83 FR 3000 - Determination of Regulatory Review Period for Purposes of Patent Extension; NINLARO
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 14 (January 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 14 (January 22, 2018)
| Page Range | 3000-3002 | |
| FR Document | 2018-00994 |
[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)] [Notices] [Pages 3000-3002] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00994] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-2463; FDA-2016-E-2464; FDA-2016-E-2465; and FDA-2016-E-2466] Determination of Regulatory Review Period for Purposes of Patent Extension; NINLARO 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 NINLARO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 [[Page 3001]] incorrect may submit either electronic or written comments and ask for a redetermination by March 23, 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 23, 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 March 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 23, 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 Nos. FDA-2016-E-2463; FDA-2016-E-2464; FDA-2016-E-2465; and FDA-2016-E-2466 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; NINLARO.'' 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 NINLARO (ixazomib). NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Subsequent to this approval, the USPTO received patent term restoration applications for NINLARO (U.S. Patent Nos. 7,442,830; 7,687,662; 8,003,819; and 8,859,504) from Millennium Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 14, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of [[Page 3002]] NINLARO 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 NINLARO is 2,538 days. Of this time, 2,404 days occurred during the testing phase of the regulatory review period, while 134 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 10, 2008. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 10, 2008. 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 10, 2015. FDA has verified the applicant's claim that the new drug application (NDA) for NINLARO (NDA 208462) was initially submitted on July 10, 2015. 3. The date the application was approved: November 20, 2015. FDA has verified the applicant's claim that NDA 208462 was approved on November 20, 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 applications for patent extension, this applicant seeks 837 or 157 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 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00994 Filed 1-19-18; 8:45 am] BILLING CODE 4164-01-P
![3000 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices
information at: https://www.gpo.gov/ hyperuricemia associated with gout in comments and, under 21 CFR 60.24, ask
fdsys/pkg/FR-2015-09-18/pdf/2015- patients who have not achieved target for a redetermination (see DATES).
23389.pdf. serum uric acid levels with a xanthine Furthermore, as specified in § 60.30 (21
Docket: For access to the docket to oxidase inhibitor alone. Subsequent to CFR 60.30), any interested person may
read background documents or the this approval, the USPTO received petition FDA for a determination
electronic and written/paper comments patent term restoration applications for regarding whether the applicant for
received, go to https:// ZURAMPIC (U.S. Patent Nos. 8,003,681; extension acted with due diligence
www.regulations.gov and insert the 8,084,483; 8,283,369; 8,357,713; and during the regulatory review period. To
docket numbers, found in brackets in 8,546,437) from Ardea Biosciences, Inc., meet its burden, the petition must
the heading of this document, into the and the USPTO requested FDA’s comply with all the requirements of
‘‘Search’’ box and follow the prompts assistance in determining the patents’ § 60.30, including but not limited to:
and/or go to the Dockets Management eligibility for patent term restoration. In must be timely (see DATES), must be
Staff, 5630 Fishers Lane, Rm. 1061, a letter dated November 10, 2016, FDA filed in accordance with § 10.20, must
Rockville, MD 20852. advised the USPTO that this human contain sufficient facts to merit an FDA
FOR FURTHER INFORMATION CONTACT: drug product had undergone a investigation, and must certify that a
Beverly Friedman, Office of Regulatory regulatory review period and that the true and complete copy of the petition
Policy, Food and Drug Administration, approval of ZURAMPIC represented the has been served upon the patent
10903 New Hampshire Ave., Bldg. 51, first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th
Rm. 6250, Silver Spring, MD 20993, use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.)
301–796–3600. USPTO requested that FDA determine Petitions should be in the format
SUPPLEMENTARY INFORMATION:
the product’s regulatory review period. specified in 21 CFR 10.30.
II. Determination of Regulatory Review Submit petitions electronically to
I. Background https://www.regulations.gov at Docket
Period
The Drug Price Competition and No. FDA–2013–S–0610. Submit written
FDA has determined that the petitions (two copies are required) to the
Patent Term Restoration Act of 1984
applicable regulatory review period for Dockets Management Staff (HFA–305),
(Pub. L. 98–417) and the Generic
ZURAMPIC is 2,245 days. Of this time, Food and Drug Administration, 5630
Animal Drug and Patent Term
1,886 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD
Restoration Act (Pub. L. 100–670)
phase of the regulatory review period, 20852.
generally provide that a patent may be
while 359 days occurred during the
extended for a period of up to 5 years Dated: January 16, 2018.
approval phase. These periods of time
so long as the patented item (human Leslie Kux,
were derived from the following dates:
drug product, animal drug product, 1. The date an exemption under Associate Commissioner for Policy.
medical device, food additive, or color section 505(i) of the Federal Food, Drug, [FR Doc. 2018–00992 Filed 1–19–18; 8:45 am]
additive) was subject to regulatory and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P
review by FDA before the item was 355(i)) became effective: October 31,
marketed. Under these acts, a product’s 2009. FDA has verified the applicant’s
regulatory review period forms the basis claim that the date the investigational DEPARTMENT OF HEALTH AND
for determining the amount of extension new drug application became effective HUMAN SERVICES
an applicant may receive. was on October 31, 2009.
A regulatory review period consists of 2. The date the application was Food and Drug Administration
two periods of time: A testing phase and initially submitted with respect to the [Docket Nos. FDA–2016–E–2463; FDA–
an approval phase. For human drug human drug product under section 2016–E–2464; FDA–2016–E–2465; and FDA–
products, the testing phase begins when 505(b) of the FD&C Act: December 29, 2016–E–2466]
the exemption to permit the clinical 2014. FDA has verified the applicant’s
investigations of the drug becomes claim that the new drug application Determination of Regulatory Review
effective and runs until the approval (NDA) for ZURAMPIC (NDA 207988) Period for Purposes of Patent
phase begins. The approval phase starts was initially submitted on December 29, Extension; NINLARO
with the initial submission of an 2014.
application to market the human drug AGENCY: Food and Drug Administration,
3. The date the application was
product and continues until FDA grants HHS.
approved: December 22, 2015. FDA has
permission to market the drug product. verified the applicant’s claim that NDA ACTION: Notice.
Although only a portion of a regulatory 207988 was approved on December 22,
review period may count toward the SUMMARY: The Food and Drug
2015. Administration (FDA or the Agency) has
actual amount of extension that the This determination of the regulatory
Director of USPTO may award (for determined the regulatory review period
review period establishes the maximum for NINLARO and is publishing this
example, half the testing phase must be potential length of a patent extension.
subtracted as well as any time that may notice of that determination as required
However, the USPTO applies several by law. FDA has made the
have occurred before the patent was statutory limitations in its calculations
issued), FDA’s determination of the determination because of the
of the actual period for patent extension. submission of applications to the
length of a regulatory review period for In its applications for patent extension,
a human drug product will include all Director of the U.S. Patent and
this applicant seeks 971 days, 127 days,
ethrower on DSK3G9T082PROD with NOTICES
of the testing phase and approval phase Trademark Office (USPTO), Department
391 days, and 237 days of patent term of Commerce, for the extension of a
as specified in 35 U.S.C. 156(g)(1)(B). extension.
FDA has approved for marketing the patent which claims that human drug
human drug product ZURAMPIC III. Petitions product.
(lesinurad). ZURAMPIC is indicated in Anyone with knowledge that any of DATES: Anyone with knowledge that any
combination with a xanthine oxidase the dates as published are incorrect may of the dates as published (see the
inhibitor for the treatment of submit either electronic or written SUPPLEMENTARY INFORMATION section) are
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![3002 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices
NINLARO represented the first Cong., 2d sess., pp. 41–42, 1984.) ways: (1) Send a request to the following
permitted commercial marketing or use Petitions should be in the format address: Ann Ferrero, MCHB, HRSA
of the product. Thereafter, the USPTO specified in 21 CFR 10.30. 5600 Fishers Lane, Room 18N100C,
requested that FDA determine the Submit petitions electronically to Rockville, MD 20857; (2) call 301–443–
product’s regulatory review period. https://www.regulations.gov at Docket 3999; or (3) send an email to: AFerrero@
No. FDA–2013–S–0610. Submit written hrsa.gov.
II. Determination of Regulatory Review
Period petitions (two copies are required) to the SUPPLEMENTARY INFORMATION: The
Dockets Management Staff (HFA–305), ACHDNC provides advice to the
FDA has determined that the Food and Drug Administration, 5630 Secretary of HHS on the development of
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD newborn screening activities,
NINLARO is 2,538 days. Of this time, 20852. technologies, policies, guidelines, and
2,404 days occurred during the testing
Dated: January 16, 2018. programs for effectively reducing
phase of the regulatory review period,
Leslie Kux, morbidity and mortality in newborns
while 134 days occurred during the
Associate Commissioner for Policy. and children having, or at risk for,
approval phase. These periods of time
heritable disorders. In addition,
were derived from the following dates: [FR Doc. 2018–00994 Filed 1–19–18; 8:45 am]
1. The date an exemption under ACHDNC’s recommendations regarding
BILLING CODE 4164–01–P
section 505(i) of the Federal Food, Drug, inclusion of additional conditions and
and Cosmetic Act (FD&C Act) (21 U.S.C. inherited disorders for screening which
355(i)) became effective: December 10, DEPARTMENT OF HEALTH AND have been adopted by the Secretary are
2008. FDA has verified the applicant’s HUMAN SERVICES then included in the Recommended
claim that the date the investigational Uniform Screening Panel (RUSP).
new drug application became effective Health Resources and Service Conditions listed on the RUSP
was on December 10, 2008. Administration constitute part of the comprehensive
2. The date the application was preventive health guidelines supported
initially submitted with respect to the Advisory Committee on Heritable by HRSA for infants and children under
human drug product under section Disorders in Newborns and Children section 2713 of the Public Health
505(b) of the FD&C Act: July 10, 2015. Service Act, codified at 42 U.S.C.
AGENCY: Health Resources and Service
FDA has verified the applicant’s claim 300gg–13. Under this provision, non-
Administration (HRSA), Department of
that the new drug application (NDA) for grandfathered health plans are required
Health and Human Services (HHS).
NINLARO (NDA 208462) was initially to cover screenings included in the
ACTION: Notice of meeting. HRSA-supported comprehensive
submitted on July 10, 2015.
3. The date the application was SUMMARY: In accordance with the guidelines without charging a co-
approved: November 20, 2015. FDA has Federal Advisory Committee Act, this payment, co-insurance, or deductible for
verified the applicant’s claim that NDA notice announces that the Advisory plan years (i.e., policy years) beginning
208462 was approved on November 20, Committee on Heritable Disorders in on or after the date that is one year from
2015. Newborns and Children (ACHDNC) will the Secretary’s adoption of the
This determination of the regulatory hold a public meeting. condition for screening. Information
review period establishes the maximum about the ACHDNC is available on the
DATES: Thursday, February 8, 2018,
potential length of a patent extension. following website: https://
from 9:30 a.m. to 5:00 p.m. and Friday, www.hrsa.gov/advisory-committees/
However, the USPTO applies several February 9, 2018, from 9:30 a.m. to 3:00
statutory limitations in its calculations heritable-disorders/index.html.
p.m. ET (meeting times are tentative). The meeting agenda will include a
of the actual period for patent extension.
ADDRESSES: The address for the meeting final evidence-based review report on
In its applications for patent extension,
this applicant seeks 837 or 157 days of is 5600 Fishers Lane, 5th Floor Pavilion, the spinal muscular atrophy (SMA)
patent term extension. Rockville, MD 20857. Participants may condition nomination for possible
also access the meeting through inclusion on the RUSP. Following this
III. Petitions Webcast. Advanced registration is report, the ACHDNC expects to vote on
Anyone with knowledge that any of required. Please register online at http:// whether to recommend to the Secretary
the dates as published are incorrect may www.achdncmeetings.org/ by 12:00 p.m. adding SMA to the RUSP. ACHDNC
submit either electronic or written ET on February 5, 2018. Instructions on members will also hear presentations on
comments and, under 21 CFR 60.24, ask how to access the meeting via Webcast states’ activities to achieve newborn
for a redetermination (see DATES). will be provided upon registration. screening timeliness goals. An overview
Furthermore, as specified in § 60.30 (21 Please note that the 5600 Fishers Lane of cutoff determinations and risk
CFR 60.30), any interested person may building requires security screening on assessment methods used for dried
petition FDA for a determination entry. Visitors must provide a driver’s bloodspot newborn screening will also
regarding whether the applicant for license, passport, or other form of be given. The Committee expects to vote
extension acted with due diligence government-issued photo identification on whether to support a guidance
during the regulatory review period. To or they cannot enter the facility. Non-US document on cutoff determinations and
meet its burden, the petition must Citizens planning to attend in person risk assessment methods. Finally, the
comply with all the requirements of will need to provide additional ACHDNC members will hear updates
§ 60.30, including but not limited to: information to HRSA by January 24, from the Laboratory Standards and
ethrower on DSK3G9T082PROD with NOTICES
Must be timely (see DATES), must be 2018, 12:00 p.m. Eastern Time. Please Procedures workgroup; the Follow-up
filed in accordance with § 10.20, must see contact information below. and Treatment workgroup, including a
contain sufficient facts to merit an FDA FOR FURTHER INFORMATION CONTACT: presentation of the final draft of a report
investigation, and must certify that a Anyone requesting information on Quality Measures in Newborn
true and complete copy of the petition regarding the ACHDNC should contact Screening; and the Education and
has been served upon the patent Ann Ferrero, Maternal and Child Health Training workgroup, including a
applicant. (See H. Rept. 857, part 1, 98th Bureau (MCHB), HRSA, in one of three presentation of the final draft of a
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Document Created: 2018-01-23 21:35:50
Document Modified: 2018-01-23 21:35:50
| 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 March 23, 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 23, 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 3000 |
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