82_FR_56833 82 FR 56605 - Determination of Regulatory Review Period for Purposes of Patent Extension; XURIDEN

82 FR 56605 - Determination of Regulatory Review Period for Purposes of Patent Extension; XURIDEN

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 228 (November 29, 2017)

Page Range56605-56606
FR Document2017-25770

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XURIDEN 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 82 Issue 228 (Wednesday, November 29, 2017) 
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56605-56606]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25770]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2181]


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

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 XURIDEN 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 
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 No. 
FDA-2016-E-2181 for ''Determination of Regulatory Review Period for 
Purposes of Patent Extension; XURIDEN.'' 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,

[[Page 56606]]

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 XURIDEN 
(uridine triacetate). XURIDEN is indicated for the treatment of 
hereditary orotic aciduria. Subsequent to this approval, the USPTO 
received a patent term restoration application for XURIDEN (U.S. Patent 
No. 6,258,795) from Wellstat Therapeutics Corp., and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated August 25, 2016, FDA advised 
the USPTO that this human drug product had undergone a regulatory 
review period and that the approval of XURIDEN 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 
XURIDEN is 8,494 days. Of this time, 8,254 days occurred during the 
testing phase of the regulatory review period, while 240 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: June 4, 1992. The applicant claims May 4, 1992, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was June 4, 
1992, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: January 8, 
2015. FDA has verified the applicant's claim that the new drug 
application (NDA) for XURIDEN (NDA 208169) was initially submitted on 
January 8, 2015.
    3. The date the application was approved: September 4, 2015. FDA 
has verified the applicant's claim that NDA 208169 was approved on 
September 4, 2015.
    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 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 must comply with all the requirements 
of 21 CFR 60.30, including but not limited to: Must be timely (see 
DATES), must be filed in accordance with 21 CFR 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 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25770 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56605 ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average Number of Number of burden per Type of respondents Form name responses per respondents response respondent (in hours) Adult Family Member ...................................... Main Supplements ......................................... 39,375 1 20/60 Adult Household Member ............................... Redesigned Household Roster ...................... 5,625 1 5/60 Sample Adult ................................................... Redesigned Adult Questionnaire ................... 4,500 1 39/60 Adult Family Member ...................................... Redesigned Child Questionnaire ................... 1,750 1 27/60 Adult Family Member ...................................... Methodological Projects ................................. 15,000 1 20/60 Adult Family Member ...................................... Main Reinterview Survey ............................... 4,375 1 5/60 Adult Family Member ...................................... Redesigned Reinterview Survey .................... 625 1 5/60 Leroy A. Richardson, considered. Electronic comments must • For written/paper comments Chief, Information Collection Review Office, be submitted on or before January 29, submitted to the Dockets Management Office of Scientific Integrity, Office of the 2018. The https://www.regulations.gov Staff, FDA will post your comment, as Associate Director for Science, Office of the electronic filing system will accept well as any attachments, except for Director, Centers for Disease Control and comments until midnight Eastern Time information submitted, marked and Prevention. identified, as confidential, if submitted at the end of January 29, 2018. [FR Doc. 2017–25739 Filed 11–28–17; 8:45 am] Comments received by mail/hand as detailed in ‘‘Instructions.’’ BILLING CODE 4163–18–P delivery/courier (for written/paper Instructions: All submissions received submissions) will be considered timely must include the Docket No. FDA– if they are postmarked or the delivery 2016–E–2181 for ’’Determination of DEPARTMENT OF HEALTH AND service acceptance receipt is on or Regulatory Review Period for Purposes HUMAN SERVICES before that date. of Patent Extension; XURIDEN.’’ Received comments, those filed in a Food and Drug Administration Electronic Submissions timely manner (see ADDRESSES), will be [Docket No. FDA–2016–E–2181] Submit electronic comments in the placed in the docket and, except for following way: those submitted as ‘‘Confidential Determination of Regulatory Review Submissions,’’ publicly viewable at • Federal eRulemaking Portal: Period for Purposes of Patent https://www.regulations.gov or at the https://www.regulations.gov. Follow the Extension; XURIDEN Dockets Management Staff between 9 instructions for submitting comments. AGENCY: Food and Drug Administration, Comments submitted electronically, a.m. and 4 p.m., Monday through HHS. including attachments, to https:// Friday. • Confidential Submissions—To ACTION: Notice. www.regulations.gov will be posted to submit a comment with confidential the docket unchanged. Because your SUMMARY: The Food and Drug information that you do not wish to be comment will be made public, you are Administration (FDA or the Agency) has made publicly available, submit your solely responsible for ensuring that your determined the regulatory review period comments only as a written/paper comment does not include any for XURIDEN and is publishing this submission. You should submit two confidential information that you or a notice of that determination as required copies total. One copy will include the third party may not wish to be posted, information you claim to be confidential by law. FDA has made the such as medical information, your or determination because of the with a heading or cover note that states anyone else’s Social Security number, or ‘‘THIS DOCUMENT CONTAINS submission of an application to the confidential business information, such Director of the U.S. Patent and CONFIDENTIAL INFORMATION.’’ The as a manufacturing process. Please note Agency will review this copy, including Trademark Office (USPTO), Department that if you include your name, contact of Commerce, for the extension of a the claimed confidential information, in information, or other information that its consideration of comments. The patent which claims that human drug identifies you in the body of your product. second copy, which will have the comments, that information will be claimed confidential information DATES: Anyone with knowledge that any posted on https://www.regulations.gov. redacted/blacked out, will be available of the dates as published (in the • If you want to submit a comment for public viewing and posted on SUPPLEMENTARY INFORMATION section) are with confidential information that you https://www.regulations.gov. Submit incorrect may submit either electronic do not wish to be made available to the both copies to the Dockets Management or written comments and ask for a public, submit the comment as a Staff. If you do not wish your name and redetermination by January 29, 2018. written/paper submission and in the contact information to be made publicly Furthermore, any interested person may manner detailed (see ‘‘Written/Paper available, you can provide this petition FDA for a determination Submissions’’ and ‘‘Instructions’’). information on the cover sheet and not regarding whether the applicant for in the body of your comments and you Written/Paper Submissions pmangrum on DSK3GDR082PROD with NOTICES1 extension acted with due diligence must identify this information as during the regulatory review period by Submit written/paper submissions as ‘‘confidential.’’ Any information marked May 29, 2018. See ‘‘Petitions’’ in the follows: as ‘‘confidential’’ will not be disclosed SUPPLEMENTARY INFORMATION section for • Mail/Hand delivery/Courier (for except in accordance with § 10.20 (21 more information. written/paper submissions): Dockets CFR 10.20) and other applicable ADDRESSES: You may submit comments Management Staff (HFA–305), Food and disclosure law. For more information as follows. Please note that late, Drug Administration, 5630 Fishers about FDA’s posting of comments to untimely filed comments will not be Lane, Rm. 1061, Rockville, MD 20852. public dockets, see 80 FR 56469, VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

56606 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices September 18, 2015, or access the Subsequent to this approval, the USPTO CFR 60.30), any interested person may information at: https://www.gpo.gov/ received a patent term restoration petition FDA for a determination fdsys/pkg/FR-2015-09-18/pdf/2015- application for XURIDEN (U.S. Patent regarding whether the applicant for 23389.pdf. No. 6,258,795) from Wellstat extension acted with due diligence Docket: For access to the docket to Therapeutics Corp., and the USPTO during the regulatory review period. To read background documents or the requested FDA’s assistance in meet its burden, the petition must electronic and written/paper comments determining this patent’s eligibility for comply with all the requirements of 21 received, go to https:// patent term restoration. In a letter dated CFR 60.30, including but not limited to: www.regulations.gov and insert the August 25, 2016, FDA advised the Must be timely (see DATES), must be docket number, found in brackets in the USPTO that this human drug product filed in accordance with 21 CFR 10.20, heading of this document, into the had undergone a regulatory review must contain sufficient facts to merit an ‘‘Search’’ box and follow the prompts period and that the approval of FDA investigation, and must certify that and/or go to the Dockets Management XURIDEN represented the first a true and complete copy of the petition Staff, 5630 Fishers Lane, Rm. 1061, permitted commercial marketing or use has been served upon the patent Rockville, MD 20852. of the product. Thereafter, the USPTO applicant. (See H. Rept. 857, part 1, 98th FOR FURTHER INFORMATION CONTACT: requested that FDA determine the Cong., 2d sess., pp. 41–42, 1984.) Beverly Friedman, Office of Regulatory product’s regulatory review period. Petitions should be in the format Policy, Food and Drug Administration, II. Determination of Regulatory Review specified in 21 CFR 10.30. 10903 New Hampshire Ave., Bldg. 51, Period Submit petitions electronically to Rm. 6250, Silver Spring, MD 20993, https://www.regulations.gov at Docket 301–796–3600. FDA has determined that the No. FDA–2013–S–0610. Submit written applicable regulatory review period for petitions (two copies are required) to the SUPPLEMENTARY INFORMATION: XURIDEN is 8,494 days. Of this time, Dockets Management Staff (HFA–305), I. Background 8,254 days occurred during the testing Food and Drug Administration, 5630 phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD The Drug Price Competition and while 240 days occurred during the 20852. Patent Term Restoration Act of 1984 approval phase. These periods of time (Pub. L. 98–417) and the Generic Dated: November 24, 2017. were derived from the following dates: Animal Drug and Patent Term 1. The date an exemption under Leslie Kux, Restoration Act (Pub. L. 100–670) section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. generally provide that a patent may be and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2017–25770 Filed 11–28–17; 8:45 am] extended for a period of up to 5 years U.S.C. 355(i)) became effective: June 4, BILLING CODE 4164–01–P so long as the patented item (human 1992. The applicant claims May 4, 1992, drug product, animal drug product, as the date the investigational new drug medical device, food additive, or color application (IND) became effective. DEPARTMENT OF HEALTH AND additive) was subject to regulatory However, FDA records indicate that the HUMAN SERVICES review by FDA before the item was IND effective date was June 4, 1992, marketed. Under these acts, a product’s which was 30 days after FDA receipt of Food and Drug Administration regulatory review period forms the basis the IND. [Docket No. FDA–2017–N–6373] for determining the amount of extension 2. The date the application was an applicant may receive. initially submitted with respect to the Roxane Laboratories, Inc.; Withdrawal A regulatory review period consists of human drug product under section of Approval of a New Drug Application two periods of time: A testing phase and 505(b) of the FD&C Act: January 8, 2015. for ROXICODONE (Oxycodone an approval phase. For human drug FDA has verified the applicant’s claim Hydrochloride) Sustained-Release products, the testing phase begins when that the new drug application (NDA) for Tablets, 10 Milligrams and 30 the exemption to permit the clinical XURIDEN (NDA 208169) was initially Milligrams investigations of the drug becomes submitted on January 8, 2015. effective and runs until the approval 3. The date the application was AGENCY: Food and Drug Administration, phase begins. The approval phase starts approved: September 4, 2015. FDA has HHS. with the initial submission of an verified the applicant’s claim that NDA ACTION: Notice. application to market the human drug 208169 was approved on September 4, product and continues until FDA grants SUMMARY: The Food and Drug 2015. Administration (FDA or Agency) is permission to market the drug product. This determination of the regulatory Although only a portion of a regulatory withdrawing approval of new drug review period establishes the maximum review period may count toward the application (NDA) 020932 for potential length of a patent extension. actual amount of extension that the ROXICODONE (oxycodone However, the USPTO applies several Director of USPTO may award (for hydrochloride (HCl)) Sustained-Release statutory limitations in its calculations example, half the testing phase must be Tablets, 10 milligrams (mg) and 30 mg, of the actual period for patent extension. subtracted as well as any time that may held by Roxane Laboratories, Inc. In its application for patent extension, have occurred before the patent was (Roxane). Roxane requested withdrawal this applicant seeks 5 years of patent issued), FDA’s determination of the of this application and waived its term extension. pmangrum on DSK3GDR082PROD with NOTICES1 length of a regulatory review period for opportunity for a hearing. a human drug product will include all III. Petitions DATES: The approval is withdrawn as of of the testing phase and approval phase Anyone with knowledge that any of November 29, 2017. as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may FOR FURTHER INFORMATION CONTACT: FDA has approved for marketing the submit either electronic or written Kristiana Brugger, Office of Regulatory human drug product XURIDEN (uridine comments and, under 21 CFR 60.24, ask Policy, Center for Drug Evaluation and triacetate). XURIDEN is indicated for the for a redetermination (see DATES). Research, Food and Drug treatment of hereditary orotic aciduria. Furthermore, as specified in § 60.30 (21 Administration, 10903 New Hampshire VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1


Document Created: 2017-11-29 01:26:37
Document Modified: 2017-11-29 01:26:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone 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.
ContactBeverly 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 Citation82 FR 56605 
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