83 FR 6577 - Determination of Regulatory Review Period for Purposes of Patent Extension; OSURNIA
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 | 6577-6579 | |
| FR Document | 2018-02991 |
[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)] [Notices] [Pages 6577-6579] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02991] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-3813] Determination of Regulatory Review Period for Purposes of Patent Extension; OSURNIA 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 OSURNIA 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 [[Page 6578]] of Commerce, for the extension of a patent which claims that animal 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 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-3813 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; OSURNIA.'' 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 animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal 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 an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B). FDA has approved for marketing the animal drug product OSURNIA (terbinafine, florfenicol and betamethasone acetate). OSURNIA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis). Subsequent to this approval, the USPTO [[Page 6579]] received a patent term restoration application for OSURNIA (U.S. Patent No. 7,854,943) from IDEXX, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated December 17, 2015, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of OSURNIA 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 OSURNIA is 4,034 days. Of this time, 3,980 days occurred during the testing phase of the regulatory review period, while 54 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 FD&C Act (21 U.S.C. 355(i)) became effective: October 21, 2003. The applicant claims September 20, 2013, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date was October 21, 2003, which was the date on which the Agency acknowledges the filing of a notice of claimed investigational exemption for a new animal drug. 2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): September 12, 2014. The applicant claims September 9, 2014, as the date the new animal drug application (NADA) for OSURNIA (NADA 141- 437) was initially submitted. However, FDA records indicate that NADA 141-437 was submitted on September 12, 2014. 3. The date the application was approved: November 4, 2014. FDA has verified the applicant's claim that NADA 141-437 was approved on November 4, 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 235 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: February 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02991 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6577
disclosure law. For more information (belinostat). BELEODAQ is a histone of the actual period for patent extension.
about FDA’s posting of comments to deacetylase inhibitor indicated for the In its application for patent extension,
public dockets, see 80 FR 56469, treatment of patients with relapsed or this applicant seeks 1,779 days of patent
September 18, 2015, or access the refractory peripheral T-cell lymphoma. term extension.
information at: https://www.gpo.gov/ This indication is approved under
III. Petitions
fdsys/pkg/FR-2015-09-18/pdf/2015- accelerated approval based on tumor
23389.pdf. response rate and duration of response. Anyone with knowledge that any of
Docket: For access to the docket to An improvement in survival or disease- the dates as published are incorrect may
read background documents or the related symptoms has not been submit either electronic or written
electronic and written/paper comments established. Continued approval for this comments and, under 21 CFR 60.24, ask
received, go to https:// indication may be contingent upon for a redetermination (see DATES).
www.regulations.gov and insert the verification and description of clinical Furthermore, as specified in § 60.30 (21
docket number, found in brackets in the benefit in the confirmatory trial. CFR 60.30), any interested person may
heading of this document, into the Subsequent to this approval, the USPTO petition FDA for a determination
‘‘Search’’ box and follow the prompts received a patent term restoration regarding whether the applicant for
and/or go to the Dockets Management application for BELEODAQ (U.S. Patent extension acted with due diligence
Staff, 5630 Fishers Lane, Rm. 1061, No. 6,888,027) from Spectrum during the regulatory review period. To
Rockville, MD 20852. Pharmaceuticals, Inc., and the USPTO meet its burden, the petition must
FOR FURTHER INFORMATION CONTACT: requested FDA’s assistance in comply with all the requirements of
Beverly Friedman, Office of Regulatory determining this patent’s eligibility for § 60.30, including but not limited to:
Policy, Food and Drug Administration, patent term restoration. In a letter dated Must be timely (see DATES), must be
10903 New Hampshire Ave., Bldg. 51, October 15, 2015, FDA advised the filed in accordance with § 10.20, must
Rm. 6250, Silver Spring, MD 20993, USPTO that this human drug product contain sufficient facts to merit an FDA
301–796–3600. had undergone a regulatory review investigation, and must certify that a
SUPPLEMENTARY INFORMATION: period and that the approval of true and complete copy of the petition
BELEODAQ represented the first has been served upon the patent
I. Background permitted commercial marketing or use applicant. (See H. Rept. 857, part 1, 98th
The Drug Price Competition and of the product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.)
Patent Term Restoration Act of 1984 requested that FDA determine the Petitions should be in the format
(Pub. L. 98–417) and the Generic product’s regulatory review period. specified in 21 CFR 10.30.
Animal Drug and Patent Term Submit petitions electronically to
II. Determination of Regulatory Review https://www.regulations.gov at Docket
Restoration Act (Pub. L. 100–670)
Period No. FDA–2013–S–0610. Submit written
generally provide that a patent may be
extended for a period of up to 5 years FDA has determined that the petitions (two copies are required) to the
so long as the patented item (human applicable regulatory review period for Dockets Management Staff (HFA–305),
drug product, animal drug product, BELEODAQ is 3,488 days. Of this time, Food and Drug Administration, 5630
medical device, food additive, or color 3,281 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD
additive) was subject to regulatory phase of the regulatory review period, 20852.
review by FDA before the item was while 207 days occurred during the Dated: February 8, 2018.
marketed. Under these acts, a product’s approval phase. These periods of time Leslie Kux,
regulatory review period forms the basis were derived from the following dates: Associate Commissioner for Policy.
for determining the amount of extension 1. The date an exemption under
[FR Doc. 2018–03041 Filed 2–13–18; 8:45 am]
an applicant may receive. section 505(i) of the Federal Food, Drug,
BILLING CODE 4164–01–P
A regulatory review period consists of and Cosmetic Act (the FD&C Act) (21
two periods of time: A testing phase and U.S.C. 355(i)) became effective:
an approval phase. For human drug December 16, 2004. FDA has verified
DEPARTMENT OF HEALTH AND
products, the testing phase begins when the Spectrum Pharmaceuticals, Inc.
HUMAN SERVICES
the exemption to permit the clinical claim that December 16, 2004, is the
investigations of the drug becomes date the investigational new drug Food and Drug Administration
effective and runs until the approval application (NDA) became effective.
phase begins. The approval phase starts 2. The date the application was [Docket No. FDA–2015–E–3813]
with the initial submission of an initially submitted with respect to the
human drug product under section Determination of Regulatory Review
application to market the human drug
505(b) of the FD&C Act: December 9, Period for Purposes of Patent
product and continues until FDA grants
2013. The applicant claims December 8, Extension; OSURNIA
permission to market the drug product.
Although only a portion of a regulatory 2013 as the date the NDA for AGENCY: Food and Drug Administration,
review period may count toward the BELEODAQ was initially submitted. HHS.
actual amount of extension that the However, FDA records indicate that ACTION: Notice.
Director of USPTO may award (for NDA 206256 was submitted on
example, half the testing phase must be December 9, 2013. SUMMARY: The Food and Drug
subtracted as well as any time that may 3. The date the application was Administration (FDA or the Agency) has
have occurred before the patent was approved: July 3, 2014. FDA has verified determined the regulatory review period
daltland on DSKBBV9HB2PROD with NOTICES
issued), FDA’s determination of the the applicant’s claim that NDA 206256 for OSURNIA and is publishing this
length of a regulatory review period for was approved on July 3, 2014. notice of that determination as required
a human drug product will include all This determination of the regulatory by law. FDA has made the
of the testing phase and approval phase review period establishes the maximum determination because of the
as specified in 35 U.S.C. 156(g)(1)(B). potential length of a patent extension. submission of an application to the
FDA has approved for marketing the However, the USPTO applies several Director of the U.S. Patent and
human drug product BELEODAQ statutory limitations in its calculations Trademark Office (USPTO), Department
VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1](https://thefederalregister.org/doc/83_FR_6608/page/1.svg)
![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
VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1](https://thefederalregister.org/doc/83_FR_6608/page/3.svg)
Document Created: 2018-02-14 03:59:14
Document Modified: 2018-02-14 03:59:14
| 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 6577 |
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