83 FR 53273 - Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

Page Range		53273-53275
FR Document		2018-22958

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.

Federal Register, Volume 83 Issue 204 (Monday, October 22, 2018)

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53273-53275]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-22958]

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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.thefederalregister.org/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

Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53273

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Average
Number of Total annual
Information collection activity; 21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

Written procedures for conducting verification ac- 11,701 1 11,701 2 ............................. 23,402
tivities; 1.506(b), 1.511(c)(3).
Determination and documentation of appropriate 11,701 4 46,804 3.25 ........................ 152,113
supplier verification activities; 1.506(d)(1)–(2),
1.511(c)(5)(i).
Review of appropriate supplier verification activi- 11,701 2 23,402 0.33 (20 minutes) ... 7,723
ties determined by another entity; 1.506(d)(3),
1.511(c)(5)(iii).
Conduct/review audits; 1.506(e)(1)(i), 11,701 2 23,402 3 ............................. 70,206
1.511(c)(4)(ii)(A).
Conduct periodic sampling/testing; 11,701 2 23,402 1 ............................. 23,402
1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C) 11,701 2 23,402 1.6 .......................... 37,443
Document your review of supplier verification ac- 11,701 6 70,206 0.25 (15 minutes) .. 17,552
tivity records; 1.506(e)(3), 1.511(c)(4)(iii).
1.507(a)(1) ............................................................ 11,701 3.17 37,092 1.25 ........................ 46,365
Written assurances; 1.507(a)(2), 1.507(a)(3), and 11,701 8.72 102,038 0.50 (30 minutes) ... 51,019
1.507(a)(4).
Disclosures that accompany assurances; 102,038 1 102,038 0.50 (30 minutes) ... 51,019
1.507(a)(2), 1.507(a)(3), and 1.507(a)(4).
Document assurances from customers; 1.507(c) 36,522 2.8 102,262 0.25 (15 minutes) .. 25,566
Document corrective actions; 1.508(a) and 2,340 1 2,340 2 ............................. 4,680
1.512(b)(4).
Investigate and determine FSVP adequacy; 2,340 1 2,340 5 ............................. 11,700
1.508(b), 1.511(c)(1).

Subtotal for FSVP Recordkeeping Itemized ........................ ........................ 4,984,046 ................................ 1,917,186
Above.

Written assurances for food produced under die- 11,701 2.88 33,699 2.25 ........................ 75,823
tary supplement current good manufacturing
practices; 1.511(b).
Document very small importer/certain small for- 50,450 1 50,450 1 ............................. 50,450
eign supplier status; 1.512(b)(1).
Written assurances associated with very small im- 50,450 2.8 141,260 2.25 ........................ 317,835
porter/certain small foreign supplier 1.512(b)(3).

Total ...................................................................... ........................ ........................ ........................ ................................ 2,361,294
1 There are no capital costs or operating and maintenance costs associated with the information collection.

We are retaining the currently ACTION: Notice. during the regulatory review period by
approved burden estimates. The FSVP April 22, 2019. See ‘‘Petitions’’ in the
requirements became effective May 30, SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION section for
2017, and we continue to evaluate Administration (FDA or the Agency) has more information.
associated burden. determined the regulatory review period ADDRESSES: You may submit comments
Dated: October 16, 2018. for BESPONSA and is publishing this as follows. Please note that late,
Leslie Kux, notice of that determination as required untimely filed comments will not be
by law. FDA has made the considered. Electronic comments must
Associate Commissioner for Policy.
determination because of the be submitted on or before December 21,
[FR Doc. 2018–22953 Filed 10–19–18; 8:45 am]
submission of applications to the 2018. The https://www.regulations.gov
BILLING CODE 4164–01–P
Director of the U.S. Patent and electronic filing system will accept
Trademark Office (USPTO), Department comments until 11:59 p.m. Eastern Time
of Commerce, for the extension of a at the end of December 21, 2018.
DEPARTMENT OF HEALTH AND
patent which claims that human Comments received by mail/hand
HUMAN SERVICES
biological product. delivery/courier (for written/paper
Food and Drug Administration DATES: Anyone with knowledge that any submissions) will be considered timely
of the dates as published (see the if they are postmarked or the delivery
[Docket Nos. FDA–2018–E–0675, FDA– SUPPLEMENTARY INFORMATION section) are service acceptance receipt is on or
daltland on DSKBBV9HB2PROD with NOTICES

2018–E–0678, and FDA–2018–E–0689] incorrect may submit either electronic before that date.
Determination of Regulatory Review or written comments and ask for a Electronic Submissions
Period for Purposes of Patent redetermination by December 21, 2018.
Furthermore, any interested person may Submit electronic comments in the
Extension; BESPONSA
petition FDA for a determination following way:
AGENCY: Food and Drug Administration, regarding whether the applicant for • Federal eRulemaking Portal:
HHS. extension acted with due diligence https://www.regulations.gov. Follow the

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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53275

initially submitted on December 20, DEPARTMENT OF HEALTH AND provides recommendations to
2016. HUMAN SERVICES transfusion services for managing RBC
3. The date the application was units labeled with historical antigen
Food and Drug Administration typing results. The guidance also
approved: August 17, 2017. FDA has
[Docket No. FDA–2016–D–4308] provides licensed blood collection
verified the applicant’s claim that BLA
establishments that choose to
761040 was approved on August 17,
Agency Information Collection implement labeling of RBC units with
2017. historical antigen typing results
Activities; Submission for Office of
This determination of the regulatory Management and Budget Review; instructions regarding how to report the
review period establishes the maximum Comment Request; Draft Guidance for manufacturing and labeling changes
potential length of a patent extension. Industry: Labeling of Red Blood Cell under 21 CFR 601.12.
However, the USPTO applies several Units With Historical Antigen Typing Description of Respondents:
statutory limitations in its calculations Results Establishments that collect blood and
of the actual period for patent extension. blood components intended for
In its applications for patent extension, AGENCY: Food and Drug Administration, transfusion.
this applicant seeks 654 days, 703 days, HHS. Burden Estimate: We believe that the
ACTION: Notice. information collection provisions in the
or 1,099 days of patent term extension.
draft guidance do not create a new
III. Petitions SUMMARY: The Food and Drug burden for respondents and are part of
Administration (FDA, or Agency) is usual and customary business practices.
Anyone with knowledge that any of announcing that a proposed collection According to the 30th edition of the
the dates as published are incorrect may of information has been submitted to the AABB Standards for Blood Banks and
submit either electronic or written Office of Management and Budget Transfusion Services, RBC units may be
comments and, under 21 CFR 60.24, ask (OMB) for review and clearance under labeled as RBC antigen negative without
for a redetermination (see DATES). the Paperwork Reduction Act of 1995. testing the current donation if two
Furthermore, as specified in § 60.30 (21 DATES: Fax written comments on the previous separate donations were tested
CFR 60.30), any interested person may collection of information by November by the collection facility and results of
petition FDA for a determination 21, 2018. RBC typing were found to be
regarding whether the applicant for ADDRESSES: To ensure that comments on
concordant. The standards indicate that
extension acted with due diligence the information collection are received, facilities have the option to put the non-
during the regulatory review period. To OMB recommends that written ABO/Rh(D) historical antigen typing
meet its burden, the petition must comments be faxed to the Office of results on a tie-tag or directly on the
comply with all the requirements of Information and Regulatory Affairs, container label.
The guidance also recommends
§ 60.30, including but not limited to: OMB, Attn: FDA Desk Officer, Fax: 202–
establishments that collect blood and
Must be timely (see DATES), must be 395–7285, or emailed to oira_
blood components for transfusion
filed in accordance with § 10.20, must submission@omb.eop.gov. All
should convey to transfusion services
contain sufficient facts to merit an FDA comments should be identified with the
the practices for repeating historical
investigation, and must certify that a OMB control number 0910–NEW and
RBC typing results on current donations
true and complete copy of the petition title ‘‘Draft Guidance for Industry:
and for labeling RBC units with
has been served upon the patent Labeling of Red Blood Cell Units with
historical RBC antigen typing results.
applicant. (See H. Rept. 857, part 1, 98th Historical Antigen Typing Results.’’ We believe that collection
Cong., 2d sess., pp. 41–42, 1984.) Also include the FDA docket number establishments have already developed
Petitions should be in the format found in brackets in the heading of this standard operating procedures for
specified in 21 CFR 10.30. document. including the non-ABO/Rh(D) historical
FOR FURTHER INFORMATION CONTACT: antigen typing results on a tie-tag or
Submit petitions electronically to JonnaLynn Capezzuto, Office of
https://www.regulations.gov at Docket directly on the container label, and for
Operations, Food and Drug conveying any change in their antigen
No. FDA–2013–S–0610. Submit written Administration, Three White Flint typing or labeling practices to their
petitions (two copies are required) to the North, 10A–12M, 11601 Landsdown St., consignees, including practices for
Dockets Management Staff (HFA–305), North Bethesda, MD 20852, 301–796– repeating historical RBC typing results
Food and Drug Administration, 5630 3794, PRAStaff@fda.hhs.gov. on current donations and for labeling
Fishers Lane, Rm. 1061, Rockville, MD SUPPLEMENTARY INFORMATION: In RBC units with historical RBC antigen
20852. compliance with 44 U.S.C. 3507, FDA typing results.
Dated: October 16, 2018. has submitted the following proposed In the Federal Register of January 3,
Leslie Kux, collection of information to OMB for 2017 (82 FR 130), FDA published a 60-
Associate Commissioner for Policy.
review and clearance. day notice requesting public comment
on the proposed collection of
[FR Doc. 2018–22958 Filed 10–19–18; 8:45 am] Labeling of Red Blood Cell Units With
information. FDA received six
BILLING CODE 4164–01–P Historical Antigen Typing Results,
comments on the guidance; however, no
OMB Control Number 0910–NEW
comments were related to the collection
The draft guidance document of information.
daltland on DSKBBV9HB2PROD with NOTICES

provides establishments that collect The draft guidance also refers to
blood and blood components for previously approved collections of
transfusion with recommendations for information found in FDA regulations.
labeling RBC units with non-ABO/Rh(D) The collections of information in 21
antigen typing results obtained from CFR 601.12 have been approved under
previous donations (historical antigen OMB control number 0910–0338; and
typing results). The draft guidance the collections of information in 21 CFR

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Document Created: 2018-10-20 01:50:32
Document Modified: 2018-10-20 01:50:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		83 FR 53273

83 FR 53273 - Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration