Personnel; Changes in Statutory Authority; Technical Corrections; Liability for Neglect of Duty or for Malfeasance Generally; Repeal of Regulation, 43246-43247 [2014-17428]
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43246
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Rules and Regulations
that include subcutaneous ports must
include the following:
(A) Labeling must include the
recommended type of needle for access
as well as detailed instructions for care
and maintenance of the port,
subcutaneous pocket, and skin
overlying the port.
(B) Performance testing must include
results on repeated use of the ports that
simulates use over the intended life of
the device.
(C) Clinical performance testing must
demonstrate safe and effective use and
capture any adverse events observed
during clinical use.
(vii) In addition to Special Controls in
paragraphs (b)(1)(i) through (v) of this
section, implanted blood access devices
with coatings or additives must include
the following:
(A) A description and material
characterization of the coating or
additive material, the purpose of the
coating or additive, duration of
effectiveness, and how and where the
coating is applied.
(B) An identification in the labeling of
any coatings or additives and a
summary of the results of performance
testing for any coating or material with
special characteristics, such as
decreased thrombus formation or
antimicrobial properties.
(C) A Warning Statement in the
labeling for potential allergic reactions
including anaphylaxis if the coating or
additive contains known allergens.
(D) Performance data must
demonstrate efficacy of the coating or
additive and the duration of
effectiveness.
(viii) The following must be included
for A–V shunt cannulae (with vessel
tips):
(A) The device must comply with
Special Controls in paragraphs (b)(1)(i)
through (v) of this section with the
exception of paragraphs (b)(1)(ii)(B),
(b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C),
which do not apply.
(B) Labeling must include Warning
Statements to address the potential for
vascular access steal syndrome, arterial
stenosis, arterial thrombosis, and
hemorrhage including exsanguination
given that the device accesses the
arterial circulation.
(C) Clinical performance testing must
demonstrate safe and effective use and
capture any adverse events observed
during clinical use.
(2) Class II (performance standards)
for the nonimplanted blood access
device.
(3) Class II (performance standards)
for accessories for both the implanted
and the nonimplanted blood access
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devices not listed in paragraph (b)(4) of
this section.
(4) Class I for the cannula clamp,
disconnect forceps, crimp plier, tube
plier, crimp ring, and joint ring,
accessories for both the implanted and
nonimplanted blood access device. The
devices subject to this paragraph (b)(4)
are exempt from the premarket
notification procedures in subpart E of
part 807 of this chapter subject to the
limitations in § 876.9.
Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–17477 Filed 7–24–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
22 CFR Part 13
[Public Notice: 8808]
RIN 1400–AD61
Personnel; Changes in Statutory
Authority; Technical Corrections;
Liability for Neglect of Duty or for
Malfeasance Generally; Repeal of
Regulation
Department of State.
Final rule.
AGENCY:
ACTION:
The Department of State is
repealing the regulation that provides
for personal liability for Consular
Officers in cases of malfeasance, and
provides updates to citations of
authorities. The deleted regulation,
which was promulgated in 1957 and last
amended in 1984, is no longer
authorized by statute.
DATES: This rule is effective July 25,
2014.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Klimow, Office of Legal Affairs,
Overseas Citizen Services, U.S.
Department of State, 2201 C Street NW.,
SA–17, Washington, DC 20520, (202)
485–6224, klimowda1@state.gov.
SUPPLEMENTARY INFORMATION: This rule
removes 22 CFR 13.3 from the Code of
Federal Regulations. 22 CFR 13.3
provides that consular officers who
willfully neglect or fail to perform any
duty imposed on them by law shall be
found liable to all persons injured by
any such neglect, or omission,
malfeasance, abuse, or corrupt conduct.
22 CFR 13.3 also provides for criminal
penalties for consular officers found
guilty for malfeasance and corrupt
conduct in office. The Department is
removing 22 CFR 13.3 because the rule’s
authorizing statute has been repealed.
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22 CFR 13.3 implemented 22 U.S.C.
1199, which explicitly provided for civil
and criminal liability against consular
officers for willful neglect or omission
in the performance of their assigned
duties. Section 1199 was repealed in
1977, and the legislative history for the
repeal of Section 1199 reflected a desire
by Congress to treat consular officers the
same as other federal employees with
respect to personal liability for acts
taken within the scope of their official
duties. Foreign Relations Authorization
Act, Fiscal Year 1978, Public Law 95–
105, title I, section 111, 91 Stat. 848
(1977); H.R. Rep. No. 95–231, at 17, 21
(1977); H.R. Rep. No. 95–537 at 33
(1977) (Conf. Rep.).
22 CFR 13.3 was also promulgated
under the authority of 22 U.S.C. 2658
and 22 U.S.C. 3926. However, 22 U.S.C.
2658 was repealed in 1994. 22 U.S.C.
3926 is still in effect and is a general
authorization for the Secretary of State
to prescribe such regulations as are
necessary to administer the foreign
service in conformity with federal law;
however, it does not grant the Secretary
specific authority to provide for the civil
and criminal liability of consular
officers in 22 CFR 13.3.
Finally, this rule updates all of the
statutory authorities cited in Part 13,
and updates one regulatory reference
(from Section 22.4 to Section 22.6).
Regulatory Analysis and Notices
Administrative Procedure Act
This action is being taken as a final
rule pursuant to the ‘‘good cause’’
provision of 5 U.S.C. 553(b). It is the
position of the Department that notice
and comment are not necessary in light
of the fact that 22 CFR 13.3 implements
a repealed statute; thus, it is no longer
authorized. In addition, there were only
technical edits to the remaining three
sections of Part 13. This rulemaking is
effective immediately in accordance
with 5 U.S.C. 553(d)(3). Finally, this
rulemaking is exempt from the notice
and comment pursuant to 5 U.S.C.
553(a)(2), as it is a matter relating to
agency management of personnel.
Regulatory Flexibility Act
The Department hereby certifies that
this rulemaking will not have a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act, 5
U.S.C. 605(b).
Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995, 2 U.S.C.
1532, generally requires agencies to
prepare a statement before proposing
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Rules and Regulations
any rule that may result in an annual
expenditure of $100 million or more by
State, local, or tribal governments, or by
the private sector. This rulemaking will
not result in any such expenditure, nor
will it significantly or uniquely affect
small governments.
Executive Orders 12866 and 13563
The Department of State has reviewed
this rule to ensure its consistency with
the regulatory philosophy and
principles set forth in Executive Order
12866 and has determined that the
benefits of this rule seeking repeal of 22
CFR 13.3 and updates to Part 13 justify
its costs. The Department does not
consider this rule to be a significant rule
as defined by E.O. 12866. The
Department has considered this rule in
light of Executive Order 13563, and
affirms that this regulation is consistent
with the guidance therein.
Federalism
This rule will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or the
distribution of power and
responsibilities among the various
levels of government. Nor will the rule
have federalism implications warranting
the application of Executive Orders
12372 and 13132.
Civil Justice Reform
The Department has reviewed this
rulemaking in light of sections 3(a) and
3(b)(2) of Executive Order 12988 to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
Consultations With Tribal Governments
The Department has determined that
this rulemaking will not have Tribal
implications, will not impose
substantial direct compliance costs on
Indian Tribal governments, and will not
pre-empt Tribal law. Accordingly, the
requirements of Executive Order 13175
do not apply to this rulemaking.
rmajette on DSK2TPTVN1PROD with RULES
Paperwork Reduction Act
This rule does not impose information
collection requirements under the
provisions of the Paperwork Reduction
Act, 44 U.S.C. Chapter 35.
List of Subjects in 22 CFR Part 13
Consular services, Crime, Government
employees.
Accordingly, 22 CFR part 13 is
amended as follows:
PART 13—PERSONNEL
1. The authority citation for Part 13 is
revised to read as follows:
■
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Authority: 22 U.S.C. 2651a; 22 U.S.C.
4198–4199, 4209, and 4217–4218.
43247
2. Section 13.1 is amended by
removing ‘‘(22 U.S.C. 1189)’’ and adding
‘‘(22 U.S.C. 4209)’’ in its place, by
removing ‘‘§ 22.4’’ and adding ‘‘§ 22.6’’
in its place in the Note, and by
removing the sectional authority
citation.
