[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34598-34599]
[FR Doc No: 2018-15508]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1098]

Metered Dose Inhaler and Dry Powder Inhaler Drug Products--
Quality Considerations; Draft Guidance for Industry; Reopening of the
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
reopening the comment period for the ``Metered Dose Inhaler and Dry
Powder Inhaler Drug Products--Quality Considerations; Draft Guidance
for Industry,'' published in the Federal Register of April 19, 2018.
FDA is reopening the comment period to allow interested persons
additional time to submit comments.

DATES: FDA is reopening the comment period on the notice published
April 19, 2018 (83 FR 17420). Submit either electronic or written
comments by September 18, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2018-D-1098 for ``Metered Dose Inhaler and Dry Powder Inhaler Drug
Products--Quality Considerations; Draft Guidance for Industry.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.
    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 Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research, 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
the 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: Richard Lostritto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796-
1697, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 19, 2018 (83 FR 17420), FDA
announced the availability of a draft guidance for industry entitled
``Metered Dose Inhaler and Dry Powder Inhaler Drug Products--Quality
Considerations; Draft Guidance for Industry.'' Interested persons were
originally given until June 18, 2018, to comment on the draft guidance.
The Agency believes that reopening the comment period for an additional
60 days from the date of publication of this notice will allow adequate
time for interested persons to submit comments without significantly
delaying Agency decision making on these important issues.

II. Electronic Access

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

    Dated: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15508 Filed 7-19-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Rules and Regulations]
[Page 19212-19213]
[DOCID:fr14ap10-9]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-1009; Airspace Docket No. 09-AWP-11]

Modification of Class E Airspace; Oxnard, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action will modify Class E airspace at Point Mugu Naval
Air Station (NAS), Oxnard, CA. Additional controlled airspace is
necessary to accommodate aircraft flying in the Los Angeles Air Route
Traffic Control Center's (ARTCC's) airspace area. The FAA is taking
this action to enhance the safety and management of aircraft operations
in Los Angeles ARTCC's airspace. This action also makes a minor change
to the name and geographic coordinates of Point Mugu NAS, Oxnard, CA.

DATES: Effective Date: 0901 UTC, June 3, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On December 29, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to establish additional controlled
airspace at Point Mugu NAS, Oxnard, CA (74 FR 68748). Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. The FAA found the acronym NAS in the airport name was
typed as NAWS, and also updates the geographic coordinates to coincide
with the FAA's National Aeronautical Charting Office.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9T signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by adding additional Class E airspace 700 and 1,200 feet above
the surface for Point Mugu NAS, Oxnard, CA, to accommodate the
vectoring of aircraft flying en route, in and out of the Los Angeles
ARTCC's airspace area. This action enhances the safety and management
of aircraft operations in Los Angeles ARTCC's airspace. This action
also changes the name from Point Mugu NAWS, to Point Mugu NAS, and
updates the geographic coordinates of Point Mugu NAS, Oxnard, CA.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it establishes
additional controlled airspace at Point Mugu NAS, Oxnard, CA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP CA E5 Oxnard, CA

Point Mugu NAS (Naval Base Ventura Co), CA
    (Lat. 34[deg]07[min]09[sec]N., long. 119[deg]07[min]10[sec]W.)

    That airspace extending upward from 700 feet above the surface
beginning at lat. 34[deg]01[min]56[sec]N., long.
119[deg]01[min]44[sec]W.; to lat. 34[deg]02[min]30[sec]N., long.
118[deg]53[min]33[sec]W.; to lat. 34[deg]19[min]30[sec]N., long.
118[deg]53[min]03[sec]W.; to lat. 34[deg]19[min]30[sec]N., long.
119[deg]29[min]53[sec]W.; thence 3 miles west of and parallel to the
shoreline to lat. 34[deg]14[min]50[sec]N., long.
119[deg]22[min]03[sec]W.; to lat. 34[deg]14[min]45[sec]N., long.
119[deg]23[min]33[sec]W.; to lat. 34[deg]06[min]55[sec]N., long.
119[deg]22[min]33[sec]W.; to lat. 34[deg]07[min]41[sec]N., long.
119[deg]15[min]40[sec]W., thence via a 7-mile radius of Point Mugu
NAS to the point of beginning. That airspace extending upward from
1,200 feet above the surface bounded by a line beginning at lat.
34[deg]30[min]00[sec]N., long. 118[deg]50[min]03[sec]W.; to lat.
34[deg]00[min]00[sec]N., long. 118[deg]50[min]03[sec]W.; to lat.
34[deg]00[min]00[sec]N., long. 119[deg]05[min]00[sec]W.; to lat.
33[deg]52[min]03[sec]N., long. 119[deg]06[min]59[sec]W.; to lat.
33[deg]28[min]30[sec]N., long. 119[deg]07[min]03[sec]W.; to lat.
33[deg]28[min]30[sec]N., long. 118[deg]47[min]00[sec]W.; to lat.
33[deg]19[min]30[sec]N., long. 118[deg]37[min]03[sec]W.; to lat.
32[deg]53[min]00[sec]N., long. 119[deg]13[min]00[sec]W.; to lat.
33[deg]05[min]00[sec]N., long. 119[deg]45[min]07[sec]W.; to lat.
33[deg]53[min]00[sec]N., long. 120[deg]38[min]00[sec]W.; lat.
33[deg]54[min]00[sec]N., long. 120[deg]00[min]03[sec]W.; to lat.
34[deg]20[min]00[sec]N., long. 120[deg]00[min]04[sec]W.; to lat.
34[deg]20[min]00[sec]N., long. 119[deg]30[min]03[sec]W.; to lat.
34[deg]30[min]00[sec]N., long. 119[deg]30[min]03[sec]W., thence to
the point of beginning, excluding that airspace more than 12
nautical miles from the shoreline. That airspace extending upward
from 5,000 feet MSL bounded by a line beginning at lat.
34[deg]08[min]00[sec]N., long. 120[deg]00[min]03[sec]W.; to lat.
33[deg]54[min]00[sec]N., long. 120[deg]00[min]03[sec]W.; to lat.
33[deg]53[min]00[sec]N., long. 120[deg]38[min]00[sec]W.; to lat.
33[deg]55[min]00[sec]N., long. 120[deg]40[min]00[sec]W.; lat.
34[deg]00[min]00[sec]N., long. 120[deg]43[min]00[sec]W.; to lat.
34[deg]06[min]15[sec]N., long. 120[deg]30[min]04[sec] W.; to lat.
34[deg]08[min]00[sec]N., long. 120[deg]26[min]04[sec]W., thence to
the point of beginning, excluding that airspace more than 12
nautical miles from the shoreline.

    Issued in Seattle, Washington, on March 31, 2010.
Robert E. Henry,
Acting Manager, Operations Support Group, Western Service Center .
[FR Doc. 2010-8407 Filed 4-13-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27260-27262]
[FR Doc No: 2012-11132]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66918; File No. SR-ICC-2012-08]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing and Order Granting Accelerated Approval of Proposed Rule Change
To Add Margin Collection Requirements for Futures Commission Merchant
Clearing Participants

May 3, 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 April 23, 2012, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I and II below, which Items have been
prepared primarily by ICC. The Commission is publishing this Notice and
Order to solicit comments on the proposed rule change from interested
persons and to approve the proposed rule change on an accelerated
basis.
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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 Substance
of the Proposed Rule Change

    ICC proposes to require FCM clearing participants to collect margin
from their customers in respect of such customers' non-hedge positions
at a level that is ten percent (10%) greater than ICC's related margin
requirement with respect to each product and swap portfolio. As
discussed in more detail in Item II(A) below, ICC published a Circular
on April 20, 2012 informing its clearing participants of this rule
change.

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

    In its filing with the Commission, ICC 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 III below. ICC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
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    \3\ The Commission has modified the text of the summaries
prepared by ICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    ICC is registered as a derivatives clearing organization (``DCO'')
with the Commodity Futures Trading Commission (``CFTC'') and clears
credit default swap contracts subject to the jurisdiction of the CFTC.
CFTC Regulation 39.13(g)(8)(ii) provides that a DCO ``shall require its
clearing members to collect customer initial margin * * *from their
customers, for non-hedge positions, at a level that is greater than 100
percent of the derivatives clearing organization's initial margin
requirements with respect to each product and swap portfolio.''
    As further described in ICC's Circular 2012/008 dated April 20,
2012, in compliance with CFTC Regulation 39.13(g)(8)(ii), no later than
the May 7, 2012 effective date, ICC will require FCM clearing
participants to collect margin from their customers in respect of such
customers' non-hedge positions, at a level that is ten percent (10%)
greater than ICC's related margin requirement with respect to each
product and swap portfolio.
    ICC believes that the proposed rule change is consistent with the
requirements of Section 17A of the Act and the rules and regulations
thereunder applicable to it. ICC believes that its proposed rule will
help protect investors and the public interest because the requirements
help safeguard customer funds held at the FCM level.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    ICC does not believe the proposed rule change would have any
impact, or impose any burden, on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. ICC represented that it will notify the
Commission of any written comments it receives.

III. 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 may be submitted by using the
Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml)
or by sending an email to<EMAIL_ADDRESS>Please include File
Number SR-ICC-2012-08 on the subject line.
     Paper comments may be sent 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-ICC-2012-08. 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 Section, 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 filings will also be
available for inspection and copying at the principal office of ICC and
on ICC's Web site at https://www.theice.com/publicdocs/regulatory_filings/042312_SEC_ICEClearCredit.pdf.
    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-ICC-2012-08
and should be submitted on or before May 30, 2012.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    Section 19(b)(2)(C) of the Act \4\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such organization. Section 17A(b)(3)(F) of the Act \5\
requires, among other things, that the rules of a clearing agency be
designed to promote the prompt and accurate clearance and settlement of
securities transactions, and to the extent applicable, derivative
agreements, contracts, and transactions. Section 17A(b)(3)(F) also
requires that the rules of a clearing agency be designed to contribute
to the safeguarding of securities and funds associated with swap
transactions.\6\
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    \4\ 15 U.S.C. 78s(b)(2)(C).
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
    \6\ Id.
---------------------------------------------------------------------------

    The proposed change would allow ICC to require ICC's clearing
participants to enhance the margin collected from clients for clients'
non-hedge positions, thereby contributing to the safeguarding of
securities and funds associated with swap transactions. It should also
allow ICC to comply with new CFTC regulatory requirements, thereby
promoting the prompt and accurate clearance and settlement of
derivative agreements, contracts, and transactions.
    Further, the Commission finds good cause, pursuant to Section
19(b)(2) of the Act,\7\ for approving the proposed rule change prior to
the 30th day after the date of publication of notice in the Federal
Register because as a registered DCO ICC is required to comply with the
new CFTC regulations by the time they become effective on May 7,
2012.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
    \8\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

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

V. Conclusion

    It is therefore ordered, pursuant to 19(b)(2) of the Act,\9\ that
the proposed rule change (SR-ICC-2012-08) is approved on an accelerated
basis.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin O'Neill,
Deputy Secretary.
[FR Doc. 2012-11132 Filed 5-8-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 142 (Thursday, July 23, 2020)]
[Notices]
[Pages 44541-44542]
[FR Doc No: 2020-15998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1648]

Pediatric Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Advisory Committee.
The general function of the committee is to provide advice and
recommendations to FDA on regulatory issues. The meeting will be open
to the public. FDA is establishing a docket for public comment on this
document.

DATES: The meeting will be held on September 15, 2020, from 10 a.m. to
4:30 p.m.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions about FDA advisory committee meetings may be accessed
at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-1648. The docket will close on
September 14, 2020. Submit either electronic or written comments on
this public meeting by September 14, 2020. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 14, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 14, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
    Comments received on or before August 31, 2020, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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-2020-N-1648 for ``Pediatric Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     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.'' FDA 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 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 the 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, September18, 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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of Pediatric
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5154, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be
heard, viewed, captioned, and recorded through an online
teleconferencing platform. On September 15, 2020, the Pediatric
Advisory Committee (PAC) will discuss pediatric-focused safety reviews,
as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-
109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).
    The PAC will meet to discuss the following products (listed by FDA
Center):
    (1) Center for Biologics Evaluation and Research
    a. GAMUNEX[supreg]-C (immune globulin intravenous (human)), 10%,
Caprylate/Chromatography Purified
    (2) Center for Devices and Radiological Health
    a. FLOURISHTM Pediatric Esophageal Atresia Device
(humanitarian device exemption)
    (3) Center for Drug Evaluation and Research
    a. ADZENYS ER (amphetamine) extended-release oral suspension,
    b. MYDAYIS (mixed salts of a single-entity amphetamine product)
extended-release capsule, for oral use,
    c. ORENCIA (abatacept) for injection, for intravenous use
    d. VYVANSE[supreg] (lisdexamfetamine dimesylate) capsule and
chewable tablet,
    FDA will discuss acute dystonia associated with the use of
attention deficit hyperactivity disorder (ADHD) medications (including
methylphenidate products, amphetamine products, and atomoxetine).
Additionally, FDA will discuss acute hyperkinetic movement disorder
associated with the combined use of ADHD stimulants and antipsychotics
(including first-generation antipsychotics and second-generation
antipsychotics).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 8, 2020. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 11:30 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before August 31, 2020. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by September 1, 2020.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Marieann Brill (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15998 Filed 7-22-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 19, 2009 (Volume 74, Number 200)]
[Notices]
[Page 53509-53510]
[DOCID:fr19oc09-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0143]

Risk Evaluation and Mitigation Strategies for Certain Opioid
Drugs; Notice of Public Meeting; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until
October 19, 2010, the comment period for the notice of public meeting
published in the Federal Register of April 20, 2009 (74 FR 17967). In
that notice, FDA announced a public meeting that took place on May 27
and 28, 2009, to solicit input on developing Risk Evaluation and
Mitigation Strategies (REMS) for certain opioid drugs. FDA is reopening
the comment period in light of continued public interest in this topic
and to provide an opportunity for all interested parties to provide
information and share views on the matter.

DATES: Submit written or electronic comments by October 19, 2010.

ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Theresa (Terry) Martin, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993-0002, 301-
796-3448; FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 20, 2009 (74 FR 17967), FDA
published a notice of a public meeting on developing REMS for certain
opioid drugs. The affected opioid drugs include long acting and
extended release brand name and generic products that are formulated
with the following active ingredients: Fentanyl, hydromorphone,
methadone, morphine, oxycodone, and oxymorphone. The REMS would be
intended to ensure that the benefits of these drugs continue to
outweigh risks associated with: (1) Use of high doses of long acting
opioid and extended release

opioid products in non-opioid tolerant and inappropriately selected
individuals; (2) abuse; (3) misuse; and (4) overdose, both accidental
and intentional. REMS for these opioids would likely include elements
to assure safe use to ensure that prescribers, dispensers, and patients
are aware of and understand the risks and proper use of these products.
The opioid drugs expected to be subject to REMS are widely prescribed
by a large number of physicians who practice in a wide variety of
areas. A REMS that will adequately manage the risks of these products
without unduly burdening the health care system or reducing patient
access to these medications must be carefully designed. Recognizing
this challenge, we identified several specific areas in which FDA
wishes to obtain information and public comment in our April 2009
notice of public meeting.
    Interested persons were originally given until June 30, 2009, to
comment. As a result of continued public interest, FDA is reopening the
comment period until October 19, 2010 to allow interested persons
additional time to provide information and share views on this topic.

II. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments to http://
www.regulations.gov or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25022 Filed 10-16-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38308-38309]
[FR Doc No: 2013-15184]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4093-031]

PK Ventures, Inc.; North Carolina; Notice Soliciting Applications

    On April 30, 2010, PK Ventures, Inc. (licensee) filed a Notice of
Intent (NOI) to file an application for a subsequent license for its
Bynum Hydroelectric Project, No. 4093, pursuant to section 16.19(b) of
the Commission's regulations.\1\ On June 30, 2010, Commission staff
noticed the NOI and approved the use of the traditional licensing
process (TLP) to develop the license application. The existing license
for Project No. 4093 expires on April 30, 2015.
---------------------------------------------------------------------------

    \1\ 18 CFR 16.19(b)(3) (2012).
---------------------------------------------------------------------------

    The 600-kilowatt (kW) Bynum project is located on the Haw River, in
Chatham County, North Carolina. No federal lands are affected.
    The principal project works consist of: (1) A 750-foot-long, 10-
foot-high

stone masonry dam with an uncontrolled spillway and a 150-foot-long
non-overflow section; (2) a 2000-foot-long canal, between 25 and 40
feet wide; (3) a powerhouse separate from the dam containing a 600-kW
generating unit; (4) a reservoir with a surface area of 20 acres at
normal pool elevation of 315 feet mean sea level and a gross storage
capacity of 100 acre-feet; and (5) appurtenant facilities. The project
operates run-of-river and generates and estimated average of 2,461,000
kW hours a year.
    Pursuant to section 16.20(c) of the Commission's regulations, an
existing licensee with a minor license not subject to sections 14 and
15 of the Federal Power Act must file an application for a subsequent
license at least 24 months prior to the expiration of the current
license.\2\ PK Ventures has not filed an application for a subsequent
license for the Bynum project.
---------------------------------------------------------------------------

    \2\ 18 CFR 16.20(c) (2012).
---------------------------------------------------------------------------

    Pursuant to section 16.24(b)(2) of the Commission's regulations, an
existing licensee that fails to file a license application pursuant to
section 16.20(b) shall be deemed to have filed a notice of intent
indicating that it does not intend to file an application for
subsequent license. Therefore, pursuant to section 16.25 of the
Commission's regulations, interested parties have 90 days from the date
of this notice to file a NOI to file an application for a subsequent
license. An application for subsequent license or exemption for the
Bynum Project (No. 4093) must be filed within 18 months of the date of
filing the NOI. The existing licensee is prohibited from filing an
application either individually or in combination with other
entities.\3\
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    \3\ 18 CFR 16.24(b)(2) (2012)
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    Questions concerning this notice should be directed to Sean Murphy
at<PHONE_NUMBER> or<EMAIL_ADDRESS>
    Dated: June 19, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-15184 Filed 6-25-13; 8:45 am]
BILLING CODE 6717-01-P