Determination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-20, 14849-14851 [2024-04229]
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14849
Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
consistent with proper and efficient
administration.
This request is for an extension with
no changes to the umbrella generic and
all currently approved information
collections, which can be found here:
https://www.reginfo.gov/public/do/
PRAICList?ref_nbr=202311-0970-010.
Respondents: Title IV–E agencies
under the Social Security Act.
Annual Burden Estimates
ANNUAL BURDEN—CURRENTLY APPROVED INFORMATION COLLECTIONS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
CCWIS
Annual
number of
responses per
respondent
Total
number of
respondents
Instrument
Average
burden
hours per
response
Annual
burden
hours
Self-Assessment—Administration .......................................................
Self-Assessment—Adoption ...............................................................
Self-Assessment—Case Management ...............................................
Self-Assessment—Foster Care and Service Provider Management
Self-Assessment—Intake ....................................................................
Self-Assessment—Investigation .........................................................
Self-Assessment: Child Welfare Contributing Agency (CWCA) .........
Self-Assessment: Data Exchanges ....................................................
Self-Assessment: Data Quality ...........................................................
Self-Assessment: Design Requirements ............................................
Self-Assessment: Financial ................................................................
Self-Assessment: Reporting ...............................................................
Self-Assessment: Security ..................................................................
Self-Assessment: Title IV–E Foster Care Maintenance Eligibility ......
Self-Assessment: User Experience ....................................................
55
55
55
55
55
55
55
55
55
55
55
55
55
55
55
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
10
10
10
10
10
10
10
10
10
24
10
10
10
10
10
550
550
550
550
550
550
550
550
550
1,320
550
550
550
550
550
Total Annual Burden for Currently Approved Generics: ..........................
........................
........................
........................
9,020
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUAL BURDEN—POTENTIAL ADDITIONAL INFORMATION COLLECTION REQUESTS
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden
hours per
response
Annual
burden
hours
Future Tools to be developed .........................................................................
55
5
10
2,750
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 5 U.S.C. 301; 42 U.S.C.
470, 620 et seq., 622(b), 629b(a), 652(b),
654A, 670 et seq., 671(a), 1302, and
1396a(a).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–04264 Filed 2–28–24; 8:45 am]
BILLING CODE 4184–25–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2022–E–2261, FDA–
2022–E–2262, and FDA–2022–E–2263]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PREVNAR–20
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PREVNAR–20 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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 29, 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
August 27, 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
April 29, 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,
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Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
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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–2261, FDA–2022–E–2262, and
FDA–2022–E–2263 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
PREVNAR–20.’’ 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
VerDate Sep<11>2014
16:39 Feb 28, 2024
Jkt 262001
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
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
PO 00000
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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 PREVNAR–20
(Pneumococcal 20-valent Conjugate
Vaccine). PREVNAR–20 is indicated for:
• Active immunization for the
prevention of invasive disease caused
by Streptococcus pneumoniae serotypes
1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A,
12F, 14, 15B, 18C, 19A, 19F, 22F, 23F,
and 33F in individuals 6 weeks of age
and older.
• Active immunization for the
prevention of otitis media caused by S.
pneumoniae serotypes 4, 6B, 9V, 14,
18C, 19F, and 23F in individuals 6
weeks through 5 years of age.
• Active immunization for the
prevention of pneumonia caused by S.
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B,
7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C,
19A, 19F, 22F, 23F, and 33F in
individuals 18 years of age and older.
The indication for the prevention of
pneumonia caused by S. pneumoniae
serotypes 8, 10A, 11A, 12F, 15B, 22F,
and 33F in individuals 18 years of age
and older is approved under accelerated
approval based on immune responses as
measured by opsonophagocytic activity
assay. Continued approval for this
indication may be contingent upon
verification and description of clinical
benefit in a confirmatory trial.
Subsequent to this approval, the
USPTO received patent term restoration
applications for PREVNAR–20 (U.S.
Patent No. 7,935,787) from Wyeth LLC,
and (U.S. Patent Nos. 9,517,274; and
9,950,054), filed by Pfizer Inc., and the
USPTO requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
January 18, 2023, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
PREVNAR–20 represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
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Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
PREVNAR–20 is 1,678 days. Of this
time, 1,434 days occurred during the
testing phase of the regulatory review
period, while 244 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: November 5, 2016.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on November 5, 2016.
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): October 8, 2020. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
PREVNAR–20 (BLA 125731) was
initially submitted on October 8, 2020.
3. The date the application was
approved: June 8, 2021. FDA has
verified the applicant’s claim that BLA
125731 was approved on June 8, 2021.
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,
these applicants seek 665 days or 961
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
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16:39 Feb 28, 2024
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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: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04229 Filed 2–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–E–2139]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NULIBRY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for NULIBRY 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.
SUMMARY:
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 April 29, 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
August 27, 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
April 29, 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.
DATES:
PO 00000
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14851
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–
2022–E–2139 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; NULIBRY.’’
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
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]]>Agencies
[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14849-14851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2022-E-2261, FDA-2022-E-2262, and FDA-2022-E-2263]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PREVNAR-20
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 PREVNAR-20 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 April 29, 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 August 27, 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 April 29, 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,
[[Page 14850]]
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-2261, FDA-2022-E-2262, and FDA-2022-E-2263 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; PREVNAR-20.'' 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 PREVNAR-
20 (Pneumococcal 20-valent Conjugate Vaccine). PREVNAR-20 is indicated
for:
Active immunization for the prevention of invasive disease
caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8,
9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in
individuals 6 weeks of age and older.
Active immunization for the prevention of otitis media
caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in
individuals 6 weeks through 5 years of age.
Active immunization for the prevention of pneumonia caused
by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A,
12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years
of age and older.
The indication for the prevention of pneumonia caused by S.
pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals
18 years of age and older is approved under accelerated approval based
on immune responses as measured by opsonophagocytic activity assay.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
Subsequent to this approval, the USPTO received patent term
restoration applications for PREVNAR-20 (U.S. Patent No. 7,935,787)
from Wyeth LLC, and (U.S. Patent Nos. 9,517,274; and 9,950,054), filed
by Pfizer Inc., and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
January 18, 2023, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of PREVNAR-20 represented the first permitted commercial marketing or
use of the product. Thereafter, the USPTO requested that FDA determine
the product's regulatory review period.
[[Page 14851]]
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
PREVNAR-20 is 1,678 days. Of this time, 1,434 days occurred during the
testing phase of the regulatory review period, while 244 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: November 5,
2016. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on November
5, 2016.
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): October 8, 2020. FDA has verified the
applicant's claim that the biologics license application (BLA) for
PREVNAR-20 (BLA 125731) was initially submitted on October 8, 2020.
3. The date the application was approved: June 8, 2021. FDA has
verified the applicant's claim that BLA 125731 was approved on June 8,
2021.
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,
these applicants seek 665 days or 961 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: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04229 Filed 2-28-24; 8:45 am]
BILLING CODE 4164-01-P
