[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Proposed Rules]
[Pages 11966-11968]
[FR Doc No: 2015-05018]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2014-N-1168]

Generic Drug User Fee Amendments of 2012; Regulatory Science
Initiatives; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing that will provide an overview of the current status of
regulatory science initiatives for generic drugs and an opportunity for
public input on research priorities in this area. FDA is seeking this
input from a variety of stakeholders--industry, academia, patient
advocates, professional societies, and other interested parties--as it
fulfills its commitment under the Generic Drug User Fee Amendments of
2012 (GDUFA) to develop an annual list of regulatory science
initiatives specific to generic drugs. FDA will take the information it
obtains from the public hearing into account in developing the fiscal
year (FY) 2016 Regulatory Science Plan.

DATES: The public hearing will be held on June 5, 2015, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
hearing participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a

Federal facility with security procedures and limited seating.
Attendance will be free and on a first-come, first-served basis. If you
wish to attend (either in person or by Webcast (see Streaming Webcast
of the Public Hearing)) and/or present at the hearing, please register
for the hearing and/or make a request for oral presentations or
comments by email to<EMAIL_ADDRESS>by May 15,
2015. The email should contain complete contact information for each
attendee (i.e., name, title, affiliation, address, email address,
telephone number, and priority number(s)). Those without email access
can register by contacting Thushi Amini by May 15, 2015 (see For
Further Information Contact).
    FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the topic, or topics, they wish to address (see section V under
Supplementary Information). This will help FDA organize the
presentations. FDA will notify registered presenters of their scheduled
presentation times. The time allotted for each presentation will depend
on the number of individuals who wish to speak. Once FDA notifies
registered presenters of their scheduled times, they are encouraged to
submit an electronic copy of their presentation to
<EMAIL_ADDRESS>on or before May 22, 2015. Persons
registered to make an oral presentation are encouraged to arrive at the
hearing room early and check in at the onsite registration table to
confirm their designated presentation time. An agenda for the hearing
and other background materials will be made available 5 days before the
hearing at http://www.fda.gov/GDUFARegScience.
    If you need special accommodations because of a disability, please
contact Thushi Amini (see For Further Information Contact) at least 7
days before the hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live Webcast of the hearing. To join the
hearing via the Webcast, please go to https://collaboration.fda.gov/gdufa2012/.
    Comments: Regardless of attendance at the public hearing,
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), 5600 Fishers Lane, Rm. 1061, Rockville, MD 20857.
The deadline for submitting comments to the docket is June 26, 2015. It
is only necessary to send one set of comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov or
http://www.fda.gov/GDUFARegScience. It may be viewed at the Division of
Dockets Management (see Comments). A transcript will also be available
in either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Send written requests to the Division of Freedom
of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4728, Silver Spring, MD 20993; 240-402-
7958, email<EMAIL_ADDRESS>or Robert Lionberger, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, Congress passed GDUFA (Title III of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is
designed to enhance public access to safe, high-quality generic drugs
and reduce costs to industry. To support this goal, FDA agreed in the
GDUFA commitment letter to work with industry and interested
stakeholders on identifying regulatory science research priorities
specific to generic drugs for each fiscal year covered by GDUFA. The
commitment letter outlines FDA's performance goals and procedures under
the GDUFA program for the years 2012-2017. The commitment letter can be
found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

II. FY 2013 Regulatory Science Priorities

    The FY 2013 regulatory science research priorities list was
developed by FDA and industry and included in the GDUFA commitment
letter. To implement the FY 2013 priorities list, the Office of Generic
Drugs awarded $17 million in external contracts and grants to initiate
new research studies during FY 2013. Four million dollars were
allocated to support internal research related to generic drugs. This
includes rapid response capabilities through equipment for FDA labs and
support for laboratory research fellows at FDA, as well as research
fellows to work on data analysis and coordination of internal
activities with external grants and contracts.

III. FY 2014 Regulatory Science Priorities

    On June 21, 2013, the Office of Generic Drugs held a public hearing
to gain input in developing the FY 2014 regulatory science priorities
list. This list was prepared based on internal Center for Drug
Evaluation and Research discussions, comments received from this public
hearing, and comments submitted to the public docket. The FY 2014
priorities list can be found at http://www.fda.gov/GDUFARegScience. To
implement the FY 2014 priorities list, the Office of Generic Drugs
awarded $17 million in external contracts and grants to initiate new
research studies during FY 2014. A list of FY 2014 awarded studies can
be found at http://www.fda.gov/GDUFARegScience.

IV. FY 2015 Regulatory Science Priorities

    On May 16, 2014, the Office of Generic Drugs held a public meeting
to allow public input in developing the FY 2015 regulatory science
priorities list. The FY 2015 Regulatory Science Priorities are as
follows:

1. Postmarket Evaluation of Generic Drugs
2. Equivalence of Complex Products
3. Equivalence of Locally Acting Products
4. Therapeutic Equivalence Evaluation and Standards
5. Computational and Analytical Tools

    For more information on these topic areas, please visit
www.fda.gov/GDUFARegScience. The Office of Generic Drugs is currently
developing research studies to support the FY 2015 priorities list.
Funding opportunities for collaborations will be posted in March 2015
at www.fda.gov/GDUFARegScience.

V. Purpose and Scope of the June 5, 2015, Public Hearing

    The purpose of the June public hearing is to obtain input from
industry and other interested stakeholders on the identification of
regulatory science priorities for FY 2016. To help fulfill FDA's
mission, FDA is particularly interested in receiving input on the
following topics:

    1. Opportunities for scientific or technical advancements that
would help to overcome specific barriers for industry that currently
limit the availability of generic drug products.
    2. Innovative approaches to preapproval development of generic
drugs, including new methodologies for design and conduct of in vitro,
ex vivo, and clinical studies and identification of scientifically
robust strategies for demonstration of bioequivalence for various
product classes.
    3. Innovations in scientific approaches to evaluating the
therapeutic equivalence of generic drug products through later stages
of their lifecycle following initial approval.
    4. Identification of high-impact public health issues involving
generic drugs that can be addressed by the prioritized allocation of FY
2016 funding for regulatory science research.
    5. Identification of specific issues related to generic drug
products where scientific recommendations and/or clarifications are
needed in developing and/or revising FDA's guidance for industry.
    6. Strategies for enhancing quality and equivalence risk management
during generic drug product development, during regulatory review, and/
or throughout the drug product's lifecycle following initial approval.
    FDA will consider all comments made at this hearing or received
through the docket (see Comments under ADDRESSES) as it develops its FY
2016 GDUFA Regulatory Science Plan. Additional information concerning
GDUFA, including the text of the law and the commitment letter, can be
found at http://www.fda.gov/gdufa.

VI. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner and the
Center for Drug Evaluation and Research. Under Sec.  15.30(f) (21 CFR
15.30), the hearing is informal and the rules of evidence do not apply.
No participant may interrupt the presentation of another participant.
Only the presiding officer and panel members may pose questions; they
may question any person during or at the conclusion of each
presentation. Public hearings under part 15 are subject to FDA's policy
and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under Sec.
10.205 (21 CFR 10.205), representatives of the media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts under ADDRESSES). To the extent that the
conditions for the hearing, as described in this document, conflict
with any provisions set out in part 15, this document acts as a waiver
of those provisions as specified in Sec.  15.30(h).

    Dated: February 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05018 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

There are a great many things that the Food and Drug Administration ("FDA") has done to benefit countless numbers of people, and has increased the quality and length of life for the general population, not only in the United States, but all around the world. I would like to do my part to help the FDA continue to accomplish this goal as an individual consumer. I believe that as a nation, the public along with the FDA, we will continue to make this nation a healthier place to live.

I am writing to you to request an extension of the comment period for FDA Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks a great many questions that I would be very interested in answering. I feel that it is my duty to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but this takes time. I am aware that the FDA took many years to even come up with the Proposed Rule, therefore I do not believe it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity as consumers that we will ever have to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Joshua L. Harbert


Docket No. A 79 15 Item No. XII D 1 MEMORANDUM Date: June 12.1997 TO: Dennis Pagano Dennis Doll Tom & say CC: David Ailor From! Nick Gudka Ellzabelh Anderson Qubjsct; Backgrmm~ ihfonnation used in Modeling of BSO Emisslons from U. S. Steei Clairton l'ha U. S. Steel Clairton coke aven SSO emissions were modeled using a process very similar to that developed by Allegheny County for the PM 10 SIP, The following clescribes the data usad to characterize the buoyancy ofcoke & en emissions, estimate plume rise, and model the dispersion of benzene salubfe organic ( BSO) Eirnlssions:

Fix the PMIO SIP rnodellng, the Allegheny County Health Department ( ACHO) develaped a total buoyancy flux far coke oven emissions that accounted for both the buoyancy associated with convective heat transfer from hot battery surfaces and the buoyancy intrinsic to coke oven emimians.

...,. .. .. . , .. . ... I.". Euov. with Convective Heat Transfer ACHD calculated the buoyancy flux associated with convective heat transfer for each battery line using the same approach developed by  PA in 1985 for the CIairton facility. The EPA methodology is discussed in a document authored by Layland and Met~~ h ( 1985) ( attached).

ACHD's resulting battery speciflcbuoyancy flux estimates are presented an the flnal page of Appendix d to the Cibedy Borough PMlO SIP ( see attachment).

Assodated with Q& QOven Ernissisns ACHD dBVelOped a methodology to account for the buayancy intrinsic to coke oven emissions. Equations presented for battery line 1 2 3in the USX Glaifbn Saunse Parameters ( see attachment) and Appendix J to the Liberty Borough PMIO SIP were initially applied to develop avit flow rate estimates for the following source3 of emissions ( charging, door leaks, lid leaks, offtake leaks, pushing, travel car, and decarbonizing) at each battery line. As ab presented in Appendix J, these process specific flow rates were then combined with process specific exit temperatures and the ambient temperature to derive an omission related buoyancy flux estimate.

The ACHD buayancy flux wtimates associated with both convective heat transferand emissions are summarized on the last page a? Appendix J 10 thal'tibertyBorough PMlO SIP ana@ is. The approach is further described in Modelhg Cuke Oven Fugitives in Cmplar Terrain ( Graham, 1996) ( see attachment),

ACHD inCorPamted the battery specifc total buoyancy llox estimates, along with benery specifK source configuratran data inta the Buoyanr Lfne and PUhf Source modal lap) t0 est'mate houdy plme tiso. ACHD provided Sciences With copies of the BLP input flies Ibr each battery Ilne, along with the meteorological data set from me Limoln monitor as used in the PMlo SIP madeling ( PKgO9lM. EIN). Input files wed bv ACHD for BLP modeling of PM 10 SIP were obtained from ACHD. The input fibs( BAmRY1. INP, BATTERY2.! NP, BATTERY8. INP) contain parameters an battery locations, battery dimensions, and total buoyancy. BATl RY 1. INP contains Ihe characterization of parallel battey lines 1 2 3and 7 8 9, while BATTERY2.1NP contains the characterization of parallel battery lines 13 14 75 and 19 20. BA7TERYQ. INP contains the characretization af battery 6. In this analysis, the ACHD 8LP input flleswere used wilhout any modlfication. Thc BLP Input filesare attached.

To model plume rise using ACHD's input data, Sciences abtalned the BLP ( version g0081) source codes from OAQPS's llN BBS. The 8LP pragram was then Modified so that program execution produces an output file called " BLPPROUT." that contains # re hourly estimates of plume rise. The amended codes were added In the subrourlne " RISE( seeattachment). The modified BLP FORTRAN source des, named ' EW 1. FOR," and the executabb pragram BLPI . WE are enclosed.

For each of the three sgtS of Clatrton coke oven batteries. he hourly plume rise was ~ characteixadby running the BLPl .= E program with input flee and meteordogtcal ) data files provided by ACHO. The 6LPl. MEprogram was executed with the fctlowing command \& ere" oahyx. inp" is name of the input file ( BAllERY1 . INP, BAlTERYZ. INP, or 13ATERYB. INP).

' Moutpul fila containing hourly pfuma rise estimates fromthe mddlfled BLP program iscalled " BWPRQUT." Prior to using the plume rise data in ISCS3. it WEE necessary to append to the end of the ouiput flle a tag to indicate ihe end of plume rise dala. Thb was achieved by adding a fila called * BLmlNY." to the plum rise data file:

copy blpprout. + blptiny. blpout.

vuhere " BLWUT." is the final name of the plume rise data file used lor ISCST3 nnodeling. The BLP pbrne rise output forthe three batteiis ( 81_ QRIG. OUT. EIZORIG. OUT, 6Q ORIG. OUT) are enclosed. Finalfy, it should be noted that the values within these output fllsscorrespond to the vatues prssented by ACHD in a ptaper authored by Sulllvan and Weaver ( i995). Sulhan and Weaver ( 1995) indicate that the buoyancy flux and souma characterization data input into the BLP modd produce plume rise estimates that correspand closely ta visual observations of plume rise that were made a1 the lacitity during extensive field investigations.

1SCST3 Dtspersion Modellng me 1SCST 3 program was modifled to utilize hourly plume rise data from an external file called   BLPOU I . The ISC source codes ( version 95250) were obtained from OAQPS lTN BBS. The SOUI CB codes were modifled in lour subroutines: MAINI. INC, HRLOOP, PUEFF, and PHEFFC ( see atiachrnent). The source codes of the modified routines and the executable program ISCPRXXE are enclosed.

For ISCST 3 modeling the 1991 meteorological data tlle used by ACHD ( PITWQ1M. 61N) was converted from binaty to ASCII format using BINTOASCEXE pmgrw lhat wa~ Qbtainedfrom OAQPSs TTN BBZ. Tho final ASCll file used for ISCST 3 was named P! TMET2ASC. The meteorologiGd data file and the file format conversion program ar4 enclosed.

In ISCm 3, the USXGlalrton batteries were characterized as llnes of point saurces beginning and ending at the UTM coordinatea speoified by ACHD in the BLP   mut files. The ratio of BSQ emissions from aach of the Clalnon banedes under 2010 UER track limits was assumed In ISCS73 ( see memorandum fmm Manrin Bmnscorne, to Amanda Agnew,  PA for battery specific 2010 MER 8S0 mimion estlrnstas for the Clajrton facility). The tatal ornlssion rates from tfro three sets of batteries w0m scaled to a sum of 106 gis in order for the ISCST 3 results to contah adequate significant dig&.

Battery 1 was represented by 60 vlnual stack sources separatsd by a dlstance equivalent t6 the battery width, slack height of 8.5 meters as ACHD indicated In BLP input files, exh temperature gf 100 OK, exit velocity of 0.0001 ds, stadr diameter Of 2 mefern, and errdsslon rates as shown in the enclosed 1SCST 3 input file. Battery 2 was mprrsentod by 56 vlrtual stack SGU~ separated by a dlatance equkalent to the battery width, slack height of 8.5 meters as ACHD indicafed in BLF input files, eltit temperature of 100%, exit velocity of 0.0001 mls, stack diameter of 2 metera, and emission rates a6 ahown In the enclosed Input ffle. Battery f3was represented by 15 VlrtUd stack SOurws separated by a distance equivalmt to the battery width, Stack height of 8.6 meters as ACHD indicated In BLP input files. exit temperature of I00  K, exlt Velocity Of 0.0001 ds, stack diameter of 2 maters, and omission rates as shown 8 in the enclosed input file. In the modified ISC code, the final plume rise esllmates from BLP are used Instead of the stack heights assigned within the input flle. Also, the exit temperature and exit velocity were selected to ensure that no further plume rise would be simulated in ISG.

For this anaIyGk, large and small recepror grlds were created from DEM ( 1: 2400 scale) data for Glassport and McKeesport, PA. The large grid has a coarser receptor density and was u6ed to identify the area of primary concern. It contained 398 nxeptars and extended in UTM coordinates fmm 4466400in the North to d4565W in the South, and fmm 598910 in the East to 590010In the West, Receptor3 of this large grid were 900meters apatt. The small grid was created based upon the reslrlts of fSC modeling with the lags grid that identified the area of maximum impad. The small grid contained 483 receptors and extended in UTM coordinates from 4463910 in the North to 4660810 in the South, and ham 598440 in the East to 595560in the Wed. In tho small grid the meptors were 150 meters apart.

The ISCSv 3 model was executed using " RURAL" mixing height ciassiffcation as characterizedby Layland and Mew& ( iBS5).

The ISCST 3 input filesused for the large grid { BI, lOLG, INP, B2 10LQ. INP, E1B 1 DLGJNP) and small grid ( Bl lOSM. INP, 82 1 OSMJNP,  38 1OSMJNP) analysis air0 enclosed.

