81 FR 21555 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPAS

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 70 (April 12, 2016)

Page Range		21555-21556
FR Document		2016-08337

The Food and Drug Administration (FDA) has determined the regulatory review period for ADEMPAS 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 81 Issue 70 (Tuesday, April 12, 2016)

[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21555-21556]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-08337]

[[Page 21555]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2345]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ADEMPAS 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 June
13, 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 11, 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-2345 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ADEMPAS.'' 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 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 ADEMPAS
(riociguat). ADEMPAS is indicated for treatment of adults with
persistent/recurrent Chronic Thromboembolic

[[Page 21556]]

Pulmonary Hypertension (CTEPH) after surgical treatment or inoperable
CTEPH to improve exercise capacity and WHO functional class; and
treatment of pulmonary arterial hypertension to improve exercise
capacity, improve WHO functional class, and to delay clinical
worsening. Subsequent to this approval, the USPTO received a patent
term restoration application for ADEMPAS (U.S. Patent No. 7,173,037)
from Bayer Intellectual Property GmbH, 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 drug product had undergone a regulatory review period
and that the approval of ADEMPAS 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
ADEMPAS is 2,394 days. Of this time, 2,151 days occurred during the
testing phase of the regulatory review period, while 243 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: March 22, 2007. FDA has verified the Bayer Intellectual
Property GmbH claim that March 22, 2007, is the date the
investigational new drug application (IND) became effective.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: February
8, 2013. FDA has verified the applicant's claim that the new drug
application (NDA) for ADEMPAS (NDA 204819) was initially submitted on
February 8, 2013.
3. The date the application was approved: October 8, 2013. FDA has
verified the applicant's claim that NDA 204819 was approved on October
8, 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 1,317 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 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08337 Filed 4-11-16; 8:45 am]
BILLING CODE 4164-01-P

