[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91839-91841]
[FR Doc No: 2016-30195]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0845; FRL-9956-62-Region 5]

Air Plan Approval; Michigan; Part 9 Miscellaneous Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
administrative revisions for incorporation into the Michigan's State
Implementation Plan (SIP). The submittal, by the Michigan Department of
Environmental Quality (MDEQ) on December 21, 2015, makes minor
corrections to Michigan's Air Pollution Control Rules entitled
``Emissions Limitations and Prohibitions--Miscellaneous.''

DATES: This rule is effective on February 17, 2017, unless EPA receives
adverse written comments by January 18, 2017. If EPA receives adverse
comments, EPA will publish a timely withdrawal of the rule in the
Federal Register and inform the public that the rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0845 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the ``For Further Information Contact'' section. For the
full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What did Michigan submit?
II. What action is EPA taking?
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. What did Michigan submit?

    On December 21, 2015, MDEQ submitted a request to EPA to make minor
administrative revisions to rules in Chapter 336, Part 9. The revisions
are described below:
    R 336.1906 (rule 906)--This existing rule requires notice to MDEQ
for the placement of a device that dilutes or conceals emissions. MDEQ
requests the rule that is currently in effect at the state level be
incorporated into the SIP. The regulatory text of Michigan's current
rule, effective May 20, 2015, is identical to the text of the SIP
approved rule, which became effective March 19, 2002. The only revision
to the text is the effective date of the rule. Because there are no
substantive changes to language in the current version of the rule
promulgated at the state, EPA finds the 2015 version of rule 906
approvable into the SIP.
    R 336.1911 (rule 911) and R 336.1912 (rule 912)--The provisions of
these rules do not allow emissions or specifically limit emissions from
a source, process equipment, or operation. In the existing rule 911, it
requires a malfunction abatement plan in certain situations. A person
responsible for the operation of a source of an air contaminant shall
prepare a malfunction abatement plan to prevent, detect, and correct
malfunctions or equipment failures resulting in emissions exceeding any
applicable emission limitation. In this rule the word ``commission''
was changed to ``department.'' Malfunction abatement plans are to be
submitted to the department because the commission no longer exists.
    The existing rule 912 addresses notification and reporting
requirements of excess emissions resulting from either an abnormal
condition, start-up, shutdown, or malfunction of a source, process
equipment, or operation. In section 912(5b), the word ``which'' was
changed to ``that.''
    Because there are no substantive changes to the language in rules
911 and 912, EPA finds the revisions acceptable for approval into the
Michigan SIP.\1\
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    \1\ On June 12, 2015 (80 FR 33840), EPA finalized a SIP Call to
address deficient SIP provisions regarding emissions during facility
start-up, shutdown, and malfunctions. In this SIP Call, Michigan was
required to revise a rule which allowed an affirmative defense for
excess emissions during start-up or shutdown. The SIP Call did not
include rule 911 or 912. These two rules address only planning and
reporting requirements. Thus, they comply with EPA's policy on
start-up, shutdown, and malfunctions.
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    Overall, the revisions to Part 9 make minor corrections to rules
906, 911, and 912. The revisions are solely administrative, and do not
make any substantive changes to the language in the rules. The
revisions to these rules will not increase emissions of pollutants into
the atmosphere.

II. What action is EPA taking?

    EPA is approving the December 21, 2015, request to revise
Michigan's air pollution control rules in Part 9. The revisions will
not increase emissions of pollutants into the atmosphere.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective February 17,
2017 without further notice unless we receive relevant adverse written
comments by January 18, 2017. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. If we do not receive any comments, this action will be
effective February 17, 2017.

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Michigan
regulations described in the amendments to 40 CFR part 52 set forth
below. Therefore, these materials have been approved by EPA for
inclusion in the State implementation plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of EPA's approval, and will be incorporated by reference by
the Director of the Federal Register in the next update to the SIP
compilation.\2\ EPA has made, and will continue to make, these
documents generally available electronically through
www.regulations.gov and/or at the EPA Region 5 Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).
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    \2\ 62 FR 27968 (May 22, 1997).
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IV. Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the CAA
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 17, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements.

    Dated: December 2, 2016.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. In Sec.  52.1170, the table in paragraph (c) is amended by revising
the entries for R 336.1906, R 336.1911, and R 336.1912 under the
heading ``Part 9. Emission Limitations and Prohibitions--
Miscellaneous'' to read as follows:

Sec.  52.1170   Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Michigan Regulations
----------------------------------------------------------------------------------------------------------------
                                                           State
    Michigan citation                Title            effective date    EPA approval date         Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                          Part 9. Emission Limitations and Prohibitions--Miscellaneous
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
R 336.1906...............  Diluting and concealing         5/20/2015  12/19/2016 [insert
                            emissions.                                 Federal Register
                                                                       citation].

                                                  * * * * * * *
R 336.1911...............  Malfunction abatement           5/20/2015  12/19/2016 [insert
                            plans.                                     Federal Register
                                                                       citation].
R 336.1912...............  Abnormal conditions,            5/20/2015  12/19/2016 [insert
                            start-up, shutdown, and                    Federal Register
                            malfunction of a source,                   citation].
                            process, or process
                            equipment, operating,
                            notification, and
                            reporting requirements.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-30195 Filed 12-16-16; 8:45 am]
 BILLING CODE 6560-50-P


" Carter, Douglas" < Douglas. Carter@ HQ. DOE. GOV>

08/ 22/ 2003 03: 39 PM To: "' Elizabeth_ A._ Stolpe@ ceq. eop. gov '" < Elizabeth_ A._ Stolpe@ ceq. eop. gov>, " Otis, Lee" < Lee. Otis@ hq. doe. gov>, " Hill, David R. ( GC)" < David. R. Hill@ hq. doe. gov>, "' Indur_ Goklany@ ios. doi. gov '" < Indur_ Goklany@ ios. doi. gov>, "' Arthur_ G._ Fraas@ omb. eop. gov '" < Arthur_ G._ Fraas@ omb. eop. gov>, "' Amy_ L._ Farrell@ omb. eop. gov '" < Amy_ L._ Farrell@ omb. eop. gov>, "' Paul_ R._ Noe@ omb. eop. gov '" < Paul_ R._ Noe@ omb. eop. gov>, Bill Wehrum/ DC/ USEPA/ US@ EPA, "' Ted_ Gayer@ cea. eop. gov '"< Ted_ Gayer@ cea. eop. gov>, "' Clay_ Sell@ opd. eop. gov '" < Clay_ Sell@ opd. eop. gov>, "' Kevin_ M._ O'Donovan@ oa. eop. gov '" < Kevin_ M._ O'Donovan@ oa. eop. gov>, Bill Harnett/ RTP/ USEPA/ US@ EPA cc:

Subject: NSR analysis Attached is an analysis by DOE of the emission implications of the NSR/ ERP rule. DOE would like for these results to be included in the RIA and cited in the Preamble, although not to the exclusion of our earlier analysis, or EPA's earlier analysis.

Please call if you have questions.

Doug Carter, DOE/ FE DOE NSR modeling Aug03. doc


[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63659-63660]
[FR Doc No: 2019-24916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1835]

Smallpox (Variola Virus) Infection: Developing Drugs for
Treatment or Prevention; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Smallpox
(Variola Virus) Infection: Developing Drugs for Treatment or
Prevention.'' The purpose of this guidance is to assist sponsors in the
clinical development of drugs for treating or preventing smallpox
(variola virus) infection. This guidance finalizes the draft guidance
of the same name issued on July 11, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on November 18, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2018-D-1835 for ``Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention.'' 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 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)).
    Submit written requests for single copies of this 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. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled

``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or
Prevention.'' This final guidance addresses nonclinical development,
key study design considerations for animal efficacy studies to support
potential new drug application (NDA) submissions under the Animal Rule,
and considerations for obtaining a human safety database. This guidance
finalizes the draft guidance of the same name issued on July 11, 2018
(83 FR 32136). Changes in this final guidance compared with the
previous draft version are:
     Clarification of the assessment of immunologically
na[iuml]ve status in animals used in the animal studies
     Minor editorial changes
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Smallpox (Variola Virus) Infection:
Developing Drugs for Treatment or Prevention.'' 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 guidance refers to previously approved collections of
information that 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 collection of information in 21 CFR part 312
(investigational new drug applications) has been approved under OMB
control number 0910-0014. The collection of information in 21 CFR part
314 (NDAs) has been approved under OMB control number 0910-0001. The
collection of information resulting from special protocol assessments
has been approved under OMB control number 0910-0470. The collection of
information resulting from emergency use authorization of medical
products has been approved under OMB control number 0910-0595. The
collection of information resulting from individual patient expanded
access applications has been approved under OMB control number 0910-
0814. The collection of information resulting from good laboratory
practices has been approved under OMB control number 0910-0119.

III. Electronic Access

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

    Dated: November 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24916 Filed 11-15-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Rules and Regulations]
[Pages 10012-10013]
[FR Doc No: 2014-03882]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0059]

Drawbridge Operation Regulation; Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Burlington Northern Santa Fe
Railway Bridge, also known as the St. Johns RR Bridge, across the
Willamette River, mile 6.9, at Portland, OR. The deviation is necessary
to facilitate replacement of the frayed counterweight wire ropes for
the lift mechanism of the bridge. This deviation allows the bridge to
remain in the closed position during maintenance activities.

