Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA, 53273-53275 [2018-22958]
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
53273
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Information collection activity; 21 CFR section
Number of
recordkeepers
Written procedures for conducting verification activities; 1.506(b), 1.511(c)(3).
Determination and documentation of appropriate
supplier verification activities; 1.506(d)(1)–(2),
1.511(c)(5)(i).
Review of appropriate supplier verification activities determined by another entity; 1.506(d)(3),
1.511(c)(5)(iii).
Conduct/review
audits;
1.506(e)(1)(i),
1.511(c)(4)(ii)(A).
Conduct
periodic
sampling/testing;
1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C)
Document your review of supplier verification activity records; 1.506(e)(3), 1.511(c)(4)(iii).
1.507(a)(1) ............................................................
Written assurances; 1.507(a)(2), 1.507(a)(3), and
1.507(a)(4).
Disclosures
that
accompany
assurances;
1.507(a)(2), 1.507(a)(3), and 1.507(a)(4).
Document assurances from customers; 1.507(c)
Document corrective actions; 1.508(a) and
1.512(b)(4).
Investigate and determine FSVP adequacy;
1.508(b), 1.511(c)(1).
Average
burden per
recordkeeping
Total annual
records
Total hours
11,701
1
11,701
2 .............................
23,402
11,701
4
46,804
3.25 ........................
152,113
11,701
2
23,402
0.33 (20 minutes) ...
7,723
11,701
2
23,402
3 .............................
70,206
11,701
2
23,402
1 .............................
23,402
11,701
11,701
2
6
23,402
70,206
1.6 ..........................
0.25 (15 minutes) ..
37,443
17,552
11,701
11,701
3.17
8.72
37,092
102,038
1.25 ........................
0.50 (30 minutes) ...
46,365
51,019
102,038
1
102,038
0.50 (30 minutes) ...
51,019
36,522
2,340
2.8
1
102,262
2,340
0.25 (15 minutes) ..
2 .............................
25,566
4,680
2,340
1
2,340
5 .............................
11,700
Subtotal for FSVP Recordkeeping Itemized
Above.
........................
........................
4,984,046
................................
1,917,186
Written assurances for food produced under dietary supplement current good manufacturing
practices; 1.511(b).
Document very small importer/certain small foreign supplier status; 1.512(b)(1).
Written assurances associated with very small importer/certain small foreign supplier 1.512(b)(3).
11,701
2.88
33,699
2.25 ........................
75,823
50,450
1
50,450
1 .............................
50,450
50,450
2.8
141,260
2.25 ........................
317,835
........................
........................
........................
................................
2,361,294
Total ......................................................................
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
We are retaining the currently
approved burden estimates. The FSVP
requirements became effective May 30,
2017, and we continue to evaluate
associated burden.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22953 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BESPONSA
Food and Drug Administration,
HHS.
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Jkt 247001
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BESPONSA 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.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 21, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
DATES:
[Docket Nos. FDA–2018–E–0675, FDA–
2018–E–0678, and FDA–2018–E–0689]
AGENCY:
ACTION:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
during the regulatory review period by
April 22, 2019. 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 December 21,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\22OCN1.SGM
22OCN1
53274
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2018–E–0675, FDA–2018–E–0678, and
FDA–2018–E–0689 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
BESPONSA.’’ 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.
• 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
VerDate Sep<11>2014
18:12 Oct 19, 2018
Jkt 247001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
PO 00000
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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 BESPONSA
(inotuzumab ozogamicin). BESPONSA
is indicated for treatment of adults with
relapsed or refractory B-cell precursor
acute lymphoblastic leukemia.
Subsequent to this approval, the USPTO
received patent term restoration
applications for BESPONSA (U.S. Patent
Nos. 8,153,768; 8,835,611; and
8,747,857) from Wyeth Holdings LLC,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated April 4, 2018, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of BESPONSA 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
BESPONSA is 5,298 days. Of this time,
5,057 days occurred during the testing
phase of the regulatory review period,
while 241 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: February 16, 2003.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on February 16, 2003.
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): December 20, 2016. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for BESPONSA (BLA 761040) was
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
initially submitted on December 20,
2016.
3. The date the application was
approved: August 17, 2017. FDA has
verified the applicant’s claim that BLA
761040 was approved on August 17,
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 applications for patent extension,
this applicant seeks 654 days, 703 days,
or 1,099 days of patent term extension.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Petitions
SUMMARY:
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.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22958 Filed 10–19–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2016–D–4308]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry: Labeling of Red Blood Cell
Units With Historical Antigen Typing
Results
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, or Agency) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
21, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Draft Guidance for Industry:
Labeling of Red Blood Cell Units with
Historical Antigen Typing Results.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Labeling of Red Blood Cell Units With
Historical Antigen Typing Results,
OMB Control Number 0910–NEW
The draft guidance document
provides establishments that collect
blood and blood components for
transfusion with recommendations for
labeling RBC units with non-ABO/Rh(D)
antigen typing results obtained from
previous donations (historical antigen
typing results). The draft guidance
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53275
provides recommendations to
transfusion services for managing RBC
units labeled with historical antigen
typing results. The guidance also
provides licensed blood collection
establishments that choose to
implement labeling of RBC units with
historical antigen typing results
instructions regarding how to report the
manufacturing and labeling changes
under 21 CFR 601.12.
Description of Respondents:
Establishments that collect blood and
blood components intended for
transfusion.
Burden Estimate: We believe that the
information collection provisions in the
draft guidance do not create a new
burden for respondents and are part of
usual and customary business practices.
According to the 30th edition of the
AABB Standards for Blood Banks and
Transfusion Services, RBC units may be
labeled as RBC antigen negative without
testing the current donation if two
previous separate donations were tested
by the collection facility and results of
RBC typing were found to be
concordant. The standards indicate that
facilities have the option to put the nonABO/Rh(D) historical antigen typing
results on a tie-tag or directly on the
container label.
The guidance also recommends
establishments that collect blood and
blood components for transfusion
should convey to transfusion services
the practices for repeating historical
RBC typing results on current donations
and for labeling RBC units with
historical RBC antigen typing results.
We believe that collection
establishments have already developed
standard operating procedures for
including the non-ABO/Rh(D) historical
antigen typing results on a tie-tag or
directly on the container label, and for
conveying any change in their antigen
typing or labeling practices to their
consignees, including practices for
repeating historical RBC typing results
on current donations and for labeling
RBC units with historical RBC antigen
typing results.
In the Federal Register of January 3,
2017 (82 FR 130), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received six
comments on the guidance; however, no
comments were related to the collection
of information.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR 601.12 have been approved under
OMB control number 0910–0338; and
the collections of information in 21 CFR
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22OCN1
]]>Agencies
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53273-53275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-E-0675, FDA-2018-E-0678, and FDA-2018-E-0689]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BESPONSA
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 BESPONSA 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
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 21, 2018. 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 April 22,
2019. 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 December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the
[[Page 53274]]
instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2018-E-0675, FDA-2018-E-0678, and FDA-2018-E-0689 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; BESPONSA.'' 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human 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 BESPONSA
(inotuzumab ozogamicin). BESPONSA is indicated for treatment of adults
with relapsed or refractory B-cell precursor acute lymphoblastic
leukemia. Subsequent to this approval, the USPTO received patent term
restoration applications for BESPONSA (U.S. Patent Nos. 8,153,768;
8,835,611; and 8,747,857) from Wyeth Holdings LLC, and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated April 4, 2018, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of BESPONSA 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
BESPONSA is 5,298 days. Of this time, 5,057 days occurred during the
testing phase of the regulatory review period, while 241 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: February
16, 2003. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on February
16, 2003.
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): December 20, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
BESPONSA (BLA 761040) was
[[Page 53275]]
initially submitted on December 20, 2016.
3. The date the application was approved: August 17, 2017. FDA has
verified the applicant's claim that BLA 761040 was approved on August
17, 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 applications for patent extension,
this applicant seeks 654 days, 703 days, or 1,099 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: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22958 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P