The ISCPREXE program was emutad for mcb of the batte'ries using the appropriate hpul files and plume rhs dam files. The program was exectit& uskg the Command:

iscpr bX 1 OW. lnp bX 1OW. out where " bX 1OW. inp' and " bX 1DW. wt'are the name of the input file, and Ihe name ctf the output file that provlde summary information Another output file from the model nun is GSc) UT PLT". The GSOUT. PLT file cudaim air concentration estlmares In nn9/ m3 at each mceptor Iocat m.

lhe lacation and concentretlon at the maximum impact polnt wem determined by surrunlng concantration estimates at each receptor within the three GSWT. PlT output fiiles that were created by running IsCPR. U< E using the smll receptor grid For E! atteries 1 2 m 8 9, 13 14 15/ 19 20, and 8. Finally, because the total emlsslon rates from the baneries were scaled to 100 gis, the modeled air concentrations are scaled to reflect aaual 2010 LAEA emission rates ( 6.91 Mgyr or 0.22$ 3). The maximum impact paint from This analysis is located at 4462260 North and 597090 East and the BSO concentration is estimated lo be 0.166 mg/ m'. While BSO rnonltoring data are not available to validate his estimate. ACHD's PMlO SIP modeling analysis, which was conducted followingan approach very similar to that of Sdenceg, predicted PMlO concentratlons that correspond closely to monitored PM10 levels;, Also. aa expected, the ACHD and Scienter' studies predicted very similar maximum impad paints,

We wi8 be providing written docurnontation early next week of how the concentration estimates at the offsite maximum impact point were combined with both exposure and toxicity factors to edirna! e n'sk to the rn; uimally exposed individual. In the meantime, we twt that the enclosed infonnatlon win plpw sufficientforyour review of the technical approach used to madel ambient BSO conGentrations associated wlth coke wen emfsstbnafrom We U. S. Steel Glalnon facility. We look forward lo hearing your comments on fie modeling appmeah and the applicability of this rnethpd to Mer U. S. coke plants. However, In the meantime, if you should have any questions concerning Me attached materbl, please call Nick Gudka at ( 703) 684 0123.


[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Rules and Regulations]
[Pages 6962-6963]
[FR Doc No: 2012-3102]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0060]

Drawbridge Operation Regulation; Oakland Inner Harbor, Oakland,
CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eleventh Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Fruitvale Avenue Drawbridge across Oakland Inner Harbor, mile 5.6,
between the cities of Alameda and Oakland, Alameda County, CA. The
deviation is necessary to allow the County of Alameda Public Works
Agency to perform seismic retrofitting on the drawbridge. This
deviation allows the bridge owner to secure the drawspan in the closed-
to-navigation position during the project.

DATES: This deviation is effective from 12:01 a.m., February 13, 2012
to 11:59 p.m. on February 24, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of the docket USCG-2012-0060 and are available
online by going to http://www.regulations.gov, inserting USCG-2012-0060
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 rule,
call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast
Guard District; 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: The County of Alameda Public Works Agency
has requested a temporary change to the operation of the Fruitvale
Avenue Drawbridge, mile 5.61, over Oakland Inner Harbor, between the
cities of Alameda and Oakland, Alameda County, CA. The drawbridge
navigation span provides a vertical clearance of 15 feet above Mean
High Water in the closed-to-navigation position. The draw opens on
signal; except that, from 8 a.m. to 9 a.m. and 4:30 p.m. to 6:30 p.m.
Monday through Friday except Federal holidays, the draw need not be
opened for the passage of vessels. However, the draw shall open during
the above closed periods for vessels which must, for reasons of safety,
move on a tide or slack water, if at least two hours notice is given,
as required by 33 CFR 117.181. Navigation on the waterway is commercial
and recreational.
    The drawspan will be secured in the closed-to-navigation position
for seismic retrofitting from 12:01 a.m., February 13, 2012 to 11:59
p.m. on February 24, 2012. At all other times, the drawspan will
promptly return to normal operation. This temporary deviation has been
coordinated with waterway users.

No objections to the proposed temporary deviation were raised.
    Vessels that can transit the bridge, while in the closed-to-
navigation position, may continue to do so at any time.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: January 27, 2012.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2012-3102 Filed 2-9-12; 8:45 am]
BILLING CODE 9110-04-P