83 FR 6579 - Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDIN
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 31 (February 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 31 (February 14, 2018)
| Page Range | 6579-6581 | |
| FR Document | 2018-02993 |
[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)] [Notices] [Pages 6579-6581] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02993] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-3488] Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDIN 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 KERYDIN 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 August 13, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 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 [[Page 6580]] 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-3488 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDIN.'' 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 KERYDIN (tavaborole). KERYDIN is indicated for the topical treatment of onychomycosis of the toenails due to Tricophyton rubrum or Tricophyton mentagrophytes. Subsequent to this approval, the USPTO received a patent term restoration application for KERYDIN (U.S. Patent No. 7,582,621) from Anacor Pharmaceuticals, Inc., 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 KERYDIN 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 KERYDIN is 3,112 days. Of this time, 2,768 days occurred during the testing phase of the regulatory review period, while 344 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: December 31, 2005. FDA has verified the applicant's claim that December 31, 2005, is the date the investigational new drug application became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: July 29, 2013. The applicant claims July 26, 2013, as the date the new drug application (NDA) for KERYDIN (NDA 204427) was initially submitted. However, FDA records indicate that NDA 204427 was submitted on July 29, 2013. 3. The date the application was approved: July 7, 2014. FDA has verified the applicant's claim that NDA 204427 was approved on July 7, 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 408 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 [[Page 6581]] 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: February 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02993 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6579
received a patent term restoration comments and, under 21 CFR 60.24, ask redetermination by April 16, 2018.
application for OSURNIA (U.S. Patent for a redetermination (see DATES). Furthermore, any interested person may
No. 7,854,943) from IDEXX, and the Furthermore, as specified in § 60.30 (21 petition FDA for a determination
USPTO requested FDA’s assistance in CFR 60.30), any interested person may regarding whether the applicant for
determining this patent’s eligibility for petition FDA for a determination extension acted with due diligence
patent term restoration. In a letter dated regarding whether the applicant for during the regulatory review period by
December 17, 2015, FDA advised the extension acted with due diligence August 13, 2018. See ‘‘Petitions’’ in the
USPTO that this animal drug product during the regulatory review period. To SUPPLEMENTARY INFORMATION section for
had undergone a regulatory review meet its burden, the petition must more information.
period and that the approval of comply with all the requirements of ADDRESSES: You may submit comments
OSURNIA represented the first § 60.30, including but not limited to: as follows. Please note that late,
permitted commercial marketing or use Must be timely (see DATES), must be untimely filed comments will not be
of the product. Thereafter, the USPTO filed in accordance with § 10.20, must considered. Electronic comments must
requested that FDA determine the contain sufficient facts to merit an FDA be submitted on or before April 16,
product’s regulatory review period. investigation, and must certify that a 2018. The https://www.regulations.gov
II. Determination of Regulatory Review true and complete copy of the petition electronic filing system will accept
Period has been served upon the patent comments until midnight Eastern Time
applicant. (See H. Rept. 857, part 1, 98th at the end of April 16, 2018. Comments
FDA has determined that the Cong., 2d sess., pp. 41–42, 1984.) received by mail/hand delivery/courier
applicable regulatory review period for Petitions should be in the format (for written/paper submissions) will be
OSURNIA is 4,034 days. Of this time, specified in 21 CFR 10.30. considered timely if they are
3,980 days occurred during the testing Submit petitions electronically to postmarked or the delivery service
phase of the regulatory review period, https://www.regulations.gov at Docket acceptance receipt is on or before that
while 54 days occurred during the No. FDA–2013–S–0610. Submit written date.
approval phase. These periods of time petitions (two copies are required) to the
were derived from the following dates: Electronic Submissions
Dockets Management Staff (HFA–305),
1. The date an exemption under Food and Drug Administration, 5630 Submit electronic comments in the
section 505(i) of the FD&C Act (21 Fishers Lane, Rm. 1061, Rockville, MD following way:
U.S.C. 355(i)) became effective: October 20852. • Federal eRulemaking Portal:
21, 2003. The applicant claims https://www.regulations.gov. Follow the
September 20, 2013, as the date the Dated: February 8, 2018. instructions for submitting comments.
investigational new animal drug Leslie Kux, Comments submitted electronically,
application (INAD) became effective. Associate Commissioner for Policy. including attachments, to https://
However, FDA records indicate that the [FR Doc. 2018–02991 Filed 2–13–18; 8:45 am] www.regulations.gov will be posted to
INAD effective date was October 21, BILLING CODE 4164–01–P the docket unchanged. Because your
2003, which was the date on which the comment will be made public, you are
Agency acknowledges the filing of a solely responsible for ensuring that your
notice of claimed investigational DEPARTMENT OF HEALTH AND comment does not include any
exemption for a new animal drug. HUMAN SERVICES confidential information that you or a
2. The date the application was third party may not wish to be posted,
initially submitted with respect to the Food and Drug Administration such as medical information, your or
animal drug product under section 512 [Docket No. FDA–2015–E–3488] anyone else’s Social Security number, or
of the FD&C Act (21 U.S.C. 360b): confidential business information, such
September 12, 2014. The applicant Determination of Regulatory Review as a manufacturing process. Please note
claims September 9, 2014, as the date Period for Purposes of Patent that if you include your name, contact
the new animal drug application Extension; KERYDIN information, or other information that
(NADA) for OSURNIA (NADA 141–437) identifies you in the body of your
AGENCY: Food and Drug Administration,
was initially submitted. However, FDA comments, that information will be
HHS.
records indicate that NADA 141–437 posted on https://www.regulations.gov.
was submitted on September 12, 2014. ACTION: Notice. • If you want to submit a comment
3. The date the application was SUMMARY: The Food and Drug with confidential information that you
approved: November 4, 2014. FDA has Administration (FDA or the Agency) has do not wish to be made available to the
verified the applicant’s claim that determined the regulatory review period public, submit the comment as a
NADA 141–437 was approved on for KERYDIN and is publishing this written/paper submission and in the
November 4, 2014. notice of that determination as required manner detailed (see ‘‘Written/Paper
This determination of the regulatory Submissions’’ and ‘‘Instructions’’).
by law. FDA has made the
review period establishes the maximum
determination because of the Written/Paper Submissions
potential length of a patent extension.
submission of an application to the
However, the USPTO applies several Submit written/paper submissions as
Director of the U.S. Patent and
statutory limitations in its calculations follows:
Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
of the actual period for patent extension.
of Commerce, for the extension of a written/paper submissions): Dockets
In its application for patent extension,
daltland on DSKBBV9HB2PROD with NOTICES
patent which claims that human drug Management Staff (HFA–305), Food and
this applicant seeks 235 days of patent
product. Drug Administration, 5630 Fishers
term extension.
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
III. Petitions of the dates as published (see the • For written/paper comments
Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
the dates as published are incorrect may incorrect may submit either electronic Staff, FDA will post your comment, as
submit either electronic or written or written comments and ask for a well as any attachments, except for
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![Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6581
No. FDA–2013–S–0610. Submit written acceptance receipt is on or before that comments only as a written/paper
petitions (two copies are required) to the date. submission. You should submit two
Dockets Management Staff (HFA–305), copies total. One copy will include the
Electronic Submissions
Food and Drug Administration, 5630 information you claim to be confidential
Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the with a heading or cover note that states
20852. following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Dated: February 8, 2018.
https://www.regulations.gov. Follow the Agency will review this copy, including
Leslie Kux, instructions for submitting comments. the claimed confidential information, in
Associate Commissioner for Policy. Comments submitted electronically, its consideration of comments. The
[FR Doc. 2018–02993 Filed 2–13–18; 8:45 am] including attachments, to https:// second copy, which will have the
BILLING CODE 4164–01–P www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your https://www.regulations.gov. Submit
HUMAN SERVICES comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
Food and Drug Administration third party may not wish to be posted, contact information to be made publicly
[Docket Nos. FDA–2016–E–1184 and FDA– such as medical information, your or available, you can provide this
2016–E–1183] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Determination of Regulatory Review as a manufacturing process. Please note must identify this information as
Period for Purposes of Patent that if you include your name, contact ‘‘confidential.’’ Any information marked
Extension; IBRANCE information, or other information that as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, identifies you in the body of your except in accordance with § 10.20 (21
HHS. comments, that information will be CFR 10.20) and other applicable
ACTION: Notice. posted on https://www.regulations.gov. disclosure law. For more information
• If you want to submit a comment about FDA’s posting of comments to
SUMMARY: The Food and Drug with confidential information that you public dockets, see 80 FR 56469,
Administration (FDA or the Agency) has do not wish to be made available to the September 18, 2015, or access the
determined the regulatory review period public, submit the comment as a information at: https://www.gpo.gov/
for IBRANCE and is publishing this written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
notice of that determination as required manner detailed (see ‘‘Written/Paper 23389.pdf.
by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
Docket: For access to the docket to
determination because of the Written/Paper Submissions read background documents or the
submission of applications to the
Submit written/paper submissions as electronic and written/paper comments
Director of the U.S. Patent and
follows: received, go to https://
Trademark Office (USPTO), Department
of Commerce, for the extension of a • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
written/paper submissions): Dockets docket number, found in brackets in the
patent which claims that human drug
Management Staff (HFA–305), Food and heading of this document, into the
product.
Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
of the dates as published (see the • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management Rockville, MD 20852.
incorrect may submit either electronic Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
or written comments and ask for a well as any attachments, except for
redetermination by April 16, 2018. Beverly Friedman, Office of Regulatory
information submitted, marked and Policy, Food and Drug Administration,
Furthermore, any interested person may identified, as confidential, if submitted
petition FDA for a determination 10903 New Hampshire Ave., Bldg. 51,
as detailed in ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993,
regarding whether the applicant for Instructions: All submissions received
extension acted with due diligence 301–796–3600.
must include the Docket Nos. FDA–
during the regulatory review period by 2016–E–1184 and FDA–2016–E–1183 SUPPLEMENTARY INFORMATION:
August 13, 2018. See ‘‘Petitions’’ in the for ‘‘For Determination of Regulatory I. Background
SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
more information. Extension; IBRANCE.’’ Received The Drug Price Competition and
ADDRESSES: You may submit comments comments, those filed in a timely Patent Term Restoration Act of 1984
as follows. Please note that late, manner (see ADDRESSES), will be placed (Pub. L. 98–417) and the Generic
untimely filed comments will not be in the dockets and, except for those Animal Drug and Patent Term
considered. Electronic comments must submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670)
be submitted on or before April 16, Submissions,’’ publicly viewable at generally provide that a patent may be
2018. The https://www.regulations.gov https://www.regulations.gov or at the extended for a period of up to 5 years
daltland on DSKBBV9HB2PROD with NOTICES
electronic filing system will accept Dockets Management Staff between 9 so long as the patented item (human
comments until midnight Eastern Time a.m. and 4 p.m., Monday through drug product, animal drug product,
at the end of April 16, 2018. Comments Friday. medical device, food additive, or color
received by mail/hand delivery/courier • Confidential Submissions—To additive) was subject to regulatory
(for written/paper submissions) will be submit a comment with confidential review by FDA before the item was
considered timely if they are information that you do not wish to be marketed. Under these acts, a product’s
postmarked or the delivery service made publicly available, submit your regulatory review period forms the basis
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Document Created: 2018-02-14 03:59:04
Document Modified: 2018-02-14 03:59:04
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 August 13, 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 6579 |
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