82 FR 56613 - Determination of Regulatory Review Period for Purposes of Patent Extension; SOLX SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 228 (November 29, 2017)

Page Range		56613-56615
FR Document		2017-25773

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOLX SYSTEM 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.

Federal Register, Volume 82 Issue 228 (Wednesday, November 29, 2017)

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56613-56615]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-25773]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-1653]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SOLX SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SOLX SYSTEM 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
29, 2018. Furthermore, any interested person may petition FDA for a
determination

[[Page 56614]]

regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 29, 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 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-2014-E-1653 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SOLX SYSTEM.'' 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 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 for marketing the human drug product SOLX SYSTEM.
SOLX SYSTEM is indicated for:
Pre-storage leukocyte reduction of Citrate Phosphate
Dextrose Solution (CPD) whole blood followed by preparation of AS-7 Red
Cells, Leukocytes Reduced, prepared at room temperature and placed at 1
to 6 [deg]C within 24 hours of collection. AS-7 Red Cells, Leukocytes
Reduced, may be stored at 1 to 6 [deg]C for up to 42 days after
collection.
Pre-storage leukocyte reduction of CPD whole blood held at
1 to 6 [deg]C and preparation of AS-7 Red Cells, Leukocytes Reduced
within 72 hours after collection. AS-7 Red Cells, Leukocytes Reduced,
may be stored at 1 to 6 [deg]C for up to 42 days after collection.
Preparation of Fresh Frozen Plasma (FFP), Leukocytes
Reduced prepared from a whole blood collection and frozen at -18 [deg]C
or below within 8 hours of collection. FFP, Leukocytes

[[Page 56615]]

Reduced may be stored at -18 [deg]C or colder for up to 1 year after
collection.
Preparation of Plasma Frozen within 24 hours after
Phlebotomy (PF24), Leukocytes Reduced prepared from a whole blood
collection. The product can be held at room temperature up to 8 hours
after collection, refrigerated at 1 to 6 [deg]C until separated, and
placed at -18 [deg]C or below within 24 hours of whole blood
collection. PF24, Leukocytes Reduced may be stored at -18 [deg]C or
colder for up to 1 year after collection.
Subsequent to this approval, the USPTO received a patent term
restoration application for SOLX SYSTEM (U.S. Patent No. 6,150,085)
from Haemonetics Corporation, and the USPTO requested FDA's assistance
in determining this patent's eligibility for patent term restoration.
In a letter dated November 5, 2015, FDA advised the USPTO that this
human drug product had undergone a regulatory review period and that
the approval of SOLX SYSTEM 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
SOLX SYSTEM is 1,250 days. Of this time, 708 days occurred during the
testing phase of the regulatory review period, while 542 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: November 24, 2009. The applicant claims November 25, 2009,
as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was November 24, 2009, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
1, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for SOLX SYSTEM (NDA BN110059) was initially
submitted on November 1, 2011.
3. The date the application was approved: April 25, 2013. FDA has
verified the applicant's claim that NDA BN110059 was approved on April
25, 2013.
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.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25773 Filed 11-28-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56615

Reduced may be stored at ¥18 °C or This determination of the regulatory ACTION: Notice.
colder for up to 1 year after collection. review period establishes the maximum
• Preparation of Plasma Frozen potential length of a patent extension. SUMMARY: The Food and Drug
within 24 hours after Phlebotomy However, the USPTO applies several Administration (FDA) is announcing
(PF24), Leukocytes Reduced prepared statutory limitations in its calculations that a proposed collection of
from a whole blood collection. The of the actual period for patent extension. information has been submitted to the
product can be held at room In its application for patent extension, Office of Management and Budget
temperature up to 8 hours after this applicant seeks 894 days of patent (OMB) for review and clearance under
collection, refrigerated at 1 to 6 °C until term extension. the Paperwork Reduction Act of 1995.
separated, and placed at ¥18 °C or III. Petitions
DATES: Fax written comments on the
below within 24 hours of whole blood collection of information by December
collection. PF24, Leukocytes Reduced Anyone with knowledge that any of 29, 2017.
may be stored at ¥18 °C or colder for the dates as published are incorrect may ADDRESSES: To ensure that comments on
up to 1 year after collection. submit either electronic or written the information collection are received,
Subsequent to this approval, the comments and, under 21 CFR 60.24, ask OMB recommends that written
USPTO received a patent term for a redetermination (see DATES). comments be faxed to the Office of
restoration application for SOLX Furthermore, as specified in § 60.30 (21 Information and Regulatory Affairs,
SYSTEM (U.S. Patent No. 6,150,085) CFR 60.30), any interested person may OMB, Attn: FDA Desk Officer, Fax: 202–
from Haemonetics Corporation, and the petition FDA for a determination 395–7285, or emailed to oira_
USPTO requested FDA’s assistance in regarding whether the applicant for submission@omb.eop.gov. All
determining this patent’s eligibility for extension acted with due diligence comments should be identified with the
patent term restoration. In a letter dated during the regulatory review period. To OMB control number 0910–0623. Also,
November 5, 2015, FDA advised the meet its burden, the petition must include the FDA docket number found
USPTO that this human drug product comply with all the requirements of in brackets in the heading of this
had undergone a regulatory review § 60.30, including but not limited to: document.
period and that the approval of SOLX Must be timely (see DATES), must be
FOR FURTHER INFORMATION CONTACT: Ila
SYSTEM represented the first permitted filed in accordance with § 10.20, must
S. Mizrachi, Office of Operations, Food
commercial marketing or use of the contain sufficient facts to merit an FDA
and Drug Administration, Three White
product. Thereafter, the USPTO investigation, and must certify that a
Flint North, 10A–12M, 11601
requested that FDA determine the true and complete copy of the petition
Landsdown St., North Bethesda, MD
product’s regulatory review period. has been served upon the patent
20852, 301–796–7726, PRAStaff@
applicant. (See H. Rept. 857, part 1, 98th
II. Determination of Regulatory Review fda.hhs.gov.
Cong., 2d sess., pp. 41–42, 1984.)
Period Petitions should be in the format SUPPLEMENTARY INFORMATION: In
FDA has determined that the specified in 21 CFR 10.30. compliance with 44 U.S.C. 3507, FDA
applicable regulatory review period for Submit petitions electronically to has submitted the following proposed
SOLX SYSTEM is 1,250 days. Of this https://www.regulations.gov at Docket collection of information to OMB for
time, 708 days occurred during the No. FDA–2013–S–0610. Submit written review and clearance.
testing phase of the regulatory review petitions (two copies are required) to the Recordkeeping and Reporting
period, while 542 days occurred during Dockets Management Staff (HFA–305), Requirements for Human Food and
the approval phase. These periods of Food and Drug Administration, 5630 Cosmetics Manufactured From,
time were derived from the following Fishers Lane, Rm. 1061, Rockville, MD Processed With, or Otherwise
dates: 20852. Containing Material From Cattle—21
1. The date an exemption under Dated: November 24, 2017. CFR 189.5 and 700.27
section 505(i) of the Federal Food, Drug, Leslie Kux,
and Cosmetic Act (the FD&C Act) (21 OMB Control Number 0910–0623—
Associate Commissioner for Policy.
U.S.C. 355(i)) became effective: Extension
[FR Doc. 2017–25773 Filed 11–28–17; 8:45 am]
November 24, 2009. The applicant FDA’s regulations in §§ 189.5 and
BILLING CODE 4164–01–P
claims November 25, 2009, as the date 700.27 (21 CFR 189.5 and 700.27) set
the investigational new drug application forth bovine spongiform
(IND) became effective. However, FDA DEPARTMENT OF HEALTH AND encephalopathy (BSE)-related
records indicate that the IND effective HUMAN SERVICES restrictions applicable to FDA-regulated
date was November 24, 2009, which was human food and cosmetics. The
30 days after FDA receipt of the IND. Food and Drug Administration regulations designate certain materials
2. The date the application was from cattle as ‘‘prohibited cattle
initially submitted with respect to the [Docket No. FDA–2009–N–0505] materials,’’ including specified risk
human drug product under section materials (SRMs), the small intestine of
Agency Information Collection
505(b) of the FD&C Act: November 1, cattle not otherwise excluded from
Activities; Submission for Office of
2011. FDA has verified the applicant’s being a prohibited cattle material,
Management and Budget Review;
claim that the new drug application material from nonambulatory disabled
Comment Request; Recordkeeping
pmangrum on DSK3GDR082PROD with NOTICES1

(NDA) for SOLX SYSTEM (NDA cattle, and mechanically separated (MS)
and Reporting Requirements for
BN110059) was initially submitted on beef. Sections 189.5(c) and 700.27(c) set
Human Food and Cosmetics
November 1, 2011. forth the requirements for recordkeeping
Manufactured From, Processed With,
3. The date the application was or Otherwise Containing Material From and records access for FDA-regulated
approved: April 25, 2013. FDA has Cattle human food, including dietary
verified the applicant’s claim that NDA supplements, and cosmetics
BN110059 was approved on April 25, AGENCY: Food and Drug Administration, manufactured from, processed with, or
2013. HHS. otherwise containing material derived

VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

Document Created: 2017-11-29 01:26:23
Document Modified: 2017-11-29 01:26:23

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 January 29, 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 May 29, 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 56613

82 FR 56613 - Determination of Regulatory Review Period for Purposes of Patent Extension; SOLX SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 228 (November 29, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration