[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74398]
[DOCID:fr31de07-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57023; File No. SR-Phlx-2007-83]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Order Approving a Proposed Rule Change Relating to Amending By-Law
Article X, Section 10-11

December 20, 2007.
    On October 29, 2007, the Philadelphia Stock Exchange, Inc.
(``Phlx'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to expand the type of business
that certain members of the Exchange's Business Conduct Committee
(``Committee'') must conduct in order to qualify as a Committee member.
The proposed rule change was published for comment in the Federal
Register on November 19, 2007.\3\ The Commission received no comments
on the proposal. This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 56775 (November 9,
2007), 72 FR 65119.
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    The Committee has exclusive jurisdiction to, among other things:
(1) Monitor compliance with the Act, the rules and regulations under
the Act, and the Exchange's By-Laws and Rules; and (2) authorize the
initiation of Exchange disciplinary actions or proceedings. Phlx By-Law
X, Section 10-11(h) currently requires that, of the nine members that
comprise the Committee, one Committee member must principally carry out
its business on XLE \4\ and one Committee member must principally carry
out its business on the equity options floor.
---------------------------------------------------------------------------

    \4\ XLE is the electronic system that is operated by the
Exchange for the entry, display, execution, and reporting of orders
in NMS stocks. See Section 1-1(ii) of Phlx's By-Laws.
---------------------------------------------------------------------------

    The proposed rule change would revise the qualification
requirements for these two Committee positions. Specifically, Phlx
proposes to amend Section 10-11(h) of its By-Laws to provide that these
two positions can be filled, respectively, by a Member or person
associated with a Member Organization who conducts equity business on
XLE and a Member who conducts options business at the Exchange.
    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\5\ In particular, the Commission finds that the proposed rule
change is consistent with Section 6(b)(5) of the Act,\6\ which requires
that an exchange have rules designed, among other things, to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
In addition, the Commission finds that the proposed rule change is
consistent with Section 6(b)(3) under the Act,\7\ which requires that
the rules of a national securities exchange assure a fair
representation of its members in the selection of its directors and the
administration of its affairs. The proposed rule change would allow a
greater pool of Members to be eligible to hold these two Committee
positions and would not alter Member participation on the Committee.
---------------------------------------------------------------------------

    \5\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78f(b)(3).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (SR-Phlx-2007-83) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Nancy M. Morris,
Secretary.
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    \9\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. E7-25367 Filed 12-28-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76812-76813]
[DOCID:fr28de05-104]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Non-Project Use of Project Lands and
Soliciting Comments, Motions To Intervene, and Protests

December 16, 2005.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Non-project use of Project Lands.
    b. Project No.: 2232-503.
    c. Date Filed: November 21, 2005.
    d. Applicant: Duke Power, a division of Duke Energy Corporation.

    e. Name of Project: Catawba-Wateree Project.
    f. Location: The project is located on Lake Norman, in Catawba
County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a) 825(r)
and 799 and 801.
    h. Applicant Contact: Joe Hall, Lake Management Representative,
Duke Energy Corporation, P.O. Box 1006, Charlotte, NC 28201-1006, (704)
382-8576.
    i. FERC Contact: Any questions on this notice should be addressed
to Ms. Rebecca Martin at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: January 17, 2006.
    All documents (original and eight copies) should be filed with: Ms.
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington DC 20426. Please include the project
number (P-2232-503) on any comments or motions filed. Comments,
protests, and interventions may be filed electronically via the
Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site at http://www.ferc.gov under

the ``e-Filing'' link. The Commission strongly encourages e-filings.
    k. Description of Request: Duke Power is seeking authorization to
lease to Syn-R-G, LLC, 0.973 acres of Project lands on Lake Norman for
a Commercial/Residential Marina which will consist of a cluster dock
with thirty-six boat docking locations. The proposed dock will consist
of three individual piers to accommodate twelve boats each for a total
of thirty-six docking locations. The cluster dock will be constructed
off-site and floated into place during low peak lake recreation usage.
These slips will serve the residents of the Long Island Airport
Subdivision.
    l. Location of the Application: This filing is available for review
at the Commission in the Public Reference Room, 888 First Street, NE.,
Room 2A, Washington, DC 20426 or may be viewed on the Commission's Web
site at http://www.ferc.gov using the ``e-library'' link. Enter the

docket number excluding the last three digits in the docket number
field to access the document. For assistance, call toll-free 1-866-208-
3676 or e-mail<EMAIL_ADDRESS>For TTY, call (202) 502-
8659. A copy is also available for inspection and reproduction at the
address in item h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described applications. Copies of the
applications may be obtained by agencies directly from the Applicant.
If an agency does not file comments within the time specified for
filing comments, it will be presumed to have no comments. One copy of
an agency's comments must also be sent to the Applicant's
representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7912 Filed 12-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48608-48609]
[FR Doc No: 2018-20889]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER18-1618-001.
    Applicants: Arizona Public Service Company.
    Description: Compliance filing: Primary Frequency Response

Compliance Filing to be effective 5/15/2018.
    Filed Date: 9/19/18.
    Accession Number: 20180919-5066.
    Comments Due: 5 p.m. ET 10/10/18.

    Docket Numbers: ER18-1969-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: 3388R1 East River/Otter Tail/MISO
Int Agr Compliance Filing to be effective 9/17/2018.
    Filed Date: 9/19/18.
    Accession Number: 20180919-5008.
    Comments Due: 5 p.m. ET 10/10/18.

    Docket Numbers: ER18-2073-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2018-09-19_SA 3134 ETI-Liberty
County Solar Project GIA (J483) 2nd Amendment to be effective 7/13/
2018.
    Filed Date: 9/19/18.
    Accession Number: 20180919-5125.
    Comments Due: 5 p.m. ET 10/10/18.

    Docket Numbers: ER18-2074-000.
    Applicants: AEP Texas Inc.
    Description: Report Filing: AEPTX-Pedernales EC TSA--Amend &
Restated--Supplement to be effective N/A.
    Filed Date: 9/18/18.
    Accession Number: 20180918-5054.
    Comments Due: 5 p.m. ET 10/9/18.

    Docket Numbers: ER18-2449-000.
    Applicants: Midcontinent Independent System Operator, Inc., ALLETE,
Inc.
    Description: Sec.  205(d) Rate Filing: 2018-09-18_SA 3167 Enbridge-
SWL&P Facilities Reimbursement Agrmt (Nemadji) to be effective 9/19/
2018.
    Filed Date: 9/18/18.
    Accession Number: 20180918-5080.
    Comments Due: 5 p.m. ET 10/9/18.

    Docket Numbers: ER18-2450-000.
    Applicants: Basin Electric Power Cooperative, Southwest Power Pool,
Inc.
    Description: Sec.  205(d) Rate Filing: Basin Electric Power
Cooperative Formula Rate Revisions to be effective 1/1/2017.
    Filed Date: 9/18/18.
    Accession Number: 20180918-5092.
    Comments Due: 5 p.m. ET 10/9/18.

    Docket Numbers: ER18-2451-000.
    Applicants: Lockhart Power Company.
    Description: Application for Reclassification as a Category 1
Seller of Lockhart Power Company.
    Filed Date: 9/18/18.
    Accession Number: 20180918-5114.
    Comments Due: 5 p.m. ET 10/9/18.

    Docket Numbers: ER18-2452-000.
    Applicants: National Choice Energy LLC.
    Description: Notice of Cancellation of MBR tariff of National
Choice Energy LLC.
    Filed Date: 9/18/18.
    Accession Number: 20180918-5124.
    Comments Due: 5 p.m. ET 10/9/18.

    Docket Numbers: ER18-2453-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: MAIT submits five ECSAs,
Service Agreement Nos. 5001, 5002, 5003, 5004, and 5005 to be effective
11/19/2018.
    Filed Date: 9/19/18.
    Accession Number: 20180919-5060.
    Comments Due: 5 p.m. ET 10/10/18.

    Docket Numbers: ER18-2454-000.
    Applicants: Central Maine Power Company.
    Description: Sec.  205(d) Rate Filing: Executed Engineering and
Procurement Agreement with Three Corners Solar, LLC to be effective 11/
19/2018.
    Filed Date: 9/19/18.
    Accession Number: 20180919-5101.
    Comments Due: 5 p.m. ET 10/10/18.

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

    Docket Numbers: RR18-10-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Amendments to the Western Electricity
Coordinating Council Bylaws.
    Filed Date: 9/18/18.
    Accession Number: 20180918-5104.
    Comments Due: 5 p.m. ET 10/9/18.

    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 5:00
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: September 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-20889 Filed 9-25-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Proposed Rules]
[Pages 83745-83749]
[FR Doc No: 2016-26164]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9301; Directorate Identifier 2015-NM-193-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2008-12-
04, which applies to certain Boeing Model 737-600, -700, -700C, -800,
and -900 series airplanes. AD 2008-12-04 currently requires various
repetitive inspections to detect cracks along the chem-milled steps of
the fuselage skin, and to detect missing or loose fasteners in the area
of the preventive modification or repairs, replacement of the time-
limited repair with the permanent repair if applicable, and applicable
corrective actions, if necessary, which would end certain repetitive
inspections. Since we issued AD 2008-12-04, an evaluation by the design
approval holder (DAH) has indicated that the upper skin panel at the
chem-milled step above the lap joint is subject to widespread fatigue
damage (WFD) if the modification was installed after 30,000 total
flight cycles. This proposed AD would reduce the post-modification
inspection compliance times, limit installation of the preventive
modification to airplanes with fewer than 30,000 total flight cycles,
and add repetitive inspections for modified airplanes. We are proposing
this AD to detect and correct cracking of the upper skin panel at the
chem-milled step above the lap joint, which could result in reduced
structural integrity of the airplane.

DATES: We must receive comments on this proposed AD by January 6, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740; telephone
562-797-1717; Internet https://www.myboeingfleet.com. You may view this
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-9301.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9301; or in person at the Docket Management Facility 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
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Gaetano Settineri, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6577; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
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-2016-9301;
Directorate Identifier 2015-NM-193-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 because of 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

    Fatigue damage can occur locally, in small areas or structural
design details, or in widespread areas. Multiple-site damage is
widespread damage that occurs in a large structural element such as a
single rivet line of a lap splice joining two large skin panels.
Widespread damage can also occur in multiple elements such as adjacent
frames or stringers. Multiple-site damage and multiple-element damage
cracks are typically too small initially to be reliably detected with
normal inspection methods. Without intervention, these cracks will
grow, and eventually compromise the structural integrity of the
airplane. This condition is known as widespread fatigue damage. It is
associated with general degradation of large areas of structure with
similar structural details and stress levels. As an airplane ages, WFD
will likely occur, and will certainly occur if the airplane is operated
long enough without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the

LOV. Many LOVs, however, do depend on accomplishment of future
maintenance actions. As stated in the WFD rule, any maintenance actions
necessary to reach the LOV will be mandated by airworthiness directives
through separate rulemaking actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    On May 29, 2008, we issued AD 2008-12-04, Amendment 39-15547 (73 FR
32991, June 11, 2008) (``AD 2008-12-04''), for certain Boeing Model
737-600, -700, -700C, -800, and -900 series airplanes. AD 2008-12-04
requires various repetitive inspections to detect cracks along the
chem-milled steps of the fuselage skin, and to detect missing or loose
fasteners in the area of the preventive modification or repairs,
replacement of the time-limited repair with the permanent repair if
applicable, and applicable corrective actions, if necessary, which
would end certain repetitive inspections. AD 2008-12-04 resulted from a
fatigue test that revealed numerous cracks in the upper skin panel at
the chem-milled step above the lap joint. We issued AD 2008-12-04 to
detect and correct such fatigue-related cracks, which could result in
the crack tips continuing to turn and grow to the point where the skin
bay flaps open, causing decompression of the airplane.

Actions Since AD 2008-12-04 Was Issued

    Since we issued AD 2008-12-04, an evaluation by the DAH indicated
that the upper skin panel at the chem-milled step above the lap joint
is subject to WFD if the modification was installed after that airplane
had accumulated 30,000 total flight cycles. We have determined that it
is necessary to reduce the post-modification inspection compliance
times, limit installation of the preventive modification to airplanes
that have accumulated fewer than 30,000 total flight cycles, and add
repetitive inspections for modified airplanes.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1232, Revision 3,
dated July 27, 2015. This service information describes procedures for
an external detailed inspection and an external nondestructive
inspection (NDI) for cracks in the fuselage skin at chem-milled steps.
Corrective actions include a permanent or time-limited repair, a
preventive modification, and replacement of loose and missing
fasteners. Related investigative actions include internal and external
detailed inspections of the repair area. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2008-12-04, this proposed AD would retain all
requirements of AD 2008-12-04. Those requirements are referenced in the
service information identified previously, which, in turn, is
referenced in paragraphs (g), (h), and (i) of this proposed AD. This
proposed AD would require accomplishing the actions specified in the
service information described previously, except as discussed under
``Difference Between this AD and the Service Information.'' This
proposed AD would reduce the post-modification compliance times
required by AD 2008-12-04, limit installation of the preventive
modification to airplanes that have not yet accumulated 30,000 total
flight cycles, and add repetitive post-modification inspections and
applicable corrective actions.
    The phrase ``related investigative actions'' is used in this
proposed AD. Related investigative actions are follow-on actions that
(1) are related to the primary action, and (2) further investigate the
nature of any condition found. Related investigative actions in an AD
could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
Corrective actions are actions that correct or address any condition
found. Corrective actions in an AD could include, for example, repairs.

Difference Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015, specifies to contact the manufacturer for certain
instructions, but this proposed AD would require accomplishment of
repair methods, modification deviations, and alteration deviations in
one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 376 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections....................  Up to 25 work-hours x                $0  Up to $2,125 per    Up to $799,000 per
                                  $85 per hour = $2,125                    inspection cycle.   inspection cycle
                                  per inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs and
replacements that would be required based on the results of the
proposed inspections. We have no way of determining the number of
aircraft that might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                Action                            Labor cost                   Parts cost             product
----------------------------------------------------------------------------------------------------------------
Fastener replacement..................  Up to 1 work-hour x $85 per     Minimal.................             $85
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the related investigative actions, certain repairs,
and other applicable actions specified in this proposed AD.

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 have 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 that the 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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2008-12-04, Amendment 39-15547 (73 FR 32991, June 11, 2008), and adding
the following new AD:

The Boeing Company: Docket No. FAA-2016-9301; Directorate Identifier
2015-NM-193-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by January 6,
2017.

(b) Affected ADs

    This AD replaces AD 2008-12-04, Amendment 39-15547 (73 FR 32991,
June 11, 2008) (``AD 2008-12-04'').

(c) Applicability

    This AD applies to The Boeing Company Model 737-600, -700, -
700C, -800, and -900 series airplanes, certificated in any category,
as identified in Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder (DAH) that indicated that the upper skin panel at the chem-
milled step above the lap joint is subject to widespread fatigue
damage (WFD) if the modification was installed after 30,000 total
flight cycles. We are issuing this AD to detect and correct cracking
of the upper skin panel at the chem-milled step above the lap joint,
which could result in reduced structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspections at Locations Without the Preventive Modification, Time-
limited Repair, or Permanent Repair Installed

    At locations where a preventive modification, time-limited
repair, or permanent repair has not been installed as specified in
Boeing Service Bulletin 737-53A1232: At the applicable time
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1232, Revision 3, dated July 27, 2015, do an
external detailed inspection and an inspection specified in either
paragraph (g)(1) or (g)(2) of this AD, for any crack in the fuselage
skin at the chem-milled steps at specified locations, in accordance
with Accomplishment Instructions of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. Do all applicable
related investigative and corrective actions before further flight
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
except as required by paragraph (l)(1) of this AD. Repeat the
inspections thereafter at the applicable time specified in paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015.
    (1) Do an external medium frequency eddy current (MFEC), or
magneto optic imager (MOI), or C-Scan inspection.
    (2) Do an external ultrasonic phased array (UTPA) inspection.

(h) Repetitive Post-Modification Inspections and Repair at Any Location
With the Preventive Modification but No Time-Limited or Permanent
Repair

    At any location with a preventive modification installed as
specified in Boeing Alert Service Bulletin 737-53A1232: At the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015, except as required by paragraph (l)(2) of this AD, do the
actions specified in paragraphs (h)(1) and (h)(2) of this AD.
    (1) Do external detailed and external high frequency and medium
frequency eddy current inspections for any crack, in accordance with
Part 7 of the Accomplishment Instructions of Boeing Alert Service
Bulletin 737-53A1232, Revision 3, dated July 27, 2015. If no crack
is found during the inspection, repeat the inspections thereafter at
the applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015. If any crack is found during any inspection required by
this paragraph, repair before further flight, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1232, Revision 3, dated July 27, 2015, except as required by
paragraph (l)(1) of this AD.

    (2) Do a detailed inspection for any crack and any loose or
missing fasteners, in accordance with Part 7 of the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015. Repeat the inspections thereafter at
applicable time specified in paragraph 1.E, ``Compliance,'' of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015. If a crack is found during the inspection, or any loose or
missing fastener is found, before further flight, do all applicable
corrective actions, in accordance with Part V of the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-53A1232, Revision
3, dated July 27, 2015, except as specified in paragraph (l)(1) of
this AD.

(i) Additional Actions for Modified Airplanes

    (1) Except for preventive modifications installed on airplanes
listed in Appendix A of Boeing Alert Service Bulletin 737-53A1232 at
the specified total flight cycles, at any location where a
preventive modification as specified in Boeing Alert Service
Bulletin 737-53A1232 was installed after the accumulation of 30,000
total flight cycles: At the applicable time specified in paragraph
1.E., ``Compliance,'' of Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015, except as required by paragraph
(l)(2) of this AD, do all applicable investigative and corrective
actions using a method approved in accordance with the procedures
specified in paragraph (p) of this AD.
    (2) For airplanes which have installed supplemental type
certificate (STC) ST01697SE (http://rgl.faa.gov/
Regulatory_and_Guidance_Library/rgstc.nsf/0/
0812969a86af879b8625766400600105/$FILE/ST01697SE.pdf) and the
preventative modification has been installed after 15,000 total
flight cycles: Before the accumulation of 25,000 total flight
cycles, do all applicable investigative and corrective actions using
a method approved in accordance with the procedures specified in
paragraph (p) of this AD.

(j) Inspections and Repair at Locations With the Permanent Chem-Milled
Step Repair Installed

    At any location where a permanent repair has been installed as
specified in Boeing Service Bulletin 737-53A1232: At the applicable
time specified in paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015: Do
the inspections specified in paragraph (j)(1) or (j)(2) of this AD,
in accordance with Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015.
Repeat the inspections thereafter at the applicable time specified
in paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. Do all applicable
related investigative and corrective actions before further flight
in accordance with Boeing Alert Service Bulletin 737-53A1232,
Revision 3, dated July 27, 2015, except as required by paragraph
(l)(1) of this AD.
    (1) Do an external low frequency eddy current (LFEC) inspection
for any crack, and doubler external LFEC and external detailed
inspections for any crack and loose or missing fasteners.
    (2) Do an external LFEC inspection for any crack, and doubler
external LFEC and external detailed inspections for any crack and
loose or missing fasteners; and an internal MFEC for any crack.

(k) Inspection and Replacement at Locations With a Chem-Milled Time-
Limited Repair Installed

    At any location where a chem-milled time-limited repair is
installed, do the actions specified in paragraphs (k)(1) and (k)(2)
of this AD, at the applicable time specified in 1.E. ``Compliance,''
of Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015.
    (1) Do internal and external detailed inspections of the time-
limited repair for any crack, or loose or missing fasteners, in
accordance with Part IV of the Accomplishment Instructions of Boeing
Alert Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015.
Repeat the inspections thereafter at the applicable time specified
in paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1232, Revision 3, dated July 27, 2015. If any crack is found
during the inspection, or if any loose or missing fastener is found,
before further flight, do all applicable corrective actions, in
accordance with Part IV of the Accomplishment Instructions of Boeing
Alert Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
except as specified in paragraph (l)(1) of this AD.
    (2) Replace the time-limited repair with the permanent repair,
in accordance with Part IV of the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015.

(l) Exceptions to Service Information Specifications

    (1) Where Boeing Alert Service Bulletin 737-53A1232, Revision 3,
dated July 27, 2015, specifies to contact Boeing for repair
instructions, this AD requires repair before further flight using a
method approved in accordance with the procedures specified in
paragraph (p) of this AD.
    (2) Where paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
specifies a compliance time ``after the date of Revision 2 of this
service bulletin,'' this AD requires compliance within the specified
compliance time after the effective date of this AD.

(m) Optional Terminating Action

    (1) For airplanes that have accumulated 30,000 total flight
cycles or fewer, or for airplanes on which supplemental type
certificate (STC) ST0l697SE (http://rgl.faa.gov/
Regulatory_and_Guidance_Library/rgstc.nsf/0/
0812969a86af879b8625766400600105/$FILE/ST01697SE.pdf) was installed
and have accumulated 15,000 total flight cycles or fewer,
accomplishment of the preventive modification specified in Part V of
Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015, terminates the inspections required by paragraph (g) of
this AD in the modified areas only.
    (2) Installation of a permanent repair as specified in Part III
of Boeing Alert Service Bulletin 737-53A1232, Revision 3, dated July
27, 2015, or a time-limited repair as specified in Part IV of Boeing
Alert Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
terminates the inspections required by paragraph (g) of this AD in
the repaired areas only.

(n) Installation Limitations of Preventive Modification

    As of the effective date of this AD, installation of the
preventive modification specified in Boeing Alert Service Bulletin
737-53A1232, is prohibited on the airplanes identified in paragraphs
(n)(1) and (n)(2) of this AD.
    (1) Airplanes that have accumulated more than 30,000 total
flight cycles.
    (2) Airplanes which have installed STC ST01697SE and that have
accumulated more than 15,000 total flight cycles.

(o) Credit for Previous Actions

    This paragraph provides credit for the corresponding actions
specified in paragraphs (g), (h), (i), (j), (k), and (m) of this AD,
if those actions were performed before the effective date of this AD
using the service information identified in paragraph (o)(1),
(o)(2), or (o)(3) of this AD.
    (1) Boeing Special Attention Service Bulletin 737-53A1232, dated
April 2, 2007, which was incorporated by reference in AD 2008-12-04.
    (2) Boeing Special Attention Service Bulletin 737-53A1232,
Revision 1, dated May 18, 2012, which is not incorporated by
reference in this AD.
    (3) Boeing Special Attention Service Bulletin 737-53A1232,
Revision 2, dated July 26, 2013, which is not incorporated by
reference in this AD.

(p) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (q)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet

the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved previously for repairs or preventive
modifications for AD 2008-12-04 are approved as AMOCs for the
installation of the repair or preventive modification specified in
this AD, provided all post-repair or post-modification inspections
are done at the applicable times specified in the AMOC, or in tables
1a, 1b, 2, and 3 of paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 737-53A1232, Revision 3, dated July 27, 2015,
whichever occurs first.

(q) Related Information

    (1) For more information about this AD, contact Gaetano
Settineri, Aerospace Engineer, Airframe Branch, ANM-120S, FAA,
Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone:
425-917-6577; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on October 25, 2016.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2016-26164 Filed 11-21-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29791-29792]
[FR Doc No: 2018-13711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1073]

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.

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

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 July 26, 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 July 25,
2018. Submit either electronic or written comments on this public
meeting by July 25, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before July 25, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of July 25, 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 12, 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-1073 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: Kalyani Bhatt, 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
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 committee will discuss new drug application (NDA)
210607, tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees
Pharmaceuticals, LLC, for the proposed indication of prevention of
malaria in adults for up to 6 months of continuous dosing.
    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 Docket (see the
ADDRESSES section) on or before July 12, 2018, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before July 3, 2018. 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 July 5, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    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 Kalyani Bhatt (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: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13711 Filed 6-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 28, 2010 (Volume 75, Number 208)]
[Rules and Regulations]
[Page 66306-66308]
[DOCID:fr28oc10-10]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0228]
RIN 1625-AA09

Drawbridge Operation Regulation; Arkansas Waterway, Little Rock,
AR

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: Drawbridge operations for the Baring Cross Railroad Drawbridge
across the Arkansas Waterway at Mile 119.6 at Little Rock, Arkansas.
Vessel operators shall contact the remote drawbridge operator via
microphone keying four times within five seconds on VHF-FM Channel 13
when requesting a draw opening. This keying will activate an indicator
on the remote drawbridge operator's console and send an acknowledgement
tone back to the vessel. The remote drawbridge operator will then
establish verbal radio communications with the vessel and operate the
drawspan as normal.

DATES: This rule is effective November 29, 2010.

ADDRESSES: Comments and related materials received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2010-0228 and are available online by
going to http://www.regulations.gov, inserting USCG-2010-0228 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 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 rule,
call or email Mr. Eric A. Washburn, Bridge Administrator, Coast Guard,
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On June 2, 2010, we published a notice of proposed rulemaking
(NPRM) entitled Drawbridge Operation Regulation; Arkansas Waterway,
Little

Rock, AR in the Federal Register (75 FR 105). We received no comments
on the proposed rule. No public meeting was requested, and none was
held.

Background and Purpose

    The Arkansas Waterway is a part of the McClellan-Kerr Arkansas
River Navigation System. The System rises in the vicinity of Catoosa,
Oklahoma, and embraces improved natural waterways and a canal to empty
into the Mississippi River in southeast Arkansas. The Arkansas Waterway
drawbridge operation regulations contained in 33 CFR 117.123(b), state
that the draw of the Baring Cross Railroad Drawbridge, mile 119.6, at
Little Rock, Arkansas, is maintained in the closed to navigation
position and is remotely operated. Vessels requesting an opening shall
establish contact by radio/telephone with the remote drawbridge
operator on VHF-FM Channel 13 in Omaha, Nebraska. In order to better
differentiate between vessel and rail traffic for the remote drawbridge
operator, Union Pacific Railroad has requested this drawbridge be
operated where vessels would key their VHF-FM radio microphone four
times in five seconds and would receive an acknowledgement tone from
the remote drawbridge operator. The keying-in will initiate an
indicator on the remote drawbridge operator's console and the operator
will then establish normal verbal radio communications with the vessel.
    The Coast Guard has determined this regulation change will improve
communications between the remote drawbridge operator and vessel
operators, reducing drawspan opening delays experienced previously from
missed calls under the prior regulatory guidance.

Discussion of Comments and Changes

    There were no comments to the proposed regulatory change.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule on commercial traffic
operating on the Arkansas Waterway to be so minimal that a full
Regulatory Evaluation is unnecessary. The operating procedures affected
by this change will be for the benefit of vessels transiting the
bridge, reduced drawspan opening delays under the new regulatory
guidance are anticipated.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these

standards would be inconsistent with applicable law or otherwise
impractical. Voluntary consensus standards are technical standards
(e.g., specifications of materials, performance, design, or operation;
test methods; sampling procedures; and related management systems
practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Revise Sec.  117.123(b)(1) and (2) to read as follows:

Sec.  117.123  Arkansas Waterway.

* * * * *
    (b) * * *
    (1) Normal flow procedures. Any vessel which requires an opening of
the draw of this bridge shall establish contact by radiotelephone with
the remote drawbridge operator on VHF-FM Channel 13 in Omaha, Nebraska.
To establish contact, the vessel shall key the VHF-FM radio microphone
four times in five seconds and listen for an acknowledgement tone. The
remote drawbridge operator will then establish normal verbal radio
communication on VHF-FM Channel 13 and advise the vessel whether the
requested span can be immediately opened and will maintain constant
radio contact with the vessel until the requested span has opened and
vessel passage has been completed. The bridge is equipped with a
Photoelectric Boat Detection System to prevent the span from lowering
if there is an obstruction under the span. If the drawbridge cannot be
opened immediately, the remote drawbridge operator will notify the
calling vessel and provide an estimated time for a drawspan opening.
    (2) High velocity flow procedures. The area from mile 118.2 to mile
125.4 is a regulated navigation area as described in Sec.  165.817.
During periods of high velocity flow rate of 70,000 cubic feet per
second or greater at the Murray Lock and Dam, mile 125.4, downbound
vessels which require that the draw of this bridge be opened for
unimpeded passage shall contact the remote drawbridge operator as
described in paragraph (b)(1) of this section either before departing
Murray Lock and Dam or before departing the mooring cells at mile 121.5
to ensure that the drawspan is opened well in advance of arrival at the
bridge. The remote drawbridge operator shall immediately respond to the
vessel's contact, ensure the drawspan is open for passage, and ensure
that it remains in the open to navigation position until the downbound
vessel has safely passed through. If it cannot be opened immediately
for unimpeded passage in accordance with Sec.  165.817, the remote
drawbridge operator will notify the downbound vessel and provide an
estimated time for a drawspan opening. Upbound vessels shall request
openings in accordance with the normal flow procedures as set forth in
paragraph (b)(1) of this section. The remote drawbridge operator shall
keep these approaching vessels informed of the position of the drawspan
at all times until safe passage is completed.
* * * * *

    Dated: October 15, 2010.
Mary E. Landry,
Rear Admiral, U.S. Coast Guard Commander, Eighth Coast Guard District.
[FR Doc. 2010-27236 Filed 10-27-10; 8:45 am]
BILLING CODE 9110-04-P


P-18-0300 Sanitized Support Documents Index:
 P-18-0300 Sanitized Determination Document (linked)
 P-18-0300 Sanitized CHEM Report (attached)
 P-18-0300 Sanitized ECO Report (attached)
 P-18-0300 Sanitized ENG Report (attached)
 P-18-0300 Sanitized EXP Report (attached)
 P-18-0300 Sanitized Fate Report (attached)
 P-18-0300 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register: March 23, 2007 (Volume 72, Number 56)]
[Notices]
[Page 13789-13790]
[DOCID:fr23mr07-77]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8291-2; Docket ID No. ORD-2005-0001]

Draft of Part 2 of the 2007 Release of the Causal Analysis/
Diagnosis Decision Information System (CADDIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of External Review Draft for Public Review and Comment.

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

SUMMARY: The U.S. Environmental Protection Agency is announcing a 30-
day public review and comment period for the external review draft of
Part 2 of the 2007 release of the EPA Web site titled, ``Causal
Analysis/Diagnosis Decision Information System (CADDIS).'' The CADDIS
Web site was developed and prepared by EPA's National Center for
Environmental Assessment (NCEA) in the Office of Research and
Development (ORD). NCEA will consider public comments received in
accordance with this notice when revising the CADDIS Web site.
    EPA is releasing the draft CADDIS 2007 Web site solely for the
purpose of pre-dissemination peer review under applicable information
quality guidelines. The draft CADDIS 2007 Web site has not been
formally disseminated by EPA. It does not represent and should not be
construed to represent any Agency policy or determination. EPA will
consider any public comments submitted in accordance with this notice
when revising the document.

DATES: The 30-day public comment period begins March 23, 2007, and ends
April 23, 2007. Technical comments should be in writing and must be
submitted electronically or postmarked by April 23, 2007.

ADDRESSES: The draft CADDIS 2007 Web site can be accessed via the
Internet at http://caddis.tetratech-ffx.com. Enter the username

``public'' and the password ``public.'' Comments may be submitted
electronically to the EPA's e-docket, by mail, by facsimile, or by hand
delivery/courier. Additional instructions for providing comments and a
description of the portions of the Web site that are available for
review are provided at the top of the home page of the CADDIS Web site
and in the section of this notice entitled, SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>For technical information, contact Vic Serveiss,

NCEA, via phone:<PHONE_NUMBER>, facsimile:<PHONE_NUMBER>, or e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    Over 2800 water bodies in the United States are listed by states as
biologically impaired. For many of these sites, the cause of impairment
is reported as ``unknown.'' To formulate appropriate management actions
for impaired water bodies, it is important to identify the causes of
biological impairment (e.g., excess fine sediments, nutrients, or toxic
substances). Effective causal analyses call for knowledge of the
mechanisms, symptoms, and stressor-response relationships for various
stressors, as well as the ability to use that knowledge to draw
appropriate, defensible conclusions. To aid in these causal analyses,
NCEA developed CADDIS. CADDIS is a Web-based decision support system
that will help regional, State, and tribal scientists find, access,
organize, and share information useful for causal evaluations of
impairment in aquatic systems. It is based on EPA's Stressor
Identification process, which is an EPA-recommended method for
identifying causes of impairments in aquatic environments. EPA released
the first version of CADDIS earlier in 2006, after addressing comments
from the public and independently selected peer reviewers. Current
features of CADDIS include a step-by-step guide to conducting causal
analysis, downloadable worksheets and examples, a library of conceptual
models, and links to useful information sources.
    Two sets of modules are being added to the CADDIS Web site in
preparation for release of a major revision in September 2007 (CADDIS
2007). On January 17, 2007, the draft of the first of the two sets of
modules was released for external peer review and public comment. This
first set of draft modules included information on six candidate
causes: metals, sediments, nutrients, dissolved oxygen, thermal
alteration, and ionic strength.
    This notice invites comment on the second set of draft modules
being developed for CADDIS 2007. Specifically, comment is invited on
two additional candidate cause models, altered flow rates and toxic
substances; an interactive conceptual model for phosphorus; and added
analytical methods, tools, and databases. Descriptive information on
ten analytical methods have been added to CADDIS 2007 including scatter
plots, linear regression, predicting environmental conditions from
biological observations, and species sensitivity distributions. The
principal analytical tool added to CADDIS is CADStat; a downloadable
software package for analyzing data using a variety of exploratory and
statistical approaches. New analytical databases include a stressor-
response gallery for metals and a tolerance value database. These
additions improve the capability of CADDIS to diagnose the causes of
biological impairments in streams.

II. How to Submit Technical Comments to the Docket at
http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2005-
0001 by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334,

1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2005-0001. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov
, including any personal information provided,

unless a 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://www.regulations.gov,

your e-mail address will be automatically captured 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 information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties 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.

    Docket: Documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the EPA

Headquarters Docket Center.

    Dated: March 20, 2007.
George Alapas,
Director, National Center for Environmental Assessment.
[FR Doc. E7-5358 Filed 3-22-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: October 29, 2007 (Volume 72, Number 208)]
[Notices]
[Page 61202]
[DOCID:fr29oc07-109]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) approval of a new
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on July 9, 2007, vol. 72, no. 130, page
37305. This project involves collecting data from individual applicants
who have recently taken, for the first time, and passed an oral and/or
practical Airframe and/or Powerplant (A and/or P) Mechanic
Certification test.

DATES: Please submit comments by November 28, 2007.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: 2008 Newly Certificated Airframe and/or Powerplant
Mechanics: Assessment of the Mechanic's Practical Test Program.
    Type of Request: Approval of a new collection.
    OMB Control Number: 2120-XXXX.
    Forms(s): There are no FAA forms associated with this collection.
    Affected Public: An estimated 2,200 respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 1 hour per
response.
    Estimated Annual Burden Hours: An estimated 2,200 hours annually.
    Abstract: This project involves collecting data from individual
applicants who have recently taken, for the first time, and passed an
oral and/or practical Airframe and/or Powerplant (A and/or P) Mechanic
Certification test. The goal of this effort is ``to reduce the number
of fatal accidents in general aviation'' by identifying areas of
concerns so that the FAA may affect corrections in FAA policy, guidance
material, and FAA-sponsored programs in order to improve the overall
quality of the designated mechanic examiner oral and/or practical test
program.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to Nathan Lesser, Desk Officer, Department of Transportation/
FAA, and sent via electronic mail to<EMAIL_ADDRESS>or
faxed to<PHONE_NUMBER>.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on October 23, 2007.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 07-5363 Filed 10-26-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5579-5580]
[FR Doc No: 2017-01042]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0154]

Considerations in Demonstrating Interchangeability With a
Reference Product; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Considerations in Demonstrating Interchangeability With a Reference
Product.'' This guidance is intended to assist sponsors in
demonstrating that a proposed therapeutic protein product (proposed
interchangeable product or proposed product) is interchangeable with a
reference product for the purposes of submitting a marketing
application or supplement under the Public Health Service Act (PHS
Act). This guidance is one in a series of guidances that FDA has
developed to implement the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 20, 2017.

ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-0154 for ``Considerations in Demonstrating
Interchangeability With a Reference Product; Draft Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Considerations in Demonstrating Interchangeability With a
Reference Product.'' This guidance is intended to assist sponsors in
demonstrating that a proposed therapeutic protein product (proposed
interchangeable product or proposed product) is interchangeable with a
reference product for the purposes of submitting a marketing
application or supplement under section 351(k) of the PHS Act (42
U.S.C. 262(k)). The BPCI Act amends the PHS Act and other statutes to
create an

abbreviated licensure pathway in section 351(k) for biological products
shown to be biosimilar to or interchangeable with an FDA-licensed
biological reference product (see sections 7001 through 7003 of the
Patient Protection and Affordable Care Act Of 2010 (Affordable Care
Act) (Pub. L. 111-148)).
    Section 351(k) of the PHS Act sets forth the requirements for an
application for a proposed biosimilar product and an application or a
supplement for a proposed interchangeable product. Specifically,
section 351(k)(4) provides that upon review of an application submitted
under section 351(k), or any supplement to such an application, FDA
will determine the biological product to be interchangeable with the
reference product if FDA determines that the information submitted in
the application (or supplement) is sufficient to show that the
biological product is biosimilar to the reference product and can be
expected to produce the same clinical result as the reference product
in any given patient; and for a biological product that is administered
more than once to an individual, the risk in terms of safety or
diminished efficacy of alternating or switching between use of the
biological product and the reference product is not greater than the
risk of using the reference product without such alternation or switch.
Section 351(i) of the PHS Act states that the term interchangeable or
interchangeability, in reference to a biological product that is shown
to meet the standards described in subsection 351(k)(4), means that the
biological product may be substituted for the reference product without
the intervention of the health care provider who prescribed the
reference product.
    This guidance gives an overview of important scientific
considerations in demonstrating interchangeability, including:
     The data and information needed to support a demonstration
of interchangeability;
     Considerations for the design and analysis of a switching
study or studies to support a demonstration of interchangeability;
     Recommendations regarding the use of U.S.-licensed
reference products in a switching study or studies; and
     Considerations for developing presentations, container
closure systems, and delivery device constituent parts for proposed
interchangeable products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on topics
sponsors should consider when seeking to demonstrate that a proposed
therapeutic protein product is interchangeable with a reference
product. It does not establish any rights for any person and is not
binding on FDA or the public.

II. Topics for Comment

    In addition to comment on the draft guidance, we also invite
general comments on interchangeability, including comments on
regulation of an interchangeable product over its lifecycle, as well as
comments on the following topics:
    1. Since the mid-1990s, FDA has approved manufacturing changes for
biological products based on data from comparability assessments
comparing the pre-change and post-change product using comparative
analytical, and, when necessary, animal and/or clinical (e.g.,
pharmacokinetic, immunogenicity) studies. A demonstration of
comparability between pre- and post-change product supports a
determination that the safety and efficacy profile remains the same for
the product. With respect to interchangeable products, are there
considerations in addition to comparability assessments that FDA should
consider in regulating post-approval manufacturing changes of
interchangeable products? Your comments should include the scientific
rationale and justification for your recommendations, as well as
recommendations for processes and systems (including key logistics) to
implement your recommendations.
    2. As explained in the guidance ``Considerations in Demonstrating
Interchangeability With a Reference Product,'' FDA expects that
sponsors seeking an interchangeability determination will submit data
and information to support a showing that the proposed interchangeable
product can be expected to produce the same clinical result as the
reference product in all of the reference product's licensed conditions
of use. How, if at all, should the Agency consider conditions of use
that are licensed for the reference product after an interchangeable
product has been licensed? Your comments should include the scientific
rationale and justification for your recommendations, as well as
recommendations for processes and systems (including key logistics) to
implement your recommendations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information under 21 CFR part 312 have been approved
under OMB control number 0910-0014; the collections of information
under 21 CFR part 601 have been approved under OMB control number 0910-
0338; and the collections of information under section 351(k) of the
PHS Act have been approved under OMB control number 0910-0719.

IV. Electronic Access

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

    Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01042 Filed 1-17-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 2, 2009 (Volume 74, Number 20)]
[Notices]
[Page 5884]
[DOCID:fr02fe09-94]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on October 31, 2008, vol. 73, no. 212, page
65004. The information collected is used to determine air operators'
compliance with the minimum safety standards set out in the regulation
and the applicant's eligibility for air operations certification.

DATES: Please submit comments by March 4, 2009.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at Carla.Mauneyfaa.gov.

SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Operating Requirements: Domestic, Flag, and Supplemental
Operations.
    Type of Request: Revision of a currently approved collection.
    OMB Control Number: 2120-0008.
    Form(s): FAA Form 8070-1.
    Affected Public: An estimated 106 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 27.5 hours per
response.
    Estimated Annual Burden Hours: An estimated 1,297,755 hours
annually.
    Abstract: 14 CFR Part 121 prescribes the requirements governing air
carrier operations. The information collected is used to determine air
operators' compliance with the minimum safety standards set out in the
regulation and the applicant's eligibility for air operations
certification.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street, NW.,
Washington, DC 20503.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on January 26, 2009.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E9-1984 Filed 1-30-09; 8:45 am]

BILLING CODE 4910-13-M