82 FR 56828 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADVANTAME

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 229 (November 30, 2017)

Page Range		56828-56829
FR Document		2017-25780

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADVANTAME 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 food additive.

Federal Register, Volume 82 Issue 229 (Thursday, November 30, 2017)

[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Notices]
[Pages 56828-56829]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-25780]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-3316 and FDA-2015-E-3315]

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

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 ADVANTAME 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 food
additive.

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.

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 Nos.
FDA-2015-E-3316 and FDA-2015-E-3315 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ADVANTAME.'' 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, human biologic product,

[[Page 56829]]

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 food and color additive
products, the testing phase begins on the date a major health or
environmental effects test is begun and runs until the approval phase
begins. The approval phase begins on the date a petition relying on the
major health or environmental effects test and requesting the issuance
of a regulation for use of the additive under section 409 or 721 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) is initially
submitted to FDA and ends upon whichever of the following occurs last:
(i) The regulation for the additive becomes effective; or (ii)
objections filed against the regulation that result in a stay of
effectiveness are resolved and commercial marketing is permitted; or
(iii) proceedings resulting from objections to the regulation, after
commercial marketing has been permitted and later stayed pending
resolution of the proceedings, are finally resolved and commercial
marketing is permitted.
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 food
and color additive will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(2)(B).
FDA has approved for marketing the food additive ADVANTAME.
ADVANTAME may be safely used as a sweetening agent and flavor enhancer
in foods generally, except in meat and poultry, in accordance with
current good manufacturing practice, in an amount not to exceed that
reasonably required to achieve the intended technical effect, in foods
for which standards of identity established under section 401 of the
FD&C Act do not preclude such use. Subsequent to this approval, the
USPTO received patent term restoration applications for ADVANTAME (U.S.
Patent Nos. 6,548,096 and 7,141,263) from Ajinomoto Co., Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 30,
2015, FDA advised the USPTO that this food and color additive had
undergone a regulatory review period and that the approval of ADVANTAME
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
ADVANTAME is 4,967 days. Of this time, 3,091 days occurred during the
testing phase of the regulatory review period, while 1,876 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date a major health or environmental effects test on the
food additive was initiated: October 16, 2000. FDA has verified the
Ajinomoto Co., Inc. claim that October 16, 2000, is the date the major
health or environmental effects test was begun.
2. The date a petition relying on the major health or environmental
effects test and requesting the issuance of a regulation for use of the
additive under section 409 or 721 of the Federal Food Drug, and
Cosmetic Act is initially submitted to FDA: April 2, 2009. The
applicant claims that the food additive petition (FAP) for ADVANTAME
(FAP 9A4778) was submitted on March 30, 2009. However, according to FDA
records, FAP 9A4778 was submitted on April 2, 2009, when a complete
application was received.
3. The date the regulation for the additive becomes effective or
the date objections filed against the regulation that result in a stay
of effectiveness are resolved and commercial marketing is permitted, or
the date proceedings resulting from objections to the regulation after
commercial marketing has been permitted and later stayed pending
resolution of the proceedings, are finally resolved and commercial
marketing is permitted: May 21, 2014.
FDA has verified the applicant's claim that FAP 9A4778 became
effective on May 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 applications for patent extension,
this applicant seeks 5 years 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 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 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25780 Filed 11-29-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Notices 56829

animal drug product, medical device, patent term restoration. In a letter dated III. Petitions
food additive, or color additive) was October 30, 2015, FDA advised the Anyone with knowledge that any of
subject to regulatory review by FDA USPTO that this food and color additive the dates as published are incorrect may
before the item was marketed. Under had undergone a regulatory review submit either electronic or written
these acts, a product’s regulatory review period and that the approval of comments and, under 21 CFR 60.24, ask
period forms the basis for determining ADVANTAME represented the first for a redetermination (see DATES).
the amount of extension an applicant permitted commercial marketing or use Furthermore, as specified in § 60.30 (21
may receive. of the product. Thereafter, the USPTO
A regulatory review period consists of CFR 60.30), any interested person may
requested that FDA determine the petition FDA for a determination
two periods of time: A testing phase and product’s regulatory review period.
an approval phase. For food and color regarding whether the applicant for
additive products, the testing phase II. Determination of Regulatory Review extension acted with due diligence
begins on the date a major health or Period during the regulatory review period. To
environmental effects test is begun and meet its burden, the petition comply
FDA has determined that the with all the requirements of § 60.30,
runs until the approval phase begins. applicable regulatory review period for
The approval phase begins on the date including but not limited to: must be
ADVANTAME is 4,967 days. Of this timely (see DATES), must be filed in
a petition relying on the major health or time, 3,091 days occurred during the
environmental effects test and accordance with § 10.20, must contain
testing phase of the regulatory review sufficient facts to merit an FDA
requesting the issuance of a regulation period, while 1,876 days occurred
for use of the additive under section 409 investigation, and must certify that a
during the approval phase. These true and complete copy of the petition
or 721 of the Federal Food, Drug, and periods of time were derived from the
Cosmetic Act (the FD&C Act) is initially has been served upon the patent
following dates: applicant. (See H. Rept. 857, part 1, 98th
submitted to FDA and ends upon
whichever of the following occurs last: 1. The date a major health or Cong., 2d sess., pp. 41–42, 1984.)
(i) The regulation for the additive environmental effects test on the food Petitions should be in the format
becomes effective; or (ii) objections filed additive was initiated: October 16, 2000. specified in 21 CFR 10.30.
against the regulation that result in a FDA has verified the Ajinomoto Co., Submit petitions electronically to
stay of effectiveness are resolved and Inc. claim that October 16, 2000, is the https://www.regulations.gov at Docket
commercial marketing is permitted; or date the major health or environmental No. FDA–2013–S–0610. Submit written
(iii) proceedings resulting from effects test was begun. petitions (two copies are required) to the
objections to the regulation, after 2. The date a petition relying on the Dockets Management Staff (HFA–305),
commercial marketing has been major health or environmental effects Food and Drug Administration, 5630
permitted and later stayed pending test and requesting the issuance of a Fishers Lane, Rm. 1061, Rockville, MD
resolution of the proceedings, are finally regulation for use of the additive under 20852.
resolved and commercial marketing is section 409 or 721 of the Federal Food Dated: November 22, 2017.
permitted. Drug, and Cosmetic Act is initially Leslie Kux,
Although only a portion of a submitted to FDA: April 2, 2009. The Associate Commissioner for Policy.
regulatory review period may count applicant claims that the food additive
[FR Doc. 2017–25780 Filed 11–29–17; 8:45 am]
toward the actual amount of extension petition (FAP) for ADVANTAME (FAP
BILLING CODE 4164–01–P
that the Director of USPTO may award 9A4778) was submitted on March 30,
(for example, half the testing phase must 2009. However, according to FDA
be subtracted as well as any time that records, FAP 9A4778 was submitted on
may have occurred before the patent DEPARTMENT OF HEALTH AND
April 2, 2009, when a complete HUMAN SERVICES
was issued), FDA’s determination of the application was received.
length of a regulatory review period for 3. The date the regulation for the Health Resources and Services
a food and color additive will include additive becomes effective or the date Administration
all of the testing phase and approval objections filed against the regulation
phase as specified in 35 U.S.C. that result in a stay of effectiveness are National Vaccine Injury Compensation
156(g)(2)(B). resolved and commercial marketing is Program; List of Petitions Received
FDA has approved for marketing the
permitted, or the date proceedings AGENCY: Health Resources and Services
food additive ADVANTAME.
resulting from objections to the Administration (HRSA), Department of
ADVANTAME may be safely used as a
regulation after commercial marketing Health and Human Services (HHS).
sweetening agent and flavor enhancer in
has been permitted and later stayed
foods generally, except in meat and ACTION: Notice.
pending resolution of the proceedings,
poultry, in accordance with current
are finally resolved and commercial SUMMARY: HRSA is publishing this
good manufacturing practice, in an
marketing is permitted: May 21, 2014. notice of petitions received under the
amount not to exceed that reasonably
required to achieve the intended FDA has verified the applicant’s claim National Vaccine Injury Compensation
technical effect, in foods for which that FAP 9A4778 became effective on Program (the program), as required by
standards of identity established under May 21, 2014. the Public Health Service (PHS) Act, as
section 401 of the FD&C Act do not This determination of the regulatory amended. While the Secretary of Health
preclude such use. Subsequent to this review period establishes the maximum and Human Services is named as the
daltland on DSKBBV9HB2PROD with NOTICES

approval, the USPTO received patent potential length of a patent extension. respondent in all proceedings brought
term restoration applications for However, the USPTO applies several by the filing of petitions for
ADVANTAME (U.S. Patent Nos. statutory limitations in its calculations compensation under the program, the
6,548,096 and 7,141,263) from of the actual period for patent extension. United States Court of Federal Claims is
Ajinomoto Co., Inc., and the USPTO In its applications for patent extension, charged by statute with responsibility
requested FDA’s assistance in this applicant seeks 5 years of patent for considering and acting upon the
determining the patents’ eligibility for term extension. petitions.

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Document Created: 2017-11-30 00:35:07
Document Modified: 2017-11-30 00:35:07

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 56828

82 FR 56828 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADVANTAME

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 229 (November 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration