Drawbridge Operation Regulation; Newark Bay, Newark, NJ, 48714 [2018-21049]
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Rules and Regulations
PART 884—OBSTETRICAL AND
GYNECOLOGICAL DEVICES
1. The authority citation for part 884
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Amend § 884.5330 by revising the
section heading and paragraph (a) to
read as follows:
■
§ 884.5330
Multiple-use female condom.
(a) Identification. A multiple-use
female condom is a sheath-like device
that lines the vaginal wall and is
inserted into the vagina prior to the
initiation of coitus. At the conclusion of
coitus, the device can be reused. It is
indicated for contraception and
prophylactic (preventing the
transmission of sexually transmitted
infections) purposes.
*
*
*
*
*
■ 3. Add § 884.5340 to subpart F to read
as follows:
daltland on DSKBBV9HB2PROD with RULES
§ 884.5340
Single-use internal condom.
(a) Identification. A single-use
internal condom is an over-the-counter
sheath-like device that lines the vaginal
or anal wall and is inserted into the
vagina or anus prior to the initiation of
coitus. At the conclusion of coitus, it is
removed and discarded. It is indicated
for contraception and/or prophylactic
(preventing the transmission of sexually
transmitted infections) purposes.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Clinical performance testing must
evaluate the following:
(i) Rate of clinical failure of the device
and rate of individual failure modes of
the device based on an acute failure
modes study evaluating the intended
use (vaginal and/or anal intercourse);
and
(ii) Cumulative pregnancy rate when
using the device based on a
contraceptive effectiveness study (when
the device is indicated for vaginal
intercourse).
(2) Viral penetration testing must
demonstrate the device is an effective
barrier to sexually transmitted
infections.
(3) Nonclinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
evaluated:
(i) Mechanical testing must
demonstrate the device can withstand
forces under anticipated use conditions,
include evaluation of tensile, tear, and
burst properties of the device; and
VerDate Sep<11>2014
16:04 Sep 26, 2018
Jkt 244001
(ii) Compatibility testing with
personal lubricants must determine
whether the physical properties of the
device are adversely affected by use of
additional lubricants.
(4) The device must be demonstrated
to be biocompatible.
(5) Shelf-life testing must demonstrate
that the device maintains its
performance characteristics and the
packaging of the device must maintain
integrity for the duration of the shelflife.
(6) Labeling of the device must
include:
(i) Contraceptive effectiveness table
comparing typical use and perfect use
pregnancy rates with the device to other
available methods of birth control;
(ii) Statement regarding the adverse
events associated with the device,
including potential transmission of
infection, adverse tissue reaction, and
ulceration or other physical trauma;
(iii) Expiration date; and
(iv) Statement regarding compatibility
with additional types of personal
lubricants.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21044 Filed 9–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2018–0836]
Drawbridge Operation Regulation;
Newark Bay, Newark, NJ
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 Lehigh Valley
Bridge across the Newark Bay, mile 4.3,
at Newark, New Jersey. The deviation is
necessary to replace bridge timber on
the lift span. This deviation allows the
bridge to remain in the closed-to
navigation position during the
construction periods.
DATES: This deviation is effective from
6 a.m. on October 14, 2018, to 6 p.m. on
November 12, 2018.
ADDRESSES: The docket for this
deviation, USCG–2018–0836 is available
at https://www.regulations.gov. Type the
docket number in the ‘‘SEARCH’’ box
and click ‘‘SEARCH.’’ Click on Open
SUMMARY:
PO 00000
Frm 00012
Fmt 4700
Sfmt 9990
Docket Folder on the line associated
with this deviation.
If
you have questions on this temporary
deviation, call or email Judy Leung-Yee,
Bridge Management Specialist, First
District Bridge Branch, U.S. Coast
Guard, telephone 212–514–4336, email
Judy.K.Leung-Yee@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
The owner
of the bridge, Consolidated Rail
Corporation, requested a temporary
deviation from the normal operating
schedule to replace bridge timber on the
lift span. The Lehigh Valley Bridge
across the Newark Bay, mile 4.3, at
Newark, New Jersey is a lift bridge with
a vertical clearance in the closed
position of 35 feet at mean high water
and 39 feet at mean low water. The
existing bridge operating regulations are
listed at §§ 117.5 and 117.735.
Under this temporary deviation, the
Lehigh Valley Bridge shall remain in the
closed position from 6 a.m. on October
14, 2018 to 6 p.m. on October 15, 2018;
from 6 a.m. on October 21 to 6 p.m. on
October 22, 2018; and from 6 a.m. on
October 28, 2018 to 6 p.m. on October
29, 2018. Should inclement weather
occur, the following rain dates may be
used: (a) From 6 a.m. on November 4,
2018 to 6 p.m. on November 5, 2018; or
(b) from 6 a.m. on November 11, 2018
to 6 p.m. on November 12, 2018.
The waterway is transited by
recreational and commercial vessels.
Coordination with known waterway
users has indicated no objection to the
closure. Vessels able to pass through the
bridge in the closed position may do so
at anytime. The bridge will not be able
to open for emergencies and there is no
immediate alternate route for vessels to
pass.
The Coast Guard will inform the users
of the waterways through our Local and
Broadcast Notices to Mariners of the
change in operating schedule for the
bridge so that vessel operators can
arrange their transits to minimize any
impact caused by the temporary
deviation.
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.
SUPPLEMENTARY INFORMATION:
Dated: September 21, 2018.
C.J. Bisignano,
Supervisory Bridge Management Specialist,
First Coast Guard District.
[FR Doc. 2018–21049 Filed 9–26–18; 8:45 am]
BILLING CODE 9110–04–P
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[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Rules and Regulations]
[Page 48714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21049]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2018-0836]
Drawbridge Operation Regulation; Newark Bay, Newark, NJ
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 Lehigh Valley Bridge across the
Newark Bay, mile 4.3, at Newark, New Jersey. The deviation is necessary
to replace bridge timber on the lift span. This deviation allows the
bridge to remain in the closed-to navigation position during the
construction periods.
DATES: This deviation is effective from 6 a.m. on October 14, 2018, to
6 p.m. on November 12, 2018.
ADDRESSES: The docket for this deviation, USCG-2018-0836 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.
FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Judy Leung-Yee, Bridge Management
Specialist, First District Bridge Branch, U.S. Coast Guard, telephone
212-514-4336, email [email protected].
SUPPLEMENTARY INFORMATION: The owner of the bridge, Consolidated Rail
Corporation, requested a temporary deviation from the normal operating
schedule to replace bridge timber on the lift span. The Lehigh Valley
Bridge across the Newark Bay, mile 4.3, at Newark, New Jersey is a lift
bridge with a vertical clearance in the closed position of 35 feet at
mean high water and 39 feet at mean low water. The existing bridge
operating regulations are listed at Sec. Sec. 117.5 and 117.735.
Under this temporary deviation, the Lehigh Valley Bridge shall
remain in the closed position from 6 a.m. on October 14, 2018 to 6 p.m.
on October 15, 2018; from 6 a.m. on October 21 to 6 p.m. on October 22,
2018; and from 6 a.m. on October 28, 2018 to 6 p.m. on October 29,
2018. Should inclement weather occur, the following rain dates may be
used: (a) From 6 a.m. on November 4, 2018 to 6 p.m. on November 5,
2018; or (b) from 6 a.m. on November 11, 2018 to 6 p.m. on November 12,
2018.
The waterway is transited by recreational and commercial vessels.
Coordination with known waterway users has indicated no objection to
the closure. Vessels able to pass through the bridge in the closed
position may do so at anytime. The bridge will not be able to open for
emergencies and there is no immediate alternate route for vessels to
pass.
The Coast Guard will inform the users of the waterways through our
Local and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
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: September 21, 2018.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2018-21049 Filed 9-26-18; 8:45 am]
BILLING CODE 9110-04-P
