Passports: Service Passports, 4143 [2018-01708]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is
amended as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
(iii) A shelf life.
PART 51—PASSPORTS
Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01639 Filed 1–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
22 CFR Part 51
2. Add § 878.5050 to subpart F to read
as follows:
[Public Notice: 9867]
rmajette on DSKBCKNHB2PROD with RULES
§ 878.5050
Surgical smoke precipitator.
15:14 Jan 29, 2018
Jkt 244001
[FR Doc. 2018–01708 Filed 1–29–18; 8:45 am]
BILLING CODE 4710–06–P
RIN 1400–AE01
(a) Identification. A surgical smoke
precipitator is a prescription device
intended for clearance of the visual field
by precipitation of surgical smoke and
other aerosolized particulate matter
created during laparoscopic surgery.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Adverse tissue reaction must be
mitigated through the following:
(i) Chemical characterization and
toxicological risk assessment of the
treated surgical smoke.
(ii) Demonstration that the elements
of the device that may contact the
patient are biocompatible.
(2) Electrical safety and
electromagnetic compatibility testing
must demonstrate that the device
performs as intended.
(3) Software verification, validation,
and hazard analysis must be performed.
(4) Performance data must
demonstrate the sterility of the patient
contacting components of the device.
(5) Performance data must support the
shelf life of the sterile components of
the device by demonstrating continued
functionality, sterility, and package
integrity over the identified shelf life.
(6) Animal simulated-use testing must
demonstrate that the device performs as
intended under anticipated conditions
of use. The following performance
characteristics must be tested:
(i) Device must be demonstrated to be
effectively inserted, positioned, and
removed from the site of use.
(ii) Device must be demonstrated to
precipitate surgical smoke particulates
to clear the visual field for laparoscopic
surgeries.
(iii) Device must be demonstrated to
be non-damaging to the site of use and
animal subject.
(7) Labeling must identify the
following:
(i) Detailed instructions for use.
(ii) Electrical safety and
electromagnetic compatibility
information.
VerDate Sep<11>2014
Accordingly, the interim final rule
amending 22 CFR part 51, which was
published at 81 FR 67156 on September
30, 2016, is adopted as a final rule
without change.
■
Carl C. Risch,
Assistant Secretary, Consular Affairs.
1. The authority citation for part 878
continues to read as follows:
■
■
4143
DEPARTMENT OF HOMELAND
SECURITY
Passports: Service Passports
Coast Guard
Department of State.
Final rule.
AGENCY:
33 CFR Part 117
ACTION:
[Docket No. USCG–2018–0025]
This rule finalizes the interim
final rule from the Department of State
that established a new service passport,
which may be approved for certain nonpersonal services contractors who travel
abroad in support of and pursuant to a
contract with the U.S. government. The
Department received no public
comments in response to the rule.
DATES: Effective January 30, 2018.
FOR FURTHER INFORMATION CONTACT:
Sitara Kedilaya, Attorney-Adviser,
PassportRules@state.gov, (202) 485–
6500.
SUMMARY:
On
September 30, 2016, the Department
published an interim final rule
amending 22 CFR part 51, to create a
‘‘service passport’’ that would be used
by non-personal services contractors to
carry out critical security, maintenance
and other functions on behalf of the U.S.
government. As noted in the interim
final rule, the Department estimates that
this rulemaking will affect
approximately 1,000 non-personal
services contractors per year. Further
information concerning the rationale for
this rule can be found in the interim
final rule.
The Department provided 60 days for
the public to comment on this rule. This
period expired on November 29, 2016.
The Department received no public
comments.
The Regulatory Findings included
with the interim final rule are
incorporated herein. This rule is not an
E.O. 13771 regulatory action because it
is not significant under E.O. 12866.
SUPPLEMENTARY INFORMATION:
List of Subjects in 22 CFR Part 51
Administrative practice and
procedure, Drug traffic control,
Passports and visas, Reporting and
recordkeeping requirements.
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
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. The deviation is
necessary to make adjustments to new
equipment. This deviation allows the
bridge to operate the double bascule
span one side at a time, single leaf.
DATES: This deviation is effective
without actual notice from January 30,
2018, to 11:59 p.m. on February 23,
2018. For the purposes of enforcement,
actual notice will be used from 1 a.m.
on January 27, 2018, through January
30, 2018.
ADDRESSES: The docket for this
deviation, USCG–2018–0025, 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 Mr. Steven
Fischer, Bridge Administrator,
Thirteenth Coast Guard District;
telephone 206–220–7282, email
Steven.M.Fischer@uscg.mil.
SUPPLEMENTARY INFORMATION:
Multnomah County, the bridge owner,
requested the Broadway Bridge be
authorized to open half the span in
single leaf mode to make adjustments to
newly installed equipment. The
Broadway Bridge crosses the Willamette
River at mile 11.7, and provides 90 feet
of vertical clearance above Columbia
SUMMARY:
E:\FR\FM\30JAR1.SGM
30JAR1
]]>Agencies
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Page 4143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01708]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF STATE
22 CFR Part 51
[Public Notice: 9867]
RIN 1400-AE01
Passports: Service Passports
AGENCY: Department of State.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule finalizes the interim final rule from the Department
of State that established a new service passport, which may be approved
for certain non-personal services contractors who travel abroad in
support of and pursuant to a contract with the U.S. government. The
Department received no public comments in response to the rule.
DATES: Effective January 30, 2018.
FOR FURTHER INFORMATION CONTACT: Sitara Kedilaya, Attorney-Adviser,
[email protected], (202) 485-6500.
SUPPLEMENTARY INFORMATION: On September 30, 2016, the Department
published an interim final rule amending 22 CFR part 51, to create a
``service passport'' that would be used by non-personal services
contractors to carry out critical security, maintenance and other
functions on behalf of the U.S. government. As noted in the interim
final rule, the Department estimates that this rulemaking will affect
approximately 1,000 non-personal services contractors per year. Further
information concerning the rationale for this rule can be found in the
interim final rule.
The Department provided 60 days for the public to comment on this
rule. This period expired on November 29, 2016. The Department received
no public comments.
The Regulatory Findings included with the interim final rule are
incorporated herein. This rule is not an E.O. 13771 regulatory action
because it is not significant under E.O. 12866.
List of Subjects in 22 CFR Part 51
Administrative practice and procedure, Drug traffic control,
Passports and visas, Reporting and recordkeeping requirements.
PART 51--PASSPORTS
0
Accordingly, the interim final rule amending 22 CFR part 51, which was
published at 81 FR 67156 on September 30, 2016, is adopted as a final
rule without change.
Carl C. Risch,
Assistant Secretary, Consular Affairs.
[FR Doc. 2018-01708 Filed 1-29-18; 8:45 am]
BILLING CODE 4710-06-P
