sacramento, CA
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
regulation that governs the Tower
Drawbridge across the Sacramento
River, mile 59.0, at Sacramento, CA. The
deviation is necessary to allow the
community to participate in the First
Annual ‘‘Biggest Loser’’ 5K walk and
run event. This deviation allows the
bridge to remain in the closed-tonavigation position during the event.
DATES: This deviation is effective from
7:30 a.m. to 9:30 a.m. on March 16,
2013.
ADDRESSES: The docket for this
deviation, [USCG–2013–0038], is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District;
telephone 510–437–3516, email
David.H.Sulouff@uscg.mil. If you have
questions on viewing the docket, call
Barbara Hairston, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION: The
California Department of Transportation
has requested a temporary change to the
SUMMARY:
PO 00000
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Fmt 4700
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15879
operation of the Tower Drawbridge,
mile 59.0, over Sacramento River, at
Sacramento, CA. The Tower Drawbridge
navigation span provides a vertical
clearance of 30 feet above Mean High
Water in the closed-to-navigation
position. As required by 33 CFR
117.189(a), the draw opens on signal
from May 1 through October 31 from 6
a.m. to 10 p.m., and from November 1
through April 30 from 9 a.m. to 5 p.m.
At all other times the draw shall open
on signal if at least four hours notice is
given. Navigation on the waterway is
commercial and recreational.
The drawspan will be secured in the
closed-to-navigation position from 7:30
a.m. to 9:30 a.m. on March 16, 2013, to
allow the community to participate in
the First Annual ‘‘Biggest Loser’’ 5K
walk and run event. This temporary
deviation has been coordinated with
waterway users. There are no scheduled
river boat cruises or anticipated levee
maintenance during this deviation
period. No objections to the proposed
temporary deviation were raised.
Vessels that can transit the bridge, while
in the closed-to-navigation position,
may continue to do so at any time. In
the event of an emergency the drawspan
can be opened without delay.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: February 25, 2013.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard
District.
[FR Doc. 2013–05713 Filed 3–12–13; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–0123]
Drawbridge Operation Regulation;
Willamette River, Portland, OR
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Broadway
Bridge across the Willamette River, mile
11.7, at Portland, OR. This deviation is
necessary to accommodate the Race for
the Roses and the Bridge to Brews Run
SUMMARY:
E:\FR\FM\13MRR1.SGM
13MRR1
Agencies
[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Rules and Regulations]
[Pages 15878-15879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05712]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2013-0044]
Drawbridge Operation Regulations; Sacramento River, Sacramento,
CA
AGENCY: Coast Guard, DHS.
ACTION: Notice of deviation from drawbridge regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Tower Drawbridge across Sacramento
River, mile 59.0, at Sacramento, CA. The deviation is necessary to
allow the community to participate in the Ninth Annual Shamrock
footrace. This deviation allows the bridge to remain in
[[Page 15879]]
the closed-to-navigation position during the event.
DATES: This deviation is effective from 7:30 a.m. to 1:05 p.m. on March
17, 2013.
ADDRESSES: The docket for this deviation, [USCG-2013-0044], is
available at https://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast
Guard District; telephone 510-437-3516, email David.H.Sulouff@uscg.mil.
If you have questions on viewing the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone 202-366-9826.
SUPPLEMENTARY INFORMATION: The California Department of Transportation
has requested a temporary change to the operation of the Tower
Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The
Tower Drawbridge navigation span provides a vertical clearance of 30
feet above Mean High Water in the closed-to-navigation position. As
required by 33 CFR 117.189(a), the draw opens on signal from May 1
through October 31 from 6 a.m. to 10 p.m. and, from November 1 through
April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open
on signal if at least four hours notice is given, Navigation on the
waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position
from 7:30 a.m. to 1:05 p.m. on March 17, 2013, to allow the community
to participate in the Ninth Annual Shamrock footrace. This temporary
deviation has been coordinated with waterway users. There are no
scheduled river boat cruises or anticipated levee maintenance during
this deviation period. No objections to the proposed temporary
deviation were raised. Vessels that can transit the bridge, while in
the closed-to-navigation position, may continue to do so at any time.
In the event of an emergency the drawspan can be opened without delay.
In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.
Dated: February 28, 2013.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2013-05712 Filed 3-12-13; 8:45 am]
BILLING CODE 9110-04-P