[Federal Register: January 14, 2008 (Volume 73, Number 9)]
[Proposed Rules]
[Page 2192-2195]
[DOCID:fr14ja08-17]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0017; Directorate Identifier 2007-NM-268-AD]
RIN 2120-AA64

Airworthiness Directives; Saab Model SAAB-Fairchild SF340A (SAAB/
SF340A) and SAAB 340B Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on [the] ground, the FAA has published Special
Federal Aviation Regulation No. 88 (SFAR-88) in June 2001 [which]
required [conducting] a design review against explosion risks.
* * * * *
    The potential of ignition sources (in certain fuel pumps, fuel
switches, refuel shutoff valves, and optical sensors/mechanical
switches), in combination with flammable fuel vapors, could result in
fuel tank explosions and consequent loss of the airplane. The proposed
AD would require actions that are intended to address the unsafe
condition described in the MCAI.

DATES: We must receive comments on this proposed AD by February 13,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0017;
Directorate Identifier 2007-NM-268-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued
Airworthiness Directive 2007-0248, dated September 7, 2007 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:
    Subsequent to accidents involving Fuel Tank System explosions in
flight * * * and on [the] ground, the FAA has published Special
Federal Aviation Regulation No. 88 (SFAR-88) in June 2001 [which]
required [conducting] a design review against explosion risks.
    In their Letters referenced 04/00/02/07/01-L296, dated March 4,
2002 and 04/00/02/07/03-L024, dated February 3, 2003 the JAA (Joint
Aviation Authorities) recommended the application of a similar
regulation to the National Aviation Authorities (NAA).
    Under this regulation, all holders of type certificates for
passenger transport aircraft with either a passenger capacity of 30
or more, or a payload capacity of 7,500 pounds (3402 kg) or more,
which have received their certification since January 1, 1958, are
required to conduct a design review against explosion risks.
    As a consequence of the design review mentioned above, this
Airworthiness Directive (AD) requires a modification to install
extra protection of wiring installed in fuel tank conduits.

    The modification includes an inspection for any damage of the
wiring to the fuel pumps, fuel level switches, the refuel shut off
valves, and optical sensors/mechanical switches, and if any damage is
found, contacting SAAB for repair and repair. These fuel pumps, fuel
switches, refuel shutoff valves, and optical sensors/mechanical
switches are potential ignition sources. You may obtain further
information by examining the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88. (The JAA is an associated body of the European
Civil Aviation Conference (ECAC) representing the civil aviation
regulatory authorities of a number of European States who have agreed
to co-operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    SAAB has issued Service Bulletin 340-28-026, dated July 5, 2007.
The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

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

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 218 products of U.S. registry. We also estimate that
it would take about 80 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $1,395,200, or $6,400 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

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

Saab Aircraft AB: Docket No. FAA-2008-0017; Directorate Identifier
2007-NM-268-AD.

Comments Due Date

    (a) We must receive comments by February 13, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Saab Model SAAB-Fairchild SF340A (SAAB/
SF340A) and SAAB 340B airplanes, all serial numbers, certificated in
any category.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Subsequent to accidents involving Fuel Tank System explosions in
flight *** and on [the] ground, the FAA has published Special
Federal Aviation Regulation No. 88 (SFAR-88) in June 2001 [which]
required [conducting] a design review against explosion risks.
    In their Letters referenced 04/00/02/07/01-L296, dated March 4,
2002 and 04/00/02/07/03-L024, dated February 3, 2003 the JAA (Joint
Aviation Authorities) recommended the application of a similar
regulation to the National Aviation Authorities (NAA).
    Under this regulation, all holders of type certificates for
passenger transport aircraft with either a passenger capacity of 30
or more, or a payload capacity of 7,500 pounds (3402 kg) or more,
which have received their certification since January 1, 1958, are
required to conduct a design review against explosion risks.
    As a consequence of the design review mentioned above, this
Airworthiness Directive (AD) requires a modification to install
extra protection of wiring installed in fuel tank conduits.
    The potential of ignition sources (in certain fuel pumps, fuel
switches, refuel shutoff valves, and optical sensors/mechanical
switches), in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane. The
modification includes an inspection for any damage of the wiring to
the fuel pumps, fuel level switches, the refuel shut off valves, and
optical sensors/mechanical switches, and if any damage is found,
contacting SAAB for repair.

Actions and Compliance

    (f) Within 72 months after the effective date of this AD, unless
already done, perform Modification No. 3164 (right-hand wing) and
Modification No. 3165 (left-hand wing) in accordance with SAAB
Service Bulletin 340-28-026, dated July 5, 2007. The modifications
include the following actions.
    (1) Removal of the fuel pumps 5QM and 6QM, the fuel switches
31EB, 32EB, 9QA, 10QA, 11QA, and 12QA, and the refuel shutoff valves
15QA and 16QA, and the optical sensors/mechanical switches 13QA and
14QA.
    (2) Inspection of the wiring to the fuel pumps, fuel level
switches, the refuel shutoff valves, and optical sensors/mechanical

switches, and if any damage is found, contact SAAB for repair
instructions and repair before further flight.
    (3) Twisting of the fuel pump wiring, fuel level switches
wiring, refuel shutoff valves wiring, and optical sensors/mechanical
switches wiring.
    (4) Installation of a shrinkable tube to the fuel pumps wiring,
fuel level switches wiring, refuel shutoff valves wiring and optical
sensors/mechanical switches wiring.
    (5) Installation of fuel pumps, the fuel level switches, the
refuel shutoff valves, and the optical sensors/mechanical switches.
    (6) Operational and functional test of the fuel measuring/
indicating system.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows:
    (1) The MCAI does not specify corrective action for the
inspection specified in paragraph (f)(2) of this AD. This AD
requires contacting SAAB for repair instructions and repairing
before further flight.
    (2) The MCAI does not include actions for optical sensors/
mechanical switches 13QA and 14QA; however, paragraph (f) of this AD
includes modification of those optical sensors/mechanical switches.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI EASA Airworthiness Directive 2007-0248, dated
September 7, 2007, and SAAB Service Bulletin 340-28-026, dated July
5, 2007, for related information.

    Issued in Renton, Washington, on January 3, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-375 Filed 1-11-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31154-31155]
[FR Doc No: 2018-14240]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2490]

Antimicrobial 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 Antimicrobial 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 August 7, 2018, from 8:30 a.m. to 4
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation 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-2018-N-1073. The docket will close on August
6, 2018. Submit either electronic or written comments on this public
meeting by August 6, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 6, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of August 6, 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.
    Comments received on or before July 24, 2018, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    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-2018-N-2490 for ``Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see the ADDRESSES
section), 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.'' 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.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.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
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minute modifications that impact a previously announced advisory
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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 committee will discuss new drug application (NDA)
207356, amikacin liposome inhalation suspension, sponsored by Insmed,
Inc., for the proposed indication of treatment of nontuberculous
mycobacterial lung disease caused by Mycobacterium avium complex in
adults as part of a combination antibacterial drug regimen.
    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.
All electronic and written submissions submitted to the Dockets
Management Staff (see the ADDRESSES section) on or before July 24,
2018, will be provided to the committee. Oral presentations from the
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Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
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16, 2018. Time allotted for each presentation may be limited. If the
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interested persons regarding their request to speak by July 17, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
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    FDA welcomes the attendance of the public at its advisory committee
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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: June 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14240 Filed 7-2-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 28, 2010 (Volume 75, Number 123)]
[Notices]
[Page 36650-36652]
[DOCID:fr28jn10-55]

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ENVIRONMENTAL PROTECTION AGENCY

[Doc EPA-HQ-OECA-2010-0531, FRL-9169-1]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Recordkeeping Requirements for Producers, Registrants,
and Applicants of Pesticides and Pesticide Devices under Section 8 of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA
ICR Number 0143.11, OMB Control Number 2070-0028

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that EPA is planning to submit a
continuing Information Collection Request (ICR) to the Office of
Management and Budget (OMB). This is a request to renew an existing
approved collection. This ICR is scheduled to expire on January 31,
2011. Before submitting the ICR to OMB for review and approval, EPA is
soliciting comments on specific aspects of the proposed information
collection as described below.

DATES: Comments must be submitted on or before August 27, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OECA-2010-0531 by one of the following methods:
    1. Electronic Submission: Access http://www.regulations.gov and
follow the on-line instructions for submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Enforcement and Compliance Docket and Information Center
(ECDIC), Environmental Protection Agency, EPA Docket Center (EPA/DC),
Mail Code: 28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
    5. Hand Delivery: Enforcement and Compliance Docket and Information
Center (ECDIC), Environmental Protection Agency, EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW.,
Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. Deliveries are
only accepted during the Docket Center's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID Number: EPA-HQ-
OECA-2010-0531. It is EPA's policy that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail.
    The http://www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
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and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
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and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form

of encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Robin Nogle, tel:<PHONE_NUMBER>; fax:
(202) 564-0085; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
number OECA-2010-0531. This docket is available for online viewing at
http://www.regulations.gov, or in person viewing at the Enforcement and
Compliance Docket and Information Center (ECDIC), in the EPA Docket
Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW.,
Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket and
Information Center (ECDIC) docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. When
in the system, select ``search,'' then key in the docket ID number
identified in this document.
    What information is EPA particularly interested in?
    Pursuant to section 3506(c) (2) (A) of the Paperwork Reduction Act
(PRA), EPA is soliciting comments and information to enable it to:
    (1) Evaluate whether the proposed collections of information are
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    (2) Evaluate the accuracy of the Agency's estimates of the burdens
of the proposed collections of information.
    (3) Enhance the quality, utility, and clarity of the information to
be collected.
    (4) Minimize the burden of the collections of information on those
who are to respond, including through the use of appropriate automated
or electronic collection technologies or other forms of information
technology, e.g., permitting electronic submission of responses.
    What should I consider when I prepare my comments for EPA?
    You may find the following suggestions helpful for preparing
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
    Affected Entities: Entities potentially affected by this action are
producers, registrants, and applicants for registration of pesticides
and pesticide devices.
    Title: Recordkeeping Requirements for Producers, Registrants, and
Applicants of Pesticides and Pesticide Devices under Section 8 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). ICR Number
0143.11, OMB Control Number 2070-0028. Expires 01/31/11.
    Abstract: Section 8 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) states that the Administrator of the
Environmental Protection Agency may prescribe regulations requiring
producers, registrants and applicants for registration to maintain such
records with respect to their operations and the effective enforcement
of this Act as the Administrator determines are necessary for the
effective enforcement of FIFRA and to make such records available for
inspection and copying as specified in the statute. The regulations at
40 CFR part 169 (Books and Records of Pesticide Production and
Distribution) specify the following records that producers must keep
and the disposition of those records: Production data for pesticides,
devices, or active ingredients (including pesticides produced pursuant
to an experimental use permit); receipt by the producer of pesticides,
devices, or active ingredients used in producing pesticides; delivery,
moving, or holding of pesticides; inventory; domestic advertising for
restricted use pesticides; guarantees; exports; disposal; human
testing; and tolerance petitions. Additionally, section 8 gives the
Agency inspectional authority to monitor the validity of research data
(including raw data), including data developed in accordance with Good
Laboratory Practice Standards, and used to support pesticide
registration. The EPA or States/Indian Tribes operating under
Cooperative Enforcement Agreements make use of the records required by
section 8 through periodically inspecting them to help determine FIFRA
compliance of this subject to the provisions of the Act. In addition,
producers themselves make use of such records in order to comply with
reporting requirements under FIFRA section 7 and 40 CFR 167.85. (Those
reporting requirements are addressed in the ICR entitled ``Pesticide
Registration Application, Notification and Report for Pesticide-
Producing Establishments.'')
    Since most of the records required to be maintained are likely to
be collected and maintained in the course of good business practice,
the records are generally stored on site at either the establishment
producing the pesticide or at the place of business of the person
holding the registration. However, the registrant may decide to
transfer records relating to disposal of pesticides and human testing
to EPA for storage because of a twenty year retention requirement for
the records. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9.
    Burden: The average annual burden to the industry over the next
three years is estimated to be 2 person hours per response.
    Respondents/Affected Entities: 11,600.
    Estimated Number of Respondents: 11,600.
    Frequency of Response: 1.
    Estimated Total Annual Hour Burden: 23,200.
    There are no capital/startup costs or operating and maintenance
(O&M) costs associated with this ICR since all equipment associated
with this ICR is present as part of ordinary business practices.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying

information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.
    EPA will consider any comments received and may amend the ICR, as
appropriate. Then the final ICR package will be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue a Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about any of the
above ICR or the approval process, please contact the person listed
under FOR FURTHER INFORMATION CONTACT.

    Dated: June 17, 2010.
Al Havinga,
Acting Director, Agriculture Division, Office of Compliance, Office of
Enforcement and Compliance Assurance.
[FR Doc. 2010-15643 Filed 6-25-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63580-63582]
[FR Doc No: 2023-20014]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]

Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Annual
Status Report Information and Other Submissions for Postmarketing
Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.''
Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and
Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and
Biologics, are intended to facilitate submissions by drug and
biological product application holders of complete and accurate
information on postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) in a consistent format. These forms are expected to
result in improved accuracy and timeliness of FDA's identification and
review of those submissions containing information on PMRs and PMCs.
This guidance covers the purpose of each form, when to use these forms,
and how to submit these forms. The guidance also explains where
applicants will be able to find the forms and instructions. This
guidance finalizes the draft guidance of the same name issued on
October 21, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on September 15, 2023.

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 should include the Docket
No. FDA-2018-N-3771 for ``Annual Status Report Information and Other
Submissions for Postmarketing Requirements and Commitments: Using Forms
FDA 3988 and FDA 3989.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    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; or the 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 that office in processing
your

requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Anne
Taylor, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989.'' This guidance is intended for applicants that are required
to report annually on the status of postmarketing studies and clinical
trials for human drug and biological products under section 506B of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and
its implementing regulations at Sec. Sec.  314.81(b)(2)(vii) and 601.70
(21 CFR 314.81(b)(2)(vii) and 601.70). The forms were developed, in
part, in response to the recommendations from the Government
Accountability Office (GAO) and the Department of Health and Human
Services (HHS) Office of the Inspector General (OIG) regarding the need
for comparable information across annual status reports (ASRs) on PMRs
and PMCs, to eliminate manual data entry and to enhance FDA's ability
to track PMRs and PMCs. These forms are expected to result in improved
accuracy and timeliness of FDA's identification and review of those
submissions containing information on PMRs and PMCs. The purpose of the
guidance is to explain why Forms FDA 3988 and FDA 3989 were created,
describe the contents of the forms, and explain how to submit the forms
electronically. The guidance also explains where applicants will be
able to find the forms and instructions for their completion. Forms FDA
3988 and FDA 3989 are available for use at FDA's Forms web page
(https://www.fda.gov/about-fda/reports-manuals-forms/forms).
    PMRs and PMCs are studies or clinical trials conducted by the
applicant after FDA has approved a drug or biological product for
marketing or licensing. These studies or clinical trials can be
required under statute or regulation (PMRs) or agreed upon in writing
by FDA and the applicant (PMCs). Section 130(a) of the Food and Drug
Administration Modernization Act of 1997 amended the FD&C Act by adding
section 506B of the FD&C Act. Under section 506B of the FD&C Act and
its implementing regulations at Sec. Sec.  314.81(b)(2)(vii) and
601.70, applicants must submit an ASR on PMRs and PMCs.\1\ This report
must address the progress of the PMR/PMC or the reasons for failing to
conduct the requirement or commitment (section 506B(a) of the FD&C
Act).
---------------------------------------------------------------------------

    \1\ FDA defines postmarketing studies or clinical trials for
which ASRs must be submitted under section 506B of the FD&C Act as
those concerning a human drug or biological product's clinical
safety, clinical efficacy, clinical pharmacology, or nonclinical
toxicology that are either required by FDA (PMRs) or that are
committed to, in writing, (PMCs) either at the time of approval of
an application or a supplement or after approval of an application
or supplement. See Sec. Sec.  314.81(b)(2)(vii) and 601.70. FDA
interprets section 506B of the FD&C Act to apply to postmarketing
studies and clinical trials that are required under section 505B of
the FD&C Act (21 U.S.C. 355c), the animal efficacy rule (21 CFR
314.610(b)(1) and 601.91(b)(1)), accelerated approval (section
506(c)(2)(A) of the FD&C Act (21 U.S.C. 356(c)(2)(A)); 21 CFR
314.510 and 601.41), and the Food and Drug Administration Amendments
Act of 2007 (section 505(o)(3) of the FD&C Act (21 U.S.C.
355(o)(3)).
---------------------------------------------------------------------------

    This guidance does not apply to postmarketing studies or clinical
trials that are not subject to the reporting requirements of section
506B of the FD&C Act.\2\ For example, the guidance does not apply to
voluntary studies or clinical trials performed by an applicant or on an
applicant's behalf that are neither required nor agreed upon in
writing. This guidance also does not apply to PMCs related to
chemistry, manufacturing, and controls or stability studies.
---------------------------------------------------------------------------

    \2\ Under Sec.  314.81(b)(2)(viii), applicants submitting an
annual report for human drug products must include a status report
of postmarketing studies and clinical trials not included under
Sec.  314.81(b)(2)(vii) that are being performed by, or on behalf
of, the applicant.
---------------------------------------------------------------------------

    In a December 2015 report from the GAO entitled ``Drug Safety: FDA
Expedites Many Applications, but Data for Postapproval Oversight Need
Improvement,'' \3\ the GAO recommended that FDA improve its data
tracking to ensure the completeness, timeliness, and accuracy of
information in its database on PMRs/PMCs. Additionally, in a July 2016
HHS OIG study entitled ``FDA is Issuing More Postmarketing
Requirements, but Challenges with Oversight Persist,'' \4\ the HHS OIG
noted that FDA continued to have problems with its data management
system and work processes, thereby hindering its ability to track PMRs.
OIG recommended that FDA provide standardized forms for ASRs, ensure
that the forms are complete, and require applicants to submit the forms
electronically.
---------------------------------------------------------------------------

    \3\ Available at https://www.gao.gov/products/GAO-16-192.
    \4\ Available at https://oig.hhs.gov/oei/reports/oei-01-14-00390.asp.
---------------------------------------------------------------------------

    Based in part on the recommendations from GAO and HHS OIG, FDA
created Forms FDA 3988 and FDA 3989 to improve the collection,
identification, and use of information regarding PMRs and PMCs. Form
FDA 3988 was developed to accompany an applicant's PMR/PMC-related
submissions (e.g., draft protocols, final protocols, interim reports,
final reports, and PMR/PMC-related correspondence), except the ASR on
PMRs and PMCs. Form FDA 3988 allows applicants to identify, in a
standardized format, the type of PMR/PMC-related submission the
applicant is making (e.g., draft protocol) and the PMR or PMC to which
the submission applies. Form FDA 3989 was developed so that applicants
may provide ASR information on their PMRs and PMCs in a standardized
format. The purpose of these forms is to assist applicants in providing
clearly identified PMR/PMC-related submissions and in meeting their
annual reporting requirements under section 506B of the FD&C Act and
Sec. Sec.  314.81(b)(2)(vii) and 601.70.
    Use of Forms FDA 3988 and 3989 is optional, but FDA encourages
their use because the forms should facilitate FDA management and review
of the applicant's submissions, as well as enhance the accuracy of data
within FDA's electronic document archiving systems. FDA uses these
archiving systems as a source from which to obtain data published
annually in the Federal Register as required under section 506B(c) of
the FD&C Act and to provide quarterly status updates of the PMR and PMC
data on FDA's Postmarket Requirements and Commitments public web page
(available at https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm). This guidance finalizes the draft guidance of the same name
issued on October 21, 2020 (85 FR 66995). In addition to editorial
changes for clarification, changes from the draft to the final included
a minor change regarding what to enter into field 9.g. of Form FDA 2252
and the removal of the appendices to the guidance, which contained
drafts of Forms FDA 3988 and 3989.
    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 ``Annual Status

Report Information and Other Submissions for Postmarketing Requirements
and Commitments: Using Forms FDA 3988 and FDA 3989.'' 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
for applicants required to submit ASRs on PMCs and PMRs under section
506B of the FD&C Act and the implementing regulations at Sec. Sec.
314.81(b)(2)(vii) and 601.70 are approved under OMB control numbers
0910-0001 and 0910-0338, respectively.

III. Electronic Access

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

    Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20014 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Pages 64937-64939]
[FR Doc No: 2011-26981]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC12-2-000.
    Applicants: Covanta Energy Corporation.
    Description: Covanta Union, Inc. Application for Authority to
Transfer Jurisdictional Facilities and Request for Expedited
Consideration and Waiver.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5106.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: EC12-3-000.
    Applicants: Epsom Investment Pte Ltd., Arlington Valley, LLC,
Griffith Energy LLC.
    Description: Joint Application for Transaction Approval Pursuant to
FPA--203 and Request for Expedited Action of Epsom Investment Pte Ltd,
Arlington Valley, LLC, and Griffith Energy LLC.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5109.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: EC12-4-000.
    Applicants: Thermo Cogeneration Partnership, LP, Stargen CO ILP,
L.L.C., Stargen CO IGP, L.L.C.
    Description: Application for Authorization under Federal Power Act

Section 203 of Thermo Cogeneration Partnership, L.P., et al.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5186.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG12-2-000.
    Applicants: Windpower Partners 1993, L.P.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Windpower Partners 1993, L.P.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5150.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2651-002.
    Applicants: Lockhart Power Company.
    Description: Lockhart Power Company submits tariff filing per 35:
Revisions to Lockhart MBR Tariff to be effective 10/11/2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5005.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 1, 2011.

    Docket Numbers: ER10-3069-002.
    Applicants: Alcoa Power Generating Inc.
    Description: Alcoa Power Generating Inc. submits tariff filing per
35: APGI Revisions to MBR Tariff--Seller Category to be effective 10/
12/2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5117.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 1, 2011.

    Docket Numbers: ER10-3070-002.
    Applicants: Alcoa Power Marketing LLC.
    Description: Alcoa Power Marketing LLC submits tariff filing per
35: APM Revisions to MBR Tariff--Seller Category to be effective 10/12/
2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5120.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 1, 2011.

    Docket Numbers: ER11-4475-002.
    Applicants: Rockland Wind Farm LLC.
    Description: Rockland Wind Farm LLC submits tariff filing per
35.17(b): Rockland Wind Farm LLC--Second Amendment to be effective 10/
7/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5161.
    Comment Date: 5 p.m. Eastern Time on Monday, October 24, 2011.

    Docket Numbers: ER11-4475-003.
    Applicants: Rockland Wind Farm LLC.
    Description: Rockland Wind Farm LLC submits tariff filing per
35.17(b): Amendment to Rate Schedule to be effective 10/11/2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5151.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 26, 2011.

    Docket Numbers: ER11-4527-001.
    Applicants: Record Hill Wind LLC.
    Description: Record Hill Wind LLC submits tariff filing per
35.17(b): Amendment to Market-Based Rate Application Under Docket ER11-
4527 to be effective 10/5/2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5118.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 1, 2011.

    Docket Numbers: ER11-4555-001.
    Applicants: ONEOK Energy Services Company, L.P.
    Description: ONEOK Energy Services Company, L.P. submits tariff
filing per 35: ONEOK Energy Services Amendment to Order 697 Compliance
Filing of MBR Tariff to be effective 9/16/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5148.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER11-4636-001.
    Applicants: Portland General Electric Company.
    Description: Portland General Electric Company submits tariff
filing per 35.17(b): Colstrip Project Transmission Agreement--Clone to
be effective 1/1/2012.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5000.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 1, 2011.

    Docket Numbers: ER11-4686-001.
    Applicants: Goldfinch Capital Management, LP.
    Description: Goldfinch Capital Management, LP submits tariff filing
per 35: Revised Baseline Filing of Goldfinch Capital to be effective
10/7/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5033.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER11-4718-001.
    Applicants: Gateway Energy Marketing.
    Description: Gateway Energy Marketing submits tariff filing per 35:
Gateway Market-Based Rate Revised Baseline Filing to be effective 10/7/
2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5031.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-45-000.
    Applicants: Alabama Power Company.
    Description: Alabama Power Company submits tariff filing per
35.13(a)(2)(iii): PowerSouth NITSA Amendment to Add Hewett Delivery
Point to be effective 3/16/2012.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5061.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-46-000.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Company submits tariff filing
per 35.13(a)(2)(iii): FPL OATT Attachment P to be effective 12/6/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5088.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-47-000.
    Applicants: Celerity Energy Partners San Diego LLC.
    Description: Celerity Energy Partners San Diego LLC submits tariff
filing per 35.37: Celerity Triennial and Category Status Filing to be
effective 10/8/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5134.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-48-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii): LGIA among NYISO, LIPA, and Long
Island Solar Farm to be effective 10/5/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5149.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-49-000.
    Applicants: Citigroup Energy Inc.
    Description: Citigroup Energy Inc. submits tariff filing per
35.13(a)(2)(iii): CEI MBR Tariff with MISO Ancillary Services to be
effective 10/8/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5162.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-50-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35.13(a)(2)(iii): 2011-10-07 CAISO Flexible
Ramping Constraint Amendment to be effective 12/13/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5163.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-51-000.
    Applicants: Citigroup Energy Canada ULC.
    Description: Citigroup Energy Canada ULC submits tariff filing per
35.13(a)(2)(iii): CECU MBR Tariff adding MISO Ancillary Servs to be
effective 10/8/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5164.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-52-000.
    Applicants: Windpower Partners 1993, L.P.
    Description: Windpower Partners 1993, L.P. submits tariff filing
per 35.12: Windpower Partners 1993, L.P. Market-Based Rate Tariff to be
effective 10/8/2011.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5165.
    Comment Date: 5 p.m. Eastern Time on Friday, October 28, 2011.