This order is effective August 25,
2014. The classification was applicable
beginning September 13, 2013.
FOR FURTHER INFORMATION CONTACT:
Mark Kreitz, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G270, Silver Spring,
MD 20993–0002, 301–796–7019.
SUPPLEMENTARY INFORMATION:
§ 13.2
I. Background
§ 13.1
[Amended]
■
[Amended]
3. Section 13.2 is amended by
removing ‘‘(22 U.S.C. 1198)’’ and adding
‘‘(22 U.S.C. 4217’’) in its place, and by
removing ‘‘(22 U.S.C. 1178 and 1179)’’
adding ‘‘(22 U.S.C. 4198 and 4199)’’ in
its place, and by removing the sectional
authority citation.
■
§ 13.3
[Removed and Reserved]
4. Section 13.3 is removed and
reserved.
■
§ 13.4
[Amended]
5. Section 13.4 is amended by
removing ‘‘(22 U.S.C. 1200)’’ and adding
‘‘(22 U.S.C. 4218)’’ in its place, and by
removing the sectional authority
citation.
■
Dated: July 18, 2014.
Michele T. Bond,
Acting Assistant Secretary, Bureau of
Consular Affairs, U.S. Department of State.
[FR Doc. 2014–17428 Filed 7–24–14; 8:45 am]
BILLING CODE 4710–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2014–M–0966]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Implantable Transprostatic Tissue
Retractor System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final Order.
The Food and Drug
Administration (FDA) is classifying the
implantable transprostatic tissue
retractor system into class II (special
controls). The special controls that will
apply to the device are identified in this
order and will be part of the codified
language. The Agency is classifying the
device into class II (special controls) in
order to provide a reasonable assurance
of safety and effectiveness of the device.
SUMMARY:
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DATES:
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
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]]>Agencies
[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43246-43247]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17428]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF STATE
22 CFR Part 13
[Public Notice: 8808]
RIN 1400-AD61
Personnel; Changes in Statutory Authority; Technical Corrections;
Liability for Neglect of Duty or for Malfeasance Generally; Repeal of
Regulation
AGENCY: Department of State.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of State is repealing the regulation that
provides for personal liability for Consular Officers in cases of
malfeasance, and provides updates to citations of authorities. The
deleted regulation, which was promulgated in 1957 and last amended in
1984, is no longer authorized by statute.
DATES: This rule is effective July 25, 2014.
FOR FURTHER INFORMATION CONTACT: Daniel Klimow, Office of Legal
Affairs, Overseas Citizen Services, U.S. Department of State, 2201 C
Street NW., SA-17, Washington, DC 20520, (202) 485-6224,
klimowda1@state.gov.
SUPPLEMENTARY INFORMATION: This rule removes 22 CFR 13.3 from the Code
of Federal Regulations. 22 CFR 13.3 provides that consular officers who
willfully neglect or fail to perform any duty imposed on them by law
shall be found liable to all persons injured by any such neglect, or
omission, malfeasance, abuse, or corrupt conduct. 22 CFR 13.3 also
provides for criminal penalties for consular officers found guilty for
malfeasance and corrupt conduct in office. The Department is removing
22 CFR 13.3 because the rule's authorizing statute has been repealed.
22 CFR 13.3 implemented 22 U.S.C. 1199, which explicitly provided
for civil and criminal liability against consular officers for willful
neglect or omission in the performance of their assigned duties.
Section 1199 was repealed in 1977, and the legislative history for the
repeal of Section 1199 reflected a desire by Congress to treat consular
officers the same as other federal employees with respect to personal
liability for acts taken within the scope of their official duties.
Foreign Relations Authorization Act, Fiscal Year 1978, Public Law 95-
105, title I, section 111, 91 Stat. 848 (1977); H.R. Rep. No. 95-231,
at 17, 21 (1977); H.R. Rep. No. 95-537 at 33 (1977) (Conf. Rep.).
22 CFR 13.3 was also promulgated under the authority of 22 U.S.C.
2658 and 22 U.S.C. 3926. However, 22 U.S.C. 2658 was repealed in 1994.
22 U.S.C. 3926 is still in effect and is a general authorization for
the Secretary of State to prescribe such regulations as are necessary
to administer the foreign service in conformity with federal law;
however, it does not grant the Secretary specific authority to provide
for the civil and criminal liability of consular officers in 22 CFR
13.3.
Finally, this rule updates all of the statutory authorities cited
in Part 13, and updates one regulatory reference (from Section 22.4 to
Section 22.6).
Regulatory Analysis and Notices
Administrative Procedure Act
This action is being taken as a final rule pursuant to the ``good
cause'' provision of 5 U.S.C. 553(b). It is the position of the
Department that notice and comment are not necessary in light of the
fact that 22 CFR 13.3 implements a repealed statute; thus, it is no
longer authorized. In addition, there were only technical edits to the
remaining three sections of Part 13. This rulemaking is effective
immediately in accordance with 5 U.S.C. 553(d)(3). Finally, this
rulemaking is exempt from the notice and comment pursuant to 5 U.S.C.
553(a)(2), as it is a matter relating to agency management of
personnel.
Regulatory Flexibility Act
The Department hereby certifies that this rulemaking will not have
a significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act, 5 U.S.C. 605(b).
Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C.
1532, generally requires agencies to prepare a statement before
proposing
[[Page 43247]]
any rule that may result in an annual expenditure of $100 million or
more by State, local, or tribal governments, or by the private sector.
This rulemaking will not result in any such expenditure, nor will it
significantly or uniquely affect small governments.
Executive Orders 12866 and 13563
The Department of State has reviewed this rule to ensure its
consistency with the regulatory philosophy and principles set forth in
Executive Order 12866 and has determined that the benefits of this rule
seeking repeal of 22 CFR 13.3 and updates to Part 13 justify its costs.
The Department does not consider this rule to be a significant rule as
defined by E.O. 12866. The Department has considered this rule in light
of Executive Order 13563, and affirms that this regulation is
consistent with the guidance therein.
Federalism
This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
the distribution of power and responsibilities among the various levels
of government. Nor will the rule have federalism implications
warranting the application of Executive Orders 12372 and 13132.
Civil Justice Reform
The Department has reviewed this rulemaking in light of sections
3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity,
minimize litigation, establish clear legal standards, and reduce
burden.
Consultations With Tribal Governments
The Department has determined that this rulemaking will not have
Tribal implications, will not impose substantial direct compliance
costs on Indian Tribal governments, and will not pre-empt Tribal law.
Accordingly, the requirements of Executive Order 13175 do not apply to
this rulemaking.
Paperwork Reduction Act
This rule does not impose information collection requirements under
the provisions of the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
List of Subjects in 22 CFR Part 13
Consular services, Crime, Government employees.
Accordingly, 22 CFR part 13 is amended as follows:
PART 13--PERSONNEL
0
1. The authority citation for Part 13 is revised to read as follows:
Authority: 22 U.S.C. 2651a; 22 U.S.C. 4198-4199, 4209, and 4217-
4218.
Sec. 13.1 [Amended]
0
2. Section 13.1 is amended by removing ``(22 U.S.C. 1189)'' and adding
``(22 U.S.C. 4209)'' in its place, by removing ``Sec. 22.4'' and
adding ``Sec. 22.6'' in its place in the Note, and by removing the
sectional authority citation.
Sec. 13.2 [Amended]
0
3. Section 13.2 is amended by removing ``(22 U.S.C. 1198)'' and adding
``(22 U.S.C. 4217'') in its place, and by removing ``(22 U.S.C. 1178
and 1179)'' adding ``(22 U.S.C. 4198 and 4199)'' in its place, and by
removing the sectional authority citation.
Sec. 13.3 [Removed and Reserved]
0
4. Section 13.3 is removed and reserved.
Sec. 13.4 [Amended]
0
5. Section 13.4 is amended by removing ``(22 U.S.C. 1200)'' and adding
``(22 U.S.C. 4218)'' in its place, and by removing the sectional
authority citation.
Dated: July 18, 2014.
Michele T. Bond,
Acting Assistant Secretary, Bureau of Consular Affairs, U.S.
Department of State.
[FR Doc. 2014-17428 Filed 7-24-14; 8:45 am]
BILLING CODE 4710-06-P
