83 FR 4214 - Determination of Regulatory Review Period for Purposes of Patent Extension; GALLIPRANT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 20 (January 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 20 (January 30, 2018)
| Page Range | 4214-4216 | |
| FR Document | 2018-01640 |
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)] [Notices] [Pages 4214-4216] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01640] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2530] Determination of Regulatory Review Period for Purposes of Patent Extension; GALLIPRANT 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 GALLIPRANT 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 U.S. Patent and Trademark Office (USPTO), Department 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and, ask for a redetermination by April 2, 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 July 30, 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 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 2, 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. [[Page 4215]] 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-2530 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; GALLIPRANT.'' 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 (the 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 GALLIPRANT (grapiprant). GALLIPRANT is indicated for the control of pain and inflammation associated with osteoarthritis in dogs. Subsequent to this approval, the USPTO received a patent term restoration application for GALLIPRANT (U.S. Patent No. 7,960,407) from AskAt Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 26, 2016, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of GALLIPRANT 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 GALLIPRANT is 1,688 days. Of this time, 1,636 days occurred during the testing phase of the regulatory review period, while 52 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: August 8, 2011. The applicant claims July 7, 2009, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date [[Page 4216]] was August 8, 2011, which was the date a major health or environmental effects test was begun. 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): January 29, 2016. The applicant claims January 25, 2016, as the date the new animal drug application (NADA) for GALLIPRANT (NADA 141- 455) was initially submitted. However, FDA records indicate that NADA 141-455 was submitted on January 29, 2016. 3. The date the application was approved: March 20, 2016. The applicant claims that NADA 141-455 was approved on March 21, 2016, however, FDA records indicate that NADA 141-455 was approved on Sunday, March 20, 2016. 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 899 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: January 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01640 Filed 1-29-18; 8:45 am] BILLING CODE 4164-01-P
![4214 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
I. Background II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written
Period petitions (two copies are required) to the
The Drug Price Competition and Dockets Management Staff (HFA–305),
Patent Term Restoration Act of 1984 FDA has determined that the
applicable regulatory review period for Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term ZEPATIER is 1,865 days. Of this time,
1,619 days occurred during the testing 20852.
Restoration Act (Pub. L. 100–670) Dated: January 24, 2018.
phase of the regulatory review period,
generally provide that a patent may be
while 246 days occurred during the Leslie Kux,
extended for a period of up to 5 years approval phase. These periods of time Associate Commissioner for Policy.
so long as the patented item (human were derived from the following dates: [FR Doc. 2018–01642 Filed 1–29–18; 8:45 am]
drug product, animal drug product, 1. The date an exemption under BILLING CODE 4164–01–P
medical device, food additive, or color section 505(i) of the Federal Food, Drug,
additive) was subject to regulatory and Cosmetic Act (FD&C Act) (21 U.S.C.
review by FDA before the item was 355(i)) became effective: December 22, DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s 2010. FDA has verified the applicant’s HUMAN SERVICES
regulatory review period forms the basis claim that the date the investigational
for determining the amount of extension new drug application became effective Food and Drug Administration
an applicant may receive. was on December 22, 2010. [Docket No. FDA–2016–E–2530]
A regulatory review period consists of 2. The date the application was
two periods of time: A testing phase and initially submitted with respect to the Determination of Regulatory Review
an approval phase. For human drug human drug product under section Period for Purposes of Patent
products, the testing phase begins when 505(b) of the FD&C Act: May 28, 2015. Extension; GALLIPRANT
the exemption to permit the clinical FDA has verified the applicant’s claim
that the new drug application (NDA) for AGENCY: Food and Drug Administration,
investigations of the drug becomes HHS.
ZEPATIER (NDA 208–261) was initially
effective and runs until the approval ACTION: Notice.
submitted on May 28, 2015.
phase begins. The approval phase starts 3. The date the application was
with the initial submission of an approved: January 28, 2016. FDA has SUMMARY: The Food and Drug
application to market the human drug verified the applicant’s claim that NDA Administration (FDA or the Agency) has
product and continues until FDA grants 208–261 was approved on January 28, determined the regulatory review period
permission to market the drug product. 2016. for GALLIPRANT and is publishing this
Although only a portion of a regulatory This determination of the regulatory notice of that determination as required
review period may count toward the review period establishes the maximum by law. FDA has made the
actual amount of extension that the potential length of a patent extension. determination because of the
Director of USPTO may award (for However, the USPTO applies several submission of an application to the
example, half the testing phase must be statutory limitations in its calculations Director of U.S. Patent and Trademark
subtracted as well as any time that may of the actual period for patent extension. Office (USPTO), Department of
In its application for patent extension, Commerce, for the extension of a patent
have occurred before the patent was
this applicant seeks 188 days of patent which claims that animal drug product.
