[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89453-89455]
[FR Doc No: 2023-28511]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-0931 and FDA-2022-E-0936]

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

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 ZOKINVY 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 patents 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 February 26, 2024.
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 June 24, 2024. 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 February 26, 2024. 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-2022-E-0931 and FDA-2022-E-0936 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ZOKINVY.'' 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 ZOKINVY
(lonafarnib). ZOKINVY is indicated in patients 12 months of age and
older with a body surface area of 0.39 m\2\ and above to reduce risk of
mortality in Hutchinson-Gilford Progeria Syndrome; and for treatment of
processing-deficient Progeroid Laminopathies with either Heterozygous
LMNA mutation with progerin-like protein accumulation or Homozygous or
compound heterozygous ZMPSTE24 mutations.
    Subsequent to this approval, the USPTO received a patent term
restoration application for ZOKINVY (U.S. Patent Nos. 7,838,531 and
8,828,356) from the Government of the United States of America as
represented by the Department of Health and Human Services; the Regents
of the University of Michigan; Progeria Research Foundation, Inc.; and
the University of North Carolina at Chapel Hill, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated November 9, 2022, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of ZOKINVY 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
ZOKINVY is 5,023 days. Of this time, 4,777 days occurred during the
testing phase of the regulatory review period, while 246 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 21, 2007. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
February 21, 2007.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 20,
2020. FDA has verified the applicant's claim that

the new drug application (NDA) for ZOKINVY (NDA 213969) was initially
submitted on March 20, 2020.
    3. The date the application was approved: November 20, 2020. FDA
has verified the applicant's claim that NDA 213969 was approved on
November 20, 2020.
    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 1,255 days or 1,948 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: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28511 Filed 12-26-23; 8:45 am]
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[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67112-67113]
[FR Doc No: 2022-24156]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Research, Engineering, and Development Advisory Committee
(REDAC); Notice of Public Meeting

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Research, Engineering,
and Development Advisory Committee (REDAC).

DATES: The meeting will be held on November 18, 2022, from 10 a.m.-12
Noon, EST. The meeting will be open to the public, except from 10 a.m.
to 11:15 a.m. when a partially closed session will occur in order to
conduct a review and discussion of the technical content contained
within the FAA's Unmanned Aircraft System-Advanced Air Mobility
Integration Research Plan. Requests for accommodations to a disability
must be received by November 10, 2022. Individuals requesting to speak
during the meeting must submit a written copy of their remarks to DOT
by November 10, 2022. Requests to submit written materials to be
reviewed during the meeting must be received no later than November 10,
2022.

ADDRESSES: The meeting will be held in a virtual setting. Virtual
attendance information will be provided upon registration. A detailed
agenda will be

available on the REDAC internet website at http://www.faa.gov/go/redac
at least one week before the meeting, along with copies of the meeting
minutes after the meeting.

FOR FURTHER INFORMATION CONTACT: Chinita Roundtree-Coleman, REDAC PM/
Lead, FAA/U.S. Department of Transportation, at [email protected] or<PHONE_NUMBER>. Any committee-related request should
be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The Research, Engineering, and Development Advisory Committee was
created under the Federal Advisory Committee Act (FACA), in accordance
with Public Law 100-591 (1988) and Public Law 101-508 (1990) to provide
advice and recommendations to the FAA Administrator in support of the
Agency's Research and Development (R&D) portfolio.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 FAA's Unmanned Aircraft System-Advanced Air Mobility
Integration Research Plan
 FAA Research and Development Strategies, Initiatives and
Planning,
 Impacts of emerging technologies, new entrant vehicles, and
dynamic operations within the National Airspace System.

III. Public Participation

    The meeting will be open to the public, except from 10 a.m. to
11:15 a.m., when a partially closed session will occur in order to
conduct a review and discussion of the technical content contained
within the FAA's Unmanned Aircraft System-Advanced Air Mobility
Integration Research Plan. The meeting will be partially closed to the
public consistent with Exemption 4 of the Government in the Sunshine
Act, 5 U.S.C. 552b(c)(4), which allows FAA to close a meeting if an
open meeting would disclose trade secrets and commercial or financial
information obtained from a person and privileged or confidential.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    There will be 45 minutes allotted for oral comments from members of
the public joining the meeting. To accommodate as many speakers as
possible, the time for each commenter may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, the FAA may conduct a
lottery to determine the speakers. Speakers are requested to submit a
written copy of their prepared remarks for inclusion in the meeting
records and circulation to REDAC members before the deadline listed in
the DATES section. All prepared remarks submitted on time will be
accepted and considered as part of the meeting's record. Any member of
the public may present a written statement to the committee at any
time.

    Issued in Washington, DC.
Chinita Roundtree-Coleman,
REDAC PM/Lead, Federal Aviation Administration.
[FR Doc. 2022-24156 Filed 11-4-22; 8:45 am]
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