[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Rules and Regulations]
[Pages 9433-9436]
[FR Doc No: 2021-03063]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0021; Project Identifier MCAI-2020-01088-R;
Amendment 39-21419; AD 2021-03-16]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

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

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Airbus Helicopters Model AS350B, AS350B1, AS350B2, AS350B3, AS350BA,
AS350D, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP
helicopters. This AD was prompted by the in-flight loss of a sliding
door. This AD requires inspecting each sliding door and replacing the
upper rail or front roller or removing the front roller from service if
necessary. The actions of this AD are intended to address an unsafe
condition on these products.

DATES: This AD becomes effective March 3, 2021.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of March 3, 2021.
    The FAA must receive comments on this AD by April 2, 2021.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0021; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Union Aviation Safety Agency (EASA) AD, any
service information that is incorporated by reference, any comments
received, and other information. The street address for Docket
Operations is listed above. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this final rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. It is also available on the internet at https://www.regulations.gov by

searching for and locating Docket No. FAA-2021-0021.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, AD Program Manager,
Operational Safety Branch, Airworthiness Products Section, General
Aviation & Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0021 and Project Identifier
MCAI-2020-01088-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Matt
Fuller, AD Program Manager, Operational Safety Branch, Airworthiness
Products Section, General Aviation & Rotorcraft Unit, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued AD No. 2020-0175, dated August 5, 2020 (EASA
AD 2020-0175), for all serial-numbered Airbus Helicopters Model AS 350
and AS 355 helicopters if equipped with a left-hand (LH) and/or right-
hand (RH) sliding door. EASA advises that an AS 350 B3 helicopter lost
the LH door in-flight. The event occurred while flying with the door
locked in the open position. The results of the technical analysis of
this event indicated that the loss of the sliding door resulted from
the disengagement of the roller from the upper rail. This condition, if
not detected and corrected, could lead to sliding door in-flight
detachment, possibly resulting in damage to the helicopter, and/or
injury to persons on the ground. EASA also advises that this scenario
may also develop on AS 355 helicopters sliding doors due to design
similarity. Accordingly, EASA AD 2020-0175 requires a one-time detailed
inspection of the LH and/or RH sliding doors and, depending on
findings, accomplishment of applicable corrective actions.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all information provided by EASA and determining the unsafe
condition exists and is likely to exist or develop on other helicopters
of the same type designs.

Related Service Information Under 1 CFR Part 51

    Airbus Helicopters has issued Alert Service Bulletin (ASB) No.
AS350-52.00.54 and ASB No. AS355-52.00.32, each Revision 1 and each
dated July 30, 2020 (ASB AS350-52.00.54 and ASB AS355-52.00.32). ASB
AS350-52.00.54 applies to Model AS350-series helicopters and ASB AS355-
52.00.32 applies to Model AS355-series helicopters. The ASBs specify
inspecting the upper rail and roller of the of the LH and/or RH sliding
doors by inspecting the upper rail, and making sure that the
parallelism between the sliding door and its frame is correct, that the
front roller is in good condition, and that the installation of the
front roller is correct. The ASBs also specify notifying Airbus
Helicopters if any part is replaced and providing the part number of
the part replaced and the serial number and time since new of the
helicopter.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD requires, within 30 hours time-in-service (TIS) after the
effective date of this AD, inspecting the upper rail of each RH and LH
door for parallelism, deformation, corrosion, and cracking and
repairing or replacing the upper rail before further flight if
necessary; and with each sliding door removed, inspecting the front
roller to determine if it is below the minimum diameter and height, if
it has any corrosion or flat spot, and if it is correctly installed. If
the front roller is below the minimum diameter, below the minimum
height, or has any flat spot or corrosion, this AD requires removing
the front roller from service before further flight. If the front
roller was not correctly installed, this AD requires reinstalling it
correctly before further flight.

Differences Between This AD and the EASA AD

    Due to a recent additional report of an in-flight door loss, this
AD requires compliance within 30 hours TIS after the effective date of
the AD; EASA AD 2020-0175 requires compliance within 165 flight hours
or 13 months and 6 days, whichever occurs first. The EASA AD requires
reporting information to Airbus Helicopters; this AD does not.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 965 helicopters of U.S.
Registry and that operators may incur the following costs in order to
comply with this AD. Labor costs are $85 per work-hour.
    Inspecting each door will take about 2 work-hours for an estimated
cost of $170 per helicopter and $164,050 for the U.S. fleet.

    Replacing each upper rail, if necessary, will take about 3 work-
hours and parts will cost about $3,200, for an estimated cost of $3,455
per door.
    Replacing each front roller, if necessary, will take about 1 work-
hour and parts will cost about $250 for an estimated cost of $335 per
door.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.)
authorizes agencies to dispense with notice and comment procedures for
rules when the agency, for ``good cause'' finds that those procedures
are ``impracticable, unnecessary, or contrary to the public interest.''
Under this section, an agency, upon finding good cause, may issue a
final rule without seeking comment prior to the rulemaking.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because an initial action is required within 30 hours TIS, which could
equate to 1 month in these high usage rotorcraft; and corrective
action, if necessary, is required before further flight. Therefore,
notice and opportunity for prior public comment are impracticable and
contrary to public interest pursuant to 5 U.S.C. 553(b)(3)(B). In
addition, for the reasons stated above, the FAA finds that good cause
exists pursuant to 5 U.S.C. 553(d) for making this amendment effective
in less than 30 days.

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.
    The FAA is 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

    The FAA 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, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866, and
    2. Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 airworthiness
directive:

2021-03-16 Airbus Helicopters: Amendment 39-21419; Docket No. FAA-
2021-0021; Project Identifier MCAI-2020-01088-R.

(a) Applicability

    This airworthiness directive (AD) applies to Airbus Helicopters
Model AS350B, AS350B1, AS350B2, AS350B3, AS350BA, AS350D, AS355E,
AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters,
certificated in any category, with any sliding door installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as an in-flight loss of a
sliding door, which could result in damage to the helicopter or
injury to persons on the ground.

(c) Affected ADs

    None.

(d) Effective Date

    This AD becomes effective March 3, 2021.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    Within 30 hours time-in-service after the effective date of this
AD:
    (1) Inspect the upper rail of each right hand (RH) and left hand
(LH) door for parallelism, deformation, corrosion, and cracking. If
necessary, adjust the sliding door, ensuring that the parallelism
between the sliding door and its frame does not exceed 1.5 mm (.059
in) on a length of 1,200 mm (47.24 in). The frame includes the
sliding door, the overhead panel, and the two rear bulkheads. Repair
or replace the upper rail before further flight if there is any
deformation, corrosion, or cracking.
    (2) With the sliding door removed, inspect the front roller to
determine if it is below the minimum diameter of 17.5 mm (0.69 in),
below the minimum height of 17 mm (0.67 in), if it has any corrosion
or flat spot, and to determine if it is correctly installed per
Figure 1 of Airbus Alert Service Bulletin (ASB) No. AS350-52.00.54
or ASB No. AS355-52.00.32, each at Revision 1 and dated July 30,
2020, as applicable to your helicopter model. If the front roller is
below the minimum diameter, below the minimum height, or has any
flat spot or corrosion, before further flight, remove the front
roller from service. If the front roller was not correctly
installed, reinstall it correctly before further flight.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, FAA, may
approve AMOCs for this AD. Send your proposal to: Matt Fuller, AD
Program Manager, Operational Safety Branch, Airworthiness Products
Section, General Aviation & Rotorcraft Unit, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggest that
you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(h) Additional Information

    The subject of this AD is addressed in European Union Aviation
Safety Agency (EASA) AD No. 2020-0175, dated August 5, 2020. You may
view the EASA AD on the internet at https://www.regulations.gov by
searching for and locating it in Docket No. FAA-2021-0021.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 5210 Passenger/
Crew Doors.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.

    (i) Airbus Helicopters Alert Service Bulletin No. AS350-
52.00.54, Revision 1, dated July 30, 2020.
    (ii) Airbus Helicopters Alert Service Bulletin No. AS355-
52.00.32, Revision 1, dated July 30, 2020.
    (3) For Airbus Helicopters service information identified in
this AD, contact Airbus Helicopters, 2701 N Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax 972-
641-3775; or at https://www.airbus.com/helicopters/services/technical-support.html.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 29, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-03063 Filed 2-10-21; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Proposed Rules]
[Page 52294-52300]
[DOCID:fr25au10-21]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 870, 884 and 892

[Docket No. FDA-2010-N-0412]
RIN 0910-AG51

Effective Date of Requirement for Premarket Approval for Four
Class III Preamendments Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for the following
four class III preamendments devices: Ventricular bypass (assist)
device; pacemaker repair or replacement material; female condom; and
transilluminator for breast evaluation. The agency is also summarizing
its proposed findings regarding the degree of risk of illness or injury
designed to be eliminated or reduced by requiring the devices to meet
the statute's approval requirements and the benefits to the public from
the use of the devices. In addition, FDA is announcing the opportunity
for interested persons to request that the agency change the
classification of any of the aforementioned devices based on new
information. This action implements certain statutory requirements.

DATES: Submit written or electronic comments by November 23, 2010.
Submit requests for a change in classification by September 9, 2010.
FDA intends that, if a final rule based on this proposed rule is
issued, anyone who wishes to continue to market the device will need to
submit a PMA within 90 days of the effective date of the final rule.
Please see section XIII of this document for the effective date of any
final rule that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0412 and/or RIN number 0910-AG51, by any of the following methods:
    Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
    Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and Docket Number and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Michael Ryan, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993, 301-796-
6283.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law
94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Public Law
101-629), and the Food and Drug Administration Modernization Act of
1997 (FDAMA) (Public Law 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250), the Medical Devices
Technical Corrections Act (Public Law 108-214), and the Food and Drug
Administration Amendments Act of 2007 (Public Law 110-85), establish a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the 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 of the 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 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 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 act (21 U.S.C. 360(k))
and 21 CFR part 807.
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a premarket approval application (PMA)
until FDA promulgates a final regulation under section 515(b) of the
act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1)
of the act (21 U.S.C. 360e(b)(1)) establishes the requirement that a
preamendments device that FDA has classified into class III is subject
to premarket approval. A preamendments class III device may be
commercially distributed without an approved PMA or a notice of
completion of a PDP until 90 days after FDA issues a final rule
requiring premarket approval for the device, or 30 months after final
classification of the device under section 513 of the act, whichever is
later. Also, a preamendments device subject to the rulemaking procedure
under section 515(b) of the act is not required to have an approved
investigational device exemption (IDE) (see 21 CFR part 812)
contemporaneous with its interstate distribution until the date
identified by FDA in the final rule requiring the submission of a PMA
for the device. At that time, an IDE is required only if a PMA has not
been submitted or a PDP completed.
    Section 515(b)(2)(A) of the act provides that a proceeding to issue
a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
regulation; (2) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
    Section 515(b)(2)(B) of the act provides that if FDA receives a
request for a change in the classification of the device within 15 days
of the publication of the notice, FDA shall, within 180 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the act. Section
515(b)(3) of the act provides that FDA shall, after the close of the
comment period on the proposed rule and consideration of any comments
received, issue a final rule to require premarket approval or publish a
document terminating the proceeding together with the reasons for such
termination. If FDA terminates the proceeding, FDA is required to
initiate reclassification of the device under section 513(e) of the
act, unless the reason for termination is that the device is a banned
device under section 516 of the act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a
preamendments device is finalized, section 501(f)(2)(B) of the act (21
U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a
PDP for any such device be filed within 90 days of the date of issuance
of the final rule or 30 months after the final classification of the
device under section 513 of the act, whichever is later. If a PMA or
notice of completion of a PDP is not filed by the later of the two
dates, commercial distribution of the device is required to cease since
the device would

be deemed adulterated under section 501(f) of the act.
    The device may, however, be distributed for investigational use if
the manufacturer, importer, or other sponsor of the device complies
with the IDE regulations. If a PMA or notice of completion of a PDP is
not filed by the later of the two dates, and the device does not comply
with IDE regulations, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the act, and subject to seizure and
condemnation under section 304 of the act (21 U.S.C. 334) if its
distribution continues. Shipment of devices in interstate commerce will
be subject to injunction under section 302 of the act (21 U.S.C. 332),
and the individuals responsible for such shipment will be subject to
prosecution under section 303 of the act (21 U.S.C. 333). In the past,
FDA has requested that manufacturers take action to prevent the further
use of devices for which no PMA or PDP has been filed and may determine
that such a request is appropriate for the class III devices that are
the subjects of this regulation.
    The act does not permit an extension of the 90-day period after
issuance of a final rule within which an application or a notice is
required to be filed. The House Report on the 1976 amendments states
that: [t]he thirty month grace period afforded after classification of
a device into class III * * * is sufficient time for manufacturers and
importers to develop the data and conduct the investigations necessary
to support an application for premarket approval (H. Rept. 94-853, 94th
Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the act requiring FDA to review
the classification of preamendments class III devices for which no
final rule requiring the submission of PMAs has been issued, and to
determine whether or not each device should be reclassified into class
I or class II or remain in class III. For devices remaining in class
III, the SMDA directed FDA to develop a schedule for issuing
regulations to require premarket approval. The SMDA does not, however,
prevent FDA from proceeding immediately to rulemaking under section
515(b) of the act on specific devices, in the interest of public
health, independent of the procedures of section 515(i). Proceeding
directly to rulemaking under section 515(b) of the act is consistent
with Congress' objective in enacting section 515(i), i.e., that
preamendments class III devices for which PMAs have not been previously
required either be reclassified to class I or class II or be subject to
the requirements of premarket approval. Moreover, in this proposal,
interested persons are being offered the opportunity to request
reclassification of any of the devices.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the act, FDA is proposing to
require that a PMA or a notice of completion of a PDP be filed with the
agency for class III devices within 90 days after issuance of any final
rule based on this proposal. An applicant whose device was legally in
commercial distribution before May 28, 1976, or whose device has been
found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA or notice of completion of the PDP. FDA intends to
review any PMA for the device within 180 days, and any notice of
completion of a PDP for the device within 90 days of the date of
filing. FDA cautions that under section 515(d)(1)(B)(i) of the act, the
agency may not enter into an agreement to extend the review period for
a PMA beyond 180 days unless the agency finds that ``the continued
availability of the device is necessary for the public health.''
    FDA intends that under Sec.  812.2(d) (21 CFR 812.2(d)), the
preamble to any final rule based on this proposal will state that, as
of the date on which the filing of a PMA or a notice of completion of a
PDP is required to be filed, the exemptions from the requirements of
the IDE regulations for preamendments class III devices in Sec.
812.2(c)(1) and (c)(2) will cease to apply to any device that is: (1)
Not legally on the market on or before that date, or (2) legally on the
market on or before that date but for which a PMA or notice of
completion of a PDP is not filed by that date, or for which PMA
approval has been denied or withdrawn.
    If a PMA or notice of completion of a PDP for a class III device is
not filed with FDA within 90 days after the date of issuance of any
final rule requiring premarket approval for the device, commercial
distribution of the device must cease. The device may be distributed
for investigational use only if the requirements of the IDE regulations
are met. The requirements for significant risk devices include
submitting an IDE application to FDA for its review and approval. An
approved IDE is required to be in effect before an investigation of the
device may be initiated or continued under 21 CFR 812.30. FDA,
therefore, cautions that IDE applications should be submitted to FDA at
least 30 days before the end of the 90-day period after the issuance of
the final rule to avoid interrupting investigations.

 III. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the act, FDA is publishing its
proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an approved PMA or a declared completed PDP, and (2) the
benefits to the public from the use of the devices.
    These findings are based on the reports and recommendations of the
advisory committees (panels) for the classification of these devices
along with information submitted in response to the 515(i) order (74 FR
16214, April 9, 2009) and any additional information that FDA has
encountered. Additional information regarding the risks as well as
classification associated with these device types can be found in the
following proposed and final rules published in the Federal Register on
these dates: Cardiovascular devices, 21 CFR part 870 (44 FR 13284,
March 9, 1979; 45 FR 7904, February 5, 1980; and 52 FR 17736, May 11,
1987); classification of female condoms (64 FR 31164, June 10, 1999;
and 65 FR 31454, May 18, 2000); and classification of transilluminators
(diaphanoscopes or lightscanners) for breast evaluation (60 FR 3168,
January 13, 1995; and 60 FR 36639, July 18, 1995).

IV. Devices Subject to This Proposal

A. Ventricular bypass (assist) device (21 CFR 870.3545)

1. Identification
    A ventricular bypass (assist) device is a device that assists the
left or right ventricle in maintaining circulatory blood flow. The
device is either totally or partially implanted in the body.
2. Summary of Data
    The Cardiovascular Devices Panel recommended that ventricular
bypass (assist) devices be classified into class III because the device
is an implant used in a life-supporting situation. The panel indicated
that general controls alone would not be sufficient and that there was
not enough information to establish a performance standard.
Consequently, the panel believed that premarket approval is necessary
to assure the safety and effectiveness of the device. FDA continues to
agree with the panel's recommendation.
3. Risks to Health
    a. Thromboembolism--inadequate blood compatibility of the materials

used in this device and inadequate surface finish and cleanliness could
lead to potentially debilitating or fatal thromboembolism.
    b. Excessive hemolysis--poor design of the hemodynamic
characteristics of the device can lead to excess hemolysis.
    c. Inability to support life--inaccurate pressure or flow control
or improper synchronization can impede the ability of the device to
support life.
    d. Cardiac arrhythmias or electrical shock--excessive electrical
leakage current can disturb the normal electrophysiology of the heart,
leading to the onset of cardiac arrhythmias. Electrical leakage can
also cause electrical shock to the physician during placement or use of
the device and this could lead to iatrogenic complications.
    e. Interference with other organs--because of the device's size and
the location of its implantation, the device may interfere with the
function of other organs.
    f. Damage to blood vessels--the mechanical design of the
attachments is associated with the possibility of damage to blood
vessels at the attachment points.
    g. Inability to maintain long-term support--low fatigue life of the
materials used or poor quality control in construction can lead to
premature breakdown of the device.

B. Pacemaker repair or replacement material (21 CFR 870.3710)

1. Identification
    A pacemaker repair or replacement material is an adhesive, a
sealant, a screw, a crimp, or any other material used to repair a
pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse
generator.
2. Summary of Data
    The Cardiovascular Devices Classification Panel recommended that
pacemaker repair or replacement material be classified into class III
because of the potential hazards associated with the inherent
properties of the device, the life-supporting function of this
implanted device, and its personal knowledge of, and experience with,
the device. FDA agreed and continues to agree with the panel's
recommendation. The agency notes that the device has fallen into disuse
and that the published data are not adequate to demonstrate the safety
and effectiveness of the device.
3. Risks to Health
    a. Tissue damage--If the biocompatibility of the materials used in
this device is inadequate, damage to the surrounding tissue may result.
    b. Loss of pacing function--Failure to properly repair or reconnect
a pacemaker lead could result in loss of pacing function. The need to
repair/reconnect the lead may be due to, among other causes, an
intrusion of fluid into the pacemaker connection, an improper
electrical connection to the pacemaker circuitry, or poor electrical
insulation of the lead body. If the lead is not repaired or
reconnected, the electrical path from the pulse generator to the lead
may be interrupted, resulting in a loss of critical and potentially
life-sustaining pacing function.

C. Female condom (21 CFR 884.5330)

1. Identification
    A female condom is a sheath-like device that lines the vaginal wall
and is inserted into the vagina prior to the initiation of coitus. It
is indicated for contraceptive and prophylactic (preventing the
transmission of sexually transmitted diseases (STDs)) purposes.
2. Summary of Data
    The Obstetrics-Gynecology Devices Panel recommended that the female
condom device be classified into Class III (premarket approval). The
panel gave reasons for recommendation, e.g., that no published data
could be found that demonstrate the safety and effectiveness of the
device. The panel based the recommendation on information provided by
FDA and on the panel members' personal knowledge of and experience with
contraceptive methods of birth control, including barrier-type
contraceptives. Additionally, the panel believed that general controls
and special controls would not provide reasonable assurance of the
safety and effectiveness of the devices. FDA has not received any new
data to affect the classification. FDA agreed and continues to agree
with the panel's recommendation. The agency notes that the device has
fallen into disuse and that the published data are not adequate to
demonstrate the safety and effectiveness of the device.
3. Risks to Health
    a. Pregnancy--Leakage, breakage, dislodgement, or displacement of
the device during sexual intercourse could result in the occurrence of
an undesired pregnancy.
    b. Transmission of infection (disease)--If the device fails due to
leakage, breakage, dislodgement, or displacement, contact with infected
semen or vaginal secretions or mucosa could result in the transmission
of STD's, including human immunodeficiency virus (HIV) (causing
acquired immunodeficiency syndrome (AIDS)).
    c. Adverse tissue reaction--Unless the biocompatibility of
materials and substances compromising the device are tested, local
tissue irritation and sensitization or systemic toxicity could occur
when the vaginal pouch contacts the vaginal wall, cervical mucosa, and
the penis.
    d. Ulceration and other physical trauma--Depending on the design of
the device, use of the female condom may cause abrasions, lacerations,
bleeding, or other adverse effects to the vaginal or penile tissue.

D. Transilluminator for breast evaluation (21 CFR 892.1990)

1. Identification
    A transilluminator, also known as a diaphanoscope or lightscanner,
is an electrically powered device that uses low intensity emissions of
visible light and near-infrared radiation (approximately 700 to 1050
nanometers (nm)), transmitted through the breast, to visualize
translucent tissue for the diagnosis of cancer, other conditions,
diseases, or abnormalities.
2. Summary of Data
    The Obstetrics and Gynecology Devices Panel recommended that
transilluminator devices for breast evaluation be classified into class
III and subject to premarket approval to provide reasonable assurance
of the safety and effectiveness of the device. The panel concluded that
there were no published studies or clinical data demonstrating the
safety and effectiveness of the device. The panel indicated that the
device presents a potential unreasonable risk of illness or injury to
the patient if the clinician relies on the device and that although the
device's illumination level, wavelength, and image quality can be
controlled through tests and specifications, insufficient evidence
exists to determine that special controls can be established to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. FDA has not received any new data to affect the
classification. FDA agreed and continues to agree with the panel's
recommendation. The agency notes that the device has fallen into disuse
and that the published data are not adequate to demonstrate the safety
and effectiveness of the device.
3. Risks to Health
    a. Missed or delayed diagnosis--As a result of the questionable
device performance of breast transilluminators, missed or delayed
diagnosis are the

most catastrophic risks to health for a woman. These devices depend on
the users' visual interpretation of their own breast illumination. One
scenario may result when a woman incorrectly interprets her
transillumination as a tumor and suffers the ensuing anxiety from her
belief that she has a cancer. Another scenario may result when a woman
incorrectly dismisses the findings of her transillumination and then
suffers from a missed diagnosis or delayed diagnosis and delayed
treatment. Ultimately, missed or delayed diagnoses could result in the
need for more aggressive treatment and a potentially higher risk of
death.
    b. Electrical shock--If a breast transilluminator is not designed
properly, the user may receive an electrical shock.
    c. Optical radiation--Prolonged gazing directly into the light of a
breast illuminator while engaged in ``bright light mode'' may result in
retinal damage.

V. PMA Requirements

    A PMA for these devices must include the information required by
section 515(c)(1) of the act. Such a PMA should also include a detailed
discussion of the risks identified previously, as well as a discussion
of the effectiveness of the device for which premarket approval is
sought. In addition, a PMA must include all data and information on:
(1) Any risks known, or that should be reasonably known, to the
applicant that have not been identified in this document; (2) the
effectiveness of the device that is the subject of the application; and
(3) full reports of all preclinical and clinical information from
investigations on the safety and effectiveness of the device for which
premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 CFR 860.7(c)(2)). Valid scientific evidence is
``evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports
of significant human experience with a marketed device, from which it
can fairly and responsibly be concluded by qualified experts that there
is reasonable assurance of the safety and effectiveness of a device
under its conditions of use. * * * Isolated case reports, random
experience, reports lacking sufficient details to permit scientific
evaluation, and unsubstantiated opinions are not regarded as valid
scientific evidence to show safety or effectiveness.'' (21 CFR
860.7(c)(2)).

VI. PDP Requirements

    A PDP for any of these devices may be submitted instead of a PMA,
and must follow the procedures outlined in section 515(f) of the act. A
PDP must provide: (1) A description of the device, (2) preclinical
trial information (if any), (3) clinical trial information (if any),
(4) a description of the manufacturing and processing of the devices,
(5) the labeling of the device, and (6) all other relevant information
about the device. In addition, the PDP must include progress reports
and records of the trials conducted under the protocol on the safety
and effectiveness of the device for which the completed PDP is sought.

VII. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

VIII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA or notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity
for interested persons to request a change in the classification of the
device based on new information relevant to the classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the act.
    A request for a change in the classification of these devices is to
be in the form of a reclassification petition containing the
information required by 21 CFR 860.123, including new information
relevant to the classification of the device.
    The agency advises that to ensure timely filing of any such
petition, any request should be submitted to the Division of Dockets
Management (see ADDRESSES) and not to the address provided in Sec.
860.123(b)(1). If a timely request for a change in the classification
of these devices is submitted, the agency will, within 180 days after
receipt of the petition, and after consultation with the appropriate
FDA resources, publish an order in the Federal Register that either
denies the request or gives notice of its intent to initiate a change
in the classification of the device in accordance with section 513(e)
of the act and 21 CFR 860.130 of the regulations.

IX. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because there have been no premarket submissions for
these devices in the past 5 years and all of the affected devices have
fallen into disuse, FDA has concluded that there is little or no
interest in marketing these devices in the future. Therefore, the
agency proposes to certify that the proposed rule, if issued as a final
rule, would not have a significant economic impact on a substantial
number of small entities. We specifically request detailed comment
regarding the appropriateness of our assumptions regarding the
potential economic impact of this proposed rule.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135

million, using the most current (2009) Implicit Price Deflator for the
Gross Domestic Product. FDA does not expect this proposed rule to
result in any 1-year expenditure that would meet or exceed this amount.
    FDA proposes to certify that this proposed rule, if issued as a
final rule, would not have a significant economic impact. We base this
determination on an analysis of registration and listing and other data
for the affected devices. Two of the devices affected by this proposed
rule, the female condom and ventricular bypass device, have never
appeared in FDA's electronic registration and listing database. These
devices were identified as preamendment devices, but since their
classification, the agency has no record of them ever being marketed.
In addition, these devices represent older technologies that have since
been replaced by newer technologies, currently being marketed under a
Premarket Approval Application, or PMA.
    One of the affected devices, pacemaker repair and replacement
material, is a material that can be used in multiple devices that was
last listed in 2001 and the agency is aware of no evidence that the
device has been marketed since 1991. In addition, on the increasingly
rare occasions when a pacemaker is repaired today, the repair is done
with materials specific to the approved device. The final affected
device, the breast transilluminator, was last listed in 2007 but FDA
has never cleared a 510(k) for this type of device. Although this
device was listed as recently as 2007, the device was never approved or
cleared for marketing. This information is summarized in table 1 of
this document as follows:

