Determination of Regulatory Review Period for Purposes of Patent Extension; ESPEROCT, 16992-16994 [2023-05658]
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16992
Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section; activity
FDA form No.
Number of
responses per
respondent
Number of
respondents
Total
annual
responses
Average
burden per
response 2
Total hours
108.25(c)(2); Food process
filing for acidified method.
108.35(c)(2); Food process
filing for low-acid retorted
method.
108.35(c)(2); Food process
filing for water activity/formulation control method.
108.35(c)(2); Food process
filing for low-acid aseptic
systems.
108.25(d); 108.35(d) and
(e); Report of any instance of potential healthendangering spoilage,
process deviation, or contamination with microorganisms where any lot
of the food has entered
distribution in commerce.
2541e
726
11
7,986
0.333 (20 minutes) .............
2,659
2541d
336
12
4,032
0.333 (20 minutes) .............
1,343
2541f
37
6
222
0.333 (20 minutes) .............
74
2541g
42
22
924
0.75 (45 minutes) ...............
693
N/A
1
1
1
4 .........................................
4
Total .............................
........................
........................
........................
........................
.............................................
4,883
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of respondents in table 1 on
registrations, process filings, and reports
received. The hours per response
reporting estimates are based on our
experience with similar programs and
information received from industry.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
108, 113, and 114 .................................
10,392
1
10,392
250
2,598,000
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our regulations require that
processors mark thermally processed
low-acid foods in hermetically sealed
containers (§ 113.60(c)) and acidified
foods (§ 114.80(b)) with an identifying
code to permit lots to be traced after
distribution. No burden has been
estimated for the third-party disclosure
requirements in §§ 113.60(c) and
114.80(b) because the coding process is
done as a usual and customary part of
normal business activities. Coding is a
business practice in foods for liability
purposes, inventory control, and
process control in the event of a
problem. Under 5 CFR 1320.3(b)(2), the
time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
OMB approval, we have made no
adjustments to our burden estimate.
Dated: March 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05742 Filed 3–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–5280]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ESPEROCT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
for ESPEROCT 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
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 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 21, 2023. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
E:\FR\FM\21MRN1.SGM
21MRN1
Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
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.
ddrumheller on DSK120RN23PROD with NOTICES1
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–
2019–E–5280 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; ESPEROCT.’’
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
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
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-201509-18/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
PO 00000
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Fmt 4703
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16993
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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
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 biological 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 biologic product ESPEROCT
(antihemophilic factor (recombinant),
glycopegylated-exei). ESPEROCT is
indicated for use in adults and children
with hemophilia A for: (1) on-demand
treatment and control of bleeding
episodes, (2) perioperative management
of bleeding, and (3) routine prophylaxis
to reduce the frequency of bleeding
episodes. Subsequent to this approval,
the USPTO received a patent term
restoration application for ESPEROCT
(U.S. Patent No. 8,536,126) from Novo
Nordisk A/S, and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated August 20,
2020, FDA advised the USPTO that this
human biological product had
undergone a regulatory review period
and that the approval of ESPEROCT
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
ESPEROCT is 3,129 days. Of this time,
2,771 days occurred during the testing
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Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
phase of the regulatory review period,
while 358 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 (21 U.S.C. 355(i))
became effective: July 29, 2010. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 29, 2010.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): February 27, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
ESPEROCT (BLA 125671) was initially
submitted on February 27, 2018.
3. The date the application was
approved: February 19, 2019. FDA has
verified the applicant’s claim that BLA
125671 was approved on February 19,
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 application for patent extension,
this applicant seeks 1,170 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
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.
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05658 Filed 3–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Council
on Graduate Medical Education
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates for consideration
for appointment as members of the
Council on Graduate Medical Education
(COGME or Council). COGME provides
advice and recommendations on policy,
program development, and other
matters of significance concerning the
physician training and the physician
workforce. Issues addressed by COGME
include the supply and distribution of
the physician workforce in the United
States, including any projected
shortages or excesses of physicians in
medical and surgical specialties and
subspecialities; international medical
graduates; the nature and financing of
undergraduate and graduate medical
education; appropriation levels for
certain programs under title VII of the
PHS Act; and deficiencies in databases
of the supply and distribution of the
physician workforce and postgraduate
programs for training physicians.
DATES: HRSA will accept nominations
on a continuous basis.
ADDRESSES: Nomination packages may
be mailed to Advisory Council
Operations, Bureau of Health
Workforce, HRSA, Room 15N–35, 5600
Fishers Lane, Rockville, Maryland
20857 or submitted electronically by
email to: BHWAdvisoryCouncilFRN@
hrsa.gov.
SUMMARY:
Curi
Kim, M.D., MPH, at 240–472–2313 or
email at ckim@hrsa.gov. A copy of the
current COGME charter, membership,
and reports can be obtained by
accessing the COGME website at https://
www.hrsa.gov/advisory-committees/
graduate-medical-edu.
SUPPLEMENTARY INFORMATION:
Authorized in 1986, COGME submits
advice and recommendations to the
Secretary of HHS; the Senate Committee
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
on Health, Education, Labor and
Pensions; and the House of
Representatives Committee on Energy
and Commerce. Additionally, COGME
encourages entities providing graduate
medical education to voluntarily
achieve the recommendations of the
Council. Meetings take place at least
twice per year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
on COGME to include individuals who
represent of practicing primary care
physicians, national and specialty
physician organizations, international
medical graduates, medical student and
house staff associations, schools of
allopathic and osteopathic medicine,
public and private teaching hospitals,
and health insurers, business, and labor.
The Secretary of HHS appoints COGME
members to fulfill the duties of the
Council. Interested applicants may selfnominate or be nominated by another
individual or organization.
Individuals selected for appointment
to COGME will be invited to serve for
4 years. Members appointed as SGEs
receive a stipend and reimbursement for
per diem and travel expenses incurred
for attending COGME meetings and/or
conducting other business on behalf of
COGME, as authorized by section 5
U.S.C. 5703 for persons employed
intermittently in government service
and PHS Act section 762(g).
A nomination package should include
the following information for each
applicant: (1) if nominated by another
individual or organization, a letter of
recommendation from the nominator
stating the basis for the nomination (i.e.,
what specific attributes, perspectives,
and/or skills does the individual
possess that would benefit the workings
of COGME) and the nominee’s field(s) of
expertise as well as the nominator’s
name, affiliation, and contact
information (address, daytime telephone
number, and email address); (2) a letter
of interest from the applicant stating the
reasons the applicant would like to
serve on COGME; and (3) a biographical
sketch of the applicant, including the
applicant’s curriculum vitae and contact
information (address, daytime telephone
number, and email address).
Nomination packages may be submitted
directly by the applicant or by the
person/organization nominating the
candidate.
HHS endeavors to ensure that the
membership of COGME is balanced
fairly in terms of points of view
represented and that individuals from a
broad representation of geographic
areas, gender, and ethnic and minority
groups, as well as individuals with
E:\FR\FM\21MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16992-16994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05658]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-E-5280]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ESPEROCT
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 ESPEROCT 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
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 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 21, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
[[Page 16993]]
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 No.
FDA-2019-E-5280 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ESPEROCT.'' 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 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, 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 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product ESPEROCT
(antihemophilic factor (recombinant), glycopegylated-exei). ESPEROCT is
indicated for use in adults and children with hemophilia A for: (1) on-
demand treatment and control of bleeding episodes, (2) perioperative
management of bleeding, and (3) routine prophylaxis to reduce the
frequency of bleeding episodes. Subsequent to this approval, the USPTO
received a patent term restoration application for ESPEROCT (U.S.
Patent No. 8,536,126) from Novo Nordisk A/S, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated August 20, 2020, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of ESPEROCT 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
ESPEROCT is 3,129 days. Of this time, 2,771 days occurred during the
testing
[[Page 16994]]
phase of the regulatory review period, while 358 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 (21 U.S.C. 355(i)) became effective: July 29,
2010. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 29,
2010.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): February 27, 2018. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ESPEROCT (BLA 125671) was initially submitted on February 27, 2018.
3. The date the application was approved: February 19, 2019. FDA
has verified the applicant's claim that BLA 125671 was approved on
February 19, 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 application for patent extension,
this applicant seeks 1,170 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 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05658 Filed 3-20-23; 8:45 am]
BILLING CODE 4164-01-P
