Your World of Legal Intelligence
 United States | 1-800-335-6202

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

As Enacted ( Federal Register) Cited authorities 5 Cited in Related
Vincent
Published date07 July 2021
Citation86 FR 35803
Record Number2021-14461
SectionNotices
CourtFood And Drug Administration
35803
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
58786 (September 24, 2013). In this
guidance, we describe the two forms of
a UDI, clarify the content of the UDI,
and address the use of data delimiters
that identify specific data elements
within the UDI. The guidance also
addresses the recommended order of the
data in the easily readable plain text
form of a UDI carrier. This guidance
does not apply to universal product
codes.
A notice of availability of the draft
guidance appeared in the Federal
Register of July 26, 2016 (81 FR 48814).
FDA considered the comments received
and revised the guidance as appropriate
in response to the comments.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Unique Device
Identification System: Form and
Content of the Unique Device Identifier
(UDI).’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensive-
regulatory-assistance/guidance-
documents-medical-devices-and-
radiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-
regulatory-information-biologics/
biologics-guidances. Persons unable to
download an electronic copy of
‘‘Unique Device Identification System:
Form and Content of the Unique Device
Identifier (UDI)’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1500035 and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
21 CFR part Topic OMB Control
No.
801 subpart B and 830 ............................................................... Unique Device Identification ....................................................... 0910–0720
Dated: July 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14462 Filed 7–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–2223]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BARHEMSYS
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BARHEMSYS 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 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 September 7, 2021.
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
January 3, 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 September 7,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 7, 2021.
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
Submission’’ 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
VerDate Sep<11>2014 17:44 Jul 06, 2021 Jkt 253001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\07JYN1.SGM 07JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
35804
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
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–
2020–E–2223 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; BARHEMSYS.’’
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, 240–402–7500.
•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 § 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, 240–402–7500.
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,
301–796–3600.
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 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 BARHEMSYS
(amisulpride) indicated in adults for: (1)
Prevention of postoperative nausea and
vomiting (PONV) either alone or in
combination with an antiemetic of a
different class, or (2) treatment of PONV
in patients who have received
antiemetic prophylaxis with an agent of
a different class or have not received
prophylaxis. Subsequent to this
approval, the USPTO received a patent
term restoration application for
BARHEMSYS (U.S. Patent No.
9,084,765) from Acacia Pharma Limited
and the USPTO requested FDA’s
assistance in determining the patent’s
eligibility for patent term restoration. In
a letter dated December 14, 2020, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of BARHEMSYS 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
BARHEMSYS is 2,960 days. Of this
time, 2,085 days occurred during the
testing phase of the regulatory review
period, while 875 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: January 21,
2012. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on January 21, 2012.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: October 5, 2017. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
BARHEMSYS (NDA 209510) was
initially submitted on October 5, 2017.
3. The date the application was
approved: February 26, 2020. FDA has
verified the applicant’s claim that NDA
209510 was approved on February 26,
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 application for patent extension,
this applicant seeks 1,085 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 § 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
§ 60.30, including but not limited to:
Must be timely (see
DATES
), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
VerDate Sep<11>2014 17:44 Jul 06, 2021 Jkt 253001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\07JYN1.SGM 07JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
35805
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
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: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14461 Filed 7–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–1315 and FDA–
2020–E–1316]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BEOVU
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BEOVU 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 biological 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 September 7, 2021.
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
January 3, 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 September 7,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 7, 2021.
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–1315 and FDA–2020–E–1316,
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; BEOVU.’’ 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, 240–402–7500.
•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 § 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, 240–402–7500.
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,
301–796–3600.
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
VerDate Sep<11>2014 17:44 Jul 06, 2021 Jkt 253001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\07JYN1.SGM 07JYN1
khammond on DSKJM1Z7X2PROD with NOTICES

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT