[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18543-18544]
[FR Doc No: 2014-07306]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2467-020]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing, Soliciting Motions To Intervene and Protests, Ready for
Environmental Analysis, and Soliciting Comments, Recommendations,
Preliminary Terms and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License.
    b. Project No.: 2467-020.
    c. Date filed: February 8, 2012.
    d. Applicant: Pacific Gas and Electric Company (PG&E).
    e. Name of Project: Merced Falls Hydroelectric Project.
    f. Location: The existing project is located on the Merced River on
the border of Merced and Mariposa counties, California, immediately
downstream of the Merced River Hydroelectric Project (FERC No. 2179),
operated by the Merced Irrigation District (Merced ID). The project
would occupy 1.62 acres of Federal land managed by the Bureau of Land
Management.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825.
    h. Applicant Contact: Pacific Gas and Electric Company, Power
Generation, P.O. Box 770000, MC N11C, San Francisco, CA 94177-0001;
Telephone<PHONE_NUMBER>.
    i. FERC Contact: Matt Buhyoff,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, recommendations, preliminary
terms and conditions, and preliminary fishway prescriptions using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-2467-020.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The existing Merced Falls Hydroelectric Project consists of: (1)
A concrete gravity dam with a structural height of 34 feet, and a crest
length of 575 feet; (2) three radial gates, each 20 feet in length and
13.5 feet high; (3) a one-mile long project impoundment has
approximately 900 acre-feet of storage capacity, a useable storage
capacity of approximately 579 acre-feet, a total surface area of
approximately 65 acres; and a normal impoundment elevation of 344 feet
msl; (4) a powerhouse housing a 3.4-megawatt (MW) turbine/generator
unit and a vertical Kaplan-type four blade turbine; (5) a 1,000-feet
long earthen levee with a crest width of eight feet; (6) an adjacent
intake structure with a debris rack, and; (7) a non-operable fish
ladder.
    The Merced Falls Project is operated in a run-of-river mode
dependent on water outflow from Merced ID's upstream Merced River
Project. Inflow to the project passes through the impoundment, which is
kept at a constant water elevation and then either through the
powerhouse or through the dam's radial gates. Flows of up to
approximately 1,750 cubic feet per second (cfs) are diverted through
the powerhouse, and then discharged to the Merced River via the
tailrace. When inflows exceed 2,200 cfs, the project spills water.
During flood events with

flows greater than 12,250 cfs, the needle beams can be dropped,
allowing the 575-feet concrete section of the dam to act as a spillway.
Power is transmitted via underground cable to a non-project switchyard
located adjacent to the powerhouse.
    The project has a dependable capacity of 1.7 MW and an annual
average generation of approximately 13.5-GWh (gigawatt-hours). PG&E is
not proposing any new or upgraded facilities or structural changes to
the project. PG&E does propose to modify the project boundary by
removing approximately 4.8 acres of project lands, which PG&E indicates
are not needed for project purposes.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application.
    A copy of all other filings in reference to this application must
be accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    o. Procedural Schedule:
    The application will be processed in conjunction with the Merced
River Hydroelectric Project application (P-2179-042) and according to
the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, preliminary   May, 2014.
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues Draft EA or EIS......  November, 2014.
Comments on Draft EA or EIS............  January, 2015.
Modified Terms and Conditions..........  March, 2015.
Commission Issues Final EA or EIS......  June, 2015.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) evidence of waiver of water quality certification.

    Dated: March 24, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-07306 Filed 4-1-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 5, 2010 (Volume 75, Number 24)]
[Proposed Rules]
[Page 5930-5931]
[DOCID:fr05fe10-19]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003; [Internal Agency Docket No. FEMA-B-1053]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule; correction.

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SUMMARY: FEMA is correcting a table for Ransom County, North Dakota,
and Incorporated Areas.

FOR FURTHER INFORMATION CONTACT: Kevin C. Long, Acting Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-2820 or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes determinations of Base (1% annual-chance) Flood
Elevations (BFEs) and modified BFEs for communities participating in
the National Flood Insurance Program (NFIP), in accordance with section
110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and
44 CFR 67.4(a). These proposed BFEs and modified BFEs, together with
the floodplain management criteria required by 44 CFR 60.3, are minimum
requirements. They should not be construed to mean that the community
must change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own, or pursuant to policies established
by other Federal, State, or regional entities. These proposed
elevations are used to meet the floodplain management requirements of
the NFIP and are also used to calculate the appropriate flood insurance
premium rates for new buildings built after these elevations are made
final, and for the contents in these buildings.

Correction

    FEMA is correcting a table in a proposed rule which published on
May 26, 2009, at 74 FR 24729. The table for Ransom County, North
Dakota, and Incorporated Areas contained incorrect information for the
flooding source ``Sheyenne River.''
    The May 26, 2009, proposed rule contained a table entitled ``Ransom
County, North Dakota, and Incorporated Areas,'' which contained errors.
For flooding source ``Sheyenne River,'' the table contained inaccurate
information as to the communities affected. FEMA is now publishing a
revised table for Ransom County, North Dakota, and Incorporated Areas,
containing the accurate information, to address these prior errors. The
information provided in the table below should be used in lieu of the
table published on May 26, 2009.

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet (NAVD)
                                       Location of referenced     Depth in feet above
         Flooding source(s)                 elevation **       ground [caret] Elevation    Communities affected
                                                                    in meters (MSL)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                               Ransom County, North Dakota, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Sheyenne River......................  Approximately 1,064             None         +990  City of Fort Ransom,
                                       feet upstream of                                   City of Lisbon,
                                       Richland County                                    Unincorporated Areas
                                       boundary.                                          of Ransom County.
----------------------------------------------------------------------------------------------------------------
                                      Approximately 7,465             None       +1,160
                                       feet downstream of
                                       State Highway 46.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
 Depth in feet above ground.
+ North American Vertical Datum.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    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 58054-4115.
----------------------------------------------------------------------------------------------------------------

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

Sandra K. Knight,
Deputy Assistant Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2010-2491 Filed 2-4-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: March 3, 2009 (Volume 74, Number 40)]
[Notices]
[Page 9329-9331]
[DOCID:fr03mr09-139]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-2000-7918; FMCSA-
2000-8398; FMCSA-2002-13411; FMCSA-2005-20027]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
11 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective April 5, 2009. Comments must be
received on or before April 2, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-1998-4334; FMCSA-2000-7006;
FMCSA-2000-7918; FMCSA-2000-8398; FMCSA-2002-13411; FMCSA-2005-20027,
using any of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.

     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 11 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 11 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Richard D. Carlson, David J. Collier, Robert P. Conrad, Sr., Donald P.
Dodson, Jr., Stephanie D. Klang, Mark J. Koscinski, Dexter L. Myhre,
Henry C. Patton, George D. Schell, James A. Stoudt, Ralph A. Thompson.
    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 11 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (63 FR 66226; 64 FR 16517; 66 FR 17994; 68 FR 15037; 70 FR
14747; 72 FR 12665; 65 FR 20245; 65 FR 57230; 67 FR 57266; 69 FR 52741;
65 FR 66286; 66 FR 13825; 68 FR 10300; 70 FR 14747; 65 FR 78256; 66 FR
16311; 68 FR 13360; 70 FR 12265; 67 FR 76439; 68 FR 10298; 70 FR 7545;
70 FR 2701; 70 FR 16887). Each of these 11 applicants has requested
renewal of the exemption and has submitted evidence showing that the
vision in the better eye continues to meet the standard specified at 49
CFR 391.41(b)(10) and that the vision impairment is stable. In
addition, a review of each record of safety while driving with the
respective vision deficiencies over the past two years indicates each
applicant continues to meet the vision exemption standards. These
factors provide an adequate basis for predicting each driver's ability
to continue to drive safely in interstate commerce. Therefore, FMCSA
concludes that extending the exemption for each renewal applicant for a
period of two years is likely to achieve a level of safety equal to
that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by April 2, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 11 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these drivers, are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is

being compromised or if continuation of the exemption would not be
consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315, FMCSA will take immediate steps to revoke the exemption of a
driver.

    Issued on: February 25, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-4448 Filed 3-2-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 55 (Wednesday, March 22, 2023)]
[Notices]
[Pages 17233-17235]
[FR Doc No: 2023-05799]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-3293 and FDA-2019-E-3294]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MULPLETA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for MULPLETA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by May 22, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 18, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 22, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-3293 and FDA-2019-E-3294 for ``Determination of Regulatory
Review Period for Purposes of Patent

Extension; MULPLETA.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, MULPLETA
(lusutrombopag) indicated for treatment of thrombocytopenia in adult
patients with chronic liver disease who are scheduled to undergo a
procedure. Subsequent to this approval, the USPTO received patent term
restoration applications for MULPLETA (U.S. Patent Nos. 7,601,746 and
8,889,722) from Shionogi & Co., Ltd. and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated October 29, 2019, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of MULPLETA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
MULPLETA is 3,464 days. Of this time, 3,246 days occurred during the
testing phase of the regulatory review period, while 218 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
February 6, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
February 6, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 26,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for MULPLETA (NDA 210923) was initially submitted on
December 26, 2017.
    3. The date the application was approved: July 31, 2018. FDA has
verified the applicant's claim that NDA 210923 was approved on July 31,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 784 days or 1,715 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written

petitions (two copies are required) to the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

    Dated: March 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05799 Filed 3-21-23; 8:45 am]
BILLING CODE 4164-01-P