    Docket Numbers: ER12-53-000.
    Applicants: Torofino Trading LLC.
    Description: Torofino Trading LLC submits tariff filing per 35.1:
FERC Electric Tariff No.1 to be effective 10/13/2009.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5003.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 1, 2011.

    Docket Numbers: ER12-55-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Notices of Termination of CalPeak Vaca Dixon and
Panoche Service Agreement Nos. 39 and 43 under Pacific Gas and Electric
Company FERC Electric Tariff Volume No. 5.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5107.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 01, 2011.

    Docket Numbers: ER12-56-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii): 10-11-11 Attachment X
Clean-Up to be effective 12/11/2011.
    Filed Date: 10/11/2011.
    Accession Number: 20111011-5150.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 01, 2011.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES11-40-000.
    Applicants: Entergy Services, Inc., Entergy Arkansas Inc., Entergy
Gulf States Louisiana, L.L.C., Entergy Louisiana, LLC, Entergy
Mississippi, Inc., Entergy New Orleans, Inc., Entergy Texas, Inc,
System Energy Resources, Inc.
    Description: Supplemental Information of Entergy Services, Inc., et
al.
    Filed Date: 10/07/2011.
    Accession Number: 20111007-5193.
    Comment Date: 5 p.m. Eastern Time on Monday, October 17, 2011.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 11, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-26981 Filed 10-18-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Page 62560]
[FR Doc No: 2019-24955]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, November 20, 2019.

PLACE: The meeting will be held at the Commission's headquarters, 100 F
Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matters of the closed meeting will consist of the
following topics:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: November 13, 2019.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2019-24955 Filed 11-13-19; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Rules and Regulations]
[Page 45232]
[FR Doc No: 2016-16471]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0643]

Drawbridge Operation Regulation; Willamette River at 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 four Multnomah County bridges: The
Broadway Bridge, mile 11.7; Burnside Bridge, mile 12.4; Morrison
Bridge, mile 12.8; and Hawthorne Bridge, mile 13.1; all crossing the
Willamette River at Portland, OR. This deviation is necessary to
accommodate the annual Portland Providence Bridge Pedal event. The
deviation allows the bridges to remain in the closed-to-navigation
position to allow safe roadway movement of event participants.

DATES: This deviation is effective from 6 a.m. to 12:30 p.m. on August
14, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-00643] 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Multnomah County has requested a temporary
deviation from the operating schedule for the Broadway Bridge, mile
11.7; Burnside Bridge, mile 12.4; Morrison Bridge, mile 12.8; and
Hawthorne Bridge, mile 13.1; all crossing the Willamette River at
Portland, OR. The requested deviation is to accommodate the annual
Portland Providence Bridge Pedal event. To facilitate this event, the
draws of theses bridges will be maintained as follows: The Broadway
Bridge provides a vertical clearance of 90 feet in the closed-to-
navigation position; Burnside Bridge provides a vertical clearance of
64 feet in the closed-to-navigation position; Morrison Bridge provides
a vertical clearance of 69 feet in the closed-to-navigation position;
and Hawthorne Bridge provides a vertical clearance of 49 feet in the
closed-to-navigation position; all clearances are referenced to the
vertical clearance above Columbia River Datum 0.0. The normal operating
schedule for all four bridges is in 33 CFR 117.897. This deviation
allows the Broadway Bridge, Burnside Bridge, Morrison Bridge, and
Hawthorne Bridge to remain in the closed-to-navigation position and
need not open for maritime traffic from 6 a.m. to 12:30 p.m. on August
14, 2016. Waterway usage on this part of the Willamette River includes
vessels ranging from commercial tug and barge to small pleasure craft.
    Vessels able to pass through the bridge in the closed-to-navigation
positions may do so at any time. The bridges will be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will inform the users of the waterway, through
our Local and Broadcast Notices to Mariners, of the change in operating
schedule for the bridges 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 drawbridges must return to
their regular operating schedules 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: July 6, 2016.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2016-16471 Filed 7-12-16; 8:45 am]
 BILLING CODE 9110-04-P