issued), FDA’s determination of the
term extension. DATES: Anyone with knowledge that any
length of a regulatory review period for
a human drug product will include all of the dates as published (in the
III. Petitions SUPPLEMENTARY INFORMATION section) are
of the testing phase and approval phase
Anyone with knowledge that any of incorrect may submit either electronic
as specified in 35 U.S.C. 156(g)(1)(B).
the dates as published are incorrect may or written comments and, ask for a
FDA has approved for marketing the submit either electronic or written redetermination by April 2, 2018.
human drug product ZEPATIER comments and, under 21 CFR 60.24, ask Furthermore, any interested person may
(grazoprevir; elbasvir). ZEPATIER is for a redetermination (see DATES). petition FDA for a determination
indicated with or without ribavirin for Furthermore, as specified in § 60.30 (21 regarding whether the applicant for
treatment of chronic hepatitis C virus CFR 60.30), any interested person may extension acted with due diligence
genotypes 1 or 4 infection in adults. petition FDA for a determination during the regulatory review period by
Subsequent to this approval, the USPTO regarding whether the applicant for July 30, 2018. See ‘‘Petitions’’ in the
received a patent term restoration extension acted with due diligence SUPPLEMENTARY INFORMATION section for
application for ZEPATIER (U.S. Patent during the regulatory review period. To more information.
No. 7,973,040) from Merck Sharp & meet its burden, the petition must ADDRESSES: You may submit comments
Dohme Corp. and MSD Italia s.r.l., and comply with all the requirements of as follows. Please note that late,
the USPTO requested FDA’s assistance § 60.30, including but not limited to: untimely filed comments will not be
in determining this patent’s eligibility Must be timely (see DATES), must be considered. Electronic comments must
for patent term restoration. In a letter filed in accordance with § 10.20, must be submitted on or before April 2, 2018.
dated November 10, 2016, FDA advised contain sufficient facts to merit an FDA The https://www.regulations.gov
the USPTO that this human drug investigation, and must certify that a electronic filing system will accept
product had undergone a regulatory true and complete copy of the petition comments until midnight Eastern Time
daltland on DSKBBV9HB2PROD with NOTICES
review period and that the approval of has been served upon the patent at the end of April 2, 2018. Comments
ZEPATIER represented the first applicant. (See H. Rept. 857, part 1, 98th received by mail/hand delivery/courier
Cong., 2d sess., pp. 41–42, 1984.) (for written/paper submissions) will be
permitted commercial marketing or use
Petitions should be in the format considered timely if they are
of the product. Thereafter, the USPTO
specified in 21 CFR 10.30. postmarked or the delivery service
requested that FDA determine the
Submit petitions electronically to acceptance receipt is on or before that
product’s regulatory review period. https://www.regulations.gov at Docket date.
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![4216 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
was August 8, 2011, which was the date Dated: January 24, 2018. identifies you in the body of your
a major health or environmental effects Leslie Kux, comments, that information will be
test was begun. Associate Commissioner for Policy. posted on https://www.regulations.gov.
[FR Doc. 2018–01640 Filed 1–29–18; 8:45 am] • If you want to submit a comment
2. The date the application was
with confidential information that you
initially submitted with respect to the BILLING CODE 4164–01–P
do not wish to be made available to the
animal drug product under section 512 public, submit the comment as a
of the FD&C Act (21 U.S.C. 360b): written/paper submission and in the
DEPARTMENT OF HEALTH AND
January 29, 2016. The applicant claims manner detailed (see ‘‘Written/Paper
HUMAN SERVICES
January 25, 2016, as the date the new Submissions’’ and ‘‘Instructions’’).
animal drug application (NADA) for Food and Drug Administration
GALLIPRANT (NADA 141–455) was Written/Paper Submissions
[Docket No. FDA–2017–D–7001] Submit written/paper submissions as
initially submitted. However, FDA
records indicate that NADA 141–455 Qualified Infectious Disease Product follows:
was submitted on January 29, 2016. • Mail/Hand delivery/Courier (for
Designation Questions and Answers;
written/paper submissions): Dockets
3. The date the application was Draft Guidance for Industry;
Management Staff (HFA–305), Food and
approved: March 20, 2016. The Availability
Drug Administration, 5630 Fishers
applicant claims that NADA 141–455 AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
was approved on March 21, 2016, HHS. • For written/paper comments
however, FDA records indicate that ACTION: Notice of availability. submitted to the Dockets Management
NADA 141–455 was approved on Staff, FDA will post your comment, as
Sunday, March 20, 2016. SUMMARY: The Food and Drug well as any attachments, except for
This determination of the regulatory Administration (FDA or Agency) is information submitted, marked and
announcing the availability of a draft identified, as confidential, if submitted
review period establishes the maximum
guidance for industry entitled as detailed in ‘‘Instructions.’’
potential length of a patent extension.
‘‘Qualified Infectious Disease Product Instructions: All submissions received
However, the USPTO applies several Designation Questions and Answers.’’ must include the Docket No. FDA–
statutory limitations in its calculations The Food and Drug Administration 2017–D–7001 for ‘‘Qualified Infectious
of the actual period for patent extension. Safety and Innovation Act (FDASIA) Disease Product Designation Questions
In its application for patent extension, creates incentives for the development and Answers; Draft Guidance for
this applicant seeks 899 days of patent of antibacterial and antifungal drug Industry.’’ Received comments will be
term extension. products that treat serious or life- placed in the docket and, except for
III. Petitions threatening infections. The purpose of those submitted as ‘‘Confidential
this draft guidance is to provide a Submissions,’’ publicly viewable at
Anyone with knowledge that any of resource for information on FDA’s https://www.regulations.gov or at the
the dates as published are incorrect may policies and procedures related to the Dockets Management Staff between 9
submit either electronic or written designation of a qualified infectious a.m. and 4 p.m., Monday through
comments and, under 21 CFR 60.24, ask disease product (QIDP). Friday.
for a redetermination (see DATES). DATES: Submit either electronic or • Confidential Submissions—To
Furthermore, as specified in § 60.30 (21 written comments on the draft guidance submit a comment with confidential
CFR 60.30), any interested person may by April 2, 2018 to ensure that the information that you do not wish to be
petition FDA for a determination Agency considers your comment on this made publicly available, submit your
regarding whether the applicant for draft guidance before it begins work on comments only as a written/paper
the final version of the guidance. submission. You should submit two
extension acted with due diligence
ADDRESSES: You may submit comments copies total. One copy will include the
during the regulatory review period. To
on any guidance at any time as follows: information you claim to be confidential
meet its burden, the petition must
with a heading or cover note that states
comply with all the requirements of Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
§ 60.30, including but not limited to: CONFIDENTIAL INFORMATION.’’ The
Submit electronic comments in the
Must be timely (see DATES), must be following way: Agency will review this copy, including
filed in accordance with § 10.20, must • Federal eRulemaking Portal: the claimed confidential information, in
contain sufficient facts to merit an FDA https://www.regulations.gov. Follow the its consideration of comments. The
investigation, and must certify that a instructions for submitting comments. second copy, which will have the
true and complete copy of the petition Comments submitted electronically, claimed confidential information
has been served upon the patent including attachments, to https:// redacted/blacked out, will be available
applicant. (See H. Rept. 857, part 1, 98th www.regulations.gov will be posted to for public viewing and posted on
Cong., 2d sess., pp. 41–42, 1984.) the docket unchanged. Because your https://www.regulations.gov. Submit
Petitions should be in the format comment will be made public, you are both copies to the Dockets Management
specified in 21 CFR 10.30. solely responsible for ensuring that your Staff. If you do not wish your name and
Submit petitions electronically to comment does not include any contact information to be made publicly
https://www.regulations.gov at Docket confidential information that you or a available, you can provide this
daltland on DSKBBV9HB2PROD with NOTICES
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
petitions (two copies are required) to the
anyone else’s Social Security number, or must identify this information as
Dockets Management Staff (HFA–305),
confidential business information, such ‘‘confidential.’’ Any information marked
Food and Drug Administration, 5630 as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note
Fishers Lane, Rm. 1061, Rockville, MD that if you include your name, contact except in accordance with 21 CFR 10.20
20852. information, or other information that and other applicable disclosure law. For
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Document Created: 2018-10-26 10:10:16
Document Modified: 2018-10-26 10:10:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and, ask for a redetermination by April 2, 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 July 30, 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 4214 |
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