83 FR 5436 - Determination of Regulatory Review Period for Purposes of Patent Extension; FARXIGA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

Page Range		5436-5438
FR Document		2018-02418

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FARXIGA 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 human drug product.

Federal Register, Volume 83 Issue 26 (Wednesday, February 7, 2018)

[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5436-5438]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-0857 and FDA-2015-E-0858]

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

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 FARXIGA and is publishing
this

[[Page 5437]]

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 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 April
9, 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 April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 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. 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 August 6, 2018. See ``Petitions'' in the
SUPPLEMENTARY INFORMATION section for more information.

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-2015-E-0857 and FDA-2015-E-0858 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; FARXIGA.'' 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 FARXIGA
(dapagliflozin). FARXIGA is indicated as an adjunct to diet and
exercise to

[[Page 5438]]

improve glycemic control in adults with type 2 diabetes mellitus.
Subsequent to this approval, the USPTO received patent term restoration
applications for FARXIGA (U.S. Patent Nos. 6,414,126 and 6,515,117)
from AstraZeneca AB, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated October 19, 2015, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of FARXIGA 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
FARXIGA is 3,673 days. Of this time, 2,565 days occurred during the
testing phase of the regulatory review period, while 1,108 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: December 21, 2003. FDA has verified the AstraZeneca AB claim
that the date the investigational new drug application became effective
was on December 21, 2003.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
28, 2010. The applicant claims December 27, 2010, as the date the new
drug application (NDA) for FARXIGA (NDA 202293) was initially
submitted. However, FDA records indicate that NDA 202293 was submitted
on December 28, 2010.
3. The date the application was approved: January 8, 2014. FDA has
verified the applicant's claim that NDA 202293 was approved on January
8, 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 1,825 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: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02418 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P

5436 Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices

data collection duration for the same designated individual) of the respective person in charge, is 112 minutes (82 +
facility types during the 2013–2014 data regulatory authority 30 minutes (0.5 30) (1.86 hours).
collection. FDA estimates that it will hours) to answer the questions related to Based on the number of entry refusals
take the persons in charge of full service Section 2 of the form. This burden from the 2013–2014 baseline data
restaurants and fast food restaurants 104 estimate is unchanged from the last data collection, we estimate a refusal rate of
minutes (1.73 hours) and 82 minutes collection. Hence, the total burden 2 percent for the data collections within
(1.36 hours), respectively, to accompany estimate for a data collection in a full restaurant facility types. The estimate of
the data collectors while they complete service restaurant, including the
Sections 1 and 3 of the form. In the time per non-respondent is 5
responses of both the program director minutes (0.08 hours) for the person in
comparison, for the 2013–2014 data
and the person in charge, is 134 minutes charge to listen to the purpose of the
collection, the burden estimate was 106
(104 + 30) (2.23 hours). The total burden visit and provide a verbal refusal of
minutes (1.76 hours) in full service
estimate for a data collection in a fast entry.
restaurants and 73 minutes (1.21 hours)
in fast food restaurants. FDA estimates food restaurant, including the responses FDA estimates the burden of this
that it will take the program director (or of both the program director and the collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Number of
Total Number of Total Average
Number of responses responses
Activity annual non- annual non- burden per Total hours
respondents per per non-
responses respondents responses response
respondent respondent

2021–2022 Data 400 1 400 ........................ ........................ ........................ 1.36 ............................ 544
Collection (Fast
Food Res-
taurants)—Com-
pletion of Sec-
tions 1 and 3.
2021–2022 Data 400 1 400 ........................ ........................ ........................ 1.73 ............................ 692
Collection (Full
Service Res-
taurants)—Com-
pletion of Sec-
tions 1 and 3.
2021–2022 Data 800 1 800 ........................ ........................ ........................ 0.5 (30 minutes) ........ 400
Collection-Com-
pletion of Section
2—All Facility
Types.
2021–2022 Data ¥ ¥ ¥ 16 1 16 0.08 (5 minutes) ........ 1.28
Collection-Entry
Refusals—All Fa-
cility Types.

Total Hours .......... ........................ ........................ ........................ ........................ ........................ ........................ .................................... 1,637.28
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden for this information Retail Food Store Facility Types (2004).’’ Dated: January 31, 2018.
collection has not changed since the last Available at: https://wayback.archive-it.org/ Leslie Kux,
OMB approval. 7993/20170406023011/https://www.fda.gov/ Associate Commissioner for Policy.
downloads/Food/GuidanceRegulation/
II. References [FR Doc. 2018–02414 Filed 2–6–18; 8:45 am]
RetailFoodProtection/FoodborneIllness
RiskFactorReduction/UCM423850.pdf. BILLING CODE 4164–01–P
The following references are on 3. ‘‘FDA Report on the Occurrence of
display in the Dockets Management Foodborne Illness Risk Factors in Selected
Staff (see ADDRESSES) and are available Institutional Foodservice, Restaurant, and DEPARTMENT OF HEALTH AND
for viewing by interested persons Retail Food Store Facility Types (2009).’’ HUMAN SERVICES
between 9 a.m. and 4 p.m., Monday Available at: https://wayback.archive-it.org/
through Friday, they are also available 7993/20170406023004/https://www.fda.gov/ Food and Drug Administration
electronically at https:// Food/GuidanceRegulation/RetailFood
Protection/FoodborneIllnessRiskFactor [Docket Nos. FDA–2015–E–0857 and FDA–
www.regulations.gov. FDA has verified 2015–E–0858]
Reduction/ucm224321.htm.
the website addresses, as of the date this
4. FDA National Retail Food Team. ‘‘FDA
document publishes in the Federal Trend Analysis Report on the Occurrence of
Determination of Regulatory Review
Register, but websites are subject to Foodborne Illness Risk Factors in Selected Period for Purposes of Patent
change over time. Institutional Foodservice, Restaurant, and Extension; FARXIGA
1. ‘‘Report of the FDA Retail Food Program Retail Food Store Facility Types (1998–
sradovich on DSK3GMQ082PROD with NOTICES

AGENCY: Food and Drug Administration,
Database of Foodborne Illness Risk Factors’’ 2008).’’ Available at: https://
wayback.archive-it.org/7993/201704
HHS.
(2000). Available at: https://wayback.archive-
it.org/7993/20170406023019/https:// 06022950/https://www.fda.gov/Food/ ACTION: Notice.
www.fda.gov/downloads/Food/Guidance GuidanceRegulation/RetailFoodProtection/
Regulation/UCM123546.pdf. FoodborneIllnessRiskFactorReduction/ SUMMARY: The Food and Drug
2. ‘‘FDA Report on the Occurrence of ucm223293.htm. Administration (FDA or the Agency) has
Foodborne Illness Risk Factors in Selected 5. ‘‘FDA Food Code.’’ Available at: https:// determined the regulatory review period
Institutional Foodservice, Restaurant, and www.fda.gov/FoodCode. for FARXIGA and is publishing this

VerDate Sep<11>2014 18:17 Feb 06, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\07FEN1.SGM 07FEN1

Document Created: 2018-10-26 13:56:44
Document Modified: 2018-10-26 13:56:44

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 April 9, 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		83 FR 5436

83 FR 5436 - Determination of Regulatory Review Period for Purposes of Patent Extension; FARXIGA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration