81 FR 83852 - Determination of Regulatory Review Period for Purposes of Patent Extension; CERDELGA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 225 (November 22, 2016)

Page Range		83852-83853
FR Document		2016-28045

The Food and Drug Administration (FDA) has determined the regulatory review period for CERDELGA 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 225 (Tuesday, November 22, 2016)

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83852-83853]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-28045]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-2724]

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

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 CERDELGA 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
23, 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 May 22, 2017. 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: 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): 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-2015-E-2724 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; CERDELGA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://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 https://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 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 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.

[[Page 83853]]

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 CERDELGA
(eliglustat). CERDELGA is indicated for the long-term treatment of
adult patients with Gaucher disease type 1 who are CYP2D6 extensive
metabolizers, intermediate metabolizers, or poor metabolizers as
detected by an FDA-cleared test. Subsequent to this approval, the USPTO
received a patent term restoration application for CERDELGA (U.S.
Patent No. 7,196,205) from Genzyme Corporation, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated October 15, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of CERDELGA 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
CERDELGA is 3,854 days. Of this time, 3,520 days occurred during the
testing phase of the regulatory review period, while 334 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: February 1, 2004. FDA has verified the applicant's claim
that the date the investigational new drug application became effective
was on February 1, 2004.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
20, 2013. FDA has verified the applicant's claim that the new drug
application (NDA) for CERDELGA (NDA 205494) was initially submitted on
September 20, 2013.
3. The date the application was approved: August 19, 2014. FDA has
verified the applicant's claim that NDA 205494 was approved on August
19, 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 1,518 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 https://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: November 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28045 Filed 11-21-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 83853

Although only a portion of a regulatory 205494 was approved on August 19, Program on matters related to program
review period may count toward the 2014. responsibilities. The Assistant Secretary
actual amount of extension that the This determination of the regulatory for Health (ASH) has been designated by
Director of USPTO may award (for review period establishes the maximum the Secretary of Health and Human
example, half the testing phase must be potential length of a patent extension. Services (HHS) as the Director of the
subtracted as well as any time that may However, the USPTO applies several National Vaccine Program. The National
have occurred before the patent was statutory limitations in its calculations Vaccine Program Office (NVPO) is
issued), FDA’s determination of the of the actual period for patent extension. located within the Office of the
length of a regulatory review period for In its application for patent extension, Assistant Secretary for Health (OASH),
a human drug product will include all this applicant seeks 1,518 days of patent Office of the Secretary, U.S. Department
of the testing phase and approval phase term extension. of Health and Human Services (HHS).
as specified in 35 U.S.C. 156(g)(1)(B). NVPO provides leadership and fosters
FDA has approved for marketing the III. Petitions
collaboration among the various Federal
human drug product CERDELGA Anyone with knowledge that any of agencies involved in vaccine and
(eliglustat). CERDELGA is indicated for the dates as published are incorrect may immunization activities. The NVPO also
the long-term treatment of adult patients submit either electronic or written supports the National Vaccine Advisory
with Gaucher disease type 1 who are comments and ask for a redetermination Committee (NVAC). The NVAC advises
CYP2D6 extensive metabolizers, (see DATES). Furthermore, any interested and makes recommendations to the
intermediate metabolizers, or poor person may petition FDA for a ASH in her capacity as the Director of
metabolizers as detected by an FDA- determination regarding whether the the National Vaccine Program on
cleared test. Subsequent to this applicant for extension acted with due matters related to vaccine program
approval, the USPTO received a patent diligence during the regulatory review responsibilities.
term restoration application for period. To meet its burden, the petition Recognizing the changes in the
CERDELGA (U.S. Patent No. 7,196,205) must be timely (see DATES) and contain immunization landscape, the ASH
from Genzyme Corporation, and the sufficient facts to merit an FDA charged the NVAC to conduct a Mid-
USPTO requested FDA’s assistance in investigation. (See H. Rept. 857, part 1, course review to evaluate the progress of
determining this patent’s eligibility for 98th Cong., 2d sess., pp. 41–42, 1984.) the National Vaccine Plan and provide
patent term restoration. In a letter dated Petitions should be in the format recommendations to optimize priority
October 15, 2015, FDA advised the specified in 21 CFR 10.30. areas. In March 2016, the NVAC formed
USPTO that this human drug product Submit petitions electronically to
the Mid-Course Review Working Group.
had undergone a regulatory review https://www.regulations.gov at Docket
Through a series of conference calls,
period and that the approval of No. FDA–2013–S–0610. Submit written
electronic communication, and public
CERDELGA represented the first petitions (two copies are required) to the
discussions during the NVAC meetings,
permitted commercial marketing or use Division of Dockets Management (HFA–
the working group identified a number
of the product. Thereafter, the USPTO 305), Food and Drug Administration,
of draft recommendations for
requested that FDA determine the 5630 Fishers Lane, Rm. 1061, Rockville,
consideration by the NVAC. These
product’s regulatory review period. MD 20852.
recommendations serve as a useful tool
II. Determination of Regulatory Review Dated: November 16, 2016. in refining collective strategies for
Period Leslie Kux, shaping the future of the U.S.
FDA has determined that the Associate Commissioner for Policy. immunization enterprise, both
applicable regulatory review period for [FR Doc. 2016–28045 Filed 11–21–16; 8:45 am] domestically and globally. The draft
CERDELGA is 3,854 days. Of this time, BILLING CODE 4164–01–P report and draft recommendations from
3,520 days occurred during the testing the working group will inform NVAC
phase of the regulatory review period, deliberations as the NVAC finalizes
while 334 days occurred during the DEPARTMENT OF HEALTH AND their recommendations for transmittal to
approval phase. These periods of time HUMAN SERVICES the ASH.
were derived from the following dates: On behalf of NVAC, NVPO is
1. The date an exemption under Solicitation of Written Comments on soliciting public comment on the draft
section 505(i) of the Federal Food, Drug, the Mid-Course Review Working Group report and draft recommendations from
and Cosmetic Act (the FD&C Act) (21 Draft Report and Draft a variety of stakeholders, including the
U.S.C. 355(i)) became effective: Recommendations for Consideration general public, for consideration by the
February 1, 2004. FDA has verified the by the National Vaccine Advisory NVAC as they develop their final
applicant’s claim that the date the Committee recommendations to the ASH. It is
investigational new drug application AGENCY: National Vaccine Program anticipated that the draft report and
became effective was on February 1, Office, Office of the Assistant Secretary draft recommendations, as revised with
2004. for Health, Office of the Secretary, consideration given to public comment
2. The date the application was Department of Health and Human and stakeholder input, will be presented
initially submitted with respect to the Services. to the NVAC for adoption in February
human drug product under section ACTION: Notice. 2017 at the quarterly NVAC meeting.
505(b) of the FD&C Act: September 20, DATES: Comments for consideration by
SUMMARY: The National Vaccine
sradovich on DSK3GMQ082PROD with NOTICES

2013. FDA has verified the applicant’s the NVAC should be received no later
claim that the new drug application Advisory Committee (NVAC) was
than 5 p.m. EDT on December 27, 2016.
(NDA) for CERDELGA (NDA 205494) established in 1987 to comply with Title
was initially submitted on September XXI of the Public Health Service Act ADDRESSES:
20, 2013. (Pub. L. 99–660) (section 2105) (42 U.S. • The draft report and draft
3. The date the application was Code 300aa–5). Its purpose is to advise recommendations are available on the
approved: August 19, 2014. FDA has and make recommendations to the Web at http://www.hhs.gov/nvpo/nvac/
verified the applicant’s claim that NDA Director of the National Vaccine index.html.

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Document Created: 2018-02-14 08:28:58
Document Modified: 2018-02-14 08:28:58

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 23, 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 May 22, 2017. 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 83852

81 FR 83852 - Determination of Regulatory Review Period for Purposes of Patent Extension; CERDELGA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 225 (November 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration