[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60256-60258]
[FR Doc No: 2021-23724]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1318, FDA-2020-E-1319, FDA-2020-E-1320, FDA-
2020-E-1321, FDA-2020-E-1322, and FDA-2020-E-1323]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VYONDYS 53

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 VYONDYS 53 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 January 3, 2022.
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 May 2, 2022. 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 January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. 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 Nos.
FDA-2020-E-1318, FDA-2020-E-1319, FDA-2020-E-1320, FDA-2020-E-1321,
FDA-2020-E-1322, and FDA-2020-E-1323 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; VYONDYS 53''. 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 VYONDYS 53
(golodirsen). VYONDYS 53 is indicated for the treatment of Duchenne
muscular dystrophy (DMD) in patients who have a confirmed mutation of
the DMD gene that is amenable to exon 53 skipping. This indication is
approved under accelerated approval based on an increase in dystrophin
production in skeletal muscle observed in patients treated with VYONDYS
53. Continued approval for this indication may be contingent upon
verification of a clinical benefit in confirmatory trials. Subsequent
to this approval, the USPTO received patent term restoration
applications for VYONDYS 53 (U.S. Patent Nos. 9,024,007; 9,994,851;
10,227,590; 10,266,827; 10,421,966; and RE47,691) from The University
of Western Australia, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated July 14, 2020, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of VYONDYS 53 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
VYONDYS 53 is 1,833 days. Of this time, 1,474 days occurred during the
testing phase of the regulatory review period, while 359 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:
December 7, 2014. The University of Western Australia claims that
January 28, 2016, is the date the investigational new drug application
(IND) became effective. However, FDA records indicate that the IND's
first effective date was December 7, 2014, which was 30 days after FDA
receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 19,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for VYONDYS 53 (NDA 211970) was initially submitted
on December 19, 2018.
    3. The date the application was approved: December 12, 2019. FDA
has verified the applicant's claim that NDA 211970 was approved on
December 12, 2019.
    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 80 days, 124 days, 276 days, 454 days, or 888 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: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23724 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Rules and Regulations]
[Pages 41368-41370]
[FR Doc No: 2020-14406]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2020-0143]
RIN 1625-AA08

Special Local Regulation; Upper Potomac River, National Harbor,
MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary special local
regulations for certain waters of the Upper Potomac River. This action
is necessary to provide for the safety of life on these navigable
waters located at National Harbor, MD, on September 27, 2020, during an
open water swim event. This regulation prohibits persons and vessels
from being in the regulated area unless authorized by the Captain of
the Port Maryland-National Capital Region or the Coast Guard Patrol
Commander.

DATES: This rule is effective from 7 a.m. to 11 a.m. on September 27,
2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0143 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ron Houck, U.S. Coast Guard Sector Maryland-National
Capital Region; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Coast Guard Patrol Commander
SNPRM Supplemental notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard published a notice of proposed rulemaking (NPRM) on
April 1, 2020 (85 FR 18157), proposing to establish a special local
regulation for the ``Washington, DC Sharkfest Swim,'' on the Upper
Potomac River. The Coast Guard published a supplemental notice of
proposed rulemaking (SNPRM) on May 22, 2020 (85 FR 31099), to amend the
date of the proposed special local regulation from June 7, 2020, to
September 27, 2020, and reopened the comment period to account for the
change. The comment period for the SNPRM closed June 22, 2020. The
Coast Guard received no comments on either the NPRM or SNPRM.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041. The Captain of the Port Maryland-National Capital Region (COTP)
has determined that potential hazards associated with this swim event
will be a safety concern for anyone intending to operate in or near the
swim area. The purpose of this rule is to protect event participants,
non-participants, and transiting vessels on certain waters of the Upper
Potomac River before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published April
1, 2020, and our SNPRM published May 22, 2020. There are no changes in
the regulatory text of this rule from the proposed rule in the SNPRM.
    This rule establishes a special local regulation to be enforced
from 7 a.m. to 11 a.m. on September 27, 2020. The regulated area will
cover all navigable waters of the Upper Potomac River, within an area
bounded by a line connecting the following points: From the Rosilie
Island shoreline at latitude 38[deg]47'30.30'' N, longitude
077[deg]01'26.70'' W, thence west to latitude 38[deg]47'30.00'' N,
longitude 077[deg]01'37.30'' W, thence south to latitude
38[deg]47'08.20'' N, longitude 077[deg]01'37.30'' W, thence east to
latitude 38[deg]47'09.00'' N, longitude 077[deg]01'09.20'' W, thence
southeast along the pier to latitude 38[deg]47'06.30'' N, longitude
077[deg]01'02.50'' W, thence north along the shoreline and west along
the southern extent of the Woodrow Wilson (I-95/I-495) Memorial Bridge
and south and west along the shoreline to the point of origin, located
at National Harbor, MD. The regulated area is approximately 1,210 yards
in length and 740 yards in width.
    The duration of the special local regulations and size of the
regulated area are intended to ensure the safety of life on these
navigable waters before, during, and after this swim event, scheduled
from 7:30 a.m. to 10:30 a.m. on September 27, 2020. The COTP and the
Coast Guard Patrol Commander (PATCOM) have authority to forbid and
control the movement of all vessels and persons, including event
participants, in the regulated area.
    Except for Washington, DC Sharkfest Swim event participants and
vessels already at berth, a vessel or person will be required to get
permission from the COTP or PATCOM before entering the regulated area.
Vessel operators can request permission to enter and transit through
the regulated area by contacting the PATCOM on VHF-FM channel 16.
Vessel traffic will be able to safely transit the regulated area once
the PATCOM deems it safe to do so. A person or vessel not registered
with the event sponsor as a participant or assigned as official patrols
will be considered a non-participant. Official

Patrols are any vessel assigned or approved by the Commander, Coast
Guard Sector Maryland-National Capital Region with a commissioned,
warrant, or petty officer on board and displaying a Coast Guard ensign.
    If permission is granted by the COTP or PATCOM, a person or vessel
will be allowed to enter the regulated area or pass directly through
the regulated area as instructed. Vessels will be required to operate
at a safe speed that minimizes wake while within the regulated area.
Official patrol vessels will direct non-participants while within the
regulated area. Vessels will be prohibited from loitering within the
navigable channel. Only participant vessels and official patrol vessels
will be allowed to enter the swim area.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size, time of
day and duration of the regulated area, which will impact a small
designated area of the Upper Potomac River for 4 hours. The Coast Guard
will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16
about the status of the regulated area. Moreover, the rule will allow
vessels to seek permission to enter the regulated area, and vessel
traffic will be able to safely transit the regulated area once the
PATCOM deems it safe to do so.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves
implementation of regulations within 33 CFR part 100 applicable to
organized marine events on the navigable waters of the United States
that could negatively impact the safety of waterway users and shore
side activities in the event area lasting for 4 hours. It is
categorically excluded from further review under paragraph L61 of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Memorandum For Record for Categorically Excluded Actions supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to

coordinate protest activities so that your message can be received
without jeopardizing the safety or security of people, places or
vessels.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.501T05-0143 to read as follows:

Sec.  100.501T05-0143  Washington, DC Sharkfest Swim, Upper Potomac
River, National Harbor, MD.

    (a) Regulated area. The regulations in this section apply to the
following area: All navigable waters of the Upper Potomac River, within
an area bounded by a line connecting the following points: From the
Rosilie Island shoreline at latitude 38[deg]47'30.30'' N, longitude
077[deg]01'26.70'' W, thence west to latitude 38[deg]47'30.00'' N,
longitude 077[deg]01'37.30'' W, thence south to latitude
38[deg]47'08.20'' N, longitude 077[deg]01'37.30'' W, thence east to
latitude 38[deg]47'09.00'' N, longitude 077[deg]01'09.20'' W, thence
southeast along the pier to latitude 38[deg]47'06.30'' N, longitude
077[deg]01'02.50'' W, thence north along the shoreline and west along
the southern extent of the Woodrow Wilson (I-95/I-495) Memorial Bridge
and south and west along the shoreline to the point of origin, located
at National Harbor, MD. These coordinates are based on datum NAD 1983.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Coast Guard Patrol Commander (PATCOM) means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Official Patrol means any vessel assigned or approved by Commander,
Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means all persons and vessels registered with the event
sponsor as participating in the Washington DC Sharkfest Swim event or
otherwise designated by the event sponsor as having a function tied to
the event.
    (c) Regulations. (1) Except for vessels already at berth, all non-
participants are prohibited from entering, transiting through,
anchoring in, or remaining within the regulated area described in
paragraph (a) of this section unless authorized by the COTP Maryland-
National Capital Region or PATCOM.
    (2) To seek permission to enter, contact the COTP Maryland-National
Capital Region at telephone number<PHONE_NUMBER> or on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz) or the PATCOM on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz). Those in the regulated area must
comply with all lawful orders or directions given to them by the COTP
Maryland-National Capital Region or PATCOM.
    (3) The COTP Maryland-National Capital Region will provide notice
of the regulated area through advanced notice via Fifth Coast Guard
District Local Notice to Mariners, broadcast notice to mariners, and
on-scene official patrols.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 7 a.m.
to 11 a.m. on September 27, 2020.

    Dated: June 29, 2020.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2020-14406 Filed 7-9-20; 8:45 am]
BILLING CODE 9110-04-P