                      Table 1.--Summary of Electronic Registration and Listing Information
----------------------------------------------------------------------------------------------------------------
                                                                                Replaced by
           Device Name             Product Code   510(k) or PMA?    Last Listed    Last Marketed     Approved
                                                                                Technology?
----------------------------------------------------------------------------------------------------------------
Female Condom                                OBY              No    Never Listed           1930s             Yes
----------------------------------------------------------------------------------------------------------------
Ventricular Bypass Device                    OKR              No    Never Listed       No Record             Yes
----------------------------------------------------------------------------------------------------------------
Pacemaker Repair and Replacement             KFJ              No            2001            1991             Yes
----------------------------------------------------------------------------------------------------------------
Breast Transillunator                        LEK              No            2007       No Record              No
----------------------------------------------------------------------------------------------------------------

    Based on our review of electronic product registration and listing
and other data, FDA concludes that there is currently little or no
interest in marketing the affected devices and that the proposed rule
would not have a significant economic impact. We specifically request
detailed comment regarding the appropriateness of our assumptions
regarding the potential economic impact of this proposed rule.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects 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.
Accordingly, the agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XII. Paperwork Reduction Act of 1995

    This proposed rule 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 812 have been approved under OMB
control number 0910-0078; the collections of information in 21 CFR 807,
subpart E have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR 814, subpart B have been approved
under OMB control number 0910-0231; and the collections of information
under 21 CFR 801 have been approved under OMB control number 0910-0485.

XIII. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective 12 months after the date of its publication in the Federal
Register or at a later date if stated in the final rule.

List of Subjects 21 CFR Parts 870, 884, and 892

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 870, 884, and 892 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

    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.
    2. Section 870.3545 is amended by revising paragraph (c) to read as
follows:

Sec.  870.3545  Ventricular bypass (assist) device.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before [date 90 days after date of publication of the final rule in the
Federal Register], for any ventricular bypass (assist) device that was
in commercial distribution before May 28, 1976, or that has, on or
before [date 90 days after date of publication of the final rule in the
Federal Register], been found to be substantially equivalent to any
ventricular bypass (assist) device that was in commercial distribution
before May 28, 1976. Any other ventricular bypass (assist) device shall
have an approved PMA or declared completed PDP in effect before being
placed in commercial distribution.
    3. Section 870.3710 is amended by revising paragraph (c) to read as
follows:

Sec.  870.3710  Pacemaker repair or replacement material.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before [date 90 days after date of publication of the

final rule in the Federal Register], for any pacemaker repair or
replacement material device that was in commercial distribution before
May 28, 1976, or that has, on or before [date 90 days after date of
publication of the final rule in the Federal Register], been found to
be substantially equivalent to any pacemaker repair or replacement
material device that was in commercial distribution before May 28,
1976. Any other pacemaker repair or replacement material device shall
have an approved PMA or declared completed PDP in effect before being
placed in commercial distribution.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    4. The authority citation for 21 CFR part 884 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    5. Section 884.5330 is amended by revising paragraph (c) to read as
follows:

Sec.  884.5330  Female condom.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before [date 90 days after date of publication of the final rule in the
Federal Register], for any female condom that was in commercial
distribution before May 28, 1976, or that has, on or before [date 90
days after date of publication of the final rule in the Federal
Register], been found to be substantially equivalent to any female
condom that was in commercial distribution before May 28, 1976. Any
other female condom shall have an approved PMA or declared completed
PDP in effect before being placed in commercial distribution.

PART 892--RADIOLOGY DEVICES

    6. The authority citation for 21 CFR part 892 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    7. Section 892.1990 is amended by revising paragraph (c) to read as
follows:

Sec.  892.1990  Transilluminator for breast evaluation.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before [date 90 days after date of publication of the final rule in the
Federal Register], for any transilluminator for breast evaluation that
was in commercial distribution before May 28, 1976, or that has, on or
before [date 90 days after date of publication of the final rule in the
Federal Register], been found to be substantially equivalent to any
transilluminator for breast evaluation that was in commercial
distribution before May 28, 1976. Any other transilluminator for breast
evaluation shall have an approved PMA or declared completed PDP in
effect before being placed in commercial distribution.

    Dated: August 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-21142 Filed 8-24-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: February 2, 2010 (Volume 75, Number 21)]
[Notices]
[Page 5334-5335]
[DOCID:fr02fe10-81]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 10 and 11, 2010,
from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On March 10 and 11, 2010, the committee will discuss the
design of medical research studies (known as ``clinical trial design'')
to evaluate serious asthma outcomes (such as hospitalizations, a
procedure using a breathing tube known as intubation, or death) with
the use of the class of asthma medications known as long acting beta-2
adrenergic agonists in the treatment of asthma in adults, adolescents,
and children.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 23, 2010. Oral presentations from the public will be scheduled
between approximately 8:30 a.m. and 9:30 a.m. on March 11, 2010. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before February 12, 2010.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by February 16, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristine T. Khuc at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on public conduct during advisory
committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 26, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-2097 Filed 2-1-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Rules and Regulations]
[Pages 52229-52230]
[FR Doc No: 2011-21290]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0867; Airspace Docket No. 09-ASW-16]
RIN 2120-AA66

Establishment of Area Navigation Route Q-37; Texas

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes a high altitude area navigation (RNAV)
route, designated Q-37, extending between the Pueblo, Colorado, VHF
omnidirectional range/tactical air navigation (VORTAC) navigation aid
and the Fort Stockton, Texas, VORTAC. The new route provides pilots and
air traffic controllers with an efficient alternate route around
potentially constrained airspace during convective weather events in
west Texas.

DATES: Effective date 0901 UTC, October 20, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On Monday, October 26, 2009, the FAA published in the Federal
Register a notice of proposed rulemaking (NPRM) to establish area
navigation route Q-37 (74 FR 54943). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal. No comments were received.

The Rule

    This action amends Title 14, Code of Federal Regulations (14 CFR)
part 71 by establishing high altitude area navigation route Q-37
between the Pueblo, CO, VORTAC, and the Fort Stockton, TX, VORTAC. The
new route provides pilots and air traffic controllers with an efficient
alternate route around potentially constrained airspace during
convective weather events in west Texas. Additionally, the new route is
being integrated into the existing severe weather national playbook
routes to Houston, TX, terminal airports through Albuquerque Air Route
Traffic Control Center's airspace, in lieu of the current process of
coordinating tactical modifications to routings with the FAA Air
Traffic Control Services Command Center.
    In the NPRM, the points CAVRN and IMMAS were erroneously identified
as a ``WP'' (waypoint). These points are being established and charted
as navigation fixes; therefore, an editorial change is being made in
this rule to replace ``WP'' with ``Fix'' in the description for CAVRN
and IMMAS. With the exception of these changes, this amendment is the
same as that proposed in the NPRM.
    High altitude RNAV routes are published in paragraph 2006 of FAA
Order 7400.9U dated August 18, 2010, and effective September 15, 2010,
which is incorporated by reference in 14 CFR 71.1. The RNAV route
listed in this document will be published subsequently in the Order.
    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.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (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 will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will 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 the
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 establishes an RNAV route to enhance the safe and efficient flow
of traffic in the central United States.

