Military Resale (MR) Commodities; Correction, 35847-35848 [2015-15284]
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Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations
AGENCY:
The Coast Guard will enforce
various safety zones within the Captain
of the Port New York Zone on the
specified dates and times. This action is
necessary to ensure the safety of vessels
and spectators from hazards associated
with fireworks displays. During the
enforcement period, no person or vessel
may enter the safety zones without
permission of the Captain of the Port
(COTP).
ACTION:
DATES:
SUMMARY:
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2015–0393]
Safety Zones; Fireworks Events in
Captain of the Port New York Zone
Coast Guard, DHS.
Notice of enforcement of
regulation.
The regulation for the safety
zones described in 33 CFR 165.160 will
35847
be enforced on the dates and times
listed in the table below.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
or email Lieutenant Douglas Neumann,
Coast Guard; telephone 718–354–4154,
email douglas.w.neumann@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the safety zones
listed in 33 CFR 165.160 on the
specified dates and times as indicated in
Table 1 below. This regulation was
published in the Federal Register on
November 9, 2011 (76 FR 69614).
TABLE 1
1. Brooklyn Law School, Ellis Island Safety Zone, 33 CFR 165.160(2.2)
2. Bronx Salutes America, Orchard Beach, The Bronx Safety Zone, 33
CFR 165.160(3.11).
3. City of Poughkeepsie Independence Day Celebration, Poughkeepsie, NY, Hudson River Safety Zone, 33 CFR 165.160(5.13).
4. City of Yonkers July 4th Celebration, Yonkers, NY, Hudson River
Safety Zone, 33 CFR 165.160(5.5).
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5. Peekskill July 4th Celebration, Peekskill Bay, Hudson River Safety
Zone, 33 CFR 165.160(5.10).
Under the provisions of 33 CFR
165.160, vessels may not enter the safety
zones unless given permission from the
COTP or a designated representative.
Spectator vessels may transit outside the
safety zones but may not anchor, block,
loiter in, or impede the transit of other
vessels. The Coast Guard may be
assisted by other Federal, State, or local
law enforcement agencies in enforcing
this regulation.
This notice is issued under authority
of 33 CFR 165.160(a) and 5 U.S.C.
552(a). In addition to this notice in the
Federal Register, the Coast Guard will
provide mariners with advanced
notification of enforcement periods via
the Local Notice to Mariners and marine
information broadcasts. If the COTP
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• Launch site: A barge located between Federal Anchorages 20–A
and 20–B, in approximate position 40°41′45″ N. 074°02′09″ W. (NAD
1983) about 365 yards east of Ellis Island. This Safety Zone is a
360-yard radius from the barge.
• Date: June 11, 2015.
• Time: 10:10 p.m.–11:20 p.m.
• Launch site: All waters of Long Island Sound in an area bound by
the following points: 40°51′43.5″ N. 073°47′36.3″ W.; thence to
40°52′12.2″ N. 073°47′13.6″ W.; thence to 40°52′02.5″ N.
073°46′47.8″ W.; thence to 40°51′32.3″ N. 073°47′09.9″ W. (NAD
1983), thence to the point of origin.
• Date: June 25, 2015.
• Time: 08:50 p.m.–10:10 p.m.
• Launch site: A barge located in approximate position 41°42′24.50″
N. 073°56′44.16″ W. (NAD 1983), approximately 420 yards north of
the Mid Hudson Bridge. This Safety Zone is a 300-yard radius from
the barge.
• Date: July 04, 2015.
• Time: 9:00 p.m.–10:00 p.m.
• Launch site: A barge located in approximate position 40°56′14.5″ N.
073°54′33″ W. (NAD 1983), approximately 475 yards northwest of
the Yonkers Municipal Pier, New York. This Safety Zone is a 360yard radius from the barge.
• Date: July 04, 2015.
• Time: 08:45 p.m.–10:15 p.m.
• Launch site: A barge located in approximate position 41°17′16″ N.
073°56′18″ W. (NAD 1983), approximately 670 yards north of Travis
Point. This Safety Zone is a 360-yard radius from the barge.
• Date: July 04, 2015.
• Rain Date: July 05, 2015.
• Time: 08:30 p.m.–10:30 p.m.
determines that a safety zone need not
be enforced for the full duration stated
in this notice, a Broadcast Notice to
Mariners may be used to grant general
permission to enter the safety zone.
COMMITTEE FOR PURCHASE FROM
PEOPLE WHO ARE BLIND OR
SEVERELY DISABLED
Dated: May 11, 2015.
G. Loebl,
Captain, U.S. Coast Guard, Captain of the
Port New York.
Military Resale (MR) Commodities;
Correction
[FR Doc. 2015–15410 Filed 6–22–15; 8:45 am]
BILLING CODE 9110–04–P
PO 00000
41 CFR 51–6
Committee for Purchase From
People Who Are Blind or Severely
Disabled.
ACTION: Correcting amendments.
AGENCY:
The Committee published a
Final Rule in the Federal Register of
June 5, 2015, adding MR numbers to a
series of MR numbers that already exist.
In the Final Rule, new MR series 11000
and 12000 were designated as
SUMMARY:
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35848
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations
‘‘Exclusive’’. This document removes
MR series 11000 and 12000 from being
designated as ‘‘Exclusive’’. All other
parameters of the Final Rule remain the
same as published on June 5, 2015.
DATES: Effective June 23, 2015.
FOR FURTHER INFORMATION CONTACT:
Barry S. Lineback, Telephone: (703)
603–2118.
SUPPLEMENTARY INFORMATION: This
document corrects § 51–6.4 by removing
MR series 11000 and 12000 from
paragraphs (b), (c)(4), and (d) so the
series are no longer designated as
‘‘Exclusive’’. All other parameters of the
Final Rule remain the same as
published on June 5, 2015.
List of Subjects in 41 CFR Part 51–6
Procurement procedures.
For the reasons set out in the
preamble, the Committee amends 41
CFR part 51–6 as follows:
PART 51–6—PROCUREMENT
PROCEDURES
1. The authority citation for part 51–
6 continues to read as follows:
■
Authority: 41 U.S.C. 8501–8506.
§ 51–6.4
[Amended]
2. In § 51–6.4, in paragraphs (b), (c)(4),
and (d), remove ‘‘, 11000 (11000–
11999); 12000 (12000–12999)’’.
■
Dated: June 17, 2015.
Barry S. Lineback,
Director, Business Operations.
[FR Doc. 2015–15284 Filed 6–22–15; 8:45 am]
BILLING CODE 6353–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AB00
National Vaccine Injury Compensation
Program: Addition of Intussusception
as Injury for Rotavirus Vaccines to the
Vaccine Injury Table
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Final rule.
AGENCY:
On July 24, 2013, the
Secretary of Health and Human Services
(the Secretary) published in the Federal
Register a Notice of Proposed
Rulemaking (NPRM) proposing changes
to the regulations governing the
National Vaccine Injury Compensation
Program (VICP). Specifically, the
Secretary proposed revisions to the
Vaccine Injury Table (Table). The basis
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SUMMARY:
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16:21 Jun 22, 2015
Jkt 235001
for this change is consistent with the
Secretary’s findings that
intussusceptions can reasonably be
determined in some circumstances to be
caused by rotavirus vaccines. The
Secretary is now making this
amendment to the Table and to the
Qualifications and Aids to
Interpretation (QAI), described below
under Background Information, as
proposed in the NPRM. These
regulations will apply only to petitions
for compensation under the VICP filed
after this final rule becomes effective.
DATES: This final rule is effective July
23, 2015.
FOR FURTHER INFORMATION CONTACT: Dr.
Avril M. Houston, Director, Division of
Injury Compensation Programs,
Healthcare Systems Bureau, HRSA,
Parklawn Building, Room 11C–06, 5600
Fishers Lane, Rockville, MD 20857, or
by telephone: (800) 338–2382. This is a
toll-free number.
SUPPLEMENTARY INFORMATION:
I. Background Information
Under Title XXI of the Public Health
Service Act, as amended (PHS Act),
individuals who demonstrate a vaccinerelated injury or death may receive
compensation through the VICP. To be
eligible for compensation from the
VICP, a petitioner must demonstrate
that the injured or deceased individual
received a vaccine set forth in the Table
(a ‘‘covered vaccine’’) and sustained a
vaccine-related injury or death. A
petitioner can prove a vaccine-related
injury or death in three ways. First, the
petitioner can show, by a
preponderance of the evidence, that the
vaccine recipient suffered an injury
listed in the Table corresponding with
the vaccine received, that the onset of
such injury occurred within the
timeframe specified in the Table, and
that the injury meets the requirements
set forth in the Table’s QAI. A Table
injury or death is given the legal
presumption that it was caused by the
vaccination. Sections 2111(c)(1)(C)(i),
2113(a)(1)(B), and 2114(a) of the PHS
Act. Second, if the petitioner cannot
demonstrate a Table injury, the
petitioner can prevail by proving, by a
preponderance of the evidence, that the
vaccine caused the injury or death (offTable injury). Third, a petitioner can
prevail by proving, by a preponderance
of the evidence, that the vaccine
significantly aggravated a pre-existing
condition. In all three cases, a petitioner
must also show that the injury was
sufficiently severe by demonstrating
that such person suffered the residual
effects of the injury for more than 6
months; died from the administration of
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the vaccine; or that the alleged injury
resulted in inpatient hospitalization and
surgical intervention. Section
2111(c)(1)(D) of the PHS Act. If the
petitioner can prove a Table injury, offTable injury, or significant aggravation
of a pre-existing condition, the
petitioner is entitled to compensation
unless it is affirmatively shown that the
injury was caused by some factor
unrelated to the vaccination.
Under section 2114(e)(2) of the PHS
Act, when the Centers for Disease
Control and Prevention (CDC)
recommends a vaccine for routine
administration to children, the Secretary
is required to amend the Table to
include such vaccine. Coverage becomes
effective when an excise tax is imposed
on the vaccine. Additionally, the
Secretary is authorized to include
specific injuries on the Table with
respect to each covered vaccine,
including the timeframe when the first
symptom or manifestation of the onset
of such adverse event may occur. The
Secretary may also define such injuries
through the QAI. Under section 2114(c)
of the PHS Act, the Secretary may make
such modifications to the Table by
promulgating regulations, with notice
and opportunity for a public hearing,
and at least 180 days of public
comment.
II. Discussion of the Final Rule
As discussed in the NPRM (78 FR
44512, July 24, 2013), the Secretary has
reviewed the currently available data
regarding the Rotarix and RotaTeq
vaccines and the risk of intussusception.
The background of the RotaShield
experience in the U.S. and the
published literature from Mexico,
Brazil, Australia, and the U.S. supports
a small attributable risk of
intussusception after the first and
second doses of Rotarix and RotaTeq
(with a greater amount of data
supporting an association with the first
dose of both vaccines). Evidence shows
the increased risk within the 1–7 days
following immunization with peaks in
the fourth and fifth days. As a
consequence, the Secretary is amending
the Table to add the injury of
intussusception to the general Table
category of ‘‘rotavirus vaccines’’ to
allow a presumption of causation for
claims that meet the requirements set
forth in the Table for that injury. To
allow for a generous timeframe that will
capture any cases related to the vaccine
after day 7, the Secretary has assigned
an onset interval of 1–21 days under
sections 2114(c) and (e) of the PHS Act.
The Secretary will stay informed of
new information in the scientific and
medical field about intussusception and
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Agencies
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35847-35848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15284]
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COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED
41 CFR 51-6
Military Resale (MR) Commodities; Correction
AGENCY: Committee for Purchase From People Who Are Blind or Severely
Disabled.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Committee published a Final Rule in the Federal Register
of June 5, 2015, adding MR numbers to a series of MR numbers that
already exist. In the Final Rule, new MR series 11000 and 12000 were
designated as
[[Page 35848]]
``Exclusive''. This document removes MR series 11000 and 12000 from
being designated as ``Exclusive''. All other parameters of the Final
Rule remain the same as published on June 5, 2015.
DATES: Effective June 23, 2015.
FOR FURTHER INFORMATION CONTACT: Barry S. Lineback, Telephone: (703)
603-2118.
SUPPLEMENTARY INFORMATION: This document corrects Sec. 51-6.4 by
removing MR series 11000 and 12000 from paragraphs (b), (c)(4), and (d)
so the series are no longer designated as ``Exclusive''. All other
parameters of the Final Rule remain the same as published on June 5,
2015.
List of Subjects in 41 CFR Part 51-6 Procurement procedures.
For the reasons set out in the preamble, the Committee amends 41
CFR part 51-6 as follows:
PART 51-6--PROCUREMENT PROCEDURES
0
1. The authority citation for part 51-6 continues to read as follows:
Authority: 41 U.S.C. 8501-8506.
Sec. 51-6.4 [Amended]
0
2. In Sec. 51-6.4, in paragraphs (b), (c)(4), and (d), remove ``,
11000 (11000-11999); 12000 (12000-12999)''.
Dated: June 17, 2015.
Barry S. Lineback,
Director, Business Operations.
[FR Doc. 2015-15284 Filed 6-22-15; 8:45 am]
BILLING CODE 6353-01-P