[Federal Register: April 22, 2010 (Volume 75, Number 77)]
[Notices]
[Page 21050-21051]
[DOCID:fr22ap10-120]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

V-GPO, Inc., Valesc Holdings, Inc., Venture Stores, Inc., Vertigo
Theme Parks, Inc. (f/k/a Snap2 Corp.), Videolan Technologies, Inc.,
VisionGateway, Inc., Vital Health Technologies, Inc. (n/k/a Caribbean
American Health Resorts), and VoiceNet, Inc.; Order of Suspension of
Trading

April 20, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
V-GPO, Inc. because it has not filed any periodic reports since the
period ended September 30, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Valesc Holdings, Inc. because it has not filed any periodic reports
since the period ended June 30, 2003.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Venture Stores, Inc. because it has not filed any periodic reports
since the period ended October 25, 1997.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Vertigo Theme Parks, Inc. (f/k/a Snap2 Corp.) because it has not filed
any periodic reports since the period ended June 30, 2005.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Videolan Technologies, Inc. because it has not filed any periodic
reports since the period ended September 30, 1997.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
VisionGateway, Inc. because it has not filed any periodic reports since
the period ended July 31, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Vital Health Technologies, Inc. (n/k/a Caribbean American Health
Resorts) because it has not filed any periodic reports since the period
ended September 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
VoiceNet, Inc. because it has not filed any periodic reports since the
period ended September 30, 2001.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EDT
on April 20, 2010, through 11:59 p.m. EDT on May 3, 2010.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2010-9455 Filed 4-20-10; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: April 21, 2008 (Volume 73, Number 77)]
[Rules and Regulations]
[Page 21229-21231]
[DOCID:fr21ap08-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0120; Directorate Identifier 2007-NM-327-AD;
Amendment 39-15473; AD 2008-08-19]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace LP Model
Gulfstream G150 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Possible chafing between [the] electrical feeder cable connected
to contactor 123P/2 and ground point 803GND, installed within the
left DC power box, discovered during routine receiving inspection.
This condition may exist on boxes installed on in-service aircraft.
If this chafing condition is left unattended, an electrical short
may develop, leading to disconnection of the battery and battery bus
from the electrical system of the aircraft, [which could result in]
overheating, arcing, smoke and fire.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective May 27, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 27,
2008.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Mike Borfitz, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2677; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on February 5, 2008 (73
FR 6627). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Possible chafing between [the] electrical feeder cable connected
to contactor 123P/2 and ground point 803GND, installed within the
left DC power box, discovered during routine receiving inspection.
This condition may exist on boxes installed on in-service aircraft.
If this chafing condition is left unattended, an electrical short
may develop, leading to disconnection of the battery and battery bus
from the electrical system of the aircraft, [which could result in]
overheating, arcing, smoke and fire.

    The corrective action includes inspecting for chafing and arcing
damage of the feeder cable, terminal lug and ground point, contacting
Gulfstream for repair if any damage is found and repairing, installing
new heat-shrink tubing if the tubing is missing or damaged, and
repositioning the feeder cable. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a Note within the AD.

Costs of Compliance

    We estimate that this AD will affect about 26 products of U.S.
registry. We also estimate that it will take about 3 work-hours per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Required parts will cost about $0 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $6,240, or $240 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-08-19 Gulfstream Aerospace LP (Formerly Israel Aircraft
Industries, Ltd.): Amendment 39-15473. Docket No. FAA-2008-0120;
Directorate Identifier 2007-NM-327-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective May 27,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Gulfstream Model Gulfstream G150
airplanes, certificated in any category, serial numbers 201 through
239 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Possible chafing between [the] electrical feeder cable connected
to contactor 123P/2 and ground point 803GND, installed within the
left DC power box, discovered during routine receiving inspection.
This condition may exist on boxes installed on in-service aircraft.
If this chafing condition is left unattended, an electrical short
may develop, leading to disconnection of the battery and battery bus
from the electrical system of the

aircraft, [which could result in] overheating, arcing, smoke and
fire.

The corrective action includes inspecting for chafing and arcing
damage of the feeder cable, terminal lug and ground point,
contacting Gulfstream for repair if any damage is found and
repairing, installing new heat-shrink tubing if the tubing is
missing or damaged, and repositioning the feeder cable.

Actions and Compliance

    (f) Unless already done, do the following actions. Within 50
flight hours or 30 days after the effective date of this AD,
whichever occurs first, inspect the feeder cable, terminal lug 123P/
2, and ground point 803GND for chafing and arcing damage, reposition
the feeder cable to maintain an adequate gap, and do all applicable
corrective actions. Do the actions in accordance with Gulfstream
Alert Service Bulletin 150-24A-046, dated October 31, 2007. Do all
applicable corrective actions before further flight.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Mike
Borfitz, Aerospace Engineer, International Branch, ANM-116, FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Israeli Airworthiness Directive 24-07-10-11,
dated October 31, 2007; and Gulfstream Alert Service Bulletin 150-
24A-046, dated October 31, 2007; for related information.

Material Incorporated by Reference

    (i) You must use Gulfstream Alert Service Bulletin 150-24A-046,
dated October 31, 2007, to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25,
Savannah, Georgia 31402-2206.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on April 8, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-8258 Filed 4-18-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7446-7452]
[FR Doc No: 2016-02876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868 and 870

[Docket No. FDA-2012-N-1174]

Anesthesiology Devices; Reclassification of Membrane Lung for
Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit
and Accessories for Long-Term Respiratory/Cardiopulmonary Failure

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 redesignate membrane lung devices for long-term pulmonary
support, a preamendments class III device, as extracorporeal circuit
and accessories for long-term respiratory/cardiopulmonary failure, and
to reclassify the device to class II (special controls) in patients
with acute respiratory failure or acute cardiopulmonary failure where
other available treatment options have failed, and continued clinical
deterioration is expected or the risk of death is imminent. A membrane
lung device for long-term pulmonary support (>6 hours) refers to the
oxygenator in an extracorporeal circuit used during long-term
procedures, commonly referred to

as extracorporeal membrane oxygenation (ECMO). Because a number of
other devices and accessories are used with the oxygenator in the
circuit, the title and identification of the regulation are revised to
include extracorporeal circuit and accessories for long-term
respiratory/cardiopulmonary failure. Although an individual device or
accessory used in an ECMO circuit may already have its own
classification regulation when the device or accessory is intended for
short-term use (<=6 hours), such device or accessory will be subject to
the same regulatory controls applied to the oxygenator (i.e., class II,
special controls) when evaluated as part of the ECMO circuit for long-
term use (>6 hours). On its own initiative, based on new information,
FDA is revising the classification of the membrane lung device for
long-term pulmonary support.

DATES: This order is effective February 12, 2016.

FOR FURTHER INFORMATION CONTACT: Fernando Aguel, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1234,
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), among other amendments,
established 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).
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification procedures (510(k)) to such a preamendments device or to a
device within that type (both the preamendments and substantially
equivalent devices are referred to as preamendments class III devices)
may be marketed without submission of a premarket approval application
(PMA) until FDA issues a final order under section 515(b) of the FD&C
Act (21 U.S.C. 360e(b)) requiring premarket approval or until the
device is subsequently reclassified into class I or class II.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) 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 provides that FDA may, by
administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act 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) of the
FD&C Act 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 Assoc. 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
PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final reclassification 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.

II. Regulatory History of the Device

    FDA published a proposed order to reclassify this device in the
Federal Register of January 8, 2013 (78 FR 1158) (the ``proposed
order''). As noted in the proposed order, on July 16, 1982, the Agency
issued a final rule classifying all membrane lungs for long-term
pulmonary support into class III (47 FR 31130). On May 11, 1987, FDA
published a final rule amending the codified language for this device
to clarify that no effective date had been

established for the requirement for premarket approval for membrane
lungs for long-term pulmonary support devices (52 FR 17732 at 17735).
This device is currently under product code BYS.
    As discussed in the proposed order, FDA considered the available
information on these devices and concluded that these devices could be
reclassified to class II, subject to the identified special controls.
As required by section 513(e)(1) of the FD&C Act, FDA convened a
meeting of a device classification panel described in section 513(b) of
the FD&C Act with respect to the membrane lung devices for long-term
pulmonary support on September 12, 2013, followed by a meeting on May
7, 2014. The deliberations of the device classification panels are
discussed in section IV of this order. FDA received and has considered
two comments on the January 8, 2013, proposed order, as discussed in
section III. Therefore, FDA has met the requirements for issuing a
final order under section 513(e)(1) of the FD&C Act.

III. Public Comments in Response to the Proposed Order

    FDA received two comments in response to the January 8, 2013,
proposed order to reclassify membrane lung devices for long-term
pulmonary support for conditions where imminent death is threatened by
cardiopulmonary failure in neonates and infants or where
cardiopulmonary failure results in the inability to separate from
cardiopulmonary bypass following cardiac surgery.
    One comment supported FDA's reclassification proposal but requested
that the Agency clarify the population covered and the conditions
included in the reclassification. According to the commenter, it seemed
that the membrane lung device could be used for long-term support in
neonates and infants only when imminent death is threatened by
cardiopulmonary failure, but for the remaining population (e.g.,
pediatric and adult patients), the membrane lung could be used for
long-term support only when cardiopulmonary failure results in the
inability to separate from cardiopulmonary bypass following cardiac
surgery. With respect to the conditions covered, the commenter sought
clarification as to whether the reclassification was limited only to
cardiopulmonary conditions or to cardiac failure as well. FDA is
clarifying the intended uses covered by the reclassification in this
final order. Specifically, after considering the input from the
September 12, 2013, and May 7, 2014, classification panel meetings,
comments on the proposed order and all other available information, FDA
has determined that the reclassification applies to ECMO as a system of
devices and accessories that provide extracorporeal circulation and
physiologic gas exchange of blood in patients with acute respiratory
failure or acute cardiopulmonary failure where other available
treatment options have failed, and continued clinical deterioration is
expected or the risk of death is imminent. This revised scope better
reflects use of ECMO as a tool that provides extracorporeal circulation
and physiologic gas exchange of blood and more accurately reflects the
function of the device. FDA has not cleared any ECMO devices that are
indicated for specific patient populations or conditions. As such, FDA
believes that the intended uses included in this final order should
remain broad, rather than specify patient populations or conditions to
be treated, to reflect use of ECMO as a tool.
    Another comment disagreed with FDA's intent to reclassify membrane
lung devices for long-term pulmonary support, stating that ``ECMO
devices must remain categorized as class III devices for all
indications because they are life-sustaining devices for which clinical
trials are necessary to provide reasonable assurance of safety and
effectiveness.'' FDA disagrees with this comment. According to section
513(a)(1)(C) of the FD&C Act, a class III device is defined as a device
which: (1) Cannot be classified as a class I device because
insufficient information exists to determine that the application of
general controls are sufficient to provide reasonable assurance of the
safety and effectiveness of the device; and (2) cannot be classified as
a class II device because insufficient information exists to determine
that the special controls would provide reasonable assurance of its
safety and effectiveness; and (3) is purported or represented to be for
a use in supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health; or (4)
presents a potential unreasonable risk of illness or injury.
    Although FDA considers membrane lung devices for long-term
pulmonary support to be life-supporting, a viewpoint that was supported
by the panel members at the September 12, 2013 (2013 Panel), and May 7,
2014 (2014 Panel), device classification panel meetings, FDA believes
that the available information supports FDA's determination that
special controls, in addition to general controls, would be sufficient
to provide a reasonable assurance of safety and effectiveness. Further,
the 2013 and 2014 Panels largely supported reclassification of ECMO for
use in patients with acute respiratory failure or acute cardiopulmonary
failure as noted in section IV of this order. As mentioned previously
and discussed further in section IV, ECMO is a tool which provides
extracorporeal circulation and physiologic gas exchange of blood. The
special controls identified in this final order, including clinical
performance data, ensure that the device can function as intended to
provide extracorporeal circulation and physiologic gas exchange of
blood for the intended duration of device use. The Agency believes that
the risks of ECMO devices are sufficiently understood based on valid
scientific evidence and that the risks of ECMO devices can be mitigated
with the special controls identified in this final order. The special
controls mitigate the risks to health identified for the device as
outlined in section IV, table 1. Therefore, FDA does not agree that
membrane lung devices for long-term pulmonary support for use in
patients with acute respiratory failure or acute cardiopulmonary
failure should remain a class III device.
    The commenter also expressed concern that the reclassification of
these devices would mean that companies manufacturing new versions of
the device would not be required to show that their products are safe
and effective. The commenter suggests that classification to class II
(special controls) precludes FDA from requesting clinical data for
these devices. FDA disagrees with this comment. FDA believes that the
identified special controls provide a reasonable assurance of safety
and effectiveness for membrane lung devices for long-term pulmonary
support for use in patients with acute respiratory failure or acute
cardiopulmonary failure, where other available treatment options have
failed, and continued clinical deterioration is expected or the risk of
death is imminent. FDA has determined that by complying with the
identified special controls, the currently legally marketed devices
within this classification regulation will be reasonably safe and
effective when used for acute respiratory failure or acute
cardiopulmonary failure. Future devices claiming substantial
equivalence to an available predicate(s) must demonstrate that they are
substantially equivalent, as defined under section 513(i) of the FD&C
Act, to the predicate device and comply with all applicable FDA
regulations and with the special

controls in order to be classified into class II. Classification to
class II (special controls) does not preclude FDA from requesting
clinical data for these devices. In some cases, clinical data may be
needed to comply with the special controls and demonstrate substantial
equivalence to an available predicate. For example, special control
Sec.  870.4100(b)(v) regarding in vivo evaluation of the device could
include clinical trial data, clinical information from the literature,
and/or animal study data.
    The commenter further expressed concern that reclassification for
some indications will reduce the incentive to undertake future studies
for untested indications due to the availability of the devices for
``off-label'' use. FDA notes in response to this comment that,
generally, FDA regulates the use of a device as indicated by the party
offering the device for interstate commerce.
    The commenter also sought assurance from FDA that membrane lung
devices for long-term pulmonary support for indications not identified
in the proposed order would remain in class III and therefore require
the submission of a PMA. FDA notes that by identifying the intended
uses covered by the revised classification regulation, uses that fall
outside the definition would not be subject to the order but rather
would be classified under section 513 of the FD&C Act.

IV. Deliberations of the Panels and FDA Consideration of Panel Input

    As required by section 513(e)(1) of the FD&C Act, FDA convened a
meeting of the Circulatory System Devices Panel to consider the
existing valid scientific evidence to support reclassification to class
II of membrane lung devices for long-term pulmonary support. One
meeting was held on September 12, 2013 (2013 Panel), regarding
pediatric uses for ECMO and another meeting was held on May 7, 2014
(2014 Panel), regarding adult uses for ECMO (Refs. 1 and 2).
    On September 12, 2013, FDA presented the risks associated with use
of the membrane lung device for long-term pulmonary support. The 2013
Panel mostly agreed that the risks to health were adequately captured
as presented by FDA. Several 2013 Panel members discussed whether the
list of risks to health should also include information on renal
dysfunction, neurologic injury, disseminated intravascular coagulation,
transfusion issues, and inflammatory responses. FDA explained that such
effects are more appropriately characterized not as risks to health but
rather as adverse events that may result from the risks to health. The
2013 Panel understood this distinction but requested that FDA consider
expanding the definition of adverse tissue reaction to include
inflammatory response. FDA considered the 2013 Panel's input when
updating the risks to health for the 2014 Panel and this final order.
    The 2013 Panel agreed that the available scientific evidence
supported the safety and effectiveness for ECMO and its accessories for
conditions where the subject is at threat of imminent death caused by
acute reversible respiratory failure (e.g., meconium aspiration,
congenital diaphragmatic hernia, pulmonary hypertension) in neonates
and infants, or where acute cardiopulmonary failure results in the
inability to separate from cardiopulmonary bypass following cardiac
surgery in all pediatric patients.
    The 2013 Panel also agreed that the probable benefits to health
from use of the extracorporeal circuit and its accessories for long-
term pulmonary and cardiopulmonary support for these uses outweigh the
probable risks. As noted previously, FDA has further considered all
available information and has determined that the risks to health
identified for ECMO are the same across neonatal, infant, pediatric,
and adult populations. This is consistent with input from the 2013 and
2014 Panels, which found that the risks to health for the pediatric and
adult populations do not differ. Further, FDA believes that the
available safety and effectiveness information supports use of ECMO as
a tool to provide extracorporeal circulation and physiologic gas
exchange of blood in patients with acute respiratory failure or acute
cardiopulmonary failure, where other available treatment options have
failed, and continued clinical deterioration is expected or the risk of
death is imminent. FDA is providing greater clarity in this final order
by simplifying the identification of ECMO devices in the classification
regulation to better reflect what an ECMO circuit performs, not specify
patient populations or conditions to be treated. Specific indications
for use for ECMO, including specific patient populations and/or
conditions, are further discussed in this document.
    In general, the 2013 Panel believed the special controls in the
proposed order would mitigate the identified risks to health and
provide reasonable assurance of safety and effectiveness of the
extracorporeal circuit and its accessories. However, some 2013 Panel
members recommended that compatibility of the various circuit
accessories be evaluated to ensure that the circuit accessories can
function together as intended. FDA believes that the special controls
will be able to address the issue of circuit accessories'
compatibility. Specifically, the following special controls from the
classification regulation address this concern: (1) The design
characteristics of the device must ensure that the geometry and design
parameters are consistent with the intended use; (2) non-clinical
performance evaluation of the device must demonstrate substantial
equivalence for performance characteristics on the bench, mechanical
integrity, electromagnetic compatibility(where applicable), software,
durability, and reliability; and (3) labeling must include a detailed
summary of the non-clinical and clinical evaluations pertinent to use
of the device and adequate instructions with respect to
anticoagulation, circuit setup, performance characteristics with
respect to compatibility with other circuit accessories, and
maintenance during a procedure.
    The 2013 Panel unanimously agreed that the membrane lung device for
long-term pulmonary support is life-supporting. The 2013 Panel further
stated that the available scientific evidence and the proposed special
controls, in conjunction with general controls, supported the
reclassification to class II of membrane lung devices for long-term
pulmonary/cardiopulmonary support in pediatric patients. The 2013 Panel
expressed concern about not having had the opportunity to review data
regarding use of the device in adults, given that use of ECMO in adults
had increased significantly over the years. The 2013 Panel recommended
that FDA convene another meeting to review the available literature
regarding use of the membrane lung device for long-term pulmonary
support in adults before finalizing the proposed reclassification.
    On May 7, 2014, FDA convened the 2014 Panel to discuss the
classification of the membrane lung for long-term support, specifically
for adult pulmonary and cardiopulmonary indications. For both pulmonary
and cardiopulmonary intended uses, the 2014 Panel believed that the
list of risks to health presented by FDA were comprehensive and
adequately captured. Of note, in response to the 2013 Panel's
recommendation regarding risks to health, FDA expanded the definition
of adverse tissue reaction to include inflammatory response.
    The majority of the 2014 Panel believed that the available
scientific evidence is adequate to support a

reasonable assurance of safety and effectiveness of the extracorporeal
circuit and its accessories for long-term pulmonary support in adults,
but recommended that FDA modify the intended use from ``pulmonary
support'' to ``acute, hypoxic, reversible respiratory failure.'' FDA
agrees with the 2014 Panel that ``respiratory failure'' is a more
accurate reflection of the use of ECMO as a tool to provide
extracorporeal circulation and physiologic gas exchange of blood in
patients rather than ``pulmonary support.'' FDA has considered this
input from the panel and has determined that acute respiratory failure
is the appropriate intended use from a clinical and regulatory
perspective to reflect such use. This change is reflected in the
classification regulation. The Panel also agreed that the available
scientific evidence is adequate to support a reasonable assurance of
safety and effectiveness of the device for long-term cardiopulmonary
support in adults suffering from ``cardiopulmonary failure due to acute
catastrophic cardiogenic shock.'' FDA agrees with the 2014 Panel that
``acute cardiopulmonary failure'' is a more accurate reflection of the
use of ECMO as a tool to provide extracorporeal circulation and
physiologic gas exchange of blood in patients rather than
``cardiopulmonary support.'' FDA has considered this input from the
panel and has determined that acute cardiopulmonary failure is the
appropriate intended use from a clinical and regulatory perspective to
reflect such use. This change is reflected in the classification
regulation. For both pulmonary and cardiopulmonary support in adults,
the 2014 Panel agreed that the probable benefits to health from use of
the device outweigh the probable risks to health where other available
treatment options have failed, and continued clinical deterioration is
expected or the risk of death is imminent.
    The 2014 Panel agreed that FDA's list of special controls were
appropriate and comprehensive. The 2014 Panel further agreed that the
special controls would mitigate the identified risks to health and
provide reasonable assurance of safety and effectiveness for the device
when used to provide long-term support in adults with acute respiratory
failure or cardiopulmonary failure.
    For both acute respiratory and acute cardiopulmonary indications in
adults, the 2014 Panel unanimously agreed that the membrane lung device
for long-term support is life-supporting. The 2014 Panel further
believes that the available scientific evidence and the proposed
special controls support the reclassification to class II of membrane
lung devices for long-term support in adults with acute respiratory
failure or acute cardiopulmonary failure.
    After considering input from both the 2013 and 2014 Panels, FDA
believes that the risks to health identified can be mitigated by the
special controls as outlined in Table 1.

     Table 1--Health Risks and Mitigation Measures for ECMO Devices
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Thrombocytopenia.......................  Technological characteristics;
                                          Non-clinical performance
                                          evaluation; In vivo
                                          evaluation; Labeling.
Hemolysis..............................  Technological characteristics;
                                          Biocompatibility testing; Non-
                                          clinical performance
                                          evaluation; Labeling.
Adverse tissue reaction (including       Biocompatibility testing;
 inflammatory response).                  Labeling.
Inadequate gas exchange................  Non-clinical performance
                                          evaluation; In vivo
                                          evaluation; Labeling.
Gas embolism...........................  Non-clinical performance
                                          evaluation; In vivo
                                          evaluation; Labeling.
Mechanical failure.....................  Technological characteristics;
                                          Non-clinical performance
                                          evaluation; Labeling.
Hemorrhage.............................  In vivo evaluation; Labeling.
Hemodilution...........................  Non-clinical performance
                                          evaluation; In vivo
                                          evaluation; Labeling.
Thrombosis/thromboembolism.............  Non-clinical performance
                                          evaluation; In vivo
                                          evaluation; Labeling.
Infection..............................  Sterility; Shelf life testing.
Mechanical injury to access vessels....  Non-clinical performance
                                          evaluation; In vivo
                                          evaluation; Labeling.
------------------------------------------------------------------------

    At both the 2013 Panel and 2014 Panel meetings, FDA provided a
summary of information from the clinical literature regarding specific
patient populations and conditions to be treated using ECMO (Refs.1 and
2). Of note, FDA has not cleared any ECMO devices that are indicated
for specific patient populations or conditions. As such, FDA believes
that the intended uses included in this final order should remain broad
to reflect use of ECMO as a tool to provide extracorporeal circulation
and physiologic gas exchange of blood in patients with acute
respiratory failure or acute cardiopulmonary failure, where other
available treatment options have failed, and continued clinical
deterioration is expected or the risk of death is imminent. However,
FDA believes that there are specific indications (patient populations
and/or conditions) that would fall within this broader intended use and
therefore be within the scope of this regulation as outlined in this
document.
    Specifically, FDA has reviewed the clinical literature and has
determined that there are sufficient data available to support labeling
ECMO devices for the following specific indications (patient
populations and/or conditions) at this time: Meconium aspiration in
neonates and infants; congenital diaphragmatic hernia in neonates and
infants; pulmonary hypertension in neonates and infants; failure to
wean from cardiopulmonary bypass following cardiac surgery in pediatric
and adult patients; and ECMO-assisted cardiopulmonary resuscitation in
adults.
    FDA has further evaluated data from the clinical literature and
determined that the data available do not support labeling ECMO devices
for certain specific indications (patient populations and/or
conditions) at this time without additional clinical data from sponsors
to support such uses, consistent with the identified special controls,
including but not limited to: High risk percutaneous coronary
intervention; trauma resuscitation; failed heart or lung transplant;
acute respiratory distress syndrome; and/or acute decompensation of
chronic obstructive pulmonary disease.
    For ECMO devices that have not been legally marketed prior to the
effective date of the final order, or models (if any) that have been
legally marketed but are required to submit a new 510(k) under Sec.
807.81(a)(3) because the device is

about to be significantly changed or modified, manufacturers must
obtain 510(k) clearance, among other relevant requirements, and
demonstrate compliance with the special controls included in the final
order, before marketing the new or changed device.

V. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the proposed order (78 FR 1158) with
modifications as discussed in section IV of this final order. FDA is
issuing this final order to reclassify the membrane lung devices for
long-term pulmonary support from class III to class II for use in
patients with acute respiratory failure or acute cardiopulmonary
failure, where other available treatment options have failed and
continued clinical deterioration is expected or the risk of death is
imminent, and to establish special controls. FDA is removing the
regulation from 21 CFR part 868 (Anesthesiology Devices) and adding it
to 21 CFR part 870 (Cardiovascular Devices) to better align this device
type (and the review thereof) with other similar types of
cardiovascular devices. The title and identification of Sec.  870.4100
(21 CFR 870.4100) reflects the Agency's intent to regulate ECMO and the
accessories used in ECMO under the same set of regulatory controls.
However, an individual device or accessory in an ECMO circuit may
already have its own classification regulation when intended for short-
term use (<=6 hours) and, in those instances, such device or accessory
is subject to the preexisting regulation(s).
    Following the effective date of this final order, firms marketing
membrane lung devices for long-term pulmonary support for use in
patients with acute respiratory failure or acute cardiopulmonary
failure, where other available treatment options have failed and
continued clinical deterioration is expected or the risk of death is
imminent, must comply with the particular mitigation measures set forth
in the special controls.
    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 membrane lung devices for long-term pulmonary support
for use in patients with acute respiratory failure or acute
cardiopulmonary failure, where other available treatment options have
failed, and continued clinical deterioration is expected or the risk of
death is imminent, and, therefore, this device type is not exempt from
premarket notification requirements.

VI. Analysis of 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.

VII. 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; the collections of information in 21 CFR part 814, subpart B,
have been approved under OMB control number 0910-0231; and the
collections of information under 21 CFR part 801 have been approved
under OMB control number 0910-0485.

VIII. 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) of the FD&C Act 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 (CFR). 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) of the
FD&C Act, as amended by FDASIA, in this final order, we are revoking
the requirements in 21 CFR 868.5610 related to the classification of
membrane lung for long-term pulmonary support as class III devices and
codifying under Sec.  870.4100 the reclassification of membrane lung
for long-term pulmonary support for use in patients with acute
respiratory failure or acute cardiopulmonary failure, where other
available treatment options have failed, and continued clinical
deterioration is expected or the risk of death is imminent into class
II (special controls).

IX. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. The panel transcript and other meeting materials for the
September 12, 2013, Circulatory System Devices Panel are available
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm.
2. The panel transcript and other meeting materials for the May 7,
2014, Circulatory System Devices Panel are available on FDA's Web
site at. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm395638.htm

List of Subjects in 21 CFR Parts 868 and 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
868 and 870 are amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 868 continues to read as
follows:

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

Sec.  868.5610  [Removed]

0
2. Remove Sec.  868.5610.

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

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

0
2. Add Sec.  870.4100 to subpart E to read as follows:

Sec.  870.4100  Extracorporeal circuit and accessories for long-term
respiratory/cardiopulmonary failure.

    (a) Identification. An extracorporeal circuit and accessories for
long-term respiratory/cardiopulmonary support (>6 hours) is a system of
devices and accessories that provides assisted extracorporeal
circulation and physiologic gas exchange of the patient's blood in
patients with acute respiratory failure or acute cardiopulmonary
failure, where other available treatment options have failed, and
continued clinical deterioration is expected or the risk of death is
imminent. The main devices and accessories of the system include, but
are not limited to, the console (hardware), software, and disposables,
including, but not limited to, an oxygenator, blood pump, heat
exchanger, cannulae, tubing, filters, and other accessories (e.g.,
monitors, detectors, sensors, connectors).
    (b) Classification--Class II (special controls). The special
controls for this device are:
    (1) The technological characteristics of the device must ensure
that the geometry and design parameters are consistent with the
intended use, and that the devices and accessories in the circuit are
compatible;
    (2) The devices and accessories in the circuit must be demonstrated
to be biocompatible;
    (3) Sterility and shelf-life testing must demonstrate the sterility
of any patient-contacting devices and accessories in the circuit and
the shelf life of these devices and accessories;
    (4) Non-clinical performance evaluation of the devices and
accessories in the circuit must demonstrate substantial equivalence of
the performance characteristics on the bench, mechanical integrity,
electromagnetic compatibility (where applicable), software, durability,
and reliability;
    (5) In vivo evaluation of the devices and accessories in the
circuit must demonstrate their performance over the intended duration
of use, including a detailed summary of the clinical evaluation
pertinent to the use of the devices and accessories to demonstrate
their effectiveness if a specific indication (patient population and/or
condition) is identified; and
    (6) Labeling must include a detailed summary of the non-clinical
and in vivo evaluations pertinent to use of the devices and accessories
in the circuit and adequate instructions with respect to
anticoagulation, circuit setup, performance characteristics with
respect to compatibility among different devices and accessories in the
circuit, and maintenance during a procedure.

    Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02876 Filed 2-11-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Page 57287]
[FR Doc No: 2020-20301]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[FAA-2020-0488]

Agency Information Collection Activities: Requests for Comments;
Clearance of New Approval of Information Collection: Survey of
Unmanned-Aircraft-Systems Operators

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval a new information collection. The
Federal Register Notice with a 60-day comment period soliciting
comments on the following collection of information was published on
May 12, 2020. The collection is a survey of unmanned aircraft systems
(UAS) operator who are registered with the FAA under part 107 and
section 349. The information to be collected will be used to prepare
and plan for the integration of UAS into the national airspace system
(NAS), as required by Section 376 under the FAA Reauthorizations Act of
2018.

DATES: Written comments should be submitted by October 12, 2020.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: William G. Ekins by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-.
    Title: Survey of Unmanned-Aircraft-Systems Operators.
    Form Numbers: N/A.
    Type of Review: new information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on May 12, 2020 (2020-10139). The FAA Reauthorizations
Act of 2018 explicitly charges the FAA with developing a plan to
implement a UAS traffic management (UTM) services. The development of
this congressionally mandated plan requires an estimation of current
activity by UAS operators and projecting this behavior into the future
as economic, technology, and regulatory condition change. Given the
lack of available data on the flight behavior of UAS operators, the FAA
proposes a survey of UAS operators who have registered with the FAA
under Section 349 or Part 107.
    Survey consists of a voluntary questionnaire administered online.
Registrants within the FAA's UAS registry under Part 107 and Section
349 are invited to complete the online questionnaire via email. The
email contains a personalized link to the questionnaire hosted by
Survey Monkey. The questionnaire contains:
    6 questions on general flight behavior,
    4 questions about the number and types of UAS operated,
    6 questions for respondents who identity as commercial operators,
and
    7 questions for respondents who identify as operating for public
safety agencies.
    Including a social-media preference and self-identifying questions,
the questionnaire contains a total 25 question. However, the majority
of respondents will only answer the first 12 questions.
    The data obtained from the survey will be used to develop national
forecasts of UAS activity. Summary data from the proposed survey will
be included in the Aviation Forecast published annually by the FAA.
    Given this Information Collection Request is for a new survey,
three post-survey studies are included in survey design: A request for
comments on questions within the questionnaire, post-survey study of
non-response bias, and a post-survey study of sampling bias. Each of
these follow-up studies have questionnaires as instruments. These
studies are used to hone the survey design.
    The main questionnaire is expected to place 10,881 hours of burden
on the public while the remainder of the post-survey studies require
23,165 hours.
    Respondents: UAS operators registered with the FAA under Part 107
or Section 349.
    Frequency: Annually.
    Estimated Average Burden per Response: 5.3 minutes on average.
    Estimated Total Annual Burden: 34,026 hours.

    Issued in Washington, DC, on September 10, 2020.
Michael Lukacs,
Deputy Division Manager, Office of Aviation Policy and Plans, APO-100,
Federal Aviation Administration, Department of Transportation.
[FR Doc. 2020-20301 Filed 9-14-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Notices]
[Page 72475]
[DOCID:fr28no08-66]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EF08-2011-000 and RM08-20-000]

Sales of Electric Power to the Bonneville Power Administration;
Revisions to the 2008 Average System Cost Methodology; Notice of
Opportunity To File Reply Comments

November 21, 2008.
    On November 10, 2008, Bonneville and other interested parties filed
comments in the above-referenced dockets on an Interim Rule that
implements Bonneville's revised Average System Cost Methodology. In its
comments, Bonneville included revisions to the regulations promulgated
by the Interim Rule in Part 301 of the Commission's regulations.
Bonneville requests the Commission to provide an opportunity for reply
comments on its proposed revised regulations.
    In response to Bonneville's request, interested parties may file
reply comments in the above-referenced dockets on or before December
15, 2008. Parties must use the filing procedures provided for the
initial comments in these proceedings.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28284 Filed 11-26-08; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM

DATE:		March 26, 2015

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	EPA Region 1

SUBJECT:	March 26, 2015, Briefing with New England Congressional Staff, Including Proposed Clean Power Plan for Existing Power Plants
--------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and the attendees listed below on March 26, 2015 to provide policy updates on EPA programs.  During this meeting, Shutsu Wong provided an overview of the proposed Clean Power Plan for Existing Power Plants.

ATTENDEES

MA
Nick Clemons, Kennedy
Kate Chang, Capuano
Kayla Scire, Markey
Jane Adams, Tsongas
Russell Pandres, Tsongas
Christian LoBoue, Clark
Anthony Moreschi, Clark
Kelsey Perkins, Clark
Wade Blackman, Clark
Jennifer Migliore, Moulton
Anthony Morse, Keating
Kathleen Polanowicz, McGovern
Morgan Bell, Moulton
Katherine Shea, Lynch

NH
Kari Thurman, Shaheen
Sarah Holmes, Shaheen
Matt Flanders, Ayotte

CT
Matthew S. LeBeau, Blumenthal
Ayanti Grant, Courtney
Lisa Perrone, Larson
Kenny Curran. Murphy

RI
Joe Masino, Langevin
Karen Bradbury, Whitehouse
Erin Donovan, Reed
Chris Albert, Reed
Alex Macfarlane, Cicilline

ME
Bonita L Pothier, King
Gail Kezer, King

VT
Haley Pero, Sanders
Leah Pickett, Welch

EPA
Curt Spalding
Deb Szaro
Ken Moraff
Doug Gutro
Kelsey O'Neil
Shutsu Wong
Dave Conroy
Cynthia Greene
Jeri Weiss
Lynn Hamjian
Jackie LeClair
Jessica Dominguez
John Podgurski

Approximately 45 people attended this conference.

Presentation slides attached.


http://www.precixinc.com/oemlist.html		downloaded 8/15/06

Alpha List of OEM Approvals

Precix has a very extensive database of Automotive Original Equipment
Manufacturer (OEM) material approvals. Below is the most current listing
– be sure to check back often for updates. As new approvals are
achieved they will be highlighted in yellow. Questions or comments?
HYPERLINK<EMAIL_ADDRESS>Please click here to send an
email to our Materials Engineering department .

OEM/Specification	Polymer	ID	Precix Compound #	Duro	Color	Typical
Temperature Range - deg C (F)

Audi (refer to Volkswagen 2.8.1 – A/T 70)	FKM	F95	13795	60	Red	-22 /
250 (-8 / 482)

Audi (refer to Volkswagen 2.8.1 / TL52424)	FVMQ	G17	13430	75	Yellow	-60
/ 200 (-76 / 392)

BMW GS 93010 5516-FPM-70-M 	FKM (GLT® Type) 	F05	13705	75	Blue	-40 to
250 (-40 to 482)

BMW GS 93010 5505-FPM-75-M, GF Type (HF – high fluorine), 	FKM (GF®
Type)	F86	13728	75	Green	-22 / 250 (-8 / 482)

BMW GS 93010 5519-FMQ-75-M 	FVMQ	G17	13430	75	Yellow	-60 / 200 (-76 /
392)

BMW GS 93010 5518-HNBR-80-M 	HNBR	H95	14595	80	Black	-40 /150 (-40 /
302)

Daimler Chrysler MS-BZ105C, SAE 5120R1 Class 1	NBR	H77	14577	70	Black
-34 / 125 (-30 / 257)

Daimler Chrysler MS-BZ623 Gr A	AEM (Vamac®)	M94	07794	80	Black	-60 /
200 (-76 / 392)

Daimler Chrysler MS-BZ832, Grade A1	FKM	F80	13710	60	Black	-25 / 250
(-13 / 482)

Daimler Chrysler MS-BZ832, Grade A3	FKM	F84	13717	75	Black	-25 / 250
(-13 / 482)

Daimler Chrysler MS-BZ832, Grade A4	FKM	F33	13743	80	Black	-22 / 250 (-8
/ 482)

Daimler Chrysler MS-BZ832, Grade B2	FKM	F50	13750	75	Black	-40 / 250
(-40 / 482)

Daimler Chrysler MS-BZ832, Grade B2	FKM	F69	13688	70	Black	-40 / 250
(-40 / 482)

Daimler Chrysler MS-BZ832, Grade C2	FKM	F43	13742	70	Black	-22 / 250 (-8
/ 482)

Daimler Chrysler MS-BZ832, Grade F3	FKM	F77	13729	75	Gray	-32 / 250 (-25
/ 482)

Daimler Chrysler MS-BZ832, Grade F5	FKM	F31	13731	80	Black	-40 / 250
(-40 / 482)

Daimler Chrysler MS-BZ832, Grade G3	FKM	F05	13705	75	Blue	-40 / 250 (-40
/ 482)

Daimler Chrysler MS-BZ832, Grade G4	FKM	F79	13724	75	Black	-40 / 250
(-40 / 482)

Daimler Chrysler MS-BZ832, Grade G5	FKM	F85	13727	85	Black	-40 / 250
(-40 / 482)

Daimler Chrysler BS-BB 40	FVMQ

13494	45	Red	-60 / 200 (-76 / 392)

Delphi 2HK715A1-10B37B38EF31EO78F15	FKM	F81	13711	75	Brown	-25 / 250
(-13 / 482)

Delphi 7HK915BLACK	FKM

13722	90	Black	-40 / 250 (-40 / 482)

Delphi 7HK915BROWN	FKM

13721	90	Brown	-22 / 250 (-8 / 482)

Delphi M54416	FKM	F84	13717	75	Black	-25 / 250 (-13 / 482)

Delphi M54427	FKM	F31	13731	80	Black	-40 / 250 (-40 / 482)

Delphi M54435	FKM

13704	75	Black	-22 / 250 (-8 / 482)

Delphi M54444	FKM	F04	13329	75	Blue	-22 / 250 (-8 / 482)

Delphi M54444	FKM	F84	13717	75	Black	-25 / 250 (-13 / 482

Delphi M54453	FKM	F05	13705	75	Blue	-40 / 250 (-40 / 482)

Delphi M54453	FKM	F79	13724	75	Black	-40 / 250 (-40 / 482)

Delphi M54472	FKM	F85	13727	85	Black	-40 / 250 (-40 / 482)

Delphi M54475	FKM

13706	75	Brown	-22 / 250 (-8 / 482)

Delphi M54481	FKM

13714	80	Red	-25 / 250 (-13 / 480)

Delphi M54489	FKM

13734	75	Brown	-25 / 250 (-13 / 480)

Delphi M54498	FKM	F07	13723	70	Black	-40 / 250 (-40 / 482)

Delphi M54498	FKM

13733	70	Green	-40 / 250 (-40 / 480)

Delphi/Saginaw 7846478	FKM	F57	13671	70	Green	-25 / 250 (-13 to 482)

Delphi M54106	NBR

14387	60	Black	-34 / 125 (-30 / 257)

Ford ESA-M9P7-A, FKM/FVMQ Blend	FKM/FVMQ Blend	F52	13661	75	Brown	-32 /
200 (-25 to 392)

Ford ESW-M2D100-A	HNBR	H76	14576	70	Black	-32 / 150 (-25 / 302)

Ford ESWM2D247 Type I	HNBR	M27	14481	70	Black	-32 / 150 (-25 / 302)

Ford ESWM2D247 Type III, Internal Lube	HNBR	M29	14482	75	Black	-34 / 150
(-30 / 302)

Ford WSA-M2D451-A2	HNBR	M30	14492	75	Black	-32 / 150 (-25 / 302)

Ford WSA-M2D401-A5, GFLT Type	FKM (GFLT® Type)	F77	13729	75	Gray	-32 /
250 (-25 / 482)

Ford WSA-M2D401-A5, GFLT Type	FKM (GFLT® Type)	F78	13730	75	Black	-32 /
250 (-25 / 482)

Ford WSA-M2D401-A6	FVMQ	G17	13430	75	Yellow	-60/200 (-76/302)

Ford WSA-M2D401-A6	FVMQ	L53	13446	70	Orange	-60 / 200 (-76 / 392)

Ford WSA-M2D401-A8, GF Type (HF - high fuorine)	FKM (GF® Type)	F86
13728	75	Green	-22 / 250 (-8 / 482)

Ford WSA-M2D451-A2	HNBR	M30	14492	75	Black	-32 / 250 (-25 / 482)

GM/Opel 6268 & 6269M Type II	FVMQ	G17	13430	75	Yellow	-60 / 200 (-76 /
392)

GM/Opel 6268 & 6269M Type III, GF Type (HF – high fluorine)	FKM (GF®
Type)	F86	13728	75	Green	-22 / 250 (-8 / 482)

GM/Opel 6268M Type I, FKM/FVMQ Blend	FKM/FVMQ Blend	F52	13661	75	Brown
-32 / 200 (-25 to 392)

GM/Opel GM6268M Type II	FVMQ	L53	13446	70	Orange	-60 / 200 (-76 / 392)

GM/Opel GM6268M Type IV 	FKM	F99	13799	65	Green	-22 to 250 (-8 to 482)

GM/Opel GM6269M Type I	FKM (GFLT® Type)	F78	13730	75	Black	-32 / 250
(-25 / 482)

GM/Opel GM6269M Type II	FVMQ	G17	13430	75	Yellow	-60 / 200 (-76 / 392)

Jaguar (refer to Ford WSA-M2D401-A6)	FVMQ	G17	13430	75	Yellow	-60 / 200
(-76 / 392)

Jaguar (refer to Ford WSA-M2D401-A8, GF Type (HF - high fluorine))	FKM
(GF® Type)	F86	13728	75	Green	-22 / 250 (-8 / 482)

John Deere JDM H4R	FKM	F105	13810	90	Black	-25 / 250 (-13 / 482)

Land Rover (refer to Ford WSA-M2D401-A6)	FVMQ	G17	13430	75	Yellow	-60 /
200 (-76 / 392)

Land Rover (refer to Ford WSA-M2D401-A8, GF Type (HF - high fluorine))
FKM (GF® Type)	F86	13728	75	Green	-22 / 250 (-8 / 482)

Magneti Marelli FKM Type A1	FKM	F75	13664	75	Black	-25 / 250 (-13 / 482)

Magneti Marelli FKM Type A2	FKM	F54	13754	75	Black	-25 / 250 (-13 / 482)

Magneti Marelli FKM Type B	FKM	F47	13757	75	Black	-25 / 250 (-13 / 482)

Magneti Marelli FKM Type C	FKM	F51	13751	75	Black	-30 / 250 (-22 / 482)

Magneti Marelli FKM Type D	FKM	F79	13724	75	Black	-40 / 250 (-40 / 482)

Magneti Marelli FKM Type E	FKM (GFLT® Type)	F78	13730	75	Black	-32 /
250 (-25 / 482)

Magneti Marelli FKM Type F	FKM	F35	13755	80	Black	-22 / 250 (-8 / 482)

Magneti Marelli FVMQ	FVMQ	L54	13443	75	Yellow	-60 / 200 (-76 / 392)

Renault 03-10-100/--D / 34-04-815/--H	FKM (GF® Type)	F86	13728	75	Green
-22 / 250 (-8 / 482)

Renault 03-10-100/--D / 34-04-815/--H	FVMQ	G17	13430	75	Yellow	-60 / 200
(-76 / 392)

Renault 03-10-100/--D / 34-04-815/--H	FKM	F95	13895	60	Red	-22 / 250 (-8
/ 482)

Renault 03-50-000 Type 2	FKM	F75	13664	75	Black	-25 / 250 (-13 / 482)

Volkswagen 2.8.1 – A/T 70	FKM	F95	13795	60	Red	-22 / 250 (-8 / 482)

Volkswagen 2.8.1.A	FVMQ	G17	13430	75	Yellow	-60 / 200 (-76 / 392)

Volvo (refer to Ford WSA-M2D401-A6)	FVMQ	G17	13430	75	Yellow	-60 / 200
(-76 / 392)

Volvo (refer to Ford WSA-M2D401-A8, GF Type (HF - high fluorine))	FKM
(GF® Type)	F86	13728	75	Green	-22 / 250 (-8 / 482)