Determination of Regulatory Review Period for Purposes of Patent Extension; PREVYMIS IV Solution, New Drug Application 209940, 68174-68176 [2022-24719]
Download as PDF
<![CDATA[
68174
Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices
Commissioner, and any other Centers
will use this mechanism to test
communications and social and
behavioral methods about regulated
drug products on a variety of subjects
related to consumer, patient, or
healthcare professional perceptions,
beliefs, attitudes, behaviors, and use of
drug and biological products and related
materials. These subjects include social
and behavioral research, decisionmaking processes, and communication
and behavioral change strategies.
Annually, FDA projects about 25
social and behavioral studies using the
variety of test methods listed in this
document. FDA is revising this burden
to account for the number of studies we
have received in the last 3 years and to
better reflect the scope of the
information collection.
In the Federal Register of August 10,
2022 (87 FR 48665), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Three comments were
received. The first comment was not
responsive. The second comment
requested that participants be informed
that participation is voluntary and can
withdraw at any time. Prior to beginning
the interview and several times
throughout, participants are informed
that their participation is voluntary and
that they can withdraw at any time. We
believe no further clarification to the
survey instruments are necessary. The
third comment expressed concerns
regarding the potential misuse of
information from the collection. We
have previously outlined the scope and
purpose of the information collection,
and we do not believe further
elaboration is necessary. Further, as
outlined in the supporting statement, all
information collections must be noncontroversial, must not retain Personally
Identifiable Information, and ‘‘will not
be used for substantially informing
influential policy decisions.’’
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Interviews and Surveys .....................
1 There
109,470
Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24693 Filed 11–10–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
1
Total annual
responses
109,470
Average burden per response
0.25 (15 minutes) .............................
Total hours
27,368
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, our burden estimate for
this information collection reflects an
overall increase of 35,886 responses
with a corresponding increase of 8,972
hours. We attribute this adjustment to
an increase in funding and need to
obtain additional information in specific
areas, particularly substance abuse (for
example, opioids and stimulants) and
COVID–19. In addition, we attribute the
increase in the number of respondents
(from 7,298 to 109,470) and decrease in
the number of responses per respondent
(from 15 to 1) to an inadvertent
administrative error reflected in the 60day notice. These changes, however, do
not impact the estimated total annual
responses or burden hours.
[Docket No. FDA–2019–E–2271]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PREVYMIS IV Solution, New
Drug Application 209940
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:30 Nov 10, 2022
Jkt 259001
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PREVYMIS IV Solution, new drug
application (NDA) 209940, and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by January 13, 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
May 15, 2023. 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
January 13, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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
E:\FR\FM\14NON1.SGM
14NON1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices
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–2271 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; PREVYMIS IV
SOLUTION, New Drug Application
209940.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-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
VerDate Sep<11>2014
17:30 Nov 10, 2022
Jkt 259001
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 drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved NDA 209940 for
marketing the human drug product,
PREVYMIS (letermovir) indicated for
prophylaxis of cytomegalovirus (CMV)
infections and disease in adult CMVseropositive recipients of an allogeneic
hematopoietic stem cell transplant.
Subsequent to this approval, the USPTO
received a patent term restoration
application for PREVYMIS (U.S. Patent
No. 8,513,255) from AiCuris Antiinfective Cures GmbH and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
68175
June 21, 2019, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of PREVYMIS IV
Solution, NDA 209940, represented a
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
PREVYMIS IV Solution, NDA 209940, is
3,157 days. Of this time, 2,911 days
occurred during the testing phase of the
regulatory review period, while 246
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: March 20,
2009. The applicant claims September
21, 2013, is the date the investigational
new drug application (IND) became
effective. However, FDA’s records
indicate that the effective date of the
first IND received for the active
ingredient was March 20, 2009.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: March 8, 2017. FDA
has verified the applicant’s claim that
the NDA for PREVYMIS IV Solution
(NDA 209940) was initially submitted
on March 8, 2017.
3. The date the application was
approved: November 8, 2017. FDA has
verified the applicant’s claim that NDA
209940 was approved on November 8,
2017.
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 894 days of patent
term extension.
Note: We have determined that the
regulatory review period for the human
drug product, PREVYMIS, approved
under NDA 209940, is the same as the
regulatory review period determined for
the human drug product, PREVYMIS,
approved under NDA 209939.
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
E:\FR\FM\14NON1.SGM
14NON1
68176
Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices
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.
Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24719 Filed 11–10–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2512]
Q5A(R2) Viral Safety Evaluation of
Biotechnology Products Derived From
Cell Lines of Human or Animal Origin;
International Council for
Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Q5A(R2)
Viral Safety Evaluation of Biotechnology
Products Derived From Cell Lines of
Human or Animal Origin.’’ The draft
guidance was prepared under the
auspices of the International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use (ICH), formerly the
International Conference on
Harmonisation. The draft guidance
updates the ICH guidance for industry
‘‘Q5A Viral Safety Evaluation of
Biotechnology Products Derived From
Cell Lines of Human or Animal Origin’’
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Nov 10, 2022
Jkt 259001
issued in September 1998 to reflect
advances in scientific knowledge and
regulatory expectations. The draft
guidance is intended to describe riskbased principles and mitigation
strategies to assure the viral safety of
biotechnology products, including the
data necessary to submit in a marketing
application.
DATES: Submit either electronic or
written comments on the draft guidance
by January 13, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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–D–2512 for ‘‘Q5A(R2) Viral Safety
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Evaluation of Biotechnology Products
Derived From Cell Lines of Human or
Animal Origin.’’ Received comments
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 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68174-68176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24719]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-E-2271]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PREVYMIS IV Solution, New Drug Application 209940
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 PREVYMIS IV Solution, new
drug application (NDA) 209940, and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect must submit either
electronic or written comments and ask for a redetermination by January
13, 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 May 15, 2023. 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 January 13, 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
[[Page 68175]]
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-2271 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; PREVYMIS IV SOLUTION, New Drug
Application 209940.'' 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved NDA 209940 for marketing the human drug product,
PREVYMIS (letermovir) indicated for prophylaxis of cytomegalovirus
(CMV) infections and disease in adult CMV-seropositive recipients of an
allogeneic hematopoietic stem cell transplant. Subsequent to this
approval, the USPTO received a patent term restoration application for
PREVYMIS (U.S. Patent No. 8,513,255) from AiCuris Anti-infective Cures
GmbH and the USPTO requested FDA's assistance in determining the
patent's eligibility for patent term restoration. In a letter dated
June 21, 2019, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of PREVYMIS
IV Solution, NDA 209940, represented a 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
PREVYMIS IV Solution, NDA 209940, is 3,157 days. Of this time, 2,911
days occurred during the testing phase of the regulatory review period,
while 246 days occurred during the approval phase. These periods of
time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
March 20, 2009. The applicant claims September 21, 2013, is the date
the investigational new drug application (IND) became effective.
However, FDA's records indicate that the effective date of the first
IND received for the active ingredient was March 20, 2009.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 8,
2017. FDA has verified the applicant's claim that the NDA for PREVYMIS
IV Solution (NDA 209940) was initially submitted on March 8, 2017.
3. The date the application was approved: November 8, 2017. FDA has
verified the applicant's claim that NDA 209940 was approved on November
8, 2017.
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 894 days of patent term extension.
Note: We have determined that the regulatory review period for the
human drug product, PREVYMIS, approved under NDA 209940, is the same as
the regulatory review period determined for the human drug product,
PREVYMIS, approved under NDA 209939.
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
[[Page 68176]]
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 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24719 Filed 11-10-22; 8:45 am]
BILLING CODE 4164-01-P