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,'' paragraphs 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.

List 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 FAA Order 7400.9U,
Airspace Designations and Reporting Points, dated August 18, 2010, and
effective September 15, 2010, is amended as follows:

Paragraph 2006 United States Area Navigation Routes

* * * * *

Q-37 FST, TX to PUB, CO [New]

FST VORTAC
    (Lat. 30[deg]57[min]08[sec] N., long. 102[deg]58[min]33[sec] W.)
CAVRN Fix
    (Lat. 31[deg]49[min]31[sec] N., long. 104[deg]00[min]42[sec] W.)
YORUB WP
    (Lat. 32[deg]55[min]52[sec] N., long. 104[deg]14[min]01[sec] W.)
IMMAS Fix
    (Lat. 34[deg]54[min]18[sec] N., long. 104[deg]18[min]53[sec] W.)
PUB VORTAC
    (Lat. 38[deg]17[min]39[sec] N., long. 104[deg]25[min]46[sec] W.)
* * * * *

    Issued in Washington, DC, on August 15, 2011.
Gary A. Norek,
Acting Manager, Airspace, Regulations and ATC Procedures Group.
[FR Doc. 2011-21290 Filed 8-19-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31550-31552]
[FR Doc No: 2022-11069]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2019-0540; FRL-9774-01-OLEM]

Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA); Notice of Grant Funding Guidance for FY 2022 State and
Tribal Response Program With Funding Provided by the Bipartisan
Infrastructure Investment and Jobs Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA), as amended, authorizes a noncompetitive grant
program to establish or enhance state and tribal response programs.
Generally, these response programs address the assessment, cleanup, and
redevelopment of brownfields and other sites with actual or perceived
contamination. Due to the passage of the Bipartisan Infrastructure
Investment and Jobs Act (``Infrastructure Law'') in

November 2021, EPA is now issuing this notice of a FY 2022 Funding
Guidance to provide information and instruction to states and tribes
requesting FY 2022 Section 128(a) funding provided by the
Infrastructure Law. EPA anticipates that it may allocate approximately
$57.9 million in FY 2022 Section 128(a) Infrastructure Law funds.

DATES: Requests for FY 2022 Section 128(a) Infrastructure Law funding
will be accepted from March 30, 2022-June 3, 2022, and should be sent
to the EPA Regional Office contact listed in Table 1.

FOR FURTHER INFORMATION CONTACT: Melissa Papasavvas, Office of
Brownfields and Land Revitalization, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number
(202) 566-0435, or the appropriate Regional EPA Brownfields contacts
identified in Table 1.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be affected by this action if you administer a State or
Tribal response program that oversees assessment and cleanup activities
at brownfield sites across the country. Note: The CERCLA definition of
``State'' includes US Territories and the District of Columbia (CERCLA
section 101(27)).

B. How can I get copies of the grant funding guidance and other related
information?

    1. Docket. The docket for this action, identified by docket
identification (ID) number EPA-HQ-OLEM-2019-0540, is available online
at https://www.regulations.gov.
    2. EPA Website. To access the FY22 section 128(a) grant funding
guidance on EPA's website, please go to https://www.epa.gov/brownfields/funding-guidance-state-and-tribal-response-programs-fiscal-year-2022-bipartisan or https://www.epa.gov/system/files/documents/2022-03/final-fy22-128a-infrastructure-law-funding-guidance.pdf.

II. Authority

    CERCLA section 128(a) (42 U.S.C. 9628(a)) authorizes a
noncompetitive grant program to ``establish or enhance'' state and
tribal response programs.

III. Background

    1. General. CERCLA section 128(a) authorizes a noncompetitive grant
program to establish or enhance state and tribal response programs.
These section 128(a) response program grants are funded with
Categorical State and Tribal Assistance Grant (STAG) appropriations and
awarded in the form of a cooperative agreement, which is a type of
assistance agreement that is used when there is substantial federal
involvement with the recipient during the performance of an activity or
project. Section 128(a) cooperative agreements are awarded and
administered by EPA regional offices.
    The Bipartisan Infrastructure Investment and Jobs Act
(Infrastructure Law), signed in November 2021, invested additional
funds to carry out section 128(a). Due to the passage of the
Infrastructure Law, EPA is now issuing this Funding Guidance to provide
information and instruction to states and tribes requesting FY 2022
Section 128(a) funding provided by the Infrastructure Law.
    This funding is intended for those states and tribes that have the
required management and administrative capacity within their government
to administer a federal grant. The primary goal of this funding is to
ensure that state and tribal response programs include, or are taking
reasonable steps to include, certain elements of an environmental
response program and that the program establishes and maintains a
public record of sites addressed. Subject to the availability of funds,
EPA regional personnel will provide technical assistance to states and
tribes as they apply for and carry out section 128(a) cooperative
agreements.
    2. Catalogue of Federal Domestic Assistance (CFDA) and EPA Funding
Opportunity Number (FON). The CFDA entry for the section 128(a) State
and Tribal Response Program cooperative agreements is 66.817. The FON
for FY 2022 section 128(a) funds is EPA-CEP-02. Section 128(a)
Infrastructure funds under this funding guidance are NOT eligible to be
included in state and tribal Performance Partnership Grants under 40
CFR part 35 subparts A and B.
    3. Application period. Requests for funding should be sent to the
appropriate Regional EPA contact and will be accepted from March 30,
2022 through June 3, 2022. Requests EPA Regional offices receive after
June 3, 2022, will not be considered for FY 2022 Infrastructure
funding. States or tribes that do not submit the request in the
appropriate manner may forfeit their ability to receive funds. First
time requestors are strongly encouraged to contact their respective
Regional EPA Brownfields contacts, identified in Table 1, prior to
submitting their funding request.
    Requests submitted by the June 3, 2022, request deadline are
preliminary; final cooperative agreement work plans and budgets will be
negotiated with the EPA regional offices once final funding allocation
determinations are made. For more information, see the funding guidance
and FAQs at https://www.epa.gov/brownfields/funding-guidance-state-and-tribal-response-programs-fiscal-year-2022-bipartisan.

                             Table 1--Regional State and Tribal Brownfields Contacts
----------------------------------------------------------------------------------------------------------------
                           Region                                       State                    Tribal
----------------------------------------------------------------------------------------------------------------
1--CT, ME, MA, NH, RI, VT...................................  AmyJean McKeown, 5 Post   AmyJean McKeown, 5 Post
                                                               Office Square, Suite      Office Square, Suite
                                                               100 (OSRR07-2), Boston,   100 (OSRR07-2), Boston,
                                                               MA 02109-3912, Phone      MA 02109-3912, Phone
<PHONE_NUMBER>, Fax<PHONE_NUMBER>, Fax
<PHONE_NUMBER>,<PHONE_NUMBER>,
                                                               [email protected].  [email protected]
                                                                                .
2--NJ, NY, PR, VI...........................................  Terry Wesley, 290         Terry Wesley, 290
                                                               Broadway, 25th Floor,     Broadway, 25th Floor,
                                                               New York, NY 10007-       New York, NY 10007-
                                                               1866, Phone (212) 637-    1866, Phone (212) 637-
                                                               5027,                     5027,
                                                               [email protected].     [email protected].
3--DE, DC, MD, PA, VA, WV...................................  Mike Taurino, 1650 Arch   Mike Taurino, 1650 Arch
                                                               Street (3HS51),           Street (3HS51),
                                                               Philadelphia, PA 19103,   Philadelphia, PA 19103,
                                                               Phone<PHONE_NUMBER>,     Phone<PHONE_NUMBER>,
                                                               Fax<PHONE_NUMBER>,       Fax<PHONE_NUMBER>,
                                                               [email protected].  [email protected]
                                                                                .
4--AL, FL, GA, KY, MS, NC, SC, TN...........................  Cindy Nolan, 61 Forsyth   Cindy Nolan, 61 Forsyth
                                                               Street SW, 10th Fl.       Street SW, 10th Fl.
                                                               (9T25), Atlanta, GA       (9T25), Atlanta, GA
                                                               30303-8960, Phone (404)   30303-8909, Phone (404)
                                                               562-8425, Fax (404)<PHONE_NUMBER>, Fax (404) 562-
                                                               8788,                     8788,
                                                               [email protected].     [email protected].

5--IL, IN, MI, MN, OH, WI...................................  Keary Cragan, 77 West     Rosita Clarke, 77 West
                                                               Jackson Boulevard (SB-    Jackson Boulevard (SB-
                                                               5J), Chicago, IL 60604-   5J), Chicago, IL 60604-
                                                               3507, Phone (312) 353-    3507, Phone (312) 886-
                                                               5669, Fax (312) 692-      7251, Fax (312) 697-
                                                               2161,                     2075,
                                                               [email protected].     [email protected].
6--AR, LA, NM, OK, TX.......................................  Ana Esquivel, 1201 Elm    Elizabeth Reyes, 1201
                                                               Street, Suite 500,        Elm Street, Suite 500,
                                                               Dallas, Texas 75270-      Dallas, Texas 75270-
                                                               2102, Phone (214) 665-    2102, Phone (214) 665-
                                                               3163, Fax (214) 665-      2194, Fax (214) 665-
                                                               6660,                     6660,
                                                               [email protected].     [email protected]
                                                                                .
7--IA, KS, MO, NE...........................................  Susan Klein, 11201        Jennifer Morris, 11201
                                                               Renner Boulevard (LCRD/   Renner Boulevard (LCRD/
                                                               BSPR), Lenexa, KS         BSPR), Lenexa, KS
                                                               66219, Phone (913) 551-   66219, Phone (913) 551-
                                                               7786,                     7341,
                                                               [email protected].      [email protected]
                                                                                .
8--CO, MT, ND, SD, UT, WY...................................  Christina Wilson, 1595    Melisa Devincenzi, 1595
                                                               Wynkoop Street (8LCR-     Wynkoop Street (8LCR-
                                                               BR), Denver, CO 80202-    BR), Denver, CO 80202-
                                                               1129, Phone (303) 312-    1129, Phone (303) 312-
                                                               6706,                     6377,
                                                               [email protected]   [email protected]
                                                               v.                        ov.
9--AZ, CA, HI, NV, AS, GU, MP...............................  Jose Garcia, Jr., 600     Jose Garcia, Jr., 600
                                                               Wilshire Blvd., Suite     Wilshire Blvd., Suite
                                                               1460, Los Angeles, CA     1460, Los Angeles, CA
                                                               90017, Phone (213) 244-   90017, Phone (213) 244-
                                                               1811, Fax (213) 244-      1811, Fax (213) 244-
                                                               1850,                     1850,
                                                               [email protected].      [email protected].
10--AK, ID, OR, WA..........................................  Madison Sanders-Curry,    Madison Sanders-Curry,
                                                               1200 Sixth Ave., Suite    1200 Sixth Ave., Suite
                                                               155 (mail code 15-H04),   155 (mail code 15-H04),
                                                               Seattle, WA 98101,        Seattle, WA 98101,
                                                               Phone<PHONE_NUMBER>,      Phone<PHONE_NUMBER>,
                                                               Fax<PHONE_NUMBER>,         Fax<PHONE_NUMBER>,
                                                               sanders-                  [email protected].    [email protected]
----------------------------------------------------------------------------------------------------------------

(Authority: 42 U.S.C. 9628(a))

    Dated: April 21, 2022.
David R. Lloyd,
Director, Office of Brownfields and Land Revitalization.
[FR Doc. 2022-11069 Filed 5-23-22; 8:45 am]
BILLING CODE 6560-50-P


Dyno Nobel Unit 3 (the only Unit DN identified as expected to be subject to NSPS)  -  All values Year No. of 30 day avgs meet 0.50 No. of 30 day avgs don't meet 0.50 Avg 30 day avgs Max 30 day avg Avg hr readings 2008* 121 14 0.25 1.08 0.32 2009 159 174 3.87 7.05 3.91 2010 22 301 3.61 14.9 3.36 2011 102 229 2.49 19.6 2.35 2012 17 295 1.37 4.3 1.39 2013* 43 106 0.94 2.24 0.82 Total                      464		      1119

Dyno Nobel Unit 3  -  Excluding very high hourly values (>500 ppm) Year No. of 30 day avgs meet 0.50 No. of 30 day avgs don't meet 0.50 Avg 30 day avgs Max 30 day avg Avg hr readings 2008* 135 0 0.089 0.17 0.09 2009 333 0 0.24 0.43 0.24 2010 58 264 1.06 2.17 1.06 2011 177 154 0.54 1.27 0.58 2012 64 248 0.92 1.78 0.89 2013* 103 46 0.43 0.81 0.40   Total	                  857	    	      725 *- Partial years  -  2008  -  from 7/1 on; 2013 up to 6/30.

Dyno Nobel  Unit  4  -  All values Year No. of 30 day avgs meet 0.50 No. of 30 day avgs don't meet 0.50 Avg 30 day avgs Max 30 day avg Avg hr readings 2009 31 271 1.43 4.28 1.41 2010 0 334 1.18 1.92 1.19 2011 166 163 0.74 2.10 0.78 2012 24 301 0.86 1.17 0.86 2013* 0 150 0.80 0.99 0.79 Total                      221		      1219	       Dyno Nobel Unit 4  -  Excluding very high hourly values (> 500 ppm) Year No. of 30 day avgs meet 0.50 No. of 30 day avgs don't meet 0.50 Avg 30 day avgs Max 30 day avg Avg hr readings 2009 69 243 1.11 2.56 1.10 2010 0 334 1.18 1.84 1.17 2011 182 147 0.69 2.10 0.75 2012 35 289 0.87 1.38 0.87 2013* 0 150 0.76 0.96 0.75   Total	    	   286    	                     1163 *- Partial year- up to 6/30.


[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73342-73343]
[DOCID:fr27de07-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-31-000 and Docket No. PF06-32-000]

Transcontinental Gas Pipe line Corporation; Notice of Application

December 17, 2007.
    Take notice that on December 3, 2007, Transcontinental Gas Pipe
line Corporation (Transco), 2800 Post Oak Boulevard, Houston, Texas
77056-6106 filed an application pursuant to sections 7(b) and 7(c) of
the Natural Gas Act (NGA) and Part 157 of the Commission's regulations,
for a certificate of public convenience and necessity to construct,
operate and abandon facilities in eastern Pennsylvania and northern New
Jersey that would expand its existing system by providing an additional
142,000 dekatherms per day of firm transportation capacity to the
northeastern U.S. market. This filing is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>or toll free
at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    Transco proposes to construct the expansion facilities, referred to
as the Sentinel Expansion Project, in two phases. Phase 1 would consist
of approximately four miles of 42-inch pipeline looping in Pennsylvania
as well as modifications to Compressor Station No. 195 and
modifications to various other existing valve settings and meter
stations in Pennsylvania. The phase 1 facilities would provide 40,000
dekatherms per day for a proposed in-service date of November 1, 2008.
The Phase 2 facilities would consist of about seven miles of 42-inch
pipeline replacement in Pennsylvania and a total of about 7 miles of
42-inch pipeline looping in Pennsylvania and New Jersey as well as
modifications to Compressor Station No. 200 and various existing meter
stations in Pennsylvania and New Jersey. Phase 2 would provide 102,000
dekatherms per day for a proposed in-service date of November 1, 2009.
    Any questions regarding the application are to be directed to Scott
Turkington, Director, Rates & Regulatory, Transcontinental Gas Pipe
Line Corporation, Post Office Box 1396, Houston, Texas 77251-1396,
telephone:<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>    On August 4, 2006, the Commission staff granted Transco's request
to utilize the National Environmental Policy Act (NEPA) Pre-Filing
Process and assigned Docket No. PF06-32-000 to staff activities
involving the project. Now, as of the filing of this application on
December 3, 2007, the NEPA Pre-Filing Process for this project has
ended. From this time forward, this proceeding will be conducted in
Docket No. CP08-31-000, as noted in the caption of this notice.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be file on or before the comment date. Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant. On or before the comment date, it is not
necessary to serve motions to intervene or protests on persons other
than the Applicant.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov
.

Persons unable to file electronically should submit the original and 14
copies of the protest or intervention to the Federal Energy regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    Comment Date: January 7, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-25003 Filed 12-26-07; 8:45 am]

BILLING CODE 6717-01-P


INTERSTATE AIR QUALITY RULE DOCKETING FORM NAME OF GROUP: Air Quality Dialogue Group  Organized by Center for Clean Air Policy MEETING_____ SPEECH_____ PHONE CALL__ X___

DATE: March 18, 2004 LOCATION OF MEETING/ SPEECH/ PHONE CALL:

PURPOSE OF MEETING/ SPEECH/ PHONE CALL:

The purpose of the meeting was to discuss different allowance allocation methods ATTENDEES:

Ned Helme, Stacey Davis, Air Quality Dialogue members, Sarah Dunham, Roman Kramarchuk COMMENTS:

ATTACHMENTS ( HANDOUTS): Included


[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Notices]
[Page 4398]
[FR Doc No: 2012-1714]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2012-0015; Notice No. 12-1]

Safety Advisory Notice: Return of Radioactively Contaminated
Tissue Holders Purchased From Bed Bath and Beyond

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Safety Advisory Notice.

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

SUMMARY: PHMSA has been notified that Bed Bath and Beyond sold a number
of tissue holders in the United States, identified as the Dual Ridge
Metal tissue holder, model number DR9M, that emit low levels of
radiation. PHMSA and the Nuclear Regulatory Commission believe that
there is no immediate danger to the public; however, PHMSA is advising
persons in possession of the contaminated tissue holders that they
should arrange with Bed Bath and Beyond for their safe return. Any
person in possession of this item should call Bed Bath and Beyond at 1-
(800) 462-3966 to obtain information about the proper return
procedures.

FOR FURTHER INFORMATION CONTACT: Mr. Rick Boyle, Acting Chief, Sciences
Branch, Office of Hazardous Materials Safety,<PHONE_NUMBER>, 1200 New
Jersey Avenue SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: On January 11, 2012, PHMSA was advised that
Bed Bath and Beyond sold Dual Ridge Metal tissue holders model number
DR9M, that were contaminated with the radioisotope Cobalt-60 during
their manufacture in India. At this time, it has been verified that at
least 220 tissue holders, sold in some of the more than 200 affected
Bed Bath and Beyond stores in the United States, are radioactively
contaminated. The highest identified radioactivity level on the surface
of the tissue holders was approximately 20 mrem/hr, however most of the
tissue holders showed much lower levels. A person who spends eight
hours in close contact with one of these tissue holders (such as having
the tissue on a bedside table next to the bed) could possibly get a
maximum yearly dose of about 500-700 mrem. While no unnecessary
radiation exposure is desirable, the dose from the tissue holders is
not expected to cause any appreciable health effects. To put this into
perspective, a person living in the United States receives a
radioactive exposure of about 360 mrem/year from naturally-occurring
background radiation.
    Bed Bath and Beyond has posted notices on its web site: http://www.bedbathandbeyond.com/tissueholdernotice.asp, its facebook pages,
and in its stores, and has been actively working with state Radiation
Control Programs, the Nuclear Regulatory Commission, the Environmental
Protection Agency, the Consumer Product Safety Commission, and Pipeline
and Hazardous Materials Safety Administration to identify and remove
all of the contaminated tissue holders. Information on radiation
exposure can be found on the Nuclear Regulatory Commission's Web site
at: http://www.nrc.gov/about-nrc/radiation/around-us/doses-daily-lives.html.

Recommended Action

    A person in possession of this item should call Bed Bath and Beyond
at 1-(800) 462-3966 to obtain information about the proper return
procedures. If a person possessing the identified tissue holders
experiences difficulties when attempting to obtain return directions or
assistance from Bed Bath and Beyond, they should contact PHMSA at the
contact number provided in this notice.

    Issued in Washington, DC, on January 23, 2012.
R. Ryan Posten,
Deputy Associate Administrator for Hazardous Materials Safety, Pipeline
and Hazardous Materials Safety Administration.
[FR Doc. 2012-1714 Filed 1-26-12; 8:45 am]
BILLING CODE 4910-60-P