81 FR 87045 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRESIBA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 232 (December 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 232 (December 2, 2016)
| Page Range | 87045-87047 | |
| FR Document | 2016-28939 |
[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)] [Notices] [Pages 87045-87047] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28939] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-5107] Determination of Regulatory Review Period for Purposes of Patent Extension; TRESIBA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TRESIBA 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 31, 2017 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 31, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://www.regulations.gov. If you want to submit a comment with confidential information that you [[Page 87046]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-5107 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; TRESIBA.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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 TRESIBA (insulin degludec). TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Subsequent to this approval, the USPTO received a patent term restoration application for TRESIBA (U.S. Patent No. 7,615,532) from Novo Nordisk A/S, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 20, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TRESIBA 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 TRESIBA is 2,914 days. Of this time, 1,456 days occurred during the testing phase of the regulatory review period, while 1,458 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: October 5, 2007. The applicant claims September 5, 2007, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 5, 2007, 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: September 29, 2011. FDA has verified the applicant's claim that the new drug application (NDA) for TRESIBA (NDA 203-314) was initially submitted on September 29, 2011. 3. The date the application was approved: September 25, 2015. FDA has verified the applicant's claim that the human drug application NDA 203-314 was approved on September 25, 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 1,803 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 ask for a redetermination (see DATES). Furthermore, any interested [[Page 87047]] 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 be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (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 http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28939 Filed 12-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices 87045
so long as the patented item (human approval phase. These periods of time DEPARTMENT OF HEALTH AND
drug product, animal drug product, were derived from the following dates: HUMAN SERVICES
medical device, food additive, or color 1. The date an exemption under
additive) was subject to regulatory section 505(i) of the Federal Food, Drug, Food and Drug Administration
review by FDA before the item was and Cosmetic Act (21 U.S.C. 355(i)) [Docket No. FDA–2015–E–5107]
marketed. Under these acts, a product’s became effective: July 28, 2006. The
regulatory review period forms the basis applicants claim July 29, 2006, as the Determination of Regulatory Review
for determining the amount of extension date the investigational new drug Period for Purposes of Patent
an applicant may receive. application (IND) became effective. Extension; TRESIBA
A regulatory review period consists of However, FDA records indicate that the
two periods of time: A testing phase and IND effective date was July 28, 2006, AGENCY: Food and Drug Administration,
an approval phase. For human which was the first date after receipt of HHS.
biological products, the testing phase the IND that the investigational studies ACTION: Notice.
begins when the exemption to permit were allowed to proceed. SUMMARY: The Food and Drug
the clinical investigations of the 2. The date the application was
Administration (FDA) has determined
biological product becomes effective initially submitted with respect to the
the regulatory review period for
and runs until the approval phase human biological product under section
begins. The approval phase starts with TRESIBA and is publishing this notice
351 of the Public Health Service Act (42
the initial submission of an application of that determination as required by
U.S.C. 262): July 30, 2014. FDA has
to market the human biological product law. FDA has made the determination
verified the applicants’ claim that the
and continues until FDA grants because of the submission of an
biologics license application (BLA) for
permission to market the biological application to the Director of the U.S.
OPDIVO (BLA 125554) was initially
product. Although only a portion of a Patent and Trademark Office (USPTO),
submitted on July 30, 2014.
regulatory review period may count Department of Commerce, for the
3. The date the application was
toward the actual amount of extension extension of a patent which claims that
approved: December 22, 2014. FDA has
that the Director of USPTO may award human drug product.
verified the applicants’ claim that BLA
(for example, half the testing phase must 125554 was approved on December 22, DATES: Anyone with knowledge that any
be subtracted as well as any time that 2014. of the dates as published (in the
may have occurred before the patent This determination of the regulatory SUPPLEMENTARY INFORMATION section) are
was issued), FDA’s determination of the review period establishes the maximum incorrect may submit either electronic
length of a regulatory review period for potential length of a patent extension. or written comments and ask for a
a human biological product will include However, the USPTO applies several redetermination by January 31, 2017
all of the testing phase and approval statutory limitations in its calculations Furthermore, any interested person may
phase as specified in 35 U.S.C. of the actual period for patent extension. petition FDA for a determination
156(g)(1)(B). In the application for patent extension, regarding whether the applicant for
FDA has approved for marketing the these applicants seek 552 days of patent extension acted with due diligence
human biologic product OPDIVO term extension. during the regulatory review period by
(nivolumab). OPDIVO is indicated for May 31, 2017. See ‘‘Petitions’’ in the
the treatment of patients with III. Petitions SUPPLEMENTARY INFORMATION section for
unresectable or metastatic melanoma Anyone with knowledge that any of more information.
and disease progression following the dates as published are incorrect may ADDRESSES: You may submit comments
ipilimumab and, if BRAF V600 submit either electronic or written as follows:
mutation positive, a BRAF inhibitor. comments and ask for a redetermination
Subsequent to this approval, the USPTO Electronic Submissions
(see DATES). Furthermore, any interested
received a patent term restoration person may petition FDA for a Submit electronic comments in the
application for OPDIVO (U.S. Patent No. determination regarding whether the following way:
8,008,449) from E.R. Squibb & Sons, applicant for extension acted with due • Federal eRulemaking Portal: http://
LLC and Ono Pharmaceutical Co., Ltd., diligence during the regulatory review www.regulations.gov. Follow the
and the USPTO requested FDA’s period. To meet its burden, the petition instructions for submitting comments.
assistance in determining this patent’s must be timely (see DATES) and contain Comments submitted electronically,
eligibility for patent term restoration. In sufficient facts to merit an FDA including attachments, to http://
a letter dated April 26, 2016, FDA investigation. (See H. Rept. 857, part 1, www.regulations.gov will be posted to
advised the USPTO that this human 98th Cong., 2d sess., pp. 41–42, 1984.) the docket unchanged. Because your
biological product had undergone a Petitions should be in the format comment will be made public, you are
regulatory review period and that the specified in 21 CFR 10.30. solely responsible for ensuring that your
approval of OPDIVO represented the Submit petitions electronically to comment does not include any
first permitted commercial marketing or https://www.regulations.gov at Docket confidential information that you or a
use of the product. Thereafter, the No. FDA–2013–S–0610. Submit written third party may not wish to be posted,
USPTO requested that FDA determine petitions (two copies are required) to the such as medical information, your or
the product’s regulatory review period. Division of Dockets Management (HFA– anyone else’s Social Security number, or
confidential business information, such
asabaliauskas on DSK3SPTVN1PROD with NOTICES
II. Determination of Regulatory Review 305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, as a manufacturing process. Please note
Period that if you include your name, contact
MD 20852.
FDA has determined that the information, or other information that
applicable regulatory review period for Dated: November 23, 2016.
identifies you in the body of your
OPDIVO is 3,071 days. Of this time, Leslie Kux, comments, that information will be
2,925 days occurred during the testing Associate Commissioner for Policy. posted on http://www.regulations.gov.
phase of the regulatory review period, [FR Doc. 2016–28917 Filed 12–1–16; 8:45 am] • If you want to submit a comment
while 146 days occurred during the BILLING CODE 4164–01–P with confidential information that you
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![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices 87047
person may petition FDA for a This notice is being published less than 15 Boulevard, Bethesda, MD 20892 (Telephone
determination regarding whether the days prior to the meeting due to the timing Conference Call).
applicant for extension acted with due limitations imposed by the review and Contact Person: Najma Begum, Ph.D.,
funding cycle. Scientific Review Officer, Review Branch,
diligence during the regulatory review
(Catalogue of Federal Domestic Assistance DEA, NIDDK, National Institutes of Health,
period. To meet its burden, the petition Room 7349, 6707 Democracy Boulevard,
Program Nos. 93.853, Clinical Research
must be timely (see DATES) and contain Bethesda, MD 20892–5452, (301) 594–8894,
Related to Neurological Disorders; 93.854,
sufficient facts to merit an FDA Biological Basis Research in the begumn@niddk.nih.gov.
investigation. (See H. Rept. 857, part 1, Neurosciences, National Institutes of Health, Name of Committee: National Institute of
98th Cong., 2d sess., pp. 41–42, 1984.) HHS) Diabetes and Digestive and Kidney Diseases
Petitions should be in the format Special Emphasis Panel; PAR–16–034:
Dated: November 28, 2016.
specified in 21 CFR 10.30. NIDDK Ancillary Studies (R01).
Submit petitions electronically to Sylvia L. Neal, Date: February 6, 2017.
http://www.regulations.gov at Docket Program Analyst, Office of Federal Advisory Time: 11:00 a.m. to 1:00 p.m.
No. FDA–2013–S–0610. Submit written Committee Policy. Agenda: To review and evaluate grant
petitions (two copies are required) to the [FR Doc. 2016–28902 Filed 12–1–16; 8:45 am] applications.
Place: National Institutes of Health, Two
Division of Dockets Management (HFA– BILLING CODE 4140–01–P
Democracy Plaza, 6707 Democracy
305), Food and Drug Administration, Boulevard, Bethesda, MD 20892 (Telephone
5630 Fishers Lane, Rm. 1061, Rockville, Conference Call).
MD 20852. DEPARTMENT OF HEALTH AND Contact Person: Najma Begum, Ph.D.,
HUMAN SERVICES Scientific Review Officer, Review Branch,
Dated: November 28, 2016.
DEA, NIDDK, National Institutes of Health,
Leslie Kux, National Institutes of Health Room 7349, 6707 Democracy Boulevard,
Associate Commissioner for Policy. Bethesda, MD 20892–5452, (301) 594–8894,
[FR Doc. 2016–28939 Filed 12–1–16; 8:45 am] National Institute of Diabetes and begumn@niddk.nih.gov.
BILLING CODE 4164–01–P
Digestive and Kidney Diseases; Notice (Catalogue of Federal Domestic Assistance
of Closed Meetings Program Nos. 93.847, Diabetes,
Pursuant to section 10(d) of the Endocrinology and Metabolic Research;
DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as 93.848, Digestive Diseases and Nutrition
HUMAN SERVICES Research; 93.849, Kidney Diseases, Urology
amended (5 U.S.C. App.), notice is and Hematology Research, National Institutes
National Institutes of Health hereby given of the following meetings. of Health, HHS)
The meetings will be closed to the
public in accordance with the Dated: November 28, 2016.
National Institute of Neurological
provisions set forth in sections David Clary,
Disorders and Stroke; Notice of Closed
Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program Analyst, Office of Federal Advisory
as amended. The grant applications and Committee Policy.
Pursuant to section 10(d) of the the discussions could disclose [FR Doc. 2016–28901 Filed 12–1–16; 8:45 am]
Federal Advisory Committee Act, as confidential trade secrets or commercial BILLING CODE 4140–01–P
amended (5 U.S.C. App.), notice is property such as patentable material,
hereby given of the following meeting. and personal information concerning
The meeting will be closed to the individuals associated with the grant DEPARTMENT OF HEALTH AND
public in accordance with the applications, the disclosure of which HUMAN SERVICES
provisions set forth in sections would constitute a clearly unwarranted
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy. Substance Abuse and Mental Health
as amended. The grant applications and Services Administration
the discussions could disclose Name of Committee: National Institute of
confidential trade secrets or commercial Diabetes and Digestive and Kidney Diseases Current List of HHS-Certified
Special Emphasis Panel; Time-Sensitive Laboratories and Instrumented Initial
property such as patentable material, Obesity Applications.
and personal information concerning Testing Facilities Which Meet Minimum
Date: January 9, 2017.
individuals associated with the grant Time: 11:30 a.m. to 2:30 p.m. Standards To Engage in Urine Drug
applications, the disclosure of which Agenda: To review and evaluate grant Testing for Federal Agencies
would constitute a clearly unwarranted applications. AGENCY: Substance Abuse and Mental
invasion of personal privacy. Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy Health Services Administration, HHS.
Name of Committee: National Institute of Boulevard, Bethesda, MD 20892 (Telephone ACTION: Notice.
Neurological Disorders and Stroke Special Conference Call).
Emphasis Panel; Review of an IGNTE Contact Person: Michele L. Barnard, Ph.D., SUMMARY: The Department of Health and
Application. Scientific Review Officer, Review Branch, Human Services (HHS) notifies federal
Date: December 9, 2016. agencies of the laboratories and
DEA, NIDDK, National Institutes of Health,
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
Room 7353, 6707 Democracy Boulevard, Instrumented Initial Testing Facilities
Bethesda, MD 20892–2542, (301) 594–8898, (IITF) currently certified to meet the
applications.
barnardm@extra.niddk.nih.gov. standards of the Mandatory Guidelines
Place: National Institutes of Health,
Name of Committee: National Institute of for Federal Workplace Drug Testing
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone Diabetes and Digestive and Kidney Diseases Programs (Mandatory Guidelines). The
Conference Call). Special Emphasis Panel; Clinical Studies in Mandatory Guidelines were first
Contact Person: Natalia Strunnikova, Kidney Transplant and Hemodialysis. published in the Federal Register on
Ph.D., Scientific Review Administrator, Date: February 2, 2017.
Time: 11:00 a.m. to 2:00 p.m.
April 11, 1988 (53 FR 11970), and
Scientific Review Branch, NINDS/NIH/
DHHS, Neuroscience Center, 6001 Executive Agenda: To review and evaluate grant subsequently revised in the Federal
Blvd., Suite 3204, MSC 9529, Bethesda, MD applications. Register on June 9, 1994 (59 FR 29908);
20892–9529, 301–496–9223, Place: National Institutes of Health, Two September 30, 1997 (62 FR 51118);
Natalia.strunnikova@nih.gov. Democracy Plaza, 6707 Democracy April 13, 2004 (69 FR 19644); November
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Document Created: 2018-02-14 09:02:02
Document Modified: 2018-02-14 09:02:02
| 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 January 31, 2017 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 31, 2017. 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 | 81 FR 87045 |
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