[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Rules and Regulations]
[Pages 77200-77201]
[FR Doc No: 2023-24845]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2023-0883]

Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun
Bay, Military Ocean Terminal Concord, CA

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a safety zone in the navigable
waters of Suisun Bay, off Concord, CA, in support of explosive on-
loading to Military Ocean Terminal Concord (MOTCO) on November 13,
2023, through November 20, 2023. This safety zone is necessary to
protect personnel, vessels, and the marine environment from potential
explosion within the explosive arc. The safety zone is open to all
persons and vessels for transitory use, but vessel operators desiring
to anchor or otherwise loiter within the safety zone must obtain the
permission of the Captain of the Port San Francisco or a designated
representative. All persons and vessels operating within the safety
zone must comply with all directions given to them by the Captain of
the Port San Francisco or a designated representative.

DATES: The regulations in 33 CFR 165.1198 will be enforced from 12:01
a.m. on November 13, 2023, until 11:59 p.m. on November 20, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call, or email LT Abby Hamann, U.S. Coast
Guard Sector San Francisco, Waterways Management Division, at 415-399-
3585, [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in 33 CFR 165.1198 for the Military Ocean Terminal Concord, CA (MOTCO)
regulated area from 12:01 a.m. on November 13, 2023, until 11:59 p.m.
on

November 20, 2023, or as announced via marine local broadcasts. This
safety zone is necessary to protect personnel, vessels, and the marine
environment from potential explosion within the explosive arc. The
regulation for this safety zone, Sec.  165.1198, specifies the location
of the safety zone which encompasses the navigable waters in the area
between 500 yards of MOTCO Pier in position 38[deg]03'30'' N,
122[deg]01'14'' W and 3,000 yards of the pier. During the enforcement
periods, as reflected in Sec.  165.1198(d), if you are the operator of
a vessel in the regulated area you must comply with the instructions of
the COTP or the designated on-scene patrol personnel. Vessel operators
desiring to anchor or otherwise loiter within the safety zone must
contact Sector San Francisco Vessel Traffic Service at<PHONE_NUMBER> or
VHF Channel 14 to obtain permission.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via marine information broadcasts.

    Dated: November 4, 2023.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2023-24845 Filed 11-8-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Notices]
[Page 26916-26917]
[DOCID:fr04jn09-128]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2009-0054]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on proposed collection of
information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before June 15, 2009.

ADDRESSES: You may submit comments [identified by DOT Docket No. NHTSA-
2009-0054] by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online 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., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Timothy M.
Pickrell, NHTSA, 1200 New Jersey Avenue, SE., W55-204, NVS-421,
Washington, DC 20590. Mr. Pickrell's telephone number is (202) 366-
2903.
    Please identify the relevant collection of information by referring
to its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: The National Survey on the Use of Booster Seats.
    OMB Control Number: 2127-0644.
    Affected Public: Motorists in passenger vehicles at gas stations,
fast food restaurants, and other types of sites frequented by children
during the time in which the survey is conducted.
    Form Number: NHTSA Form 1010.
    Abstract: The National Survey of the Use of Booster Seats is being
conducted to respond to Section 14(i) of the Transportation Recall
Enhancement, Accountability, and Documentation (TREAD) Act of 2000. The
Act directs the Department of Transportation to reduce the deaths and
injuries among children in the 4 to 8 year old age group that are
caused by failure to use a booster seat by 25%. Conducting the National
Survey of the Use of Booster Seats provides the Department with
invaluable information on who is and is not using booster seats,
helping the Department better direct its outreach programs to ensure
that children are protected to the greatest degree possible when they
ride in motor vehicles. The OMB approval for this survey is scheduled
to expire on July 31, 2009. NHTSA seeks an extension to this approval
in order to obtain this important survey data, saving more children and
helping to comply with the TREAD Act requirement.
    Estimated Annual Burden: 320 hours
    Estimated Number of Respondents: Approximately 4,800 adult
motorists in passenger vehicles at gas stations, fast food restaurants,
and other types of sites frequented by children during the time in
which the survey is conducted.
    Comments are invited on: whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden

of the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued on: May 7, 2009.
Marilena Amoni,
Associate Administrator, National Center for Statistics and Analysis,
National Highway Traffic Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590.
[FR Doc. E9-13076 Filed 6-3-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4490-4492]
[FR Doc No: 2018-01889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-0640]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MOBI-C CERVICAL DISC PROSTHESIS

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 MOBI-C CERVICAL DISC
PROSTHESIS and is publishing this notice of that determination as
required by law. FDA has made the

determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
2, 2018. 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 July 30, 2018. 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. Electronic comments
must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-E-0640 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; MOBI-C CERVICAL DISC PROSTHESIS.''
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.
     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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 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 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device MOBI-C CERVICAL
DISC PROSTHESIS. MOBI-C CERVICAL DISC PROSTHESIS is indicated in
skeletally mature patients for reconstruction of the disc at one level
from C3-C7 following single-level discectomy for intractable
radiculopathy (arm pain and/or a neurological deficit) with or without
neck pain or

myelopathy due to a single-level abnormality localized to the level of
the disc space and at least one of the following conditions confirmed
by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus,
spondylosis (defined by the presence of osteophytes), and/or visible
loss of disc height compared to adjacent levels. Subsequent to this
approval, the USPTO received a patent term restoration application for
MOBI-C CERVICAL DISC PROSTHESIS (U.S. Patent No. 8,627,999) from
Beaurain et al., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated November 5, 2015, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of MOBI-C CERVICAL DISC PROSTHESIS 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
MOBI-C CERVICAL DISC PROSTHESIS is 2,758 days. Of this time, 1,821 days
occurred during the testing phase of the regulatory review period,
while 937 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: January 20, 2006. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
October 14, 2005. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to begin on
January 20, 2006, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): January
14, 2011. FDA has verified the applicant's claim that the premarket
approval application (PMA) for MOBI-C CERVICAL DISC PROSTHESIS (PMA
P110002) was initially submitted January 14, 2011.
    3. The date the application was approved: August 7, 2013. FDA has
verified the applicant's claim that PMA P110002 was approved on August
7, 2013.
    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 application for patent extension,
this applicant seeks 323 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: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01889 Filed 1-30-18; 8:45 am]
 BILLING CODE 4164-01-P