81 FR 22276 - Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 73 (April 15, 2016)

Page Range		22276-22277
FR Document		2016-08692

The Food and Drug Administration (FDA) has determined the regulatory review period for CYRAMZA 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 biological product.

Federal Register, Volume 81 Issue 73 (Friday, April 15, 2016)

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22276-22277]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-08692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2353]

Determination of Regulatory Review Period for Purposes of Patent
Extension; CYRAMZA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CYRAMZA 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 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 June
14, 2016. 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 October 12, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2353 for Determination of Regulatory Review Period for
Purposes of Patent Extension; CYRAMZA.
Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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

[[Page 22277]]

an approval phase. For human biological products, the testing phase
begins when the exemption to permit the clinical investigations of the
biological 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 CYRAMZA
(ramucirumab). CYRAMZA is indicated for treatment of gastric cancer.
Subsequent to this approval, the U.S. Patent and Trademark Office
(USPTO) received a patent term restoration application for CYRAMZA
(U.S. Patent No. 7,498,414) from Eli Lilly and Co., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated March 19, 2015, FDA advised
the USPTO that this human biological product had undergone a regulatory
review period and that the approval of CYRAMZA 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
CYRAMZA is 3,521 days. Of this time, 3,279 days occurred during the
testing phase of the regulatory review period, while 242 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: September
1, 2004. FDA has verified the applicant's claim that the date the
investigational new drug application (IND) became effective was on
September 1, 2004.
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): August 23, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
CYRAMZA (BLA 125477) was initially submitted on August 23, 2013.
3. The date the application was approved: April 21, 2014. FDA has
verified the applicant's claim that BLA 125477 was approved on April
21, 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 application for patent extension,
this applicant seeks 1,059 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 ask for
a redetermination (see DATES). 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.
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 http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: April 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08692 Filed 4-14-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22277

an approval phase. For human verified the applicant’s claim that the that a proposed collection of
biological products, the testing phase biologics license application (BLA) for information has been submitted to the
begins when the exemption to permit CYRAMZA (BLA 125477) was initially Office of Management and Budget
the clinical investigations of the submitted on August 23, 2013. (OMB) for review and clearance under
biological becomes effective and runs 3. The date the application was the Paperwork Reduction Act of 1995.
until the approval phase begins. The approved: April 21, 2014. FDA has DATES: Fax written comments on the
approval phase starts with the initial verified the applicant’s claim that BLA collection of information by May 16,
submission of an application to market 125477 was approved on April 21, 2014. 2016.
the human biological product and This determination of the regulatory
ADDRESSES: To ensure that comments on
continues until FDA grants permission review period establishes the maximum
potential length of a patent extension. the information collection are received,
to market the biological product.
However, the USPTO applies several OMB recommends that written
Although only a portion of a regulatory
statutory limitations in its calculations comments be faxed to the Office of
review period may count toward the
of the actual period for patent extension. Information and Regulatory Affairs,
actual amount of extension that the
In its application for patent extension, OMB, Attn: FDA Desk Officer, FAX:
Director of USPTO may award (for
this applicant seeks 1,059 days of patent 202–395–7285, or emailed to
example, half the testing phase must be
term extension. oira_submission@omb.eop.gov. All
subtracted as well as any time that may
comments should be identified with the
have occurred before the patent was III. Petitions OMB control number 0910–0738. Also
issued), FDA’s determination of the
Anyone with knowledge that any of include the FDA docket number found
length of a regulatory review period for
a human biological product will include the dates as published are incorrect may in brackets in the heading of this
all of the testing phase and approval submit either electronic or written document.
phase as specified in 35 U.S.C. comments and ask for a redetermination FOR FURTHER INFORMATION CONTACT: FDA
156(g)(1)(B). (see DATES). Furthermore, any interested PRA Staff, Office of Operations, Food
FDA has approved for marketing the person may petition FDA for a and Drug Administration, 8455
human biologic product CYRAMZA determination regarding whether the Colesville Rd., COLE–14526, Silver
(ramucirumab). CYRAMZA is indicated applicant for extension acted with due Spring, MD 20993–0002,
for treatment of gastric cancer. diligence during the regulatory review PRAStaff@fda.hhs.gov.
Subsequent to this approval, the U.S. period. To meet its burden, the petition SUPPLEMENTARY INFORMATION: In
Patent and Trademark Office (USPTO) must be timely (see DATES) and contain compliance with 44 U.S.C. 3507, FDA
received a patent term restoration sufficient facts to merit an FDA has submitted the following proposed
application for CYRAMZA (U.S. Patent investigation. (See H. Rept. 857, part 1, collection of information to OMB for
No. 7,498,414) from Eli Lilly and Co., 98th Cong., 2d sess., pp. 41–42, 1984.) review and clearance.
and the USPTO requested FDA’s Petitions should be in the format
assistance in determining this patent’s specified in 21 CFR 10.30. Center for Devices and Radiological
eligibility for patent term restoration. In Submit petitions electronically to Health Appeals Processes—
a letter dated March 19, 2015, FDA http://www.regulations.gov at Docket
OMB Control Number 0910–0738—
advised the USPTO that this human No. FDA–2013–S–0610. Submit written
Extension
biological product had undergone a petitions (two copies are required) to the
regulatory review period and that the Division of Dockets Management (HFA– The guidance document entitled
approval of CYRAMZA represented the 305), Food and Drug Administration, ‘‘Guidance for Industry and Food and
first permitted commercial marketing or 5630 Fishers Lane, Rm. 1061, Rockville, Drug Administration Staff; Center for
use of the product. Thereafter, the MD 20852. Devices and Radiological Health
USPTO requested that FDA determine Appeals Processes’’ describes the
Dated: April 11, 2016.
the product’s regulatory review period. processes available to outside
Leslie Kux,
stakeholders to request additional
II. Determination of Regulatory Review Associate Commissioner for Policy. review of decisions or actions by Center
Period [FR Doc. 2016–08692 Filed 4–14–16; 8:45 am] for Devices and Radiological Health
FDA has determined that the BILLING CODE 4164–01–P (CDRH) employees. FDA is seeking
applicable regulatory review period for approval for the new reporting burden
CYRAMZA is 3,521 days. Of this time, associated with requests for additional
3,279 days occurred during the testing DEPARTMENT OF HEALTH AND review of decisions and actions by
phase of the regulatory review period, HUMAN SERVICES CDRH employees as described in the
while 242 days occurred during the Food and Drug Administration guidance.
approval phase. These periods of time Individuals outside of FDA who
were derived from the following dates: [Docket No. FDA–2011–D–0893] disagree with a decision or action taken
1. The date an exemption under by CDRH and wish to have it reviewed
section 505(i) of the Federal Food, Drug, Agency Information Collection or reconsidered have several processes
and Cosmetic Act (21 U.S.C. 355(i)) Activities; Submission for Office of for resolution from which to choose,
became effective: September 1, 2004. Management and Budget Review; including: Requests for supervisory
FDA has verified the applicant’s claim Comment Request; Center for Devices review of an action; petitions; and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

that the date the investigational new and Radiological Health Appeals hearings. Of these, by far the most
drug application (IND) became effective Processes commonly used is a request for
was on September 1, 2004. AGENCY: Food and Drug Administration, supervisory review under § 10.75 (21
2. The date the application was HHS. CFR 10.75) (a ‘‘10.75 appeal’’). Section
initially submitted with respect to the ACTION: Notice. 517A of the Federal Food, Drug, and
human biological product under section Cosmetic Act (the FD&C Act) (21 U.S.C.
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug 360g–1), added by section 603 of the
U.S.C. 262): August 23, 2013. FDA has Administration (FDA) is announcing Food and Drug Safety and Innovation

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Document Created: 2016-04-15 00:55:50
Document Modified: 2016-04-15 00:55:50

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 June 14, 2016. 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 October 12, 2016. 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		81 FR 22276

81 FR 22276 - Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 73 (April 15, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration