Determination of Regulatory Review Period for Purposes of Patent Extension; TRODELVY, 67065-67067 [2021-25612]
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67065
Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
Average
burden per
response
Total annual
responses
Total hours
§ 312.130; requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 ................
§ 312.145; Guidance Documents:
Oversight of Clinical Investigations (2013) .........................................................
Pharmacogenomic Data Submissions (2005) ....................................................
Adaptive Designs for Clinical Trials of Drugs and Biologics (2019) ...................
3
1
3
8
24
88
1
55
1.5
1
4.727
132
1
260
4
50
50
528
50
13,000
Subtotal Subpart F CDER ...........................................................................
..........................
........................
15,117
........................
491,555
Total ......................................................................................................
..........................
........................
142,114
........................
22,872,609
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; information collection activity
Average
burden per
recordkeeping
Total annual
records
Total hours
Subpart D—Responsibilities of Sponsors and Investigators
§ 312.52(a); transfer of obligations to a contract research organization
§ 312.57; records showing the receipt, shipment, or other disposition
of the investigational drug and any financial interests.
§ 312.62(a); records on disposition of drugs .........................................
§ 312.62(b); records on case histories of individuals ............................
466
13,000
3.107
1
1,448
13,000
300 ..............................
100 ..............................
434,400
1,300,000
13,000
2,192
1
6.587
13,000
14,439
40 ................................
40 ................................
520,000
577,560
Subtotal Subpart D CDER ..............................................................
..........................
........................
41,887
.....................................
2,831,960
Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.
§ 312.160(c); shipper records of alternative disposition of unused
drugs.
Subtotal ...........................................................................................
547
1.43
782
0.50 (30 minutes) .......
391
547
1.43
782
0.50 (30 minutes) .......
391
..........................
........................
1,564
.....................................
782
Total .........................................................................................
..........................
........................
43,451
.....................................
2,832,742
I
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects
program changes and adjustments. We
have revised the information collection
to account for burden that may be
incurred by respondents who choose to
adopt or implement recommendations
discussed in referenced Agency
guidance documents intended to assist
respondents in complying with
regulatory requirements in part 312. We
have also made adjustments to
individual collection elements. As a
result of these changes and adjustments,
the information collection reflects an
overall decrease in both annual
responses and burden hours. Finally, we
have removed burden we attribute to
provisions in part 312, subpart I:
Expanded Access to Investigational
Drugs for Treatment Use and are
revising OMB control number 0910–
0814 to include burden associated with
information collection applicable to
these regulatory provisions for
efficiency of Agency operations.
VerDate Sep<11>2014
17:05 Nov 23, 2021
Jkt 256001
Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25615 Filed 11–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–2122]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TRODELVY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TRODELVY 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
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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 January 24, 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 23, 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 24,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 24, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
E:\FR\FM\24NON1.SGM
24NON1
67066
Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2020–E–2122 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; TRODELVY.’’
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
VerDate Sep<11>2014
17:05 Nov 23, 2021
Jkt 256001
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
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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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 TRODELVY
(sacituzumab govitecan-hziy).
TRODELVY is indicated for the
treatment of adult patients with
metastatic triple-negative breast cancer
who have received at least two prior
therapies for metastatic disease. This
indication is approved under
accelerated approval based on tumor
response rate and duration of response.
Continued approval for this indication
may be contingent upon verification and
description of clinical benefit in
confirmatory trials. Subsequent to this
approval, the USPTO received a patent
term restoration application for
TRODELVY (U.S. Patent No. 7,999,083)
from Immunomedics, Inc., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
January 4, 2021, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
TRODELVY 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
TRODELVY is 2,856 days. Of this time,
2,150 days occurred during the testing
phase of the regulatory review period,
while 706 days occurred during the
E:\FR\FM\24NON1.SGM
24NON1
Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
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: June 29, 2012. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
June 29, 2012.
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): May 18, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
TRODELVY (BLA 761115) was initially
submitted on May 18, 2018.
3. The date the application was
approved: April 22, 2020. FDA has
verified the applicant’s claim that BLA
761115 was approved on April 22, 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 1,780 days of patent
term extension.
khammond on DSKJM1Z7X2PROD with NOTICES
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
17:05 Nov 23, 2021
Jkt 256001
Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25612 Filed 11–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have
withdrawn the delegations to the
Director, Office for Civil Rights (OCR),
or their successor, with respect to the
Religious Freedom Restoration Act
(RFRA) and the Religion Clauses of the
First Amendment, as well as any other
delegation of authority to OCR with
respect to enforcing or complying with
RFRA or the First Amendment.
On December 7, 2017, the then-Acting
Secretary of the Department of Health
and Human Services issued a notice,
published on January 19, 2018 (83 FR
2804), that delegated authority for
implementation and compliance with
the Religious Freedom Restoration Act,
42 U.S.C. 2000bb et seq., within the
Department to the Director of OCR.
On January 15, 2021, the Secretary
further delegated to OCR authority to
receive and investigate complaints,
conduct compliance reviews, provide
technical assistance and training,
evaluate complaint processing and
provide reports, and ensure uniform
compliance with the Religion Clauses of
the First Amendment. This delegation
was not published in the Federal
Register.
The Department takes its obligations
to comply with RFRA and the First
Amendment seriously, and it will
continue to do so. Department
components have the greatest
knowledge about their respective
programs and are best able to determine
whether the Department has a
compelling interest in a particular
action and whether less restrictive
means are available to further that
interest, critical aspects of the legal test
under RFRA. Furthermore, under the
current Statement of Organization,
Functions, and Delegations of Authority
for the Office of General Counsel (OGC),
OGC provides legal advice to the
Secretary, Deputy Secretary, and all
subordinate organization components of
the Department. See 85 FR 47228 (July
7, 2020). Department components, in
consultation with OGC, have the
responsibility, and are best positioned,
to evaluate RFRA-based requests for
exemptions, waivers, and modifications
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
67067
of program requirements in the
programs they operate or oversee.
Department components, further, are
best situated to craft exemptions or
other modifications when required
under RFRA and to monitor the impact
of such exemptions or modifications on
programs and those they serve.
Moreover, they are best positioned to
evaluate how their programs must be
run to comply with the Free Exercise
Clause and the Establishment Clause of
the First Amendment.
I therefore rescind the December 7,
2017, and the January 15, 2021
delegations with respect to the Religion
Clauses of the First Amendment and/or
RFRA, as well as any other delegation
of authority to OCR with respect to
enforcing or complying with RFRA or
the First Amendment. Effective today, I
delegate responsibility to Department
components to ensure full compliance
with RFRA and other constitutional
requirements. Department components
must consult with OGC on such matters
and provide appropriate consideration
to RFRA- or Constitution-based
objections or requests, as well as take
any actions that may be appropriate.
This delegation of authority is
effective upon date of signature.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–25632 Filed 11–23–21; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Investigational
Agent Accountability Record Forms
and International Investigator
Statement in the Conduct of
Investigational Trials for the Treatment
of Cancer (National Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
E:\FR\FM\24NON1.SGM
24NON1
]]>Agencies
[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67065-67067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25612]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-E-2122]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TRODELVY
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 TRODELVY 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 January 24, 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 23, 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 24, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 24, 2022. Comments
received by mail/hand delivery/courier (for written/paper
[[Page 67066]]
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 No.
FDA-2020-E-2122 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TRODELVY.'' 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 TRODELVY
(sacituzumab govitecan-hziy). TRODELVY is indicated for the treatment
of adult patients with metastatic triple-negative breast cancer who
have received at least two prior therapies for metastatic disease. This
indication is approved under accelerated approval based on tumor
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials. Subsequent to this approval,
the USPTO received a patent term restoration application for TRODELVY
(U.S. Patent No. 7,999,083) from Immunomedics, Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated January 4, 2021, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of TRODELVY 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
TRODELVY is 2,856 days. Of this time, 2,150 days occurred during the
testing phase of the regulatory review period, while 706 days occurred
during the
[[Page 67067]]
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: June 29,
2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 29,
2012.
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): May 18, 2018. FDA has verified the
applicant's claim that the biologics license application (BLA) for
TRODELVY (BLA 761115) was initially submitted on May 18, 2018.
3. The date the application was approved: April 22, 2020. FDA has
verified the applicant's claim that BLA 761115 was approved on April
22, 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 1,780 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: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25612 Filed 11-23-21; 8:45 am]
BILLING CODE 4164-01-P
