[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31178-31179]
[FR Doc No: 2014-12438]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety

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

ACTION: Notice of actions on Special Permit Applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
Subpart B), notice is hereby given of the actions on special permits
applications in (April to April 2014). The mode of transportation
involved are identified by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft. Application numbers prefixed by the letters EE represent
applications for Emergency Special Permits. It should be noted that
some of the sections cited were those in effect at the time certain
special permits were issued.

    Issued in Washington, DC, on May 13, 2014.
Donald Burger,
Chief, Special Permits and Approvals Branch.

------------------------------------------------------------------------
                                                      Nature of special
     S.P No.         Applicant      Regulation(s)      permit thereof
------------------------------------------------------------------------
                   MODIFICATION SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
15577-M.........  Olin             49 CFR 172.101   To modify the
                   Corporation,     column 8,        special permit to
                   Oxford, MS.      173.62(b),       authorize a
                                    173.60(b)(8),    contract carrier.
                                    172.300(d).

14867-M.........  GTM              49 CFR 173.302a  To modify the
                   Manufacturing,   and 173.304.     special permit to
                   LLC, Amarillo,                    authorize a 30 year
                   TX.                               service life for
                                                     the cylinders, add
                                                     a Division 2.3
                                                     material and remove
                                                     the water jacket as
                                                     a test Method.
14296-M.........  GasCon (Pty)     49 CFR           To modify the
                   Ltd. Elsies      178.274(b)(1),   special permit to
                   River 7480.      and              authorize the
                                    178.276(b)(1).   latest revision of
                                                     the ASME, Section
                                                     VIII Division 2.
15847-N.........  Safariland,      49 CFR 173.4a..  To authorize the
                   LLC,                              transportation in
                   Jacksonville,                     commerce of Nitric
                   FL.                               acid up to 65% as
                                                     an excepted
                                                     quantity by cargo
                                                     aircraft only.
                                                     (modes 1, 4).
15985-N.........  Space            49 CFR Part 172  To authorize the
                   Exploration      and 173.         transportation in
                   Technologies                      commerce of certain
                   Corp.,                            hazardous material
                   Hawthorne, CA.                    as part of the
                                                     Falcon Space
                                                     capsule without
                                                     requiring shipping
                                                     papers, marking and
                                                     labeling. (mode 1).
16079-N.........  Wal-Mart Stores  49 CFR 171.2(k)  To authorize the
                   East, LP,                         transportation in
                   Bentonville,                      commerce of certain
                   AR.                               used cylinders
                                                     containing Helium,
                                                     compressed as fully
                                                     regulated without
                                                     first determining
                                                     that a hazardous
                                                     material is
                                                     present. (mode 1).
------------------------------------------------------------------------
                    EMERGENCY SPECIAL PERMIT GRANTED
------------------------------------------------------------------------
12706-M.........  Hexagon Ragasco  49 CFR 173.34;   To modify the
                   As Raufoss.      173.201;         special permit to
                                    173.301;         authorize an
                                    173.304.         alternative test
                                                     and inspection
                                                     procedure.
16127-N.........  Linde Gas North  49 CFR           To authorize the
                   America LLC,     171.23(a)(1)     transportation in
                   Murray Hill,     and              commerce of certain
                   NJ.              171.23(a)(2)(i   non-DOT
                                    i).              Specification
                                                     foreign cylinders
                                                     containing Neon by
                                                     motor vehicle and
                                                     cargo vessel (modes
                                                     1, 3).
16135-N.........  Austin Powder    49 CFR,          To authorize the
                   Company,         Necessary to     transportation in
                   Cleveland, OH.   prevent          commerce of
                                    significant      ammonium nitrate by
                                    economic         cargo air in
                                    impact.          amounts exceeding
                                                     what is currently
                                                     authorized. (mode
                                                     4).
16147-N.........  Michigan State   49 CFR 171-180.  To authorize the
                   Police,                           transportation in
                   Lansing, MI.                      commerce of certain
                                                     hazardous materials
                                                     in support of the
                                                     recovery and relief
                                                     efforts within the
                                                     flood disaster
                                                     areas Newaygo and
                                                     Osceola Counties in
                                                     Michigan. (mode 1).
------------------------------------------------------------------------
                      NEW SPECIAL PERMIT WITHDRAWN
------------------------------------------------------------------------
16134-N.........  Massachusetts    49 CFR 49 CFR    We are requesting
                   Department of    Parts 106, 107   party status to
                   Public Health,   and 171-180.     Special Permit DOT
                   Jamaica Plain,                    SP 14599 to
                   MA.                               authorize the
                                                     transportation in
                                                     commerce of
                                                     packages of non
                                                     hazardous material
                                                     identified as
                                                     ``Biological
                                                     substance, Category
                                                     B'', for purposes
                                                     of shipping and
                                                     packaging srill
                                                     conducted to
                                                     evaluate
                                                     bioterrorism and
                                                     chemical terrorism
                                                     preparedness.
                                                     (modes 1, 4).
------------------------------------------------------------------------
                                 DENIED
------------------------------------------------------------------------
7616-M..........  Request by Mississippi Export Railroad Company, Moss
                   Point, MS April 16, 2014.
15996-N.........  Request by University of York York, April 10, 2014. To
                   authorize the transportation in commerce of 53 non-
                   DOT specification EU certified cylinders from the
                   United Kingdom into the U.S. Territory of Guam for
                   the atmospheric research field campaign ``CONTRAST''.
------------------------------------------------------------------------

[FR Doc. 2014-12438 Filed 5-29-14; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Page 32274]
[FR Doc No: 2014-12879]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC14-83-000]

Koch Alaska Pipeline Company, LLC; Notice of Filing

    Take notice that on April 24, 2014, Koch Alaska Pipeline Company,
LLC submitted a letter to the Federal Energy Regulatory Commission
(Commission) informing that they no longer own FERC-jurisdictional
assets, therefore they will no longer be filing the FERC Form 6,
starting with the 2013 third quarter Form 6Q.
    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 or 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 filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    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 an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: June 18, 2014.

    Dated: May 28, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-12879 Filed 6-3-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Rules and Regulations]
[Page 37175]
[FR Doc No: 2014-15209]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2014-N-0108]

New Animal Drug Applications; Confidentiality of Data and
Information in a New Animal Drug Application File; Confirmation of
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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

SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of July 30, 2014, for the final rule that appeared in
the Federal Register of March 17, 2014. The direct final rule amends
the regulation regarding the confidentiality of data and information in
and about new animal drug application files to change when certain
approval-related information will be disclosed by the Agency. This
change ensures that the Agency is able to update its list of approved
new animal drug products within the statutory timeframe. It also
permits more timely public disclosure of approval-related information,
increasing the transparency of FDA decisionmaking in the approval of
new animal drugs. This document confirms the effective date of the
direct final rule.

DATES: Effective date of final rule published in the Federal Register
of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.

FOR FURTHER INFORMATION CONTACT: Scott Fontana, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 17, 2014
(79 FR 14609), FDA solicited comments concerning the direct final rule
for a 75-day period ending June 2, 2014. FDA stated that the effective
date of the direct final rule would be on July 30, 2014, 30 days after
the end of the comment period, unless any significant adverse comment
was submitted to FDA during the comment period. FDA did not receive any
significant adverse comments.

    Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e,
381.

    Accordingly, the amendments issued thereby are effective.

    Dated: June 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15209 Filed 6-30-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Page 71124]
[FR Doc No: 2011-29495]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2011-0241, (Notice No. 11-10)]

Safety Advisory: Unauthorized Marking of Compressed Gas Cylinders

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

ACTION: Safety Advisory Notice.

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

SUMMARY: An undetermined number of high pressure DOT specification
cylinders were improperly marked from approximately August 2007 to
August 2011 and marked with a RIN of B377.
    Prior to filling these cylinders, a person must verify that the
cylinder has been properly requalified by an authorized requalification
company and properly marked.

FOR FURTHER INFORMATION CONTACT: Morgan Welding and Supply, Mr. Daniel
Horosko, Owner or Mr. Matthew Stepps, Manager, 488 Finley Road, Albion,
MI, Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    This notice advises the public that PHMSA has recently confirmed
the marking and sale of certain high pressure DOT specification
cylinders that were marked with a requalification identification number
(RIN) without performing a visual inspection and hydrostatic test. The
company that marked the cylinders does not have authority from the
Associate Administrator to requalify high pressure DOT cylinders. The
evidence suggests that if a cylinder purchased from Morgan Welding and
Supply, Albion, Michigan is marked with a ``B377'' in which the
individual letter and numbers appear to be stamped individually, the
mark may have been improperly placed on the cylinder. The cylinder did
not undergo the complete series of safety tests and inspections
required by the Hazardous Materials Regulations (HMR) and may not
possess the structural integrity to safely contain its contents under
pressure during normal transportation and use. Extensive property
damage, serious personal injury, or death could result from a rupture
of the cylinder. Individuals who identify a cylinder marked with the
RIN ``B377'' stamped with individual letter/numbers that are not in a
square pattern, are advised to remove these cylinders from service and
contact Morgan Welding and Supply, Albion, MI for further instructions.
    However, the RIN ``B377'' is currently authorized to Midwest
Cylinder Inc., located in Cleaves, OH. Cylinders purchased from Midwest
Cylinder Inc. will have the proper RIN ``B377'' and have been properly
requalified. Cylinders from Midwest Cylinder Inc. can also be
identified by blue paint highlighting the requalification markings. The
RIN, ``B377'' has been stamped on the cylinder with a square pattern
stamp so the marks will appear uniform and straight.

    Issued in Washington, DC, on November 4, 2011.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 2011-29495 Filed 11-15-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44897-44898]
[FR Doc No: 2011-18916]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP11-509-000; CP11-510-000]

Columbia Gulf Transmission Company and Energy Interchange, LLC;
Notice of Application

    Take notice that on July 1, 2011, Columbia Gulf Transmission
Company (Columbia Gulf), and Energy Interchange, LLC (Energy
Interchange), filed in the above referenced dockets a joint application
pursuant to sections 7(c) and 7(b), of the Natural Gas Act (NGA), and
Parts 157 and 284 of the Federal Energy Regulatory Commission's (FERC)
Regulations for (1) A certificate of public convenience and necessity
under section 7(c) authorizing the lease of interstate pipeline
capacity by Energy Interchange from Columbia Gulf; (2) approval of the
related abandonment under section 7(b) by Columbia Gulf of the
interstate pipeline capacity through an operating lease; (3) a blanket
certificate pursuant to part 284, subparts B and G, authorizing Energy
Interchange to provide interruptible hub support services in interstate
commerce pursuant to the terms of Energy Interchange's pro forma FERC
Gas Tariff set forth in Exhibit P hereto; (4) a blanket certificate of
public convenience and necessity pursuant to section 157.204 of the
Commission's Regulations authorizing future facility construction,
operations, and abandonment as set forth in the blanket certificate
Regulations in 18 CFR subpart F; and (5) authority for Energy
Interchange to charge market-based rates for the proposed open access
hub support services that Energy Interchange will offer. In addition,
Columbia Gulf and Energy Interchange respectfully request waiver of
certain Commission regulations, all as more fully set forth in the
application. 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>.
    Any questions regarding this application should be directed to J.
Curtis Moffatt, Van Ness Feldman PC, 1050 Thomas Jefferson Street, NW.,
Washington, DC 20007-3877, or by phone at<PHONE_NUMBER> or Carlos F.
Pe[ntilde]a, Assistant General Counsel, NiSource Corporate Services
Company, 5151 San Felipe, Suite 2500, Houston, Texas 77056, or by phone
at<PHONE_NUMBER>.
    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.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    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 commentors 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 commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors 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 strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    Comment Date: August 4, 2011.

    Dated: July 14, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-18916 Filed 7-26-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13167-13168]
[FR Doc No: 2020-04603]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5572]

Inclusion of Older Adults in Cancer Clinical Trials; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Inclusion
of Older Adults in Cancer Clinical Trials.'' This draft guidance
provides recommendations regarding the inclusion of older adult
patients in clinical trials of drugs for the treatment of cancer. For
the purpose of this draft guidance, older adults are those age 65 years
and older. The draft guidance emphasizes the particular importance of
including adults over age 75 years in cancer clinical trials.
Specifically, this draft guidance includes recommendations for
including an adequate representation of older adults in cancer clinical
trials to better enable evaluation of the benefit-risk profile of
cancer drugs in this population.

DATES: Submit either electronic or written comments on the draft
guidance by May 5, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-5572 for ``Inclusion of Older Adults in Cancer Clinical
Trials.''

Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Harpreet Singh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2137, Silver Spring, MD 20993-0002, 240-
402-3561; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Inclusion of Older Adults in Cancer Clinical Trials.'' This
draft guidance provides recommendations for stakeholders, including
sponsors and institutional review boards, responsible for the
development and oversight of clinical trials regarding the inclusion of
older adult patients (i.e., age 65 years and older) in clinical trials
of drugs for the treatment of cancer. The draft guidance emphasizes the
particular importance of including adults over age 75 years in cancer
clinical trials.
    Enrolling an adequate representation of the range of patients in a
clinical trial that may be exposed to a drug after approval can
maximize the generalizability of the trial results. It provides the
ability to understand the drug's benefit-risk profile across the
patient population likely to use the drug in clinical practice.
Including information in the labeling describing use in older adults
helps to promote the safe and effective use of these products and
better informs treatment decisions in clinical practice.
    Older adults are underrepresented in cancer clinical trials despite
representing a growing segment of the population of cancer patients.
Therefore, more information is needed to better inform treatment
decisions for older adults with cancer. The issue persists in oncology
despite FDA's efforts to increase the inclusion of older adults in
clinical trials.
    The draft guidance recommends that sponsors of cancer trials
consider the age demographics of their target population early in
development and that a strategy for inclusion of older adults be
informed by any known information for older adults. The draft guidance
includes recommendations for inclusion of older adults related to early
clinical development; clinical trials, including considerations for
trial design, recruitment, and developing and reporting discrete age
subgroups; and the postmarket setting.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Inclusion of
Older Adults in Cancer Clinical Trials.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved FDA collections
of information. 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. 3501-3521). The collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR 201.56
and 201.57 have been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04603 Filed 3-5-20; 8:45 am]
BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION I

5 POST OFFICE SQUARE, SUITE 100

BOSTON, MASSACHUSETTS 02109-3912

MEMORANDUM

SUBJECT:	Tribal Technical Consultation: Maine Water Quality Standards:
Copper and Asbestos

FROM:	Michael Stover, EPA Region 1 Indian Program Manager

TO:		file

DATE: 	March 31, 2016

On Wednesday, October 28, 2015 from 11:00am – 12:00pm, a technical
consultation conference call was held with the Maine tribal
environmental directors regarding the application of water quality
standards pertaining to waters in Indian lands in Maine, specifically
regarding copper and asbestos standards. Present on the conference call
were:

Fred Corey, Environmental Director, Aroostook Band of Micmacs

Sharri Venno, Environmental Planner, Houlton Band of Maliseet Indians

Cara O’Donnell, Water Resources Manager, Houlton Band of Maliseet
Indians

Jane Stedman, Attorney, Kanji & Katzen (Houlton Band of Maliseet
Indians)

Tim Williamson, Deputy Director, Office of Regional Counsel, EPA Region
1

Ann Williams, Office of Regional Counsel, EPA Region 1

Ken Moraff, Director, Office of Ecosystem Protection, EPA Region 1

Ellen Weitzler, Municipal Permits Section Chief, EPA Region 1

Jeanne Voorhees, Water Quality Standards Coordinator, EPA Region 1

Matt Hoagland, Branch Chief, Wetlands, EPA Region 1

Sara Levinson, Office of Regional Administrator, EPA Region 1

Michael Stover, Indian Program Manager, EPA Region 1

EPA opened the consultation by discussing this opportunity for EPA to
receive input from the tribes on Maine’s water quality standards for
copper and asbestos as applicable to waters in Indian lands. EPA
explained that on February 2, 2015, EPA disapproved Maine’s new or
revised human health criteria (HHC), set forth in DEP Rule Chapter 584,
as they relate to waters in Indian lands in Maine.  The disapprovals
were based on EPA’s conclusion that the HHC do not protect the
sustenance fishing use in those waters because Maine’s 32.4 g/day fish
consumption rate is not representative of an unsuppressed sustenance
fish consumption rate by the tribes, who are the target general
population in waters in Indian lands.

EPA explained that among the new or revised HHC that EPA disapproved
were the HHC for copper and asbestos.  However, unlike the other HHC
that EPA disapproved, EPA’s Clean Water Act (CWA) section 304(a)
National Recommended Water Quality Criteria (NRWQC) for these
pollutants, on which Maine’s criteria are based, were not derived
using a fish consumption rate.  Rather, EPA set its NRWQC for copper
and asbestos (water only, no organism/fish component) equal to EPA’s
Safe Drinking Water Act (SDWA) Maximum Contaminant Level Goals (MCLGs)
for those pollutants.  These MCLGs are based on ingestion of water, and
are not based on or affected by specific fish consumption rates. EPA is
considering whether the basis for EPA’s disapprovals of the HHC in the
first decision letter should not apply to these criteria, and sought
feedback from the tribes.

Sharri Venno asked EPA to speak to the level of exposure and associated
risk of tribal members. Ellen Weitzler responded that from the
literature that she has read, copper and asbestos is not prone to
significant bioaccumulation in fish that would pose human health risk.

 PAGE

  PAGE   \* MERGEFORMAT  2


[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Proposed Rules]
[Pages 67633-67635]
[FR Doc No: 2011-28362]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1166; Directorate Identifier 2010-NM-169-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Model Mystere-Falcon
50 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

    The Maintenance Procedure (MP) 57-607, related to non
destructive check of the flap tracks 2 and 5, has been introduced
thru revision 4 (01/2009) of section 5-10 of the Recommended
Maintenance Schedules chapter of the Aircraft Maintenance
Documentation.

    After the implementation of this MP cracks have been detected in
service.
* * * * *
    Cracking of the flap tracks could lead to flap asymmetry and loss
of control of the airplane. The proposed AD would require actions that
are intended to address the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 19,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, New Jersey 07606;
telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-1166;
Directorate Identifier 2010-NM-169-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0080, dated April 29, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    The Maintenance Procedure (MP) 57-607, related to non
destructive check of the flap tracks 2 and 5, has been introduced
thru revision 4 (01/2009) of section 5-10 of the Recommended
Maintenance Schedules chapter of the Aircraft Maintenance
Documentation.
    After the implementation of this MP cracks have been detected in
service.
* * * * *
Cracking of the flap tracks could lead to flap asymmetry and loss of
control of the airplane. The required actions include revising the
maintenance program to include Dassault Aviation, Falcon 50/50EX
Maintenance Manual, Non-Destructive Check of Flap Tracks 2 and 5, 57-
607, dated January 2009 (commonly referred to as Dassault Falcon 50/
50EX Maintenance Procedure 57-607, Non-Destructive Check of Flap Tracks
2 and 5, of Chapter 5-40 Airworthiness Limitations, of the Dassault
Falcon 50/50EX Maintenance Manual, Revision 21, dated June 2011). You
may obtain further information by examining the MCAI in the AD docket.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 250 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $21,250, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

Dassault Aviation: Docket No. FAA-2011-1166; Directorate Identifier
2010-NM-169-AD.

Comments Due Date

    (a) We must receive comments by December 19, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Dassault Aviation Model Mystere-Falcon 50
airplanes, all serial numbers, certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    The Maintenance Procedure (MP) 57-607, related to non
destructive check of the flap tracks 2 and 5, has been introduced
thru revision 4 (01/2009) of section 5-10 of the Recommended
Maintenance Schedules chapter of the Aircraft Maintenance
Documentation.
    After the implementation of this MP cracks have been detected in
service.
* * * * *
Cracking of the flap tracks could lead to flap asymmetry and loss of
control of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 30 days after the effective date of the AD, revise
the maintenance program to include Dassault Aviation, Falcon 50/50EX
Maintenance Manual, Non-Destructive Check of Flap Tracks 2 and 5,
57-607, dated January 2009 (commonly referred to as Dassault Falcon
50/50EX Maintenance Procedure 57-607, Non-Destructive Check of Flap
Tracks 2 and 5, of Chapter 5-40 Airworthiness Limitations, of the
Dassault Falcon 50/50EX Maintenance Manual, Revision 21, dated June
2011). The initial compliance time for doing the check is prior to
the accumulation of 7,900 total flight cycles or within 600 flight
cycles after the effective date of this AD, whichever occurs later.

No Alternative Actions or Intervals

    (h) After accomplishing the revision required by paragraph (g)
of this AD, no alternative actions (e.g., inspections) or intervals
may be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i)(1) of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows:

    No difference.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to Attn: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; phone: (425) 227--1137; fax:<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (j) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2010-0080, dated April 29, 2010; and
Dassault Aviation, Falcon 50/50EX Maintenance Manual, Non-
Destructive Check of Flap Tracks 2 and 5, 57-607, dated January 2009
(commonly referred to as Dassault Falcon 50/50EX Maintenance
Procedure 57-607, Non-Destructive Check of Flap Tracks 2 and 5, of
Chapter 5-40 Airworthiness Limitations, of the Dassault Falcon 50/
50EX Maintenance Manual, Revision 21, dated June 2011); for related
information.

    Issued in Renton, Washington, on October 21, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-28362 Filed 11-1-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Rules and Regulations]
[Pages 14013-14015]
[FR Doc No: 2013-04899]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2011-P-0882]

Medical Devices; Exemption From Premarket Notification; Class II
Devices; Wheelchair Elevator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
granting a petition requesting exemption from premarket notification
requirements for wheelchair elevator devices commonly known as inclined
platform lifts and vertical platform lifts. These devices are used to
provide a means for a person with a mobility impairment caused by
injury or other disease to move from one level to another, usually in a
wheelchair. This order exempts wheelchair elevators, class II devices,
from premarket notification and establishes conditions for exemption
for this device that will provide a reasonable assurance of the safety
and effectiveness of the device without submission of a premarket
notification (510(k)). This exemption from 510(k), subject to these
conditions, is immediately in effect for wheelchair elevators. All
other devices classified under FDA's wheelchair elevator regulations,
including attendant-operated stair climbing devices for wheelchairs and
portable platform lifts, continue to require submission of 510(k)s. FDA
is publishing this order in accordance with the section of the Food,
Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a
device from the requirement to submit a 510(k).

DATES: This order is effective March 4, 2013.

FOR FURTHER INFORMATION CONTACT: Brian Pullin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1554, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations (21 CFR part 807) require persons who propose
to begin the introduction or delivery for introduction into interstate
commerce for commercial distribution of a device intended for human use
to submit a 510(k) to FDA.

The device may not be marketed until FDA finds it ``substantially
equivalent'' within the meaning of section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a legally marketed device that does not require
premarket approval.
    On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115), section 206 of which added section 510(m) to the FD&C Act.
Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after
enactment of FDAMA, to publish in the Federal Register a list of each
type of class II device that does not require a report under section
510(k) of the FD&C Act to provide reasonable assurance of safety and
effectiveness. Section 510(m) of the FD&C Act further provides that a
510(k) will no longer be required for these devices upon the date of
publication of the list in the Federal Register. FDA published that
list in the Federal Register of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
device from premarket notification requirements on its own initiative,
or upon petition of an interested person, if FDA determines that a
510(k) is not necessary to provide reasonable assurance of the safety
and effectiveness of the device. This section requires FDA to publish
in the Federal Register a notice of intent to exempt a device, or of
the petition, and to provide a 30-day comment period. FDA must publish
in the Federal Register its final determination regarding the exemption
of the device that was the subject of the notice. If FDA fails to
respond to a petition under this section within 180 days of receiving
it, the petition shall be deemed granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance that the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions From Premarket
Notification, Guidance for Industry and CDRH Staff '' (Class II 510(k)
Exemption Guidance). That guidance can be obtained through the Internet
on the Center for Devices and Radiological Health home page at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 159 to identify the guidance you are requesting.

III. Petition

    On December 2, 2011, FDA received a petition requesting an
exemption from premarket notification for a wheelchair elevator
commonly known as an inclined platform lift and a vertical platform
lift. (See Docket No. FDA-2011-P-0882.) These devices are currently
classified under 21 CFR 890.3930, Wheelchair elevator. On May 3, 2012,
FDA responded to the petition with a letter explaining that the
information provided in the petition was insufficient for the Agency to
assess whether the risks posed by this type of device could be
sufficiently mitigated in the absence of premarket notification
requirements. To address the Agency's concerns, the petitioner
submitted additional information regarding standards that could be
relied upon to mitigate the device risks, which the Agency received on
June 7, 2012. This restarted the 180-day clock under section 510(m)(2)
of the FD&C Act. (See Class II Exemption Guidance, p. 3.)
    In the Federal Register of June 1, 2012 (77 FR 32644), FDA
published a notice announcing that this petition had been received and
provided opportunity for interested persons to submit comments on the
petition by July 2, 2012. FDA received one comment supporting an
exemption from premarket notification for this type of device. The
comment stated that these devices have been produced for many years and
have a very good safety record. It noted that all of these products
already need to comply with the FDA-recognized American Society of
Mechanical Engineers (ASME) standard ``ASME A18.1 Safety Standard for
Platform Lifts and Stairway Chairlifts'' (ASME A18.1), which provides
that these products are to be built and certified to the provisions of
the National Electric Code and the Canadian Standards Association
(CSA)/ASME standard ``CSA B44.1/ASME A17.5 Elevator and Escalator
Electrical Equipment'' for elevator and escalator electrical equipment.
    FDA has assessed the need for 510(k) clearance for this type of
device against the criteria laid out in the Class II 510(k) Exemption
Guidance and in 63 FR 3142, and agrees they weigh in favor of 510(k)
exemption, as long as certain conditions are met. FDA agrees that the
risks posed by the device and the characteristics of the device
necessary for its safe and effective performance are well established.
FDA believes that changes in the device that could affect safety and
effectiveness will be readily detectable by certain types of routine
analysis and nonclinical testing, such as those detailed in certain
consensus standards. Therefore, after reviewing the petition, the
additional information received on June 7, 2012, and the comment on the
petition, FDA has determined that premarket notification is not
necessary to assure the safety and effectiveness of inclined and
vertical platform lifts, as long as the conditions for 510(k) exemption
listed in this document are met. FDA responded to the petition by
letter dated December 3, 2012, to inform the petitioner of this
decision within the 180-day timeframe under section 510(m)(2) of the
FD&C Act.
    For clarity, this order: (1) Defines a subset of wheelchair
elevators classified under Sec.  890.3930 identified as ``permanently
mounted wheelchair platform lifts'' and (2) exempts this subset of
devices from premarket notification requirements provided certain
conditions are met, which will be codified in this classification
regulation. This order does not affect other devices classified under
Sec.  890.3930, such as attendant-operated stair climbing devices for
wheelchairs and portable platform lifts, which remain subject to
premarket notification requirements, and does not change the class of
any of the devices classified under this regulation, which all remain
in class II. These devices will remain subject to current good
manufacturing practices requirements and other general controls under
the statute.

IV. Conditions for Exemption

    This final order provides conditions for exemption from premarket
notification on appropriate testing and labeling of the device. The
following conditions must be met for the device to be 510(k)-exempt:
(1) Appropriate analysis and nonclinical testing (such as that outlined
in the currently FDA-recognized edition of ASME A18.1 ``Safety Standard
for Platform Lifts and Stairway Chair Lifts'') must demonstrate that
the safety controls are adequate to prevent a free fall of the platform
in the event of a device failure; (2) appropriate analysis and
nonclinical testing must demonstrate the ability of the device to
withstand the rated load with an appropriate factor of safety; (3)
appropriate analysis and nonclinical testing must demonstrate the
ability of the enclosures to prevent the user from falling from the
device; and (4) appropriate analysis and nonclinical testing (such as
that outlined in the currently FDA-recognized edition of AAMI/ANSI/IEC
60601-1-2, ``Medical

Electrical Equipment--Part 1-2: General Requirements for Safety--
Collateral Standard: Electromagnetic Compatibility--Requirements and
Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and
Stairway Chair Lifts'') must validate electromagnetic compatibility and
electrical safety.
    Firms are now exempt from 510(k) requirements for vertical and
inclined platform lifts as long as they meet these conditions of
exemption. Firms must comply with the particular mitigation measures
set forth in the conditions for exemption or submit and receive
clearance for a 510(k) prior to marketing.

V. 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.

VI. Paperwork Reduction Act of 1995

    This final order contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

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

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

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

0
2. Section 890.3930 is revised to read as follows:

Sec.  890.3930  Wheelchair elevator.

    (a) Permanently mounted wheelchair platform lift--(1)
Identification. A permanently mounted wheelchair platform lift is a
motorized vertical or inclined platform lift device permanently
installed in one location that is intended for use in mitigating
mobility impairment caused by injury or other disease by providing a
guided platform to move a person from one level to another, with or
without a wheelchair.
    (2) Classification. Class II. The permanently mounted wheelchair
platform lift is exempt from premarket notification procedures in
subpart E of part 807 of this chapter, subject to Sec.  890.9 and the
following conditions for exemption:
    (i) Appropriate analysis and nonclinical testing (such as that
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety
Standard for Platform Lifts and Stairway Chair Lifts'') must
demonstrate that the safety controls are adequate to prevent a free
fall of the platform in the event of a device failure;
    (ii) Appropriate analysis and nonclinical testing (such as that
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety
Standard for Platform Lifts and Stairway Chair Lifts'') must
demonstrate the ability of the device to withstand the rated load with
an appropriate factor of safety;
    (iii) Appropriate analysis and nonclinical testing (such as that
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety
Standard for Platform Lifts and Stairway Chair Lifts'') must
demonstrate the ability of the enclosures to prevent the user from
falling from the device; and
    (iv) Appropriate analysis and nonclinical testing (such as that
outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC
60601-1-2, ``Medical Electrical Equipment--Part 1-2: General
Requirements for Safety--Collateral Standard: Electromagnetic
Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety
Standard for Platform Lifts and Stairway Chair Lifts'') must validate
electromagnetic compatibility and electrical safety.
    (b) Portable wheelchair elevators--(1) Identification. A portable
wheelchair elevator is a motorized lift device that is not permanently
mounted in one location and that is intended for use in mitigating
mobility impairment caused by injury or other disease by providing a
means to move a person, with or without a wheelchair, from one level to
another (e.g., portable platform lifts, attendant-operated stair
climbing devices for wheelchairs).
    (2) Classification. Class II.

    Dated: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04899 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 203 (Friday, October 19, 2012)]
[Notices]
[Pages 64369-64372]
[FR Doc No: 2012-25736]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68053; File No. SR-NASDAQ-2012-118]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change To Modify Certain Disclosure
Requirements To Require Listed Companies To Publicly Describe the
Specific Basis and Concern Identified by Nasdaq When a Company Does Not
Meet a Listing Standard and Give Nasdaq the Authority To Make Such
Public Announcement When a Listed Company Fails To Do so

October 15, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 3, 2012, The NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by Nasdaq. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Nasdaq proposes to modify certain disclosure requirements
surrounding a company's non-compliance with the listing rules. Nasdaq
will implement the proposed rule upon approval.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\3\
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    \3\ Changes are marked to the rule text that appears in the
electronic manual of Nasdaq found at http://nasdaqomx.cchwallstreet.com.
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5250. Obligations for Companies Listed on The Nasdaq Stock Market

    (a) No change.

(b) Obligation To Make Public Disclosure

    (1) No change.

(2) Disclosure of Notification of Deficiency

    As set forth in Rule 5810(b) and IM-5810-1, a Company that receives
a notification of deficiency from Nasdaq is required to make a public
announcement by filing a Form 8-K, where required by SEC rules, or by
issuing a press release disclosing receipt

of the notification and the Rule(s) upon which the deficiency is based,
and describing each specific basis and concern identified by Nasdaq in
reaching its determination that the Company does not meet the listing
standard. However, note that in the case of a deficiency related to the
requirement to file a periodic report contained in Rule 5250(c)(1) or
(2), the Company is required to make the public announcement by issuing
a press release. As described in Rule 5250(b)(1) and IM-5250-1, the
Company must notify Nasdaq's MarketWatch Department about the
announcement through the electronic disclosure submission system
available at www.nasdaq.net, except in emergency situations when
notification may instead be provided by telephone or facsimile. If the
public announcement is made during Nasdaq market hours, the Company
must notify MarketWatch at least ten minutes prior to the announcement.
If the public announcement is made outside of Nasdaq market hours, the
Company must notify MarketWatch of the announcement prior to 6:50 a.m.
ET.
    (c)-(f) No change.

5810. Notification of Deficiency by the Listing Qualifications
Department

    When the Listing Qualifications Department determines that a
Company does not meet a listing standard set forth in the Rule 5000
Series, it will immediately notify the Company of the deficiency. As
explained in more detail below, deficiency notifications are of four
types:
    (1) Staff Delisting Determinations, which are notifications of
deficiencies that, unless appealed, subject the Company to immediate
suspension and delisting;
    (2) Notifications of deficiencies for which a Company may submit a
plan of compliance for staff review;
    (3) Notifications of deficiencies for which a Company is entitled
to an automatic cure or compliance period; and
    (4) Public Reprimand Letters.
    Notifications of deficiencies that allow for submission of a
compliance plan or an automatic cure or compliance period may result,
after review of the compliance plan or expiration of the cure or
compliance period, in issuance of a Staff Delisting Determination or a
Public Reprimand Letter.
    (a) No change.

(b) Company Disclosure Obligations

    A Company that receives a notification of deficiency, Staff
Delisting Determination, or Public Reprimand Letter is required to make
a public announcement disclosing receipt of the notification and the
Rule(s) upon which the deficiency is based, and describing each
specific basis and concern identified by Nasdaq in reaching its
determination that the Company does not meet the listing standard. [A
Company that receives a notification of] If the deficiency or Staff
Delisting Determination [related] relates to the requirement to file a
periodic report contained in Rule 5250(c)(1) or (2), the Company is
required to make the public announcement by issuing a press release
[disclosing receipt of the notification and the Rule(s) upon which the
deficiency is based], in addition to filing any Form 8-K required by
SEC rules. In all other cases, the Company may make the public
announcement either by filing a Form 8-K, where required by SEC rules,
or by issuing a press release. Additional information about this
disclosure obligation is provided in IM-5810-1.
    As described in Rule 5250(b)(1) and IM-5250-1, the Company must
notify Nasdaq's MarketWatch Department about the announcement through
the electronic disclosure submission system available at
www.nasdaq.net, except in emergency situations when notification may
instead be provided by telephone or facsimile. If the public
announcement is made during Nasdaq market hours, the Company must
notify MarketWatch at least ten minutes prior to the announcement. If
the public announcement is made outside of Nasdaq market hours, the
Company must notify MarketWatch of the announcement prior to 6:50 a.m.
ET. The Company should make the public announcement as promptly as
possible but not more than four business days following receipt of the
notification.

IM-5810-1. Disclosure of Written Notice of Staff Determination

    Rule 5810(b) requires that a Company make a public announcement by
filing a Form 8-K, where required by SEC rules, or by issuing a press
release disclosing the receipt of (i) a notice that the Company does
not meet a listing standard set forth in the Rule 5000 Series, (ii) a
Staff Delisting Determination to limit or prohibit continued listing of
the Company's securities under Rule 5810 as a result of the Company's
failure to comply with the continued listing requirements, or (iii) a
Public Reprimand Letter; provided, however, that if the notification
relates to a failure to meet the requirements of Rules 5250(c)(1) or
(2), the Company must make the public announcement by issuing a press
release. Such public announcement shall be made as promptly as
possible, but not more than four business days following the receipt of
the notification, Staff Delisting Determination, or Public Reprimand
Letter, as applicable. In addition to containing all disclosure
required by Form 8-K, if applicable, the public announcement must
describe each specific basis and concern identified by Nasdaq in its
determination that the Company does not meet the listing standard and
identify the Rules upon which the deficiency is based. For example, if
the Listing Qualifications Department determines to delist a Company
based on its discretionary authority under Rule 5101, the Company must
include in its public announcement the specific concerns cited in the
Staff Delisting Determination. In addition, a Company may provide its
own analysis of the issues raised in the Staff Delisting Determination.
    If the public announcement is not made by the Company within the
time allotted or does not include all of the required information,
trading of its securities shall be halted (if not already halted), even
if the Company appeals the Staff Delisting Determination or Public
Reprimand Letter as set forth in Rule 5815, and Nasdaq may make a
public announcement with the required information. If the company's
failure to make this public announcement is the only basis for a
trading halt, Nasdaq would ordinarily resume trading if Nasdaq makes
the public announcement. If the Company fails to make the public
announcement by the time that the Hearings Panel issues its Decision,
that Decision will also determine whether to delist the Company's
securities for failure to make the public announcement.
    Rule 5810(b) does not relieve a Company of its disclosure
obligation under the federal securities laws, nor should it be
construed as providing a safe harbor under the federal securities laws.
It is suggested that the Company consult with corporate/securities
counsel in assessing its disclosure obligations under the federal
securities laws.
    (c) No change.
    IM-5810-2. No change.
    (d) No change.
* * * * *

5840. Adjudicatory Process: General Information

    (a)-(k) No change.

(l) Disclosure by Nasdaq

    In order to maintain the quality of and public confidence in its
market and

to protect investors and the public interest, Nasdaq may, at any level
of a proceeding under this Rule 5800 Series, make a public
announcement, including by press release, describing a notification,
Public Reprimand Letter, Staff Delisting Determination, Adjudicatory
Body Decision, or other event involving a Company's listing or trading
on Nasdaq.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq rules require that a company that receives a Staff Delisting
Determination, Public Reprimand Letter or a notice that the company
does not meet a listing standard (collectively, a ``Staff
Determination'') make a public announcement, either by filing a Form 8-
K, where required by SEC rules, or by issuing a press release
disclosing its receipt of the notification.\4\ These rules also require
that this disclosure identify ``the Rule(s) upon which the deficiency
is based.''
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    \4\ See Nasdaq Listing Rules 5250(b)(2) and 5810(b).
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    Nasdaq's intent in adopting this requirement was to ensure that the
public is provided with adequate information whenever a company is
deficient under Nasdaq's rules. However, Nasdaq has observed that some
companies merely disclose the rule number and a description of the
rule, without providing additional disclosure to enable the public to
understand the deficiency or the underlying basis for it. While this
may be sufficient in most cases where the deficiency is related to a
quantitative requirement, such as a bid price deficiency, it is
insufficient when qualitative issues are raised. For example, a company
may disclose that Nasdaq has determined to delist it for ``public
interest concerns under Rule 5101'' without describing the nature of
Nasdaq's concerns. Nasdaq believes that disclosure made without a
description of the specific underlying concerns that gave rise to the
delisting proceeding will prevent investors from making fully informed
investment decisions. Furthermore, since the remedy for failing to make
this disclosure is for Staff to halt trading in the company's
securities, Nasdaq is concerned that a company that has already been
halted by Staff due to regulatory concerns may decline altogether to
make the required disclosure.
    Accordingly, Nasdaq proposes to modify IM-5810-1 to specifically
require that the company's public announcement of receipt of a Staff
Determination describe each of the bases and specific concerns
underlying Nasdaq's determination. The IM would also provide that the
company may include its own analysis of the issues raised.\5\ The IM
would also be modified to specify that Nasdaq may itself make a public
announcement, such as by issuing a press release, in the circumstance
that the company makes insufficient disclosure or refuses to make the
required disclosure altogether. If the company's failure to make this
required disclosure is the only basis for a trading halt, Nasdaq would
ordinarily resume trading after issuing its disclosure. If, on the
other hand, the company's securities were already subject to a trading
halt for another reason, such as the failure to respond to a request
for information to Nasdaq, the halt would remain in effect
notwithstanding the disclosure made by Nasdaq.
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    \5\ For example, the company could choose to describe its plan
to regain compliance, or describe why it believes the concerns
identified by Nasdaq should not result in delisting. However, if the
company's analysis or description is inaccurate or misleading,
Nasdaq could use the authority in proposed Rule 5840(l) to issue a
clarifying public announcement. In this event, the Hearings Panel
would also consider the inaccurate or misleading disclosure when
determining whether it is appropriate to continue the company's
listing. Nasdaq could also halt trading under Rule 4120(a)(5) based
on the inaccurate or misleading disclosure.
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    Similarly, Nasdaq also proposes to provide that it may make a
public announcement, including by press release, describing an action
involving a company's listing or trading on Nasdaq. This authority
could be used, for example, where a company that is late in filing its
periodic reports is not granted an extended stay of delisting by the
Hearings Panel pursuant to Rule 5815(a)(1)(B), and is therefore trading
in the over-the-counter market pending a final decision by a hearings
Panel. If the Panel ultimately determines to delist this company, its
securities would continue to trade in the over-the-counter market and,
unless the company chose to issue its own public announcement,
investors would not know that the Panel had determined to delist the
Company until Nasdaq filed a Form 25 with the Commission to formally
delist the Company some months later.\6\ If the company does not make
this disclosure, proposed Rule 5840(l) would allow Nasdaq to make a
public announcement to provide transparency to the Panel's decision and
the change in the status of the company's Nasdaq listing.\7\
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    \6\ Rule 5815(d)(2) provides that when a Hearings Panel issues a
decision to delist a company's securities, Nasdaq will File a Form
25 after the Nasdaq Listing and Hearing Council has determined not
to call the decision [sic] review. The Listing Council has 45 days
to call the decision for review pursuant to Rule 5820(b). In
addition, if the Company appeals the Panel's decision to the Listing
Council, the Form 25 would not be filed until after the Listing
Council issues its decision and the Nasdaq Board of Directors has
had an opportunity to call that decision for review. Rule
5820(e)(6).
    \7\ See, also, footnote 5, supra, for another example where
Nasdaq may use the authority in proposed Rule 5840(l).
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2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\8\ in general and with Sections
6(b)(5) of the Act,\9\ in particular in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The proposed rule change
will require disclosure to the public of the specific bases for Staff's
determination to delist or reprimand the company, thereby helping
assure adequate information for investors and potential investors. In
addition, it will allow Nasdaq to provide information to the public
about a company's listing status. As such, it is designed to protect
investors and the public interest.
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    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not

necessary or appropriate in furtherance of the purposes of the Act, as
amended.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve or disapprove such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2012-118 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2012-118. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2012-118 and should
be submitted on or before November 9, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-25736 Filed 10-18-12; 8:45 am]
BILLING CODE 8011-01-P