[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3739-3740]
[FR Doc No: 2018-01349]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5570]

Select Updates for Recommendations for Clinical Laboratory
Improvement Amendments of 1988 Waiver Applications for Manufacturers of
In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of November 29, 2017. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Select Updates for Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices.'' The Agency is
taking this action in response to a request for an extension to allow
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published
November 29, 2017 (82 FR 56607). Submit either electronic or written
comments on the draft guidance by March 30, 2018, to ensure that the
Agency considers your comment on this draft guidance before it begins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-2017-D-5570 for ``Select Updates for Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability.''
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.gpo.gov/fdsys/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)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Select Updates for Recommendations for Clinical Laboratory
Improvement Amendments of 1988 Waiver Applications for Manufacturers of
In Vitro Diagnostic Devices'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Marina Kondratovich, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002,
301-796-6036; or Peter Tobin, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5657, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 29, 2017, FDA published a
notice of availability with a 60-day comment period to request comments
on draft guidance for industry and FDA staff entitled ``Select Updates
for Recommendations for Clinical Laboratory Improvement Amendments of
1988 (CLIA) Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices.''
    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 the FDA on the
guiding principles and recommended approach for FDA staff and industry
to facilitate consistent application of least burdensome principles to
the activities pertaining to products meeting the statutory definition
of a device regulated under the Federal Food, Drug, and Cosmetic Act.
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. This draft
guidance is not subject to Executive Order 12866.
    The Agency has received a request for a 60-day extension of the
comment period. The request conveyed concern that the current 60-day
comment period does not allow sufficient time to develop a meaningful
or thoughtful response.
    FDA has considered the request and is extending the comment period
for the notice of availability for 60 days, until March 30, 2018. The
Agency believes that a 60-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: January 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01349 Filed 1-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18620-18622]
[FR Doc No: 2011-7841]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2007-29320]

Operating Limitations at John F. Kennedy International Airport

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Extension to Order.

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SUMMARY: This action amends the Order Limiting Operations at John F.
Kennedy International Airport (JFK) that published on January 18, 2008,
and was amended on February 14, 2008, and October 7, 2009. The Order
remains effective until the final Congestion Management Rule for
LaGuardia Airport, John F. Kennedy International Airport, and Newark
Liberty International Airport becomes effective but not later than
October 26, 2013.

DATES: This amendment is effective on April 4, 2011.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this Order contact: Gerry Shakley, System Operations Services, Air
Traffic Organization, Federal Aviation Administration, 800 Independence
Avenue, SW., Washington, DC 20591; telephone:<PHONE_NUMBER>;
facsimile:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    For legal questions concerning this Order contact: Robert Hawks,
Office of the Chief Counsel, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
7240; facsimile:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Availability of Rulemaking Documents

    You may obtain an electronic copy using the Internet by:
    (1) Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    (2) Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or
    (3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
    You also may obtain a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking.

Background

    Until recently, most operations at JFK took place during relatively
pronounced arrival and departure banks corresponding to the operating
windows of transatlantic flights. The FAA had limited the number of
arrivals and departures at JFK during the peak afternoon demand period
through the implementation of the High Density Rule (HDR).\1\ By
statute enacted in April 2000, the HDR's applicability to JFK
operations terminated as of January 1, 2007.\2\ Using AIR-21 exemptions
and the HDR phase-out, U.S. air carriers serving JFK significantly
increased their domestic scheduled operations throughout the day. This
increase in operations resulted in significant congestion and delays
that negatively impacted the National Airspace System (NAS). In January
2008, the FAA placed temporary limits on scheduled operations at JFK to
mitigate persistent congestion and delays at the airport.\3\ With a
temporary schedule limit order in place, the FAA proposed a long-term
rule that would limit the number of scheduled and unscheduled
operations at JFK.\4\ On October 10, 2008, the FAA published the
Congestion Management Rule for John F. Kennedy International Airport
and Newark Liberty International Airport, which would have become
effective on December 9, 2008.\5\ That rule was stayed by the U.S.
Court of Appeals for the District of Columbia Circuit and subsequently
rescinded by the FAA.\6\ This Order was further extended on October 7,
2009.\7\
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    \1\ 33 FR 17896 (Dec. 3, 1968). The FAA codified the rules for
operating at high density traffic airports in 14 CFR part 93,
subpart K. The HDR required carriers to hold a reservation, which
came to be known as a ``slot,'' for each takeoff or landing under
instrument flight rules at the high density traffic airports.
    \2\ Aviation Investment and Reform Act for the 21st Century
(AIR-21), Public Law 106-181 (Apr. 5, 2000), 49 U.S.C. 41715(a)(2).
    \3\ 73 FR 3512 (Jan. 18, 2008), as amended by 73 FR 8737 (Feb.
14, 2008).
    \4\ 73 FR 29626 (May 21, 2008); Docket FAA-2008-0517.
    \5\ 73 FR 60574, amended by 73 FR 66516 (Nov. 10, 2008).
    \6\ 74 FR 52134 (Oct. 9, 2009).
    \7\ 74 FR 51650.
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    Under the Order, as amended, the FAA (1) maintains the current
hourly limits on 81 scheduled operations at JFK during the peak period;
(2) imposes an 80 percent minimum usage requirement for Operating
Authorizations (OAs) with defined exceptions; (3) provides a mechanism
for withdrawal of OAs for FAA operational reasons; (4) establishes
procedures to allocate withdrawn, surrendered, or unallocated OAs; and
(5) allows for trades and leases of OAs for consideration for the
duration of the Order. Without the operational limitations imposed by
this Order, the FAA expects severe congestion-related delays would
occur at JFK and at other airports throughout the NAS.
    The FAA is engaged in a rulemaking effort to implement a long-term
congestion management rule at LaGuardia Airport (LGA), JFK, and Newark
Liberty International Airport (EWR). The FAA anticipates publishing a
notice of proposed rulemaking for the Congestion Management Rule for
LaGuardia Airport, John F. Kennedy International Airport, and Newark
Liberty International Airport (RIN 2120-AJ89) during the summer of
2011. To prevent this Order from expiring prior

to a final rule becoming effective, the FAA has concluded it is
necessary to extend the expiration date of this Order until the final
Congestion Management Rule for LaGuardia Airport, John F. Kennedy
International Airport, and Newark Liberty International Airport becomes
effective but not later than October 26, 2013. This expiration date
coincides with the expiration dates for the Orders limiting scheduled
operations at EWR and LGA, as also amended by notices in today's
Federal Register.
    Therefore, the FAA finds that notice and comment procedures under 5
U.S.C. section 553(b) are impracticable and contrary to the public
interest. The FAA further finds that good cause exists to make this
Order effective in less than 30 days.

The Amended Order

    The Order, as amended, is recited below in its entirety.
    1. This Order assigns operating authority to conduct an arrival or
a departure at JFK during the affected hours to the U.S. air carrier or
foreign air carrier identified in the appendix to this Order. The FAA
will not assign operating authority under this Order to any person or
entity other than a certificated U.S. or foreign air carrier with
appropriate economic authority and FAA operating authority under 14 CFR
part 121, 129, or 135. This Order applies to the following:
    a. All U.S. air carriers and foreign air carriers conducting
scheduled operations at JFK as of the date of this Order, any U.S. air
carrier or foreign air carrier that operates under the same designator
code as such a carrier, and any air carrier or foreign-flag carrier
that has or enters into a codeshare agreement with such a carrier.
    b. All U.S. air carriers or foreign air carriers initiating
scheduled or regularly conducted commercial service to JFK while this
Order is in effect.
    c. The Chief Counsel of the FAA, in consultation with the Vice
President, System Operations Services, is the final decisionmaker for
determinations under this Order.
    2. This Order governs scheduled arrivals and departures at JFK from
6 a.m. through 10:59 p.m., Eastern Time, Sunday through Saturday.
    3. This Order takes effect on March 30, 2008, and will expire when
the final Congestion Management Rule for LaGuardia Airport, John F.
Kennedy International Airport, and Newark Liberty International Airport
becomes effective but not later than October 26, 2013.
    4. Under the authority provided to the Secretary of Transportation
and the FAA Administrator by 49 U.S.C. 40101, 40103 and 40113, we
hereby order that:
    a. No U.S. air carrier or foreign air carrier initiating or
conducting scheduled or regularly conducted commercial service at JFK
may conduct such operations without an Operating Authorization assigned
by the FAA.
    b. Except as provided in the appendix to this Order, scheduled U.S.
air carrier and foreign air carrier arrivals and departures will not
exceed 81 per hour from 6 a.m. through 10:59 p.m., Eastern Time.
    c. The Administrator may change the limits if he determines that
capacity exists to accommodate additional operations without a
significant increase in delays.
    5. For administrative tracking purposes only, the FAA will assign
an identification number to each Operating Authorization.
    6. A carrier holding an Operating Authorization may request the
Administrator's approval to move any arrival or departure scheduled
from 6 a.m. through 10:59 p.m. to another half hour within that period.
Except as provided in paragraph seven, the carrier must receive the
written approval of the Administrator, or his delegate, prior to
conducting any scheduled arrival or departure that is not listed in the
appendix to this Order. All requests to move an allocated Operating
Authorization must be submitted to the FAA Slot Administration Office,
facsimile<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>and must
come from a designated representative of the carrier. If the FAA cannot
approve a carrier's request to move a scheduled arrival or departure,
the carrier may then apply for a trade in accordance with paragraph
seven.
    7. For the duration of this Order, a carrier may enter into a lease
or trade of an Operating Authorization to another carrier for any
consideration. Notice of a trade or lease under this paragraph must be
submitted in writing to the FAA Slot Administration Office, facsimile
(202) 267-7277 or e-mail<EMAIL_ADDRESS>and must come from a
designated representative of each carrier. The FAA must confirm and
approve these transactions in writing prior to the effective date of
the transaction. The FAA will approve transfers between carriers under
the same marketing control up to five business days after the actual
operation, but only to accommodate operational disruptions that occur
on the same day of the scheduled operation. The FAA's approval of a
trade or lease does not constitute a commitment by the FAA to grant the
associated historical rights to any operator in the event that slot
controls continue at JFK after this order expires.
    8. A carrier may not buy, sell, trade, or transfer an Operating
Authorization, except as described in paragraph seven.
    9. Historical rights to Operating Authorizations and withdrawal of
those rights due to insufficient usage will be determined on a seasonal
basis and in accordance with the schedule approved by the FAA prior to
the commencement of the applicable season.
    a. For each day of the week that the FAA has approved an operating
schedule, any Operating Authorization not used at least 80% of the time
over the time-frame authorized by the FAA under this paragraph will be
withdrawn by the FAA for the next applicable season except:
    i. The FAA will treat as used any Operating Authorization held by a
carrier on Thanksgiving Day, the Friday following Thanksgiving Day, and
the period from December 24 through the first Saturday in January.
    ii. The Administrator of the FAA may waive the 80% usage
requirement in the event of a highly unusual and unpredictable
condition which is beyond the control of the carrier and which affects
carrier operations for a period of five consecutive days or more.
    b. Each carrier holding an Operating Authorization must forward in
writing to the FAA Slot Administration Office a list of all Operating
Authorizations held by the carrier along with a listing of the
Operating Authorizations and:
    i. The dates within each applicable season it intends to commence
and complete operations.
    A. For each winter scheduling season, the report must be received
by the FAA no later than August 15 during the preceding summer.
    B. For each summer scheduling season, the report must be received
by the FAA no later than January 15 during the preceding winter.
    ii. The completed operations for each day of the applicable
scheduling season:
    A. No later than September 1 for the summer scheduling season.
    B. No later than January 15 for the winter scheduling season.
    iii. The completed operations for each day of the scheduling season
within 30 days after the last day of the applicable scheduling season.
    10. In the event that a carrier surrenders to the FAA any Operating
Authorization assigned to it under this Order or if there are
unallocated Operating Authorizations, the FAA will determine whether
the Operating

Authorizations should be reallocated. The FAA may temporarily allocate
an Operating Authorization at its discretion. Such temporary
allocations will not be entitled to historical status for the next
applicable scheduling season under paragraph 9.
    11. If the FAA determines that an involuntary reduction in the
number of allocated Operating Authorizations is required to meet
operational needs, such as reduced airport capacity, the FAA will
conduct a weighted lottery to withdraw Operating Authorizations to meet
a reduced hourly or half-hourly limit for scheduled operations. The FAA
will provide at least 45 days' notice unless otherwise required by
operational needs. Any Operating Authorization that is withdrawn or
temporarily suspended will, if reallocated, be reallocated to the
carrier from which it was taken, provided that the carrier continues to
operate scheduled service at JFK.
    12. The FAA will enforce this Order through an enforcement action
seeking a civil penalty under 49 U.S.C. 46301(a). A carrier that is not
a small business as defined in the Small Business Act, 15 U.S.C. 632,
will be liable for a civil penalty of up to $25,000 for every day that
it violates the limits set forth in this Order. A carrier that is a
small business as defined in the Small Business Act will be liable for
a civil penalty of up to $10,000 for every day that it violates the
limits set forth in this Order. The FAA also could file a civil action
in U.S. District Court, under 49 U.S.C. 46106, 46107, seeking to enjoin
any air carrier from violating the terms of this Order.
    13. The FAA may modify or withdraw any provision in this Order on
its own or on application by any carrier for good cause shown.

    Issued in Washington, DC on March 28, 2011.
Rebecca B. MacPherson,
Assistant Chief Counsel for Regulations.
[FR Doc. 2011-7841 Filed 4-1-11; 8:45 am]
BILLING CODE 4910-13-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on October 14, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 1997-2884

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  TAXIREY, S.A. de C.V.
                               Date Filed:  September 22, 2003

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charters in accordance
with 14 CFR Part 212, using small equipment.

If renewal, date and citation of last action:  October 23, 2002, in this
Docket.

Applicant representative:  Daniel Elizondo,<PHONE_NUMBER>       DOT
analyst:  Allen Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved
                                            Action date:  October 14,
2003

Effective dates of authority granted:  October 14, 2003, through October
23, 2004

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

     X  Standard exemption conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a
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