Visas: Documentation of Nonimmigrants Under the Immigration and Nationality Act, as Amended, 7454 [2016-02962]
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7454
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations
the frequency and severity of alopecia
during chemotherapy in which
alopecia-inducing chemotherapeutic
agents are used.
(b) Classification—Class II (special
controls). The special controls for this
device are:
(1) Non-clinical performance testing
must demonstrate that the device meets
all design specifications and
performance requirements, and that the
device performs as intended under
anticipated conditions of use. This
information must include testing to
demonstrate accuracy of the
temperature control mechanism.
(2) Performance testing must
demonstrate the electromagnetic
compatibility and electrical safety of the
device.
(3) Software verification, validation,
and hazard analysis must be performed.
(4) The patient contacting
components of the device must be
demonstrated to be biocompatible.
Material names must be provided.
(5) Labeling must include the
following:
(i) A statement describing the
potential risk of developing scalp
metastasis.
(ii) Information on the patient
population and chemotherapeutic
agents/regimen for which the device has
been demonstrated to be effective.
(iii) A summary of the non-clinical
and/or clinical testing pertinent to use
of the device.
(iv) A summary of the device
technical parameters, including
temperature cooling range and duration
of cooling.
(v) A summary of the device- and
procedure-related adverse events
pertinent to use of the device.
(vi) Information on how the device
operates and the typical course of
treatment.
(6) Patient labeling must be provided
and must include:
(i) Relevant contraindications,
warnings, precautions, and adverse
effects/complications.
(ii) Information on how the device
operates and the typical course of
treatment.
(iii) Information on the patient
population for which there is clinical
evidence of effectiveness.
(iv) The potential risks and benefits
associated with use of the device.
(v) Postoperative care instructions.
(vi) A statement describing the
potential risk of developing scalp
metastasis.
VerDate Sep<11>2014
16:06 Feb 11, 2016
Jkt 238001
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02878 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
Dated: February 9, 2016.
David S. Newman,
Director of Legal Affairs, Visa Services,
Bureau of Consular Affairs, U.S. Department
of State.
[FR Doc. 2016–02962 Filed 2–11–16; 8:45 am]
BILLING CODE 4710–06–P
DEPARTMENT OF STATE
22 CFR Part 41
[Public Notice: 9439]
PENSION BENEFIT GUARANTY
CORPORATION
RIN 1400–AD17
29 CFR Part 4022
Visas: Documentation of
Nonimmigrants Under the Immigration
and Nationality Act, as Amended
Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions
for Paying Benefits
Department of State.
Interim final rule; correction.
AGENCY:
ACTION:
The Department of State
published a Federal Register interim
final rule on February 4, 2016, in
Volume 81, No. 23, page 5906. The
document contains an error in the
Regulatory Findings. This document
corrects the rule by replacing the text,
‘‘included elsewhere in this edition of
the Federal Register’’ with ‘‘published
in the Federal Register on February 8,
2016, 81 FR 6430.’’ There is also a
correction in the ADDRESSES section, to
provide the correct public notice
number to find the rule to submit
comments on www.regulations.gov.
DATES: This correction is effective on
February 19, 2016. Written comments
must be received on or before April 4,
2016.
FOR FURTHER INFORMATION CONTACT:
Paul-Anthony L. Magadia, U.S.
Department of State, Visa Services,
Legislation and Regulations Division,
Washington, DC 20006, 202–485–7641;
email: magadiapl@state.gov.
SUPPLEMENTARY INFORMATION: The
Department of State published an
interim final rule on February 4, 2016
(81 FR 5906); this document corrects
text in the ADDRESSES section and in the
discussion of Executive Order 12866.
SUMMARY:
Correction
In the FR Doc 2016–02191, appearing
on page 5906 in the Federal Register of
February 4, 2016 (81 FR 5906):
1. In the second column of page 5906,
third item under ADDRESSES, the term
‘‘XXXX’’ is corrected to read ‘‘9428.’’
2. In the third column of page 5907,
the first sentence of the discussion
regarding ‘‘Executive Order 12866:
Regulatory Review’’ is corrected to read:
‘‘The costs of this rulemaking are
discussed in the companion DHS rule,
RIN 1651–AB09, published in the
Federal Register on February 8, 2016,
81 FR 6430.’’
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulation on Benefits Payable in
Terminated Single-Employer Plans to
prescribe interest assumptions under
the regulation for valuation dates in
March 2016. The interest assumptions
are used for paying benefits under
terminating single-employer plans
covered by the pension insurance
system administered by PBGC.
DATES: Effective March 1, 2016.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion (Klion.Catherine@
pbgc.gov), Assistant General Counsel for
Regulatory Affairs, Pension Benefit
Guaranty Corporation, 1200 K Street
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll-free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: PBGC’s
regulation on Benefits Payable in
Terminated Single-Employer Plans (29
CFR part 4022) prescribes actuarial
assumptions—including interest
assumptions—for paying plan benefits
under terminating single-employer
plans covered by title IV of the
Employee Retirement Income Security
Act of 1974. The interest assumptions in
the regulation are also published on
PBGC’s Web site (https://www.pbgc.gov).
PBGC uses the interest assumptions in
Appendix B to Part 4022 to determine
whether a benefit is payable as a lump
sum and to determine the amount to
pay. Appendix C to Part 4022 contains
interest assumptions for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using PBGC’s historical
methodology. Currently, the rates in
Appendices B and C of the benefit
payment regulation are the same.
SUMMARY:
E:\FR\FM\12FER1.SGM
12FER1
]]>Agencies
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Page 7454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02962]
=======================================================================
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DEPARTMENT OF STATE
22 CFR Part 41
[Public Notice: 9439]
RIN 1400-AD17
Visas: Documentation of Nonimmigrants Under the Immigration and
Nationality Act, as Amended
AGENCY: Department of State.
ACTION: Interim final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Department of State published a Federal Register interim
final rule on February 4, 2016, in Volume 81, No. 23, page 5906. The
document contains an error in the Regulatory Findings. This document
corrects the rule by replacing the text, ``included elsewhere in this
edition of the Federal Register'' with ``published in the Federal
Register on February 8, 2016, 81 FR 6430.'' There is also a correction
in the ADDRESSES section, to provide the correct public notice number
to find the rule to submit comments on www.regulations.gov.
DATES: This correction is effective on February 19, 2016. Written
comments must be received on or before April 4, 2016.
FOR FURTHER INFORMATION CONTACT: Paul-Anthony L. Magadia, U.S.
Department of State, Visa Services, Legislation and Regulations
Division, Washington, DC 20006, 202-485-7641; email:
magadiapl@state.gov.
SUPPLEMENTARY INFORMATION: The Department of State published an interim
final rule on February 4, 2016 (81 FR 5906); this document corrects
text in the ADDRESSES section and in the discussion of Executive Order
12866.
Correction
In the FR Doc 2016-02191, appearing on page 5906 in the Federal
Register of February 4, 2016 (81 FR 5906):
1. In the second column of page 5906, third item under ADDRESSES,
the term ``XXXX'' is corrected to read ``9428.''
2. In the third column of page 5907, the first sentence of the
discussion regarding ``Executive Order 12866: Regulatory Review'' is
corrected to read: ``The costs of this rulemaking are discussed in the
companion DHS rule, RIN 1651-AB09, published in the Federal Register on
February 8, 2016, 81 FR 6430.''
Dated: February 9, 2016.
David S. Newman,
Director of Legal Affairs, Visa Services, Bureau of Consular Affairs,
U.S. Department of State.
[FR Doc. 2016-02962 Filed 2-11-16; 8:45 am]
BILLING CODE 4710-06-P
