82 FR 32002 - Determination of Regulatory Review Period for Purposes of Patent Extension; Intercept Blood System for Platelets

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 131 (July 11, 2017)

Page Range		32002-32003
FR Document		2017-14455

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Intercept Blood System for Platelets 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 medical device.

Federal Register, Volume 82 Issue 131 (Tuesday, July 11, 2017)

[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32002-32003]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-14455]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-0627 and FDA-2016-E-0629]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Intercept Blood System for Platelets

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 Intercept Blood System for
Platelets 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 medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
September 11, 2017. 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 January 8,
2018. 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 September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 11, 2017. 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 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-2016-E-0627 and FDA-2016-E-0629 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; INTERCEPT BLOOD SYSTEM
FOR PLATELETS.'' 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 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,

[[Page 32003]]

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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
FDA grants permission to market the device. 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 medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device Intercept Blood
System for Platelets. Intercept Blood System for Platelets is indicated
for ex vivo preparation of apheresis platelet components in order to
reduce the risk of transfusion-transmitted infection including sepsis,
and to potentially reduce the risk of transfusion-associated graft
versus host disease. Subsequent to this approval, the USPTO received
patent term restoration applications for Intercept Blood System for
Platelets (U.S. Patent Nos. 7,037,642 and 7,611,831) from Cerus
Corporation, and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
April 29, 2016, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of Intercept
Blood System for Platelets 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
Intercept Blood System for Platelets is 7,080 days. Of this time, 6,909
days occurred during the testing phase of the regulatory review period,
while 171 days occurred during the approval phase. These periods of
time were derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: August 2, 1995. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
July 26, 1995. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
August 2, 1995, which represents the IDE effective date.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): July 1,
2014. The applicant claims August 15, 2014, as the date the premarket
approval application (PMA) for Intercept Blood System for Platelets
(PMA BP140143) was initially submitted. However, FDA records indicate
that the complete PMA BP140143 was submitted on July 1, 2014.
3. The date the application was approved: December 18, 2014. FDA
has verified the applicant's claims that PMA BP140143 was approved on
December 18, 2014.
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 1,640 days or 999 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 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 be timely (see DATES) and contain sufficient facts to
merit an FDA investigation. (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 (see ADDRESSES).

Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14455 Filed 7-10-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 32003

Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the timely (see DATES) and contain sufficient
301–796–3600. product’s regulatory review period. facts to merit an FDA investigation. (See
SUPPLEMENTARY INFORMATION: H. Rept. 857, part 1, 98th Cong., 2d
II. Determination of Regulatory Review
sess., pp. 41–42, 1984.) Petitions should
I. Background Period
be in the format specified in 21 CFR
The Drug Price Competition and FDA has determined that the 10.30.
Patent Term Restoration Act of 1984 applicable regulatory review period for Submit petitions electronically to
(Pub. L. 98–417) and the Generic Intercept Blood System for Platelets is https://www.regulations.gov at Docket
Animal Drug and Patent Term 7,080 days. Of this time, 6,909 days No. FDA–2013–S–0610. Submit written
Restoration Act (Pub. L. 100–670) occurred during the testing phase of the petitions (two copies are required) to the
generally provide that a patent may be regulatory review period, while 171 Dockets Management Staff (see
extended for a period of up to 5 years days occurred during the approval ADDRESSES).
so long as the patented item (human phase. These periods of time were
Dated: July 5, 2017.
drug product, animal drug product, derived from the following dates:
1. The date an exemption under Anna K. Abram,
medical device, food additive, or color Deputy Commissioner for Policy, Planning,
section 520(g) of the Federal Food, Drug,
additive) was subject to regulatory Legislation, and Analysis.
and Cosmetic Act (the FD&C Act) (21
review by FDA before the item was
U.S.C. 360j(g)) involving this device [FR Doc. 2017–14455 Filed 7–10–17; 8:45 am]
marketed. Under these acts, a product’s
became effective: August 2, 1995. The BILLING CODE 4164–01–P
regulatory review period forms the basis
applicant claims that the investigational
for determining the amount of extension
device exemption (IDE) required under
an applicant may receive. DEPARTMENT OF HEALTH AND
section 520(g) of the FD&C Act for
A regulatory review period consists of HUMAN SERVICES
human tests to begin became effective
two periods of time: A testing phase and
on July 26, 1995. However, FDA records
an approval phase. For medical devices, Food and Drug Administration
indicate that the IDE was determined
the testing phase begins with a clinical
substantially complete for clinical [Docket No. FDA–2017–N–2166]
investigation of the device and runs
studies to have begun on August 2,
until the approval phase begins. The Draft Standardization of
1995, which represents the IDE effective
approval phase starts with the initial Pharmaceutical Quality/Chemistry
date.
submission of an application to market 2. The date an application was Manufacturing and Control Data
the device and continues until FDA initially submitted with respect to the Elements and Terminologies; Request
grants permission to market the device. device under section 515 of the FD&C for Comments
Although only a portion of a regulatory Act (21 U.S.C. 360e): July 1, 2014. The
review period may count toward the AGENCY: Food and Drug Administration,
applicant claims August 15, 2014, as the
actual amount of extension that the HHS.
date the premarket approval application
Director of USPTO may award (for (PMA) for Intercept Blood System for ACTION: Notice; request for comments.
example, half the testing phase must be Platelets (PMA BP140143) was initially
subtracted as well as any time that may SUMMARY: The Food and Drug
submitted. However, FDA records Administration (FDA or Agency) is
have occurred before the patent was indicate that the complete PMA
issued), FDA’s determination of the requesting comment on the draft
BP140143 was submitted on July 1, standardized Pharmaceutical Quality/
length of a regulatory review period for 2014.
a medical device will include all of the Chemistry Manufacturing and Control
3. The date the application was
testing phase and approval phase as (PQ/CMC) data elements and
approved: December 18, 2014. FDA has
specified in 35 U.S.C. 156(g)(3)(B). terminologies for the electronic
verified the applicant’s claims that PMA
FDA has approved for marketing the submission of PQ/CMC data. The
BP140143 was approved on December
medical device Intercept Blood System establishment of standardized
18, 2014.
for Platelets. Intercept Blood System for This determination of the regulatory pharmaceutical quality data elements
Platelets is indicated for ex vivo review period establishes the maximum and terminologies will provide
preparation of apheresis platelet potential length of a patent extension. opportunities for FDA and industry to
components in order to reduce the risk However, the USPTO applies several transform PQ/CMC submission data into
of transfusion-transmitted infection statutory limitations in its calculations a readily useable electronic format. As
including sepsis, and to potentially of the actual period for patent extension. a result, these established data elements
reduce the risk of transfusion-associated In its applications for patent extension, and terminologies will improve the
graft versus host disease. Subsequent to this applicant seeks 1,640 days or 999 efficiency and quality of the drug review
this approval, the USPTO received days of patent term extension. process. The Agency is seeking
patent term restoration applications for comment on the accuracy, suitability,
Intercept Blood System for Platelets III. Petitions and appropriateness of these data
(U.S. Patent Nos. 7,037,642 and Anyone with knowledge that any of elements and terminologies for
7,611,831) from Cerus Corporation, and the dates as published are incorrect may submission of PQ/CMC data. FDA is
the USPTO requested FDA’s assistance submit either electronic or written considering implementing PQ/CMC
in determining the patents’ eligibility comments and, under 21 CFR 60.24, ask requirements as a Health Level 7 (HL7)
for patent term restoration. In a letter for a redetermination (see DATES). Structured Product Labeling (SPL)
mstockstill on DSK30JT082PROD with NOTICES

dated April 29, 2016, FDA advised the Furthermore, as specified in 21 CFR document. The proposed data elements
USPTO that this medical device had 60.30, any interested person may and terminologies can be obtained on
undergone a regulatory review period petition FDA for a determination https://www.regulations.gov in Docket
and that the approval of Intercept Blood regarding whether the applicant for No. FDA–2017–N–2166.
System for Platelets represented the first extension acted with due diligence DATES: Submit either electronic or
permitted commercial marketing or use during the regulatory review period. To written comments by September 11,
of the product. Thereafter, the USPTO meet its burden, the petition must be 2017. Late, untimely filed comments

VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1

Document Created: 2018-11-14 10:21:30
Document Modified: 2018-11-14 10:21:30

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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by September 11, 2017. 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 January 8, 2018. 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		82 FR 32002

82 FR 32002 - Determination of Regulatory Review Period for Purposes of Patent Extension; Intercept Blood System for Platelets

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 131 (July 11, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration