[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Notices]
[Pages 56828-56829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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