21556 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices

Pulmonary Hypertension (CTEPH) after III. Petitions 202–395–7285, or emailed to oira_
surgical treatment or inoperable CTEPH Anyone with knowledge that any of submission@omb.eop.gov. All
to improve exercise capacity and WHO the dates as published are incorrect may comments should be identified with the
functional class; and treatment of submit either electronic or written OMB control number 0910—New and
pulmonary arterial hypertension to comments and ask for a redetermination title ‘‘Comparing Food Safety
improve exercise capacity, improve (see DATES). Furthermore, any interested Knowledge, Attitude and Behavior
WHO functional class, and to delay person may petition FDA for a Among English-dominant Hispanics,
clinical worsening. Subsequent to this determination regarding whether the Spanish-dominant Hispanics, and Other
approval, the USPTO received a patent applicant for extension acted with due Consumers.’’ Also include the FDA
term restoration application for diligence during the regulatory review docket number found in brackets in the
ADEMPAS (U.S. Patent No. 7,173,037) period. To meet its burden, the petition heading of this document.
from Bayer Intellectual Property GmbH, must be timely (see DATES) and contain FOR FURTHER INFORMATION CONTACT: FDA
and the USPTO requested FDA’s sufficient facts to merit an FDA PRA Staff, Office of Operations, Food
assistance in determining this patent’s investigation. (See H. Rept. 857, part 1, and Drug Administration, 8455
eligibility for patent term restoration. In 98th Cong., 2d sess., pp. 41–42, 1984.) Colesville Rd., COLE–14526, Silver
a letter dated March 19, 2015, FDA Petitions should be in the format Spring, MD 20993–0002, PRAStaff@
advised the USPTO that this human specified in 21 CFR 10.30. fda.hhs.gov.
drug product had undergone a Submit petitions electronically to
regulatory review period and that the SUPPLEMENTARY INFORMATION: In
http://www.regulations.gov at Docket compliance with 44 U.S.C. 3507, FDA
approval of ADEMPAS represented the No. FDA–2013–S–0610. Submit written
first permitted commercial marketing or has submitted the following proposed
petitions (two copies are required) to the collection of information to OMB for
use of the product. Thereafter, the Division of Dockets Management (HFA–
USPTO requested that FDA determine review and clearance.
305), Food and Drug Administration,
the product’s regulatory review period. 5630 Fishers Lane, Rm. 1061, Rockville, Comparing Food Safety Knowledge,
II. Determination of Regulatory Review MD 20852. Attitude and Behavior Among English-
Period Dated: April 6, 2016.
Dominant Hispanics, Spanish-
Dominant Hispanics, and Other
FDA has determined that the Leslie Kux,
Consumers—OMB Control Number
applicable regulatory review period for Associate Commissioner for Policy. 0910—NEW
ADEMPAS is 2,394 days. Of this time, [FR Doc. 2016–08337 Filed 4–11–16; 8:45 am]
I. Background
2,151 days occurred during the testing BILLING CODE 4164–01–P
phase of the regulatory review period, We conduct research and educational
while 243 days occurred during the and public information programs
approval phase. These periods of time DEPARTMENT OF HEALTH AND relating to food safety and nutrition
were derived from the following dates: HUMAN SERVICES issued in our broad statutory authority,
1. The date an exemption under set forth in section 1003(b)(2) of the
Food and Drug Administration Federal Food, Drug, and Cosmetic Act
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 [Docket No. FDA–2014–N–1904] (the FD&C Act) (21 U.S.C. 393(b)(2)), to
U.S.C. 355(i)) became effective: March protect the public health by ensuring
22, 2007. FDA has verified the Bayer Agency Information Collection that foods are ‘‘safe, wholesome,
Intellectual Property GmbH claim that Activities; Submission for Office of sanitary, and properly labeled,’’ and in
March 22, 2007, is the date the Management and Budget Review; section 1003(d)(2)(C) of the FD&C Act
investigational new drug application Comment Request; Comparing Food (21 U.S.C. 393(d)(2)(C)), to conduct
(IND) became effective. Safety Knowledge, Attitude and research relating to foods, drugs,
Behavior Among English-Dominant cosmetics, devices and tobacco
2. The date the application was Hispanics, Spanish-Dominant products.
initially submitted with respect to the Hispanics, and Other Consumers Our current food safety education and
human drug product under section
outreach programs and materials
505(b) of the FD&C Act: February 8, AGENCY: Food and Drug Administration,
generally are developed and provided
2013. FDA has verified the applicant’s HHS.
for the English-speaking population in
claim that the new drug application ACTION: Notice. the United States (U.S.) (Ref. 1). To
(NDA) for ADEMPAS (NDA 204819)
SUMMARY: The Food and Drug better protect public health and to help
was initially submitted on February 8,
Administration (FDA) is announcing consumers practice safe food handling,
2013.
that a proposed collection of we need empirical data on how different
3. The date the application was population groups understand, perceive
approved: October 8, 2013. FDA has information has been submitted to the
Office of Management and Budget and practice food safety and food
verified the applicant’s claim that NDA handling. An emerging and important
204819 was approved on October 8, (OMB) for review and clearance under
the Paperwork Reduction Act of 1995. demographic trend in the United States
2013. is the increase in Hispanics. Recent
DATES: Fax written comments on the
This determination of the regulatory estimates suggest that Hispanics
asabaliauskas on DSK3SPTVN1PROD with NOTICES

review period establishes the maximum collection of information by May 12, (defined as those who identify
potential length of a patent extension. 2016. themselves as of Hispanic or Latino
However, the USPTO applies several ADDRESSES: To ensure that comments on origin) are the largest and fastest
statutory limitations in its calculations the information collection are received, growing minority group in the nation;
of the actual period for patent extension. OMB recommends that written the proportion of the U.S. population
In its application for patent extension, comments be faxed to the Office of that was Hispanic was 14 percent in
this applicant seeks 1,317 days of patent Information and Regulatory Affairs, 2005 and is projected to increase to 29
term extension. OMB, Attn: FDA Desk Officer, FAX: percent in 2050 (Ref. 2).

VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1

Document Created: 2016-04-12 00:46:45
Document Modified: 2016-04-12 00:46:45

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 June 13, 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 11, 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 21555

81 FR 21555 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPAS

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 70 (April 12, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration