Determination of Regulatory Review Period for Purposes of Patent Extension; YESCARTA, 18055-18057 [2019-08609]

Download as PDF Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting SUPPLEMENTARY INFORMATION: 18055 statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Survey of Current Manufacturing Practices for the Cosmetic Industry ................................................................... Environmental Impact Considerations ..................................................................................................................... Generic Clearance for Quantitative Testing of the Development of Food and Drug Administration ..................... Investigational New Drug Regulations .................................................................................................................... Prescription Drug User Fee Program ...................................................................................................................... Food Additives, Food Contact Substance Notification System ............................................................................... SPF Labeling and Testing Requirements for OTC Sunscreen Products ............................................................... Generic Drug User Fee Program ............................................................................................................................ Experimental Study of Cigarette Warnings ............................................................................................................. Assessment of Combination Product Review Practices ......................................................................................... Dated: April 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–08607 Filed 4–26–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–E–1140] Determination of Regulatory Review Period for Purposes of Patent Extension; YESCARTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YESCARTA 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 biological 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 June 28, 2019. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:56 Apr 26, 2019 Jkt 247001 extension acted with due diligence during the regulatory review period by October 28, 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 June 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 28, 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 0910–0867 0910–0322 0910–0865 0910–0014 0910–0297 0910–0495 0910–0717 0910–0727 0910–0866 0910–0868 Date approval expires 3/31/2020 2/28/2022 2/28/2022 3/31/2022 3/31/2022 3/31/2022 3/31/2022 3/31/2022 3/31/2022 3/31/2022 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– 2018–E–1140 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; YESCARTA.’’ 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 E:\FR\FM\29APN1.SGM 29APN1 18056 Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 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 § 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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: khammond on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 16:56 Apr 26, 2019 Jkt 247001 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological 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 biologic product YESCARTA (axicabtagene ciloleucel), a CD 19directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Subsequent to this approval, the USPTO received a patent term restoration application for YESCARTA (U.S. Patent No. 7,741,465) from Cabaret Biotech Ltd., and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated April 5, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of YESCARTA 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 YESCARTA is 3,243 days. Of this time, 3,041 days occurred during the testing phase of the regulatory review period, while 202 days occurred during the approval phase. These periods of time were derived from the following dates: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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 3, 2008. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was December 3, 2008. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): March 31, 2017. The applicant claims December 2, 2016, as the date the biologics license application (BLA) for YESCARTA (BLA 125643) was initially submitted. However, FDA records indicate that BLA 125643 was completely submitted on March 31, 2017, which is considered to be the BLA initial submission date. 3. The date the application was approved: October 18, 2017. FDA has verified the applicant’s claim that BLA 125643 was approved on October 18, 2017. 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 1,498 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 § 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 § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 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. E:\FR\FM\29APN1.SGM 29APN1 18057 Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices Dated: April 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. include the FDA docket number found in brackets in the heading of this document. [FR Doc. 2019–08609 Filed 4–26–19; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2018–N–4465] Administrative Detention and Banned Medical Devices—21 CFR 800.55(g)(1), (g)(2), and (k), 895.21(d), and 895.229(a) OMB Control Number 0910–0114— Extension Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by May 29, 2019. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0114. Also ADDRESSES: FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated or misbranded. Section 800.55 (21 CFR 800.55), on administrative detention, includes among other things certain reporting requirements (§ 800.55(g)(1) and (2)) and recordkeeping requirements (§ 800.55(k)). Under § 800.55(g), an appellant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, in addition to records of distribution of the detained devices. These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained. FDA also has the statutory authority under section 516 of the FD&C Act (21 U.S.C. 360f) to ban devices that present substantial deception or an unreasonable and substantial risk of illness or injury. Section 895.21 (21 CFR 895.21), on banned devices, contains certain reporting requirements. Section 895.21(d) describes the procedures for banning a device when the Commissioner of Food and Drugs (the Commissioner) decides to initiate such a proceeding. Under 21 CFR 895.22, a manufacturer, distributor, or importer of a device may be required to submit to FDA all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. During the past several years, there has been an average of less than one new administrative detention action per year. Each administrative detention will have varying amounts of data and information that must be maintained. In the Federal Register of December 21, 2018 (83 FR 65683), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR section Average burden per response Total annual responses Total hours Documentation of ownership—800.55(g) ............................ Banned devices reporting requirements—895.21(d)(8) and 895.22(a) .......................................................................... 1 1 1 25 25 26 1 26 16 416 Total .............................................................................. ........................ ........................ ........................ ........................ 441 1 There are no capital costs or operating and maintenance costs associated with this collection of information. khammond on DSKBBV9HB2PROD with NOTICES TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k) ... 1 There Number of records per recordkeeper 1 Average burden per recordkeeping Total annual records 1 1 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 16:56 Apr 26, 2019 Jkt 247001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1 20 Total hours 20

Agencies

[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18055-18057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08609]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-1140]

Determination of Regulatory Review Period for Purposes of Patent
Extension; YESCARTA

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 YESCARTA 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
biological 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 June
28, 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 October 28, 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 June 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 28, 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-2018-E-1140 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; YESCARTA.'' 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

[[Page 18056]]

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.gpo.gov/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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological 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
biological 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 biologic product YESCARTA
(axicabtagene ciloleucel), a CD 19-directed genetically modified
autologous T cell immunotherapy indicated for the treatment of adult
patients with relapsed or refractory large B-cell lymphoma after two or
more lines of systemic therapy, including diffuse large B-cell lymphoma
(DLBCL) not otherwise specified, primary mediastinal large B-cell
lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular
lymphoma. Subsequent to this approval, the USPTO received a patent term
restoration application for YESCARTA (U.S. Patent No. 7,741,465) from
Cabaret Biotech Ltd., and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated April 5, 2018, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of YESCARTA 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
YESCARTA is 3,243 days. Of this time, 3,041 days occurred during the
testing phase of the regulatory review period, while 202 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 3, 2008. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was December
3, 2008.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 31, 2017. The applicant claims
December 2, 2016, as the date the biologics license application (BLA)
for YESCARTA (BLA 125643) was initially submitted. However, FDA records
indicate that BLA 125643 was completely submitted on March 31, 2017,
which is considered to be the BLA initial submission date.
3. The date the application was approved: October 18, 2017. FDA has
verified the applicant's claim that BLA 125643 was approved on October
18, 2017.
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 1,498 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.

[[Page 18057]]

Dated: April 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08609 Filed 4-26-19; 8:45 am]
BILLING CODE 4164-01-P

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