83 FR 61645 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61645-61646 | |
| FR Document | 2018-26035 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61645-61646] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26035] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-3305] Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE 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 PROVAYBLUE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 29, 2019. 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 29, 2019. 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 January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 29, 2019. 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-2016-E-3305 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE.'' 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 [[Page 61646]] 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, PROVAYBLUE (methylene blue) indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Subsequent to this approval, the USPTO received a patent term restoration application for PROVAYBLUE (U.S. Patent No. 8,765,942) from Provepharm S.A.S. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated February 6, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of PROVAYBLUE 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 PROVAYBLUE is 415 days. Of this time, 232 days occurred during the testing phase of the regulatory review period, while 183 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: February 20, 2015. FDA has verified the applicant's claim that the date the investigational new drug application became effective was February 20, 2015. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 9, 2015. FDA has verified the applicant's claim that the new drug application (NDA) for PROVAYBLUE (NDA 204630) was initially submitted on October 9, 2015. 3. The date the application was approved: April 8, 2016. FDA has verified the applicant's claim that NDA 204630 was approved on April 8, 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 298 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: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26035 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61645
approval phase. These periods of time Dated: November 26, 2018. instructions for submitting comments.
were derived from the following dates: Leslie Kux, Comments submitted electronically,
1. The date an exemption under Associate Commissioner for Policy. including attachments, to https://
section 505(i) of the Federal Food, Drug, [FR Doc. 2018–26033 Filed 11–29–18; 8:45 am] www.regulations.gov will be posted to
and Cosmetic Act (21 U.S.C. 355(i)) BILLING CODE 4164–01–P the docket unchanged. Because your
became effective: November 15, 2007. comment will be made public, you are
FDA has verified the applicant’s claim solely responsible for ensuring that your
DEPARTMENT OF HEALTH AND comment does not include any
that the date the investigational new
HUMAN SERVICES confidential information that you or a
drug application became effective was
third party may not wish to be posted,
on November 15, 2007. Food and Drug Administration such as medical information, your or
2. The date the application was anyone else’s Social Security number, or
[Docket No. FDA–2016–E–3305]
initially submitted with respect to the confidential business information, such
human biological product under section Determination of Regulatory Review as a manufacturing process. Please note
351 of the Public Health Service Act (42 Period for Purposes of Patent that if you include your name, contact
U.S.C. 262): October 30, 2015. FDA has Extension; PROVAYBLUE information, or other information that
verified the applicant’s claim that the identifies you in the body of your
biologics license application (BLA) for AGENCY: Food and Drug Administration, comments, that information will be
KEVZARA (BLA 761037) was initially HHS. posted on https://www.regulations.gov.
submitted on October 30, 2015. ACTION: Notice. • If you want to submit a comment
3. The date the application was with confidential information that you
SUMMARY: The Food and Drug do not wish to be made available to the
approved: May 22, 2017. FDA has Administration (FDA or the Agency) has
verified the applicant’s claim that BLA public, submit the comment as a
determined the regulatory review period
761037 was approved on May 22, 2017. written/paper submission and in the
for PROVAYBLUE and is publishing
manner detailed (see ‘‘Written/Paper
This determination of the regulatory this notice of that determination as
Submissions’’ and ‘‘Instructions’’).
review period establishes the maximum required by law. FDA has made the
potential length of a patent extension. determination because of the Written/Paper Submissions
However, the USPTO applies several submission of an application to the Submit written/paper submissions as
statutory limitations in its calculations Director of the U.S. Patent and follows:
of the actual period for patent extension. Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
In its applications for patent extension, of Commerce, for the extension of a written/paper submissions): Dockets
this applicant seeks 1,234 or 937 days patent which claims that human drug Management Staff (HFA–305), Food and
of patent term extension. product. Drug Administration, 5630 Fishers
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
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
Anyone with knowledge that any of
incorrect may submit either electronic Staff, FDA will post your comment, as
the dates as published are incorrect may
or written comments and ask for a well as any attachments, except for
submit either electronic or written
redetermination by January 29, 2019. information submitted, marked and
comments and, under 21 CFR 60.24, ask
Furthermore, any interested person may identified, as confidential, if submitted
for a redetermination (see DATES).
petition FDA for a determination as detailed in ‘‘Instructions.’’
Furthermore, as specified in § 60.30 (21 Instructions: All submissions received
regarding whether the applicant for
CFR 60.30), any interested person may must include the Docket No. FDA–
extension acted with due diligence
petition FDA for a determination 2016–E–3305 for ‘‘Determination of
during the regulatory review period by
regarding whether the applicant for Regulatory Review Period for Purposes
May 29, 2019. See ‘‘Petitions’’ in the
extension acted with due diligence of Patent Extension; PROVAYBLUE.’’
SUPPLEMENTARY INFORMATION section for
during the regulatory review period. To Received comments, those filed in a
more information.
meet its burden, the petition must timely manner (see ADDRESSES), will be
ADDRESSES: You may submit comments
comply with all the requirements of placed in the docket and, except for
§ 60.30, including but not limited to: as follows. Please note that late,
untimely filed comments will not be those submitted as ‘‘Confidential
Must be timely (see DATES), must be Submissions,’’ publicly viewable at
filed in accordance with § 10.20, must considered. Electronic comments must
be submitted on or before January 29, https://www.regulations.gov or at the
contain sufficient facts to merit an FDA Dockets Management Staff between 9
investigation, and must certify that a 2019. The https://www.regulations.gov
electronic filing system will accept a.m. and 4 p.m., Monday through
true and complete copy of the petition Friday.
has been served upon the patent comments until 11:59 p.m. Eastern Time
at the end of January 29, 2019. • Confidential Submissions—To
applicant. (See H. Rept. 857, part 1, 98th submit a comment with confidential
Cong., 2d sess., pp. 41–42, 1984.) Comments received by mail/hand
delivery/courier (for written/paper information that you do not wish to be
Petitions should be in the format made publicly available, submit your
specified in 21 CFR 10.30. submissions) will be considered timely
if they are postmarked or the delivery comments only as a written/paper
Submit petitions electronically to service acceptance receipt is on or submission. You should submit two
amozie on DSK3GDR082PROD with NOTICES1
https://www.regulations.gov at Docket before that date. copies total. One copy will include the
No. FDA–2013–S–0610. Submit written information you claim to be confidential
petitions (two copies are required) to the Electronic Submissions with a heading or cover note that states
Dockets Management Staff (HFA–305), Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration, 5630 following way: CONFIDENTIAL INFORMATION.’’ The
Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal: Agency will review this copy, including
20852. https://www.regulations.gov. Follow the the claimed confidential information, in
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![61646 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
its consideration of comments. The with the initial submission of an This determination of the regulatory
second copy, which will have the application to market the human drug review period establishes the maximum
claimed confidential information product and continues until FDA grants potential length of a patent extension.
redacted/blacked out, will be available permission to market the drug product. However, the USPTO applies several
for public viewing and posted on Although only a portion of a regulatory statutory limitations in its calculations
https://www.regulations.gov. Submit review period may count toward the of the actual period for patent extension.
both copies to the Dockets Management actual amount of extension that the In its application for patent extension,
Staff. If you do not wish your name and Director of USPTO may award (for this applicant seeks 298 days of patent
contact information to be made publicly example, half the testing phase must be term extension.
available, you can provide this subtracted as well as any time that may
III. Petitions
information on the cover sheet and not have occurred before the patent was
in the body of your comments and you issued), FDA’s determination of the Anyone with knowledge that any of
must identify this information as length of a regulatory review period for the dates as published are incorrect may
‘‘confidential.’’ Any information marked a human drug product will include all submit either electronic or written
as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase comments and, under 21 CFR 60.24, ask
except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). for a redetermination (see DATES).
CFR 10.20) and other applicable FDA has approved for marketing the Furthermore, as specified in § 60.30 (21
disclosure law. For more information human drug product, PROVAYBLUE CFR 60.30), any interested person may
about FDA’s posting of comments to (methylene blue) indicated for the petition FDA for a determination
public dockets, see 80 FR 56469, treatment of pediatric and adult patients regarding whether the applicant for
September 18, 2015, or access the with acquired methemoglobinemia. extension acted with due diligence
information at: https://www.gpo.gov/ Subsequent to this approval, the USPTO during the regulatory review period. To
fdsys/pkg/FR-2015-09-18/pdf/2015- received a patent term restoration meet its burden, the petition must
23389.pdf. application for PROVAYBLUE (U.S. comply with all the requirements of
Docket: For access to the docket to Patent No. 8,765,942) from Provepharm § 60.30, including but not limited to:
read background documents or the S.A.S. and the USPTO requested FDA’s Must be timely (see DATES), must be
electronic and written/paper comments assistance in determining the patent’s filed in accordance with § 10.20, must
received, go to https:// eligibility for patent term restoration. In contain sufficient facts to merit an FDA
www.regulations.gov and insert the a letter dated February 6, 2018, FDA investigation, and must certify that a
docket number, found in brackets in the advised the USPTO that this human true and complete copy of the petition
heading of this document, into the drug product had undergone a has been served upon the patent
‘‘Search’’ box and follow the prompts regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th
and/or go to the Dockets Management approval of PROVAYBLUE represented Cong., 2d sess., pp. 41–42, 1984.)
Staff, 5630 Fishers Lane, Rm. 1061, the first permitted commercial Petitions should be in the format
Rockville, MD 20852. marketing or use of the product. specified in 21 CFR 10.30.
Thereafter, the USPTO requested that Submit petitions electronically to
FOR FURTHER INFORMATION CONTACT: https://www.regulations.gov at Docket
FDA determine the product’s regulatory
Beverly Friedman, Office of Regulatory No. FDA–2013–S–0610. Submit written
review period.
Policy, Food and Drug Administration, petitions (two copies are required) to the
10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review Dockets Management Staff (HFA–305),
Rm. 6250, Silver Spring, MD 20993, Period Food and Drug Administration, 5630
301–796–3600. FDA has determined that the Fishers Lane, Rm. 1061, Rockville, MD
SUPPLEMENTARY INFORMATION: applicable regulatory review period for 20852.
I. Background PROVAYBLUE is 415 days. Of this time, Dated: November 26, 2018.
232 days occurred during the testing Leslie Kux,
The Drug Price Competition and phase of the regulatory review period,
Patent Term Restoration Act of 1984 Associate Commissioner for Policy.
while 183 days occurred during the
(Pub. L. 98–417) and the Generic [FR Doc. 2018–26035 Filed 11–29–18; 8:45 am]
approval phase. These periods of time
Animal Drug and Patent Term were derived from the following dates: BILLING CODE 4164–01–P
Restoration Act (Pub. L. 100–670) 1. The date an exemption under
generally provide that a patent may be section 505(i) of the Federal Food, Drug,
extended for a period of up to 5 years and Cosmetic Act (FD&C Act) (21 U.S.C. DEPARTMENT OF HEALTH AND
so long as the patented item (human 355(i)) became effective: February 20, HUMAN SERVICES
drug product, animal drug product, 2015. FDA has verified the applicant’s Food and Drug Administration
medical device, food additive, or color claim that the date the investigational
additive) was subject to regulatory new drug application became effective [Docket No. FDA–2011–D–0597]
review by FDA before the item was was February 20, 2015.
marketed. Under these acts, a product’s 2. The date the application was Agency Information Collection
regulatory review period forms the basis initially submitted with respect to the Activities; Proposed Collection;
for determining the amount of extension human drug product under section Comment Request; Oversight of
an applicant may receive. 505(b) of the FD&C Act: October 9, 2015. Clinical Investigations: A Risk-Based
A regulatory review period consists of FDA has verified the applicant’s claim Approach to Monitoring
amozie on DSK3GDR082PROD with NOTICES1
two periods of time: A testing phase and that the new drug application (NDA) for AGENCY: Food and Drug Administration,
an approval phase. For human drug PROVAYBLUE (NDA 204630) was HHS.
products, the testing phase begins when initially submitted on October 9, 2015. ACTION: Notice.
the exemption to permit the clinical 3. The date the application was
investigations of the drug becomes approved: April 8, 2016. FDA has SUMMARY: The Food and Drug
effective and runs until the approval verified the applicant’s claim that NDA Administration (FDA or Agency) is
phase begins. The approval phase starts 204630 was approved on April 8, 2016. announcing an opportunity for public
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Document Created: 2018-11-30 04:35:53
Document Modified: 2018-11-30 04:35:53
| 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 January 29, 2019. 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 29, 2019. 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 61645 |
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