[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43241-43246]
[FR Doc No: 2014-17477]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2012-N-0303]

Gastroenterology-Urology Devices; Reclassification of Implanted
Blood Access Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify implanted blood access devices, a preamendments
class III device, into class II (special controls) based on new
information and subject to premarket notification and to further
clarify the identification.

DATES: This order is effective July 25, 2014.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), establishes a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
Panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
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).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the mechanism for
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
or an interested person may petition FDA to reclassify a preamendments
device. The term ``new information,'' as used in section 513(e) of the
FD&C Act, includes information developed as a result of a reevaluation
of the data before the Agency when the device was originally
classified, as well as information not presented, not available, or not
developed at that time. (See, e.g., Holland-Rantos Co. v. United States
Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1
(D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell
v. Goddard, 366 F.2d 177 (7th Cir. 1966)).
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers
Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474
U.S. 1062 (1986)).
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA). (See section 520(c) of the FD&C
Act (21 U.S.C. 360j(c))). Section 520(h)(4) of the FD&C Act, added by
FDAMA, provides that FDA may use, for reclassification of a device,
certain information in a PMA 6 years after the application has been
approved. This includes information from clinical and preclinical tests
or studies that demonstrate the safety or effectiveness of the device
but does not include descriptions of methods of manufacture or product
composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments to a public docket. FDA published a
proposed order to reclassify this device in the Federal Register of
June 28, 2013 (78 FR 38867). FDA received and has considered one
comment on this proposed order, as discussed in section II. FDA has
held a meeting of a device classification panel described in section
513(b) of the FD&C Act with respect to implanted blood access devices,
and therefore, has met this requirement under section 513(e)(1) of the
FD&C Act. As explained further in section III, a meeting of a device
classification panel described in section 513(b) of the FD&C Act, the
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee (the Panel), took place on June 27, 2013 (78 FR
25747, May 2,

2013), to discuss whether implanted blood access devices should be
reclassified or remain in class III. The reclassification of implanted
blood access devices was mostly supported by the Panel. During
deliberations, the Panel recommended that implanted hemodialysis
catheters and implanted coated hemodialysis catheters be reclassified
into class II because there was sufficient information to establish
special controls, with the provision of slight modifications to the
risks to health, as well as the proposed special controls. The majority
of the Panel members expressed concern that the risks associated with
the fully subcutaneous implanted blood access devices (port-catheter
systems or fully subcutaneous port-catheter systems) or the
arteriovenous (A-V) shunt cannulae might not be mitigated by the
proposed special controls and recommended that these two implanted
blood access device subtypes remain in class III. Details of the
Panel's recommendations and FDA's response are provided in section III.
    FDA is not aware of new information since the Panel meeting that
would provide a basis for a different recommendation or findings.

II. Public Comments in Response to the Proposed Order

    In response to the June 28, 2013, proposed order to reclassify
implanted blood access devices, FDA did not receive any comments.
However, in response to the draft guidance that published the same day
(78 FR 38994, June 28, 2013) FDA received one comment. The comment
included suggestions for revision to the proposed special controls, and
is therefore relevant to the proposed order. In general, the comment
supported FDA's intent to reclassify implanted blood access devices
including the implementation of special controls. Regarding the special
controls, the commenter recommended that the special control relating
to mechanical hemolysis be modified to specify that it only applies to
devices that include a new or altered blood flow pattern. They also
recommended that chemical tolerance testing only be necessary for the
disinfection agents listed within the product labeling, and not to all
``commonly used disinfection agents,'' and that the compatible agents
must be listed in the labeling, as opposed to a listing of the
disinfecting agents that cannot be used. Finally, in relation to
disinfecting agents, the commenter suggested that the term
``contraindicated'' be avoided and suggested alternative language
regarding providing appropriate information to users regarding
incompatible disinfecting agents. It was also recommended that the
special control relating to sterility be modified to specify that not
only the package remain sterile, but also its contents.
    FDA continues to believe that the proposed special controls
(section VIII of the proposed order), with minor modifications as
discussed in section III, provide a reasonable assurance of safety and
effectiveness. Although the Panel did not comment specifically on any
of the revisions recommended by the commenter, FDA considered the
suggestions and adopted the recommendations regarding mechanical
hemolysis testing, as reflected in the revised special control.
    Regarding the comments relating to the testing and labeling of
compatible cleaning and disinfecting agents, FDA agrees that an
alternative to printing contraindicated disinfecting agents directly on
the catheter would be to provide the information on both the patient's
medical record and directly to the patient via an implant card. The
associated special control has been modified from that proposed only to
specifically state that a patient implant card must be provided, which
was not previously stated. FDA disagrees, however, with the other
comments regarding disinfecting agents, and believes that in order to
reasonably assure the safety and effectiveness of implanted blood
access devices, due to the variation in facility protocols regarding
care and maintenance of this device type, chemical tolerance to or
incompatibility with commonly used disinfection agents must be
established. It is insufficient to only conduct chemical tolerance
testing for the compatible disinfection agents listed within the
product labeling. Therefore, the related special control regarding the
requirement to establish the device's chemical tolerance to repeated
exposure to commonly used disinfection agents remains unchanged. FDA
believes that the requirement that the device remain sterile in
addition to the packaging has been adequately captured in the proposed
special control, and therefore no associated changes were made.
    FDA believes that the special controls provide a reasonable
assurance of safety and effectiveness for implanted blood access
devices that feature similar technology and indications. The Agency
believes it has now identified all relevant risks to health (see
section V of the proposed order for the originally identified risks to
health and section III of this document for updated risks to health
based on Panel recommendations) and that the mitigation methods
described in the associated special controls will be effective in
mitigating these risks. These risks and mitigations were based on
recommendations from the June 27, 2013, Gastroenterology and Urology
Devices Panel of the Medical Devices Advisory Committee (Ref. 1) as
further described in section III; the information gathered from the
Manufacturer and User Facility Device Experience database and FDA's
literature review (see FDA's Executive Panel Summary, Ref. 2); and
information provided in response to the proposed order.

III. Deliberations of the Panel

    In Session II of the June 27, 2013, device classification panel
meeting, the Panel considered the reclassification of implanted blood
access devices (Ref. 1) from class III to class II (special controls).
The Panel was asked to provide input on the risks to health, safety,
and effectiveness of these devices.
    The reclassification of implanted blood access devices was
partially supported by the Panel. During deliberations, the Panel
concluded that it would be acceptable to reclassify the implanted
hemodialysis catheters and the implanted coated hemodialysis catheters
into class II with slight modifications to the risks to health as well
as the proposed special controls, as discussed further in this
document. However, the Panel expressed concern that the proposed
special controls may not be adequate to mitigate the risks associated
with the fully subcutaneous port-catheter systems or the A-V shunt
cannulae and, as a result of this concern over the ability to establish
adequate special controls, recommended that these two implanted blood
access device subtypes remain in class III. The concern for the fully
subcutaneous port-catheter devices was based on a higher risk of
infectious complications historically noted for these devices compared
with other types of implanted blood access devices for hemodialysis.
Because the A-V shunt cannulae access the arterial circulation, the
Panel expressed concerns that the risks of arterial thrombosis,
premature separation, severe bleeding, air embolism, and steal syndrome
might not be mitigated by the proposed special controls.
    FDA does not agree with the Panel that these two device subtypes
should remain in class III. To address the concerns expressed by the
Panel, FDA has modified the special controls by including additional
special controls that will require the submission of

clinical performance data for these two device subtypes. Of note,
arteriovenous grafts (vascular graft prostheses), another type of
implanted vascular access for hemodialysis, are similar to A-V shunt
cannulae in that they also access the arterial circulation. These
devices are currently regulated as class II medical devices (21 CFR
870.3450). A-V shunt cannulae are unique in that they have an external
component, but FDA believes the overall categories of risk are similar.
Fully subcutaneous port-catheter systems indicated for infusion, which
have similar design features and a similar risk profile to the fully
subcutaneous port-catheter systems indicated for hemodialysis, are
currently also regulated as class II medical devices (21 CFR 880.5965).
Based on reported adverse events and device recalls, and on the lack of
increased infection being noted in current practice guidelines for
these devices, FDA believes that arteriovenous grafts and fully
subcutaneous port-catheter systems indicated for infusion are
adequately regulated as class II devices. Given that devices with
similar risk profiles, indications, and technologies are currently
regulated as class II medical devices, FDA believes that special
controls can be established for fully subcutaneous port-catheter
devices and A-V shunt cannulae to mitigate the identified risks to
health and provide a reasonable assurance of safety and effectiveness.
    FDA presented the risks to health to the Panel, and the Panel fully
supported the risks as originally identified, and provided the
following additional comments. Several Panel members felt that the
risks of arterial thrombosis (in addition to venous thrombosis),
premature separation and bleeding, potential for exsanguination, air
embolism, and steal syndrome should be included for A-V shunt cannulae.
With the exception of steal syndrome, FDA believes that these risks
were already included, but appreciates the Panel input with regard to
the increased risks of thrombosis, bleeding, and air embolism when the
devices are inserted into the arterial circulation. Clarifying comments
have been added to the previously identified risks, and a new risk was
added for vascular access steal syndrome. The Panel also felt that the
risk of ``Infection and pyrogen reactions'' should be expanded to state
that improper insertion, care, or maintenance of the device can also
lead to infection. As a result, FDA has added clarifying statements to
this previously identified risk to health. Similarly, the Panel members
felt that the risk of anaphylaxis should be included as a risk for
coated devices. FDA does not believe that this is a newly identified
risk and has now included clarifying statements to include this risk
subtype under the category of ``Adverse tissue reaction'' as well as
additional language regarding the risks specific to coated devices.
Clarifying statements have also been added to the category of ``Device
Failure'' specifically relating the risk to coated devices in addition
to non-coated devices.
    Based upon the Panel's input as described and FDA's review, FDA has
updated the risks to the following:
     Thrombosis in patient, device occlusion, or central venous
stenosis: Inadequate blood compatibility of the materials used in this
device, blood pooling between dialysis sessions, or turbulent blood
pathways could lead to potentially debilitating or fatal
thromboembolism. If the device accesses the arterial circulation, the
device could cause arterial stenosis or thrombosis.
     Adverse tissue reaction: Inadequate tissue compatibility
of the materials used in this device, including coatings or additives,
could cause an immune reaction. This could include anaphylaxis for
coated devices.
     Infection and pyrogen reactions: Skin or bloodstream
infections could result from an improperly sterilized device,
inappropriate preparation of the insertion site, or improper care and
maintenance of the device exit site.
     Device failure: Weakness of connections or materials
(including coatings or additives) could lead to breakage, which could
result in blood loss or device fragment embolization.
     Cardiac arrhythmia, hemorrhage, embolism, nerve injury, or
vessel perforation: Improper placement into the heart or blood vessel
could damage tissues and result in injuries, such as vessel
perforation. Inappropriate placement or removal of the device could
cause air embolism or hemorrhage.
     Hemolysis: Turbulence or high pressure created by narrow
openings or changes in blood flow paths could cause the destruction of
red blood cells.
     Accidental withdrawal or device migration: The cuff of
implanted devices may not allow adequate ingrowth from the surrounding
subcutaneous tissue, which could cause the device to dislodge or fall
out with subsequent blood loss. If the device accesses the arterial
circulation, inadvertent separation could result in severe hemorrhage
including exsanguination.
     Vascular access steal syndrome associated with devices
inserted into the artery and vein: Alterations in blood flow paths
could result if the device accesses both the arterial and venous
circulation, which could result in decreased blood flow to the distal
extremity.
    The Panel agreed that general controls were not sufficient to
provide a reasonable assurance of safety and effectiveness, and also
that these devices are life-supporting or life-sustaining. The Panel
mostly agreed that FDA's list of special controls from the June 28,
2013, proposed order would mitigate the identified risks and provide
reasonable assurance of safety and effectiveness for the implanted
hemodialysis catheters and the implanted coated hemodialysis catheters.
Some of the panelists expressed concerns regarding the specificity of
some of the proposed special controls and suggested modifications. As
described further in this document, FDA largely agreed with the special
control recommendations and has revised the special controls
accordingly (see section IV. The Final Order). The special controls
were also modified in response to the modifications to the risks to
health previously described.
    The Panel recommended updating the special control for labeling to
include proper care and maintenance of the device and device exit-site
and to specify appropriate qualifications for clinical providers
performing the insertion, maintenance, and removal of the devices. FDA
agreed with this recommendation. In response to the Panel's recommended
modifications to the risks to health, a special control for labeling
was also added for coated devices to include a Warning Statement for
potential allergic reactions including anaphylaxis if the coating or
additive contains known allergens. FDA also added labeling special
controls for A-V shunt cannulae to include Warning Statements for
vascular access steal syndrome, arterial stenosis, arterial thrombosis,
and hemorrhage including exsanguination given that the device accesses
the arterial circulation.
    FDA added new special controls requiring clinical performance data
for the fully subcutaneous port-catheter devices and the A-V shunt
cannulae in order to address the Panel concerns for a higher risk of
infectious complications historically noted for the fully subcutaneous
devices and the risks of arterial thrombosis, premature separation,
severe bleeding, air embolism, and steal syndrome for the A-V shunt
cannulae. FDA believes that

clinical performance data could adequately characterize adverse events
observed during clinical use in the intended population in order to
inform FDA and therefore provide a reasonable assurance of safety and
effectiveness.
    Table 1 shows how FDA believes that the risks to health identified
and listed in this document can be mitigated by the special controls.

Table 1--Health Risks and Mitigation Measures for Implanted Blood Access
                                 Devices
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          Identified risk                    Mitigation measures
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Thrombosis in patient and catheter  Performance testing.
                                    Labeling.
                                    Sterility.
                                    Clinical performance testing
                                     (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
Adverse tissue reaction...........  Biocompatibility.
                                    Sterility.
                                    Expiration date testing.
                                    Labeling (with inclusion of Warning
                                     Statement for anaphylaxis for
                                     devices with coatings or
                                     additives).
                                    Materials characterization (devices
                                     with coatings or additives).
Infection and pyrogen reactions...  Performance testing.
                                    Clinical performance testing (fully
                                     subcutaneous port-catheter
                                     devices).
                                    Sterility.
                                    Expiration date testing.
                                    Labeling.
Device failure....................  Performance testing.
                                    Expiration date testing.
                                    Labeling.
Cardiac arrhythmia, hemorrhage,     Performance testing.
 embolism, nerve injury, or vessel
 perforation.
                                    Labeling.
                                    Clinical performance testing
                                     (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
Hemolysis.........................  Performance testing.
                                    Labeling.
Accidental withdrawal or device     Biocompatibility.
 migration.
                                    Performance testing.
                                    Clinical performance testing
                                     (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
                                    Labeling.
Vascular access steal syndrome      Labeling.
 associated with devices inserted   Clinical performance testing
 into the artery and vein.           (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
------------------------------------------------------------------------

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings,
as published in the preamble to the June 28, 2013, proposed order. FDA
has made revisions in this final order in response to the comments
received (see section II) and the deliberations of the Panel (see
section III). As published in the proposed order, FDA is issuing this
final order to reclassify implanted blood access devices from class III
to class II and establish special controls by revising Sec.  876.5540
(21 CFR 876.5540). The identification for Sec.  876.5540(a)(1) has been
revised to provide a more accurate description of devices in this
classification regulation.
    In response to the input of the Panel, FDA also made refinements to
the proposed special controls as described previously. FDA added new
special controls requiring clinical performance data for the fully
subcutaneous port-catheter devices and the A-V shunt cannulae.
Additionally, FDA updated the special controls for labeling and updated
special controls for implanted blood access devices with coatings.
    Following the effective date of this final order, firms submitting
a premarket notification (510(k)) for an implanted blood access device
will need either to (1) comply with the particular mitigation measures
set forth in the codified special controls or (2) use alternative
mitigation measures, but demonstrate to the Agency's satisfaction that
those alternative measures identified by the firm will provide at least
an equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of implanted blood access devices, and therefore, this
device type is not exempt from premarket notification requirements.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; and the collections of information under 21 CFR part 801 have
been approved under OMB control number 0910-0485.

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) as amended requires FDA to issue final orders rather
than regulations, FDASIA also provides for FDA to revoke previously
issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations. Changes resulting from final orders will appear in the CFR
as changes to codified classification determinations or as newly
codified orders. Therefore, under section 513(e)(1)(A)(i), as amended
by FDASIA, in this final order, we are revoking the requirements in
Sec.  876.5540(b)(1) related to the classification of implanted blood
access devices as class III devices and codifying the reclassification
of implanted blood access devices into class II (special controls).

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)
1. Transcript of the June 27, 2013, meeting of the Gastroenterology
and Urology Devices Panel (available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM362271.pdf).
2. FDA Executive Summary prepared for the June 27, 2013, meeting of
the Gastroenterology and Urology Devices Panel (available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM358369.pdf).

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Amend Sec.  876.5540 by revising paragraphs (a)(1) and (b)(1) and by
removing paragraph (c) to read as follows:

Sec.  876.5540  Blood access device and accessories.

    (a) * * *
    (1) The implanted blood access device is a prescription device and
consists of various flexible or rigid tubes, such as catheters, or
cannulae, which are surgically implanted in appropriate blood vessels,
may come through the skin, and are intended to remain in the body for
30 days or more. This generic type of device includes various
catheters, shunts, and connectors specifically designed to provide
access to blood. Examples include single and double lumen catheters
with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt
cannulae (with vessel tips). The implanted blood access device may also
contain coatings or additives which may provide additional
functionality to the device.
* * * * *
    (b) Classification. (1) Class II (special controls) for the
implanted blood access device. The special controls for this device
are:
    (i) Components of the device that come into human contact must be
demonstrated to be biocompatible. Material names and specific
designation numbers must be provided.
    (ii) Performance data must demonstrate that the device performs as
intended under anticipated conditions of use. The following performance
characteristics must be tested:
    (A) Pressure versus flow rates for both arterial and venous lumens,
from the minimum flow rate to the maximum flow rate in 100 milliliter
per minute increments, must be established. The fluid and its viscosity
used during testing must be stated.
    (B) Recirculation rates for both forward and reverse flow
configurations must be established, along with the protocol used to
perform the assay, which must be provided.
    (C) Priming volumes must be established.
    (D) Tensile testing of joints and materials must be conducted. The
minimum acceptance criteria must be adequate for its intended use.
    (E) Air leakage testing and liquid leakage testing must be
conducted.
    (F) Testing of the repeated clamping of the extensions of the
catheter that simulates use over the life of the device must be
conducted, and retested for leakage.
    (G) Mechanical hemolysis testing must be conducted for new or
altered device designs that affect the blood flow pattern.
    (H) Chemical tolerance of the device to repeated exposure to
commonly used disinfection agents must be established.
    (iii) Performance data must demonstrate the sterility of the
device.
    (iv) Performance data must support the shelf life of the device for
continued sterility, package integrity, and functionality over the
requested shelf life that must include tensile, repeated clamping, and
leakage testing.
    (v) Labeling of implanted blood access devices for hemodialysis
must include the following:
    (A) Labeling must provide arterial and venous pressure versus flow
rates, either in tabular or graphical format. The fluid and its
viscosity used during testing must be stated.
    (B) Labeling must specify the forward and reverse recirculation
rates.
    (C) Labeling must provide the arterial and venous priming volumes.
    (D) Labeling must specify an expiration date.
    (E) Labeling must identify any disinfecting agents that cannot be
used to clean any components of the device.
    (F) Any contraindicated disinfecting agents due to material
incompatibility must be identified by printing a warning on the
catheter. Alternatively, contraindicated disinfecting agents must be
identified by a label affixed to the patient's medical record and with
written instructions provided directly to the patient.
    (G) Labeling must include a patient implant card.
    (H) The labeling must contain comprehensive instructions for the
following:
    (1) Preparation and insertion of the device, including recommended
site of insertion, method of insertion, and a reference on the proper
location for tip placement;
    (2) Proper care and maintenance of the device and device exit site;
    (3) Removal of the device;
    (4) Anticoagulation;
    (5) Management of obstruction and thrombus formation; and
    (6) Qualifications for clinical providers performing the insertion,
maintenance, and removal of the devices.
    (vi) In addition to Special Controls in paragraphs (b)(1)(i)
through (v) of this section, implanted blood access devices

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 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 Sec.  876.9.

    Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17477 Filed 7-24-14; 8:45 am]
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[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Rules and Regulations]
[Page 27031]
[FR Doc No: 2013-10815]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0831; Airspace Docket No. 12-AEA-13]

Amendment of Class E Airspace; Kingston, NY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E Airspace at Kingston, NY, creating
controlled airspace to accommodate new Standard Instrument Approach
Procedures at Kingston-Ulster Airport. This action enhances the safety
and management of Instrument Flight Rules (IFR) operations at the
airport. This action also updates the geographic coordinates of the
airport.

DATES: Effective 0901 UTC, August 22, 2013. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On January 30, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace at Kingston, NY
(78 FR 6260) Docket No. FAA-2012-0831. Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9W dated
August 8, 2012, and effective September 15, 2012, which is incorporated
by reference in 14 CFR 71.1. The Class E airspace designations listed
in this document will be published subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace extending upward from 700 feet
above the surface at Kingston, NY to accommodate the new area
navigation global positioning system Standard Instrument Approach
Procedures developed for Kingston-Ulster Airport. Runway 15 is being
extended 700 feet and the controlled airspace area is increased to
within an 8.6-mile radius of the airport due to terrain in the
surrounding area. Also, the geographic coordinates of the airport are
adjusted to coincide with the FAA's aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Kingston-Ulster Airport, Kingston,
NY.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9W, Airspace Designations and Reporting
Points, dated August 8, 2012, effective September 15, 2012, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

AEA NY E5 Kingston, NY [Amended]

Kingston-Ulster Airport
    (Lat. 41[deg]59'07'' N., long 73[deg]57'52'' W.)

    That airspace extending upward from 700 feet above the surface
of the Earth within an 8.6-mile radius of Kingston-Ulster Airport.

    Issued in College Park, Georgia, on April 30, 2013.
Barry A. Knight,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2013-10815 Filed 5-8-13; 8:45 am]
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[Federal Register Volume 86, Number 51 (Thursday, March 18, 2021)]
[Notices]
[Page 14759]
[FR Doc No: 2021-05613]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4506-DR; Docket ID FEMA-2021-0001]

Pennsylvania; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Pennsylvania (FEMA-4506-DR), dated March 30,
2020, and related determinations.

DATES: This change occurred on January 20, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Janice P.
Barlow, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of MaryAnn Tierney as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton Jr.,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-05613 Filed 3-17-21; 8:45 am]
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[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Proposed Rules]
[Pages 43205-43206]
[FR Doc No: 2012-18075]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2012-0026, FRL-9704-5]

Notice of Data Availability for Approval, Disapproval and
Promulgation of Implementation Plans; State of Wyoming; Regional Haze
State Implementation Plan; Federal Implementation Plan for Regional
Haze

AGENCY: Environmental Protection Agency.

ACTION: Notice of data availability (NODA).

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SUMMARY: EPA is providing notice that information has been posted in
the docket pertaining to EPA's proposed action on the State
Implementation Plan (SIP) revision submitted by the State of Wyoming on
January 12, 2011, that addresses regional haze. (Docket ID No. EPA-R08-
OAR-2012-0026). This information is relevant to the portion of the
rulemaking pertaining to the proposed Federal Implementation Plan (FIP)
and proposals in the alternative for PacifiCorp Jim Bridger Unit 1 and
Unit 2. EPA is requesting comment on the new data provided in the
docket. This information could impact EPA's final decision on the
rulemaking as it pertains to Jim Bridger Unit 1 and Unit 2.

DATES: Comments on the NODA must be received on or before August 3,
2012. This date corresponds to the date comments must be received for
the proposed rulemaking.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2012-0026, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Carl Daly, Director, Air Program, Environmental
Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street,
Denver, Colorado 80202-1129.
     Hand Delivery: Carl Daly, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129. Such deliveries are only
accepted Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding
Federal holidays. Special arrangements should be made for deliveries of
boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2012-0026. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://ww.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or
email. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA, without going through http://www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional instructions on submitting comments, go to
Section I. General Information of the SUPPLEMENTARY INFORMATION section
of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly-available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129. EPA requests that if at all
possible, you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8:00 a.m.
to 4:00 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Laurel Dygowski, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. Proposed Rulemaking

    Detailed background information describing the proposed rulemaking
may be found in a previously published document: Approval, Disapproval
and Promulgation of Implementation Plans; State of Wyoming; Regional
Haze State Implementation Plan; Federal Implementation Plan for
Regional Haze; Proposed Rule (77 FR 33022, June 4, 2012).

III. New Information Placed in the Docket

    EPA requests comment on the information described below that has
been added to docket EPA-R08-OAR-2012-0026.
     A July 12, 2012 letter from Micheal Dunn, PacifiCorp, to
Carl Daly, EPA Region 8. The information provided in the letter is to
support EPA's third proposal in the alternative for Jim Bridger Unit 1
and Unit 2 as described in the proposed rulemaking.

    Dated: July 16, 2012.
Judith Wong,
Acting Regional Administrator, Region 8.
[FR Doc. 2012-18075 Filed 7-23-12; 8:45 am]
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