DATES: This deviation is effective from 7 a.m. on March 19, 2014 to 7
p.m. on April 15, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0059] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Coast Guard Thirteenth District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Burlington Northern Santa Fe (BNSF) Railway
requested this deviation to facilitate replacement of the frayed
counterweight wire ropes for the lift mechanism of the bridge. The
bridge, also known as the St. Johns RR Bridge, crosses the Willamette
River at mile 6.9 and provides 54 feet of vertical clearance above
Columbia River Datum 0.0, while in the closed position. Under normal
operations this bridge opens on signal as required by 33 CFR 117.5. The
deviation period is from 7 a.m. on March 19, 2014 to 7 p.m. on April
15, 2014. This deviation allows the lift span of the BNSF Railway
Bridge across the Willamette River, mile 6.9, to remain in the closed
position and need not open for maritime traffic during following four
12 hour periods: 7 a.m. to 7 p.m. on Wednesday, March 19, 2014; 7 a.m.
to 7 p.m. on Monday, March 24, 2014; 7 a.m. to 7 p.m. on Thursday,
March 27, 2014; and 7 a.m. to 7 p.m. on Tuesday, April 1, 2014. The
bridge shall operate in accordance to 33 CFR 117.5 at all other times.
BNSF will entertain requests from mariners to change the above listed
schedule for emergent vessel arrivals or departures that are water
level dependant given 72 hours advanced notice. BNSF contact is Ron
Berry, who can be reached at<PHONE_NUMBER>. Waterway usage on this
stretch of the Willamette River includes vessels ranging from
commercial tug and barge to small pleasure craft.
    Vessels which do not require a bridge opening may continue to
transit beneath the bridge during this closure period. Due to the
nature of work being performed the draw span will be unable to open for
for emergencies. Mariners have been notified and will be kept informed
of the bridge's operational status via the Coast Guard Notice to
Mariners publication and Broadcast Notice to Mariners as appropriate so
that vessels can arrange their transits to minimize any impact caused
by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: February 10, 2014.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2014-03882 Filed 2-21-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Notices]
[Pages 43531-43533]
[FR Doc No: 2022-15609]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0634]

Oncologic Drugs 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 Oncologic Drugs 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 22, 2022, from 9 a.m. to 6
p.m. Eastern Time and September 23, 2022, from 9 a.m. to 1:15 p.m.
Eastern Time.

ADDRESSES: Please note that due to the impact of this 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-2022-N-0634. The docket will close on
September 21, 2022. Submit either electronic or written comments on
this public meeting by September 21, 2022. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 21, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 21, 2022. 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 September 8, 2022, 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 canceled, 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-2022-N-0634 for ``Oncologic Drugs 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, 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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: She-Chia Chen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, Fax:<PHONE_NUMBER>, [email protected], 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. During the
first session of September 22, 2022, the committee will discuss new
drug application (NDA) 215643, for poziotinib tablets, submitted by
Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this
product is for the treatment of patients with previously treated,
locally advanced or metastatic non-small cell lung cancer (NSCLC)
harboring HER2 exon 20 insertion mutations. Select patients with NSCLC
for treatment with poziotinib based on the presence of HER2 exon 20
insertion mutations using an FDA-approved test. During the second
session of September 22, 2022, the committee will hear an update on new
drug application (NDA) 214383, for PEPAXTO (melphalan flufenamide) for
injection, submitted by Oncopeptides A.B. This product was approved
under 21 CFR 314.500 (subpart H, accelerated approval regulations) for
use in combination with dexamethasone for the treatment of adult
patients with relapsed or refractory multiple myeloma who have received
at least four prior lines of therapy and whose disease is refractory to
at least one proteasome inhibitor, one immunomodulatory agent, and one
CD38-directed monoclonal antibody. The confirmatory trial demonstrated
a worse overall survival and failed to verify clinical benefit.
Confirmatory studies are post-marketing studies to verify and describe
the clinical benefit of a drug after it receives accelerated approval.
Based on the updates provided, the committee will have a general
discussion focused on next steps for the product.
    On September 23, 2022, the committee will hear an update on new
drug application (NDA) 211155, for COPIKTRA (duvelisib) capsule,
submitted by Secura Bio, Inc. This product was approved under section
505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use
in the treatment of adult patients with relapsed or refractory chronic
lymphocytic leukemia or small lymphocytic lymphoma after at least two
prior therapies. The update includes the final overall survival data
from the DUO trial (IPI-145-07) submitted in response to post-marketing
requirement 3494-3 detailed in the September 24, 2018 approval letter,
available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211155Orig2s000ltr.pdf. Based on the updated overall survival
information along with the safety data with duvelisib, the committee
will discuss a current assessment of benefit-risk.
    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 on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before September 8, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 11:40 a.m. to 12:10 p.m. and 4:30 p.m. to 5 p.m. Eastern
Time on September 22, 2022. Oral presentations from the public will be
scheduled between approximately 11:45 a.m. to 12:15 p.m. Eastern Time
on September 23, 2022. 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 30, 2022. 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 August
31, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] 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 She-Chia Chen (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 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15609 Filed 7-20-22; 8:45 am]
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[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Page 32937]
[FR Doc No: 2014-13369]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-52-000]

ISO New England Inc., New England Power Pool; Notice of
Institution of Section 206 Proceeding and Refund Effective Date

    On May 30, 2014, the Commission issued an order in Docket No. EL14-
52-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into the justness and
reasonableness of ISO New England Inc.'s (ISO-NE) Transmission,
Markets, and Services Tariff, and establishing the just and reasonable
rate. ISO New England Inc., et al. 147 FERC ] 61,172 (2014).
    The refund effective date in Docket No. EL14-52-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: June 3, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-13369 Filed 6-6-14; 8:45 am]
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