[Federal Register: November 9, 2010 (Volume 75, Number 216)]
[Rules and Regulations]
[Page 68710-68714]
[DOCID:fr09no10-15]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: The date of issuance of the Flood Insurance Rate Map (FIRM)
showing BFEs and modified BFEs for each community. This date may be
obtained by contacting the office where the maps are available for
inspection as indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Roy E. Wright, Deputy Director, Risk
Analysis Division, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Federal Insurance and
Mitigation Administrator has resolved any appeals resulting from this
notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community. The BFEs and modified BFEs are
made final in the communities listed below. Elevations at selected
locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

0
Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

0
1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

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                                                                                * Elevation in
                                                                                feet (NGVD)  +
                                                                                Elevation in feet
                                                                                (NAVD)
              State                City/town/county   Source of flooding       Location          Depth in feet
                                                                                above ground
                                                                                [caret] Elevation
                                                                                in  meters (MSL)
                                                                                modified
----------------------------------------------------------------------------------------------------------------
                               Unincorporated Areas of Siskiyou County, California
                             Docket Nos.: FEMA-B-7762, FEMA-B-7795, and FEMA-B-1053
----------------------------------------------------------------------------------------------------------------
California......................  Unincorporated      Oregon Slough.....  City of Montague    +2503
                                   Areas of Siskiyou                       and
                                   County.                                 Unincorporated
                                                                           Siskiyou County
                                                                           corporate limits.
                                  ..................  ..................  Approximately 0.4   +2515
                                                                           mile downstream
                                                                           of Ager Road.
                                  ..................  ..................  Approximately 325   +2523
                                                                           feet downstream
                                                                           of Ager Road.
California......................  Unincorporated      Panther Creek       Shallow flooding    1, 3
                                   County.             flooding).          Squaw Valley
                                                                           Creek and McCloud
                                                                           River Railroad.
California......................  Unincorporated      Panther Creek       Approximately       2
                                   Areas of Siskiyou   (shallow            1,200 feet
                                   County.             flooding).          southwest of the
                                                                           intersection of
                                                                           Squaw Valley Road
                                                                           and State Route
                                                                           89 (flooding
                                                                           extends west
                                                                           towards Modoc
                                                                           Avenue).

California......................  Unincorporated      Panther Creek       Immediately south   2
                                   Areas of Siskiyou   Overflow (shallow   of and adjacent
                                   County.             flooding).          to State Route
                                                                           89, starting near
                                                                           the intersection
                                                                           of Squaw Valley
                                                                           Road and State
                                                                           Route 89
                                                                           (flooding
                                                                           encompasses
                                                                           portions of both
                                                                           sides of Squaw
                                                                           Valley Road for
                                                                           approximately
                                                                           3,000 feet).
California......................  Unincorporated      Squaw Valley Creek  At the downstream   +3094
                                   Areas of Siskiyou                       side of Cemetery
                                   County.                                 Road.
                                  ..................  ..................  Approximately 100   +3403
                                                                           feet upstream of
                                                                           McCloud River
                                                                           Railroad.
California......................  Unincorporated      Squaw Valley Creek  Shallow flooding    1, 3
                                   County.             flooding).          Cemetery Road and
                                                                           McCloud River
                                                                           Railroad.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[and] Mean Sea Level, rounded to the nearest 0.1 meter.
                                                    ADDRESSES
                                     Unincorporated Areas of Siskiyou County
Maps are available for inspection at the Siskiyou County Public Health and Community Development Department, 806
 South Main Street, Yreka, CA.
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                      * Elevation in
                                                                      feet (NGVD)  +
                                                                    Elevation in feet
                                                                      (NAVD)   Depth in feet
           Flooding source(s)                    elevation             above ground      Communities  affected
                                                                    [caret] Elevation
                                                                     in  meters (MSL)
                                                                         modified

----------------------------------------------------------------------------------------------------------------
                                Cherokee County, Alabama, and Incorporated Areas
                                             Docket No.: FEMA-B-1080
----------------------------------------------------------------------------------------------------------------
Coosa River............................  Approximately 1,080 feet                +575  Town of Gaylesville.
                                          downstream of State
                                          Route 35.
                                         Approximately 2.0 miles                 +579
                                          upstream of State Route
                                          35.
Weiss Lake.............................  Entire shoreline.........               +573  Town of Cedar Bluff.
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* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Town of Cedar Bluff
Maps are available for inspection at 3420 Spring Street, Cedar Bluff, AL 35959.

Town of Gaylesville
Maps are available for inspection at 4740 Main Street, Gaylesville, AL 35973.
----------------------------------------------------------------------------------------------------------------

                                       City and County of Honolulu, Hawaii
                                             Docket No.: FEMA-B-1076
----------------------------------------------------------------------------------------------------------------
Pacific Ocean..........................  Approximately 1,275 feet            [caret]1  City and County of
                                          north of the                                  Honolulu.
                                          intersection of Lihue
                                          Drive and Plantation
                                          Road.
                                         Approximately 5,025 feet           [caret]81
                                          southeast of the
                                          intersection of Poipu
                                          Drive and Nawilliwilli
                                          Street.
Pacific Ocean/Pearl Harbor.............  Approximately 700 feet            2  City and County of
                                          east of the intersection                      Honolulu.
                                          of Wasp Boulevard and
                                          Lexington Boulevard.
                                         Approximately 600 feet            2
                                          south of the
                                          intersection of Lehua
                                          Avenue and Coral Avenue.
                                         Approximately 880 feet            1
                                          northwest of the
                                          intersection of
                                          Kamehameha Street and
                                          Kalaloa Street.
                                         Approximately 325 feet            2
                                          southeast of the
                                          intersection of Ibis
                                          Avenue and Heron Avenue.

                                         Approximately 3,250 feet          2
                                          southwest of the
                                          intersection of
                                          Plantation Road and
                                          Waipio Point Access Road.
                                         Approximately 450 feet              [caret]1
                                          east of the intersection
                                          of 101st Street and
                                          Heron Avenue.
                                         Approximately 1,775 feet           [caret]11
                                          southwest of the
                                          intersection of Signer
                                          Boulevard and 2nd Street.
                                         Approximately 1,565 feet          2
                                          south of the
                                          intersection of Signer
                                          Boulevard and 2nd Street.
----------------------------------------------------------------------------------------------------------------

* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City and County of Honolulu
Maps are available for inspection at the Honolulu City and County Emergency Management Department, 650 South
 King Street, Honolulu, HI 96813.
----------------------------------------------------------------------------------------------------------------

                               Vermilion Parish, Louisiana, and Incorporated Areas
                                    Docket Nos.: FEMA-B-7773 and FEMA-B-7786
----------------------------------------------------------------------------------------------------------------
Gulf of Mexico.........................  Base Flood Elevation                      +7  Town of Gueydan.
                                          changes of 7 feet in the
                                          form of VE-Zones.
Gulf of Mexico.........................  Base Flood Elevation                   +9-11  Town of Delcambre.
                                          changes ranging from 9
                                          to 11 feet in the form
                                          of AE- and VE-Zones.
Gulf of Mexico.........................  Base Flood Elevation                  +10-13  Town of Erath.
                                          changes ranging from 10
                                          to 13 feet in the form
                                          of AE- and VE-Zones.
Gulf of Mexico.........................  Base Flood Elevations                 +11-18  Unincorporated Areas of
                                          changes ranging from 11                       Vermilion Parish.
                                          to 18 feet in the form
                                          of AE- and VE-Zones.
Gulf of Mexico.........................  At the confluence of the                 +15  Unincorporated Areas of
                                          Gulf of Mexico and                            Vermilion Parish.
                                          Vermilion Bay.
                                         Entire coastline east of                 +17
                                          the intersection with
                                          Rollover Bayou.
Vermilion Bay..........................  At the divergence from                   +14  Unincorporated Areas of
                                          the Gulf of Mexico.                           Vermilion Parish.
                                         At the confluence with                   +15
                                          the Gulf of Mexico.
----------------------------------------------------------------------------------------------------------------

* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Town of Delcambre
Maps are available for inspection at 107 North Railroad Street, Delcambre, LA 70528.

Town of Erath
Maps are available for inspection at 115 West Edwards Street, Erath, LA 70533.

Town of Gueydan
Maps are available for inspection at 600 Main Street, Gueydan, LA 70542.

                                    Unincorporated Areas of Vermilion Parish
Maps are available for inspection at 100 North State Street, Suite 200, Abbeville, LA 70510.
----------------------------------------------------------------------------------------------------------------

                               Ransom County, North Dakota, and Incorporated Areas
                                             Docket No.: FEMA-B-1053
----------------------------------------------------------------------------------------------------------------
Sheyenne River.........................  Approximately 1,064 feet                +990  City of Fort Ransom, City
                                          upstream of the Richland                      of Lisbon,
                                          County boundary.                              Unincorporated Areas of
                                                                                Ransom County.
                                         Approximately 7,465 feet               +1160
                                          downstream of State
                                          Highway 46.
----------------------------------------------------------------------------------------------------------------

* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Fort Ransom
Maps are available for inspection at P.O. Box 17, Fort Ransom, ND 58033.

City of Lisbon
Maps are available for inspection at P.O. Box 1079, Lisbon, ND 58054.

                                      Unincorporated Areas of Ransom County
Maps are available for inspection at 204 5th Avenue West, Lisbon, ND 58054.
----------------------------------------------------------------------------------------------------------------

                                  Crawford County, Ohio, and Incorporated Areas
                                             Docket No.: FEMA-B-1078
----------------------------------------------------------------------------------------------------------------
Sandusky River.........................  Approximately 0.8 mile                  +970  Unincorporated Areas of
                                          downstream of Gay Street.                     Crawford County.
                                         Approximately 0.6 mile                  +985
                                          downstream of U.S. Route
                                          30.
Zuber Ditch............................  Approximately 0.6 mile                 +1131  Unincorporated Areas of
                                          upstream of the                               Crawford County.
                                          confluence with the
                                          Olentangy River.
                                         Approximately 900 feet                 +1131
                                          downstream of North
                                          Market Street.
----------------------------------------------------------------------------------------------------------------

* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

                                     Unincorporated Areas of Crawford County
Maps are available for inspection at the Crawford County Administration Building, 112 East Mansfield Street,
 Bucyrus, OH 44820.
----------------------------------------------------------------------------------------------------------------

                                   Gallia County, Ohio, and Incorporated Areas
                                             Docket No.: FEMA-B-1083
----------------------------------------------------------------------------------------------------------------
Campaign Creek (backwater effects from   Approximately 640 feet                  +571  Unincorporated Areas of
 Ohio River).                             upstream of Bulaville                         Gallia County.
                                          Pike.
                                         Approximately 0.7 mile                  +571
                                          upstream of Bulaville
                                          Pike.
Clear Fork (backwater effects from Ohio  At the confluence with                  +566  Unincorporated Areas of
 River).                                  Raccoon Creek.                                Gallia County.
                                         Approximately 0.6 mile                  +566
                                          downstream of State
                                          Route 141.
Little Swan Creek (backwater effects     At the confluence with                  +561  Unincorporated Areas of
 from Ohio River).                        Swan Creek.                                   Gallia County.
                                         Approximately 0.7 mile                  +561
                                          upstream of the
                                          confluence with Swan
                                          Creek.
Raccoon Creek..........................  Approximately 1.9 mile                  +605  Unincorporated Areas of
                                          downstream of State                           Gallia County, Village
                                          Route 160 in the Village                      of Vinton.
                                          of Vinton.
                                         Approximately 0.8 mile                  +613
                                          upstream of State Route
                                          160 in the Village of
                                          Vinton.
Raccoon Creek (backwater effects from    Approximately 0.6 mile                  +566  Unincorporated Areas of
 Ohio River).                             upstream of the                               Gallia County.
                                          confluence with Little
                                          Raccoon Creek.
                                         Approximately 0.7 mile                  +566
                                          upstream of Lincoln Pike.
Swan Creek (backwater effects from Ohio  Approximately 1,020 feet                +561  Unincorporated Areas of
 River).                                  downstream of Swan Creek                      Gallia County.
                                          Road.
                                         Approximately 1,360 feet                +561
                                          downstream of Peters
                                          Branch Road.
----------------------------------------------------------------------------------------------------------------

* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

                                      Unincorporated Areas of Gallia County
Maps are available for inspection at 111 Jackson Pike, Suite 1569, Gallipolis, OH 45631.

Village of Vinton
Maps are available for inspection at 111 Jackson Pike, Suite 1569, Gallipolis, OH 45631.
----------------------------------------------------------------------------------------------------------------

                                   Huron County, Ohio, and Incorporated Areas
                                             Docket No.: FEMA-B-1080
----------------------------------------------------------------------------------------------------------------
East Branch Huron River................  Approximately 50 feet                   +666  Unincorporated Areas of
                                          downstream of Norfolk                         Huron County.
                                          and Western Railroad.
                                         Approximately 0.5 mile                  +672
                                          downstream of West Main
                                          Street.
                                         Approximately 50 feet                   +674
                                          downstream of West Main
                                          Street.
                                         Just downstream of State                +677
                                          Route 61.
Norwalk Creek..........................  Just downstream of State                +677  Unincorporated Areas of
                                          Route 61.                                     Huron County.
                                         Approximately 1,800 feet                +680
                                          upstream of State Route
                                          61.
Norwalk Creek..........................  Approximately 700 feet                  +688  City of Norwalk,
                                          downstream of Southwest                       Unincorporated Areas of
                                          Street.                                       Huron County.
                                         Approximately 400 feet                  +709
                                          downstream of East Elm
                                          Street.
----------------------------------------------------------------------------------------------------------------

* National Geodetic Vertical Datum
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Norwalk
Maps are available for inspection at 38 Whittlesey Avenue, Norwalk, OH 44857.

                                      Unincorporated Areas of Huron County
Maps are available for inspection at 8 Fair Road, Norwalk, OH 44857.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: October 29, 2010.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-28227 Filed 11-8-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4358-4361]
[FR Doc No: 2017-00722]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1525]

Mixing, Diluting, or Repackaging Biological Products Outside the
Scope of an Approved Biologics License Application; Revised Draft
Guidance For Industry; Availability

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a revised draft guidance for industry
entitled ``Mixing, Diluting, or Repackaging Biological Products Outside
the Scope of an Approved Biologics License Application.'' This revised
draft guidance describes the conditions under which FDA does not intend
to take action against a State-licensed pharmacy, a Federal facility,
or an outsourcing facility that mixes, dilutes, or repackages certain
biological products outside the scope of an approved biologics license
application (BLA). It also describes the conditions under which FDA
does not intend to take action when a State-licensed pharmacy, a
Federal facility, an outsourcing facility, or a physician prepares
prescription sets of allergenic extracts for subcutaneous
immunotherapy. This revised draft guidance for industry replaces the
draft guidance for industry of the same title issued in February 2015.

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 14, 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-2014-D-1525 for ``Mixing, Diluting, or Repackaging Biological
Products Outside the Scope of an Approved Biologics License
Application.'' 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 the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Avenue, 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: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796-
3110; 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 revised draft guidance for
industry entitled ``Mixing, Diluting, or Repackaging Biological
Products Outside the Scope of an Approved Biologics License
Application.'' Certain licensed biological products may sometimes be
mixed, diluted, or repackaged in a way not described in the approved
labeling for the product to meet the needs of a specific patient. For
example, for some biological products there is no licensed pediatric
strength and/or dosage form. In addition, there may be certain
circumstances when a person would remove a licensed biological product
from its original container and place it into a different container(s)
(repackage it), in a manner that is not within the scope of the
approved labeling for the product. As described in the draft guidance,
mixed, diluted, or repackaged biological products are not eligible for
the statutory exemptions available to certain compounded drugs under
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353a and 353b). In addition, a biological product
that is mixed, diluted, or repackaged outside the scope of an approved
BLA is considered an unlicensed biological product under section 351 of
the Public Health Service (PHS) Act (42 U.S.C. 262).
    This draft guidance describes the conditions under which FDA does
not intend to take action for violations of section 351 of the PHS Act
and section 502(f)(1) (21 U.S.C. 352(f)(1)), section 582 (21 U.S.C.
360eee-1), and where specified, section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) of the FD&C Act, when a state-licensed pharmacy, a
Federal facility, or an outsourcing facility dilutes, mixes, or
repackages certain biological products outside the scope of an approved
BLA.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance, when
finalized, will represent FDA's current thinking on mixing, diluting,
and repackaging of biological products not within the scope of the
product's approved BLA as described in the approved labeling for the
product. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The title, description, and respondent
description of the information collection are given under this section
with an estimate of the annual reporting and recordkeeping burdens.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    The draft guidance includes the following collection of information
under the PRA.
    One condition described in the draft guidance is that if the
labeling for the licensed biological product includes storage and/or
handling instructions (e.g., protect from light, do not freeze, keep at
specified storage temperature), the labeling for the biological product
that is mixed, diluted, or repackaged specifies the same storage
conditions.
    Another condition described in the draft guidance is that, if the
biological product is mixed, diluted, or repackaged by an outsourcing
facility, the label on the immediate container (primary packaging,
e.g., the syringe) of the mixed, diluted, or repackaged product
includes the following information:
     The statement ``This biological product was mixed/diluted
by [name of outsourcing facility],'' or ``This product was repackaged
by [name of outsourcing facility],'' whichever statement is
appropriate;
     The address and phone number of the outsourcing facility
that mixed, diluted, or repackaged the biological product;
     The proper name of the original biological product that
was mixed, diluted, or repackaged;
     The lot or batch number of the mixed, diluted, or
repackaged biological product;
     The dosage form and strength;
     A statement of either the quantity or the volume of the
mixed, diluted, or repackaged biological product, whichever is
appropriate;
     The date the biological product was mixed, diluted, or
repackaged;
     The beyond-use-date (BUD) of the mixed, diluted, or
repackaged biological product;
     Storage and handling instructions for the mixed, diluted,
or repackaged biological product;
     The National Drug Code (NDC) number of the mixed, diluted,
or repackaged biological product, if available; \1\
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    \1\ The NDC number of the original licensed biological product
should not be placed on the mixed, diluted, or repackaged biological
product.
---------------------------------------------------------------------------

     The statement ``Not for resale,'' and, if the biological
product is distributed by an outsourcing facility other than pursuant
to a prescription for an individual identified patient, the statement
``Office Use Only''; and
     If included on the label of the FDA-licensed product from
which the biological product is being mixed, diluted, or repackaged, a
list of the active and inactive ingredients; and if the biological
product is mixed or diluted, a list of any ingredients that appear in
the mixed or diluted product in addition to those ingredients that are
on the label of the original FDA-licensed biological product.
    In addition, the draft guidance includes as a condition for
biological products mixed, diluted, or repackaged by an outsourcing
facility that, if the immediate product label is too small to bear the
active and inactive ingredients, such information should be included on
the label of the container from which the individual units are removed
for administration (secondary packaging, e.g., the bag, box, or other
package in which the mixed, diluted, or repackaged biological products
are distributed).
    The draft guidance also describes the condition for biological
products mixed, diluted, or repackaged by an outsourcing facility that
the label on the container from which the individual units are removed
for administration

include directions for use, including, as appropriate, dosage and
administration, and the following information to facilitate adverse
event reporting: http://www.fda.gov/medwatch and 1-800-FDA-1088.
    Finally, the draft guidance described a condition for biological
products repackaged by an outsourcing facility for which the BUD is
established based on a stability program conducted in accordance with
Appendix A of the draft guidance, that the outsourcing facility
maintains records of the testing performed in accordance with Appendix
A.
    We estimate that annually a total of approximately 15 outsourcing
facilities that mix, dilute, or repackage biological products (``Number
of Respondents'' in table 1, row 1) will each design, test, and produce
approximately five different labels (``Frequency per Disclosure'' in
table 1, row 1), for a total of 75 labels that include the information
set forth in section III.B of the draft guidance (including directions
for use) as well as inclusion of storage and/or handling instructions
(``Total Disclosures'' in table 1, row 1). We also estimate that
designing, testing, and producing each label will take approximately
0.5 hours (``Hours per Disclosure'' in table 1, row 1). The provision
to add http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included
in this burden estimate because it is not considered a collection of
information under the PRA because the information is ``originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
    Section III.C of the draft guidance discusses the preparation of
prescription sets (i.e., licensed allergenic extracts that are mixed
and diluted to provide subcutaneous immunotherapy to an individual
patient) by a physician, State-licensed pharmacy, a Federal facility,
or outsourcing facility. One of the conditions described in the draft
guidance is if the prescription set is mixed or diluted by an
outsourcing facility, the label on the immediate container of the
prescription set (primary packaging) includes:
     The patient's name as identified on the prescription or
order;
     The statement ``This prescription set was prepared by
[name of outsourcing facility]'';
     The address and phone number of the outsourcing facility
that prepared the prescription set;
     The identity of each allergenic extract in the
prescription set and the quantity of each;
     The dilution of each dilution vial;
     The lot or batch number of the prescription set;
     The date the prescription set was prepared;
     The BUD as the expiry date for the prescription set;
     Storage and handling instructions for the prescription
set; and
     The statement ``Not for resale.''
    Another condition under the draft guidance is that if the
prescription set is prepared by an outsourcing facility, the label of
the container from which the individual units of the prescription set
are removed for administration (secondary packaging) includes the
following information to facilitate adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA-1088. Each prescription set prepared
by an outsourcing facility is also accompanied by instructions for use.
    We estimate that annually a total of approximately five outsourcing
facilities that prepare prescription sets (``Number of Respondents'' in
table 2, row 1) will each include the information set forth in section
III.C of the draft guidance (including directions for use) on the
labels, packages, and/or containers of approximately 300 prescription
sets (``Frequency per Disclosure'' in table 2, row 1) for a total of
1500 disclosures (``Total Disclosures'' in table 2, row 1). We also
estimate that the initial process of designing, testing, and producing,
and attaching each label, package, and/or container to each
prescription set will take approximately 0.5 hours (``Hours per
Disclosure'' in table 2, row 1). The provision to add ``http://www.fda.gov/medwatch'' and ``1-800-FDA-1088'' is not included in this
burden estimate because it is not considered a collection of
information under the PRA because the information is ``originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
    We estimate that annually a total of approximately 5 outsourcing
facilities that repackage biological products and establish a BUD in
accordance with Appendix A (``No. of Recordkeepers'' in table 3) will
maintain approximately 150 records of the testing, as described in
Appendix A (``total annual records'' in table 3). We estimate that
maintaining the records will take approximately 5 minutes per record.
    The total estimated third-party disclosure burden resulting from
the draft guidance is as follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
 Biological product mixing, diluting, and     Number of      disclosures per     Total annual        Average burden per disclosure         Total hours
               repackaging                   respondents        respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing the                  15                  5               75   0.5 (30 minutes).......................            37.5
 label, container, packages, and/or outer
 containers for each mixed, diluted, or
 repackaged biological product.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
     Preparation of prescription sets         Number of      disclosures per     Total annual        Average burden per disclosure         Total hours
                                             respondents        respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing each                  5                300            1,500   0.5 (30 minutes).......................             750
 label on immediate containers, packages,
 and/or outer containers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Number of     Number of records    Total annual
          Type of recordkeeping             recordkeepers    per recordkeeper      records          Average burden per recordkeeping       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records that the outsourcing facility                   5                 30              150   0.083 (5 minutes)......................            12.5
 maintains of the testing performed in
 accordance with Appendix A of the
 guidance.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The draft guidance also references registration, adverse event
reporting, product reporting, and current good manufacturing practice
(CGMP) requirements for outsourcing facilities. The collections of
information for outsourcing facility registration have been approved by
the Office of Management and Budget (OMB) under OMB control number
0910-0777 (79 FR 69859). The collections of information for adverse
event reporting by outsourcing facilities have been approved by OMB
under OMB control number 0910-0800 (80 FR 60917). In the Federal
Register of December 4, 2013 (78 FR 72897), FDA estimated the burden
resulting from outsourcing facility electronic drug product reporting.
In the Federal Register of July 2, 2014 (79 FR 37743), FDA estimated
the burden resulting from outsourcing facility compliance with CGMP
requirements.

IV. Electronic Access

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

    Dated: January 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00722 Filed 1-12-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Rules and Regulations]
[Pages 14970-14972]
[FR Doc No: 2012-6137]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-1174]
RIN 1625-AA00

Safety Zones; Sellwood Bridge Project, Willamette River;
Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing two safety zones to remain in
effect throughout the duration of the construction and renewal of the
Sellwood Bridge on the Willamette River, in Portland, OR. This action
is necessary to ensure the safety of vessels transiting in close
proximity to cranes, barges, and temporary structures associated with
this construction project. During the effective period, all vessels
will be required to remain outside the prescribed safe distance from
the construction area while transiting in the vicinity of the Sellwood
Bridge project; however, the establishment of these safety zones does
not entirely close this section of the Willamette River. The section of
the Willamette River between the safety zones will remain open for
vessel transits, and it will have a minimum channel width of 138 feet
at all times.

DATES: This rule is effective in the CFR from March 14, 2012 through 11
a.m., July 1, 2012. This rule is effective with actual notice for
purposes of enforcement from 4 p.m., March 1, 2012, through 11 a.m.
July 1, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-1174 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-1174 in the
``Keyword'' box, and then clicking ``Search''. They are 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
temporary rule, call or email ENS Ian McPhillips, Waterways Management
Division, Coast Guard MSU Portland; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest''.
    Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause
exists for not publishing a notice of proposed rulemaking (NPRM) with
respect to this rule because to do so would be contrary to public
interest. The Sellwood Bridge is an 86 year old bridge that is
structurally inadequate and functionally obsolete. Although public
outreach for the Sellwood Bridge renewal project began in June 2006,
specific construction dates were not predetermined due to funding
constraints. As a result of the delay in determining a specific date to
commence work and in order to avoid the imposition of financial
penalties on the state and local governments funding construction due
to delays, the safety zones are immediately necessary. Should
construction commence without a safety zone in place, the safety of
recreational and commercial vessels transiting the area may be
threatened by their close proximity to cranes, barges, and temporary
structures associated with this construction project. Thus, any delay
in the effective date of this rule would be contrary to the public
interest because immediate action is needed to minimize potential
danger to the public during the bridge construction. Additionally, in
order to allow public comment on safety zones in this area, the Coast
Guard will issue a notice of proposed rulemaking for a temporary rule
that establishes safety zones in the same locations from the expiration
of this rule through January 1, 2015.
    For the same reason discussed above, under 5 U.S.C. 553(d)(3) the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register.

Background and Purpose

    The Sellwood Bridge project will replace the existing 86 year old
bridge that is structurally inadequate and functionally obsolete. The
project will renew the bridge with a new deck arch structure compliant
with current loading and seismic requirements, upgrade the interchange
at Oregon Route 43, and provide substantially improved bicycle and
pedestrian facilities. The project includes the construction of two
temporary structures and two new bridge piers which will each require a
cofferdam. The temporary structures will be constructed to facilitate
the moving of the older bridge. To ensure the safety of construction
crews on the barges, temporary structures, and cranes, two safety zones
on each side of the river are being established to require vessels in
the vicinity of the construction area to remain outside of the two
designated safety zones. Additionally, this will ensure that the
vessels operating in the vicinity of the designated areas will not be
in any dangerous areas near the temporary structures or cranes.
    Construction work is anticipated to continue through January 1,
2015. During the effective period of this rule a notice of proposed
rulemaking will be issued for a temporary rule that establishes safety
zones in the same locations from the expiration of this rule through
January 1, 2015.

Discussion of Rule

    The two safety zones created by this rule cover all waters of the
Willamette River; however, the establishment of these safety zones does
not entirely close this section of the Willamette River. The section of
the Willamette River between the safety zones will remain open for
vessel transits, and it will have a minimum channel width of 138 feet
at all times. The first safety zone on the West river bank is
encompassed within the following four lines: Line one starting at 45-
27'53.5'' N/122-40'03.5'' W then heading 375 feet offshore to 45-
27'53.5'' N/122-39'58.5'' W then heading up river 200 feet to 45-
27'49.5'' N/122-39'58.5'' W then heading 375 feet back to the shore at
45-27'49.5'' N/122-40'04.5'' W then following the shoreline to end at
45-27'53.5'' N/122-40'03.5'' W. The second safety zone on the East
river bank is encompassed within the following four lines: Line one
starting at 45-27'53.5'' N/122-39'50.5'' W then heading 420 feet
offshore to 45-27'53.5'' N/122-39'55.0'' W then heading up river 200
feet to 45-27'49.5'' N/122-39'55.0'' W then heading 420 feet back to
the shore at 45-27'49.5'' N/122-39'47.0'' W then following the
shoreline to end at 45-27'49.5'' N/122-39'47.0'' W. Geographically,
this rule will cover all waters of the Willamette River 100 feet
upriver and downriver of the existing Sellwood Bridge, inward 375 feet
from the Western side shoreline, and inward 420 feet from the Eastern
side shoreline. The section of the Willamette River between the safety
zones will remain open for vessel transits, and it will have a minimum
width of 138 feet at all times. These safety zones will ensure the
safety of all vessels and crew that are working and transiting in the
construction areas.

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

    Executive Orders 13563, Improving Regulation and Regulatory Review,
and 12866, Regulatory Planning and Review, direct agencies to assess
the costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a significant regulatory
action under section 3(f) of Executive Order 12866. Accordingly, the
Office of Management and Budget has not reviewed this regulation under
Executive Order 12866. The Coast Guard has made this determination
based on the fact that the safety zones created by this rule will not
significantly affect the maritime public because vessels may still
transit in the vicinity of the safety zones.

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. This rule may affect the following entities, some of which
may be small entities: The owners and operators of vessels intending to
operate in the area covered by the safety zones. The safety zones will
not have a significant economic impact on a substantial number of small
entities because the area can still be used to transit through this
section of the river, which will maintain a minimum width of 138 feet.
Other maritime users, such as dragon boats, kayaks, and canoes, will be
able to transit around the safety zones or through the open section.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

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 any 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 does not create an
environmental risk to health or risk to safety that may
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
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of safety zones.
An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T13-207 to read as follows:

Sec.  165.T13-207  Safety Zones; Sellwood Bridge project, Willamette
River; Portland, OR

    (a) Location. The safety zone on the western river bank encompasses
all waters of the Willamette River within the following four lines:
Line one starting at 45-27'53.5'' N/122-40'03.5'' W then heading 375
feet offshore to 45-27'53.5'' N/122-39'58.5'' W then heading up river
200 feet to 45-27'49.5'' N/122-39'58.5'' W then heading 375 feet back
to the shore at 45-27'49.5'' N/122-40'04.5'' W then following the
shoreline to end at 45-27'53.5'' N/122-40'40'03.5'' W. The safety zone
on the eastern river bank is encompassed within the following four
lines: Line one starting at 45-27'53.5'' N/122-39'50.5'' W then heading
420 feet offshore to 45-27'53.5'' N/122-39'55.0'' W then heading up
river 200 feet to 45-27'49.5'' N/122-39'55.0'' W then heading 420 feet
back to the shore at 45-27'49.5'' N/122-39'47.0'' W then following the
shoreline to end at 45-27'49.5'' N/122-39'47.0'' W. Geographically,
this rule will cover all waters of the Willamette River 100 feet
upriver and downriver of the existing Sellwood Bridge, inward 375 feet
from the Western side shoreline, and inward 420 feet from the Eastern
side shoreline. The section of the Willamette River between the safety
zones will remain open for vessel transits, and it will have a minimum
width of 138 feet at all times.
    (b) Regulations. In accordance with the general regulations in 33
CFR part 165, subpart C, no person may enter or remain in the safety
zones created in this section or bring, cause to be brought, or allow
to remain in the safety zones created in this section any vehicle,
vessel, or object unless authorized by the Captain of the Port or his
designated representative. The Captain of the Port may be assisted by
other Federal, state, or local agencies with the enforcement of the
safety zones.
    (c) Enforcement period. The safety zones created by this section
will be in effect from 4 p.m. March 1, 2012, through 11 a.m. July 1,
2012.

    Dated: March 1, 2012.
B.C. Jones,
Captain, U. S. Coast Guard, Captain of the Port, Columbia River.
[FR Doc. 2012-6137 Filed 3-13-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Pages 23983-23985]
[FR Doc No: 2018-10969]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83268; File No. SR-NYSEArca-2018-34]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE
Arca Equities Fees and Charges

May 17, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on May 9, 2018, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Equities Fees and
Charges (``Fee Schedule'') to introduce a new pricing tier, Retail
Order Step-Up Tier. The Exchange proposes to implement the fee change
effective May 9, 2018.\4\ The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.
---------------------------------------------------------------------------

    \4\ The Exchange originally filed to amend the Fee Schedule on
May 1, 2018 (SR-NYSEArca-2018-30) and withdrew such filing on May 9,
2018.

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

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule, as described
below, to introduce a new pricing tier, Retail Order Step-Up Tier.
    The Exchange currently provides a credit of $0.0033 per share under
the Retail Order Tier for Retail Orders \5\ that provide liquidity
during the month in Tape A, Tape B and Tape C Securities to ETP
Holders, including Market Makers, that execute an average daily volume
(``ADV'') of Retail Orders that provide liquidity during the month that
is 0.15% or more of U.S. consolidated ADV (``CADV'').\6\ For all other
fees and credits, tiered or basic rates apply based on a firm's
qualifying levels. In order to encourage participation from a greater
number of ETP Holders, and promote additional liquidity in Retail
Orders, the Exchange proposes to introduce a new pricing tier, Retail
Order Step-Up Tier.
---------------------------------------------------------------------------

    \5\ A Retail Order is an agency order that originates from a
natural person and is submitted to the Exchange by an ETP Holder,
provided that no change is made to the terms of the order to price
or side of market and the order does not originate from a trading
algorithm or any other computerized methodology. See Securities
Exchange Act Release No. 67540 (July 30, 2012), 77 FR 46539 (August
3, 2012) (SR-NYSEArca-2012-77).
    \6\ U.S. CADV means United States Consolidated Average Daily
Volume for transactions reported to the Consolidated Tape, excluding
odd lots through January 31, 2014 (except for purposes of Lead
Market Maker pricing), and excludes volume on days when the market
closes early and on the date of the annual reconstitution of the
Russell Investments Indexes. Transactions that are not reported to
the Consolidated Tape are not included in U.S. CADV.
---------------------------------------------------------------------------

    As proposed, a new Retail Order Step-Up Tier credit of $0.0033 per
share for Retail Orders that provide liquidity during the month in Tape
A, Tape B and Tape C Securities would apply to ETP Holders, including
Market Makers, that execute an ADV of Retail Orders with a time-in-
force designation of Day that add or remove liquidity during the month
that is an increase of 0.12% or more of the U.S. CADV above their April
2018 ADV taken as a percentage of U.S. CADV. Retail Orders with a time-
in-force designation of Day that remove liquidity from the Book will
not be charged a fee. For all other fees and credits, tiered or basic
rates apply based on a firm's qualifying levels.
    For example, assume an ETP Holder averages 1 million shares in
Retail Orders with a time-in-force designation of Day that add or
remove liquidity per day in April, or 0.015% of U.S. CADV, where U.S.
CADV was 6.6 billion shares.
    If that ETP holder then averages 9 million shares in Retail Orders
with a time-in-force designation of Day that add or remove liquidity in
the billing month, or 0.136% of U.S. CADV, where U.S. CADV was also 6.6
billion shares, that ETP Holder would qualify for the Retail Order
Step-Up Tier because it would have met the requirement of the proposed
new pricing tier, i.e., an increase of at least 0.12% of the U.S. CADV
over the ETP Holder's April 2018 ADV taken as a percentage of U.S.
CADV, or 0.121% (0.136% in the billing month over 0.015% in the
baseline month).
    Also assume that same ETP holder averages 5 million shares in
Retail Order that remove liquidity in Tape A Securities, of which 1
million shares are in Retail Orders with a time-in-force designation of
Day. As a result, the 4 million shares in Retail Orders that remove
liquidity would be subject to the Tape A fee for removing liquidity of
$0.0030 per share while the 1 million shares in Retail Orders with a
time-in-force designation of Day would not be charged a fee.
    Further assume that the same ETP Holder qualified for both the
Cross-Asset Tier 3 credit of $0.0030 per share and the Tape C
incremental credit of $0.0004 per share and receive a combined credit
for adding liquidity in Tape C of $0.0034. Since the combined Cross-
Asset Tier and Tape C Tier credit is higher than the proposed Retail
Order Step-Up Tier, the ETP holder would receive the higher credit of
$0.0034 per share instead of the Retail Order Step-Up Tier credit of
$0.0033 per share.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\8\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes it is reasonable to add the new Retail Order
Step-Up Tier because the Exchange believes it would encourage
participation from a greater number of ETP Holders, which would promote
additional liquidity in Retail Orders. In this regard, an ETP Holder
that does not qualify for the proposed higher credit could still be
eligible for a credit for its Retail Orders that provide liquidity
under the current Retail Order Tier or under Basic Rates. The proposed
new Retail Order Step-Up Tier would create an added financial incentive
for ETP Holders to bring additional retail flow to a public market. The
proposed new credit is also reasonable because it would reduce the
costs of ETP Holders that represent retail flow and potentially also
reduce costs to their customers.
    The Exchange believes that it is reasonable that only Retail Orders
with a time-in-force designation of Day that add or remove liquidity
would count toward qualifying for the Retail Order Step-Up Tier. This
would largely result in the type of orders to which the corresponding
credit applies being the same as the volume that counts toward
qualification--i.e., only Retail Orders with a time-in-force
designation of Day. The Exchange believes that the proposed threshold
of 0.12% or more of CADV above the ETP Holder's April 2018 ADV taken as
a percentage of U.S. CADV is reasonable because it is within a range
that the Exchange believes would continue to incentivize ETP Holders to
submit Retail Orders to the Exchange in order to qualify for the
proposed credit.
    The Exchange believes that the proposed rule change is equitable
and not unfairly discriminatory because maintaining or increasing the
proportion of Retail Orders in exchange-listed securities that are
executed on a registered national securities exchange (rather than
relying on certain available off-exchange execution methods) would
contribute to investors' confidence in the fairness of their
transactions and would benefit all investors by deepening the
Exchange's liquidity pool, supporting the quality of price discovery,
promoting market transparency and improving investor protection. This
aspect of the proposed

rule change also is consistent with the Act because all similarly
situated ETP Holders would pay the same rate, as is currently the case,
and because all ETP Holders would be eligible to qualify for the rates
by satisfying the related threshold, where applicable. Furthermore, the
submission of Retail Orders is optional for ETP Holders, in that an ETP
Holder could choose whether to submit Retail Orders and, if it does,
the extent of its activity in this regard.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\9\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, the Exchange believes that the proposed
rule change would encourage the submission of additional liquidity to a
public exchange, thereby promoting price discovery and transparency and
enhancing order execution opportunities for ETP Holders and Market
Makers. The Exchange believes that this could promote competition
between the Exchange and other execution venues, including those that
currently offer comparable transaction pricing, by encouraging
additional orders to be sent to the Exchange for execution. The
Exchange also believes that the proposed rule change is consistent with
the Act because it strikes an appropriate balance between fees and
credits, which will encourage submission of orders to the Exchange,
thereby promoting competition.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues if they
deem fee levels at a particular venue to be excessive or rebate
opportunities available at other venues to be more favorable. In such
an environment, the Exchange must continually adjust its fees and
rebates to remain competitive with other exchanges and to attract order
flow to the Exchange. Because competitors are free to modify their own
fees and credits in response, and because market participants may
readily adjust their order routing practices, the Exchange believes
that the degree to which fee changes in this market may impose any
burden on competition is extremely limited. As a result of all of these
considerations, the Exchange does not believe that the proposed changes
will impair the ability of ETP Holders or competing order execution
venues to maintain their competitive standing in the financial markets.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2018-34 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2018-34. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEArca-2018-34, and should be
submitted on or before June 13, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10969 Filed 5-22-18; 8:45 am]
 BILLING CODE 8011-01-P