83 FR 4494 - Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Application 207501
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 21 (January 31, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 21 (January 31, 2018)
| Page Range | 4494-4495 | |
| FR Document | 2018-01892 |
[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)] [Notices] [Pages 4494-4495] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01892] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1586 and FDA-2017-E-4452] Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA--New Drug Application 207501 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 CRESEMBA as approved under new drug application (NDA) 207501 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 as approved under NDA 207501. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 2, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 30, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 2, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-1586 and FDA-2017-E-4452 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA--NDA 207501.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the dockets and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 [[Page 4495]] 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 CRESEMBA (isavuconazonium sulfate). CRESEMBA is indicated for use in the treatment of invasive aspergillosis and invasive mucormycosis. Subsequent to this approval, the USPTO received patent term restoration applications for CRESEMBA as approved under NDA 207501 (U.S. Patent Nos. 6,812,238 and 7,459,561) from Basilea Pharmaceutica International Ltd., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 28, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of CRESEMBA 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 CRESEMBA is 3,528 days. Of this time, 3,286 days occurred during the testing phase of the regulatory review period, while 242 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: July 10, 2005. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on July 10, 2005. 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 8, 2014. FDA has verified the applicant's claim that the NDA for CRESEMBA (NDA 207501) was initially submitted on July 8, 2014. 3. The date the application was approved: March 6, 2015. FDA has verified the applicant's claim that NDA 207501 was approved on March 6, 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 based on NDA 207501, this applicant seeks 5 years or 1,264 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 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 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01892 Filed 1-30-18; 8:45 am] BILLING CODE 4164-01-P
![4494 Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices
KEYTRUDA is 1,338 days. Of this time, Submit petitions electronically to at the end of April 2, 2018. Comments
1,148 days occurred during the testing https://www.regulations.gov at Docket received by mail/hand delivery/courier
phase of the regulatory review period, No. FDA–2013–S–0610. Submit written (for written/paper submissions) will be
while 190 days occurred during the petitions (two copies are required) to the considered timely if they are
approval phase. These periods of time Dockets Management Staff (HFA–305), postmarked or the delivery service
were derived from the following dates: Food and Drug Administration, 5630 acceptance receipt is on or before that
1. The date an exemption under Fishers Lane, Rm. 1061, Rockville, MD date.
section 505(i) of the Federal Food, Drug, 20852.
and Cosmetic Act (21 U.S.C. 355(i)) Electronic Submissions
Dated: January 24, 2018.
became effective: January 7, 2011. The Submit electronic comments in the
Leslie Kux,
applicant claims January 8, 2011, as the following way:
Associate Commissioner for Policy.
date the investigational new drug • Federal eRulemaking Portal:
application (IND) became effective. [FR Doc. 2018–01890 Filed 1–30–18; 8:45 am]
https://www.regulations.gov. Follow the
However, FDA records indicate that the BILLING CODE 4164–01–P
instructions for submitting comments.
IND effective date was January 7, 2011, Comments submitted electronically,
which was the first date after FDA including attachments, to https://
receipt of the IND that the DEPARTMENT OF HEALTH AND
www.regulations.gov will be posted to
investigational studies were allowed to HUMAN SERVICES
the docket unchanged. Because your
proceed. comment will be made public, you are
2. The date the application was Food and Drug Administration
solely responsible for ensuring that your
initially submitted with respect to the [Docket Nos. FDA–2016–E–1586 and FDA– comment does not include any
human biological product under section 2017–E–4452] confidential information that you or a
351 of the Public Health Service Act (42 third party may not wish to be posted,
U.S.C. 262): February 27, 2014. FDA has Determination of Regulatory Review
such as medical information, your or
verified the applicant’s claim that the Period for Purposes of Patent
anyone else’s Social Security number, or
biologics license application (BLA) for Extension; CRESEMBA—New Drug
confidential business information, such
KEYTRUDA (BLA 125514/0) was Application 207501
as a manufacturing process. Please note
initially submitted on February 27, AGENCY: Food and Drug Administration, that if you include your name, contact
2014. HHS. information, or other information that
3. The date the application was
ACTION: Notice. identifies you in the body of your
approved: September 4, 2014. FDA has
comments, that information will be
verified the applicant’s claim that BLA SUMMARY: The Food and Drug posted on https://www.regulations.gov.
125514/0 was approved on September 4, Administration (FDA or the Agency) has
2014. • If you want to submit a comment
determined the regulatory review period with confidential information that you
This determination of the regulatory for CRESEMBA as approved under new
review period establishes the maximum do not wish to be made available to the
drug application (NDA) 207501 and is public, submit the comment as a
potential length of a patent extension. publishing this notice of that
However, the USPTO applies several written/paper submission and in the
determination as required by law. FDA manner detailed (see ‘‘Written/Paper
statutory limitations in its calculations has made the determination because of
of the actual period for patent extension. Submissions’’ and ‘‘Instructions’’).
the submission of applications to the
In its application for patent extension, Director of the U.S. Patent and Written/Paper Submissions
this applicant seeks 83 days of patent Trademark Office (USPTO), Department
term extension. Submit written/paper submissions as
of Commerce, for the extension of a follows:
III. Petitions patent which claims that human drug • Mail/Hand delivery/Courier (for
Anyone with knowledge that any of product as approved under NDA written/paper submissions): Dockets
the dates as published are incorrect may 207501. Management Staff (HFA–305), Food and
submit either electronic or written DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
comments and, under 21 CFR 60.24 ask of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852.
for a redetermination (see DATES). SUPPLEMENTARY INFORMATION section) are • For written/paper comments
Furthermore, as specified in § 60.30 (21 incorrect may submit either electronic submitted to the Dockets Management
CFR 60.30), any interested person may or written comments and ask for a Staff, FDA will post your comment, as
petition FDA for a determination redetermination by April 2, 2018. well as any attachments, except for
regarding whether the applicant for Furthermore, any interested person may information submitted, marked and
extension acted with due diligence petition FDA for a determination identified, as confidential, if submitted
during the regulatory review period. To regarding whether the applicant for as detailed in ‘‘Instructions.’’
meet its burden, the petition must extension acted with due diligence Instructions: All submissions received
comply with all the requirements of during the regulatory review period by must include the Docket Nos. FDA–
§ 60.30, including but not limited to: July 30, 2018. See ‘‘Petitions’’ in the 2016–E–1586 and FDA–2017–E–4452
Must be timely (see DATES), must be SUPPLEMENTARY INFORMATION section for for ‘‘Determination of Regulatory
filed in accordance with § 10.20, must more information. Review Period for Purposes of Patent
contain sufficient facts to merit an FDA ADDRESSES: You may submit comments Extension; CRESEMBA—NDA 207501.’’
sradovich on DSK3GMQ082PROD with NOTICES
investigation, and must certify that a as follows. Please note that late, Received comments, those filed in a
true and complete copy of the petition untimely filed comments will not be timely manner (see ADDRESSES), will be
has been served upon the patent considered. Electronic comments must placed in the dockets and, except for
applicant. (See H. Rept. 857, part 1, 98th be submitted on or before April 2, 2018. those submitted as ‘‘Confidential
Cong., 2d sess., pp. 41–42, 1984.) The https://www.regulations.gov Submissions,’’ publicly viewable at
Petitions should be in the format electronic filing system will accept https://www.regulations.gov or at the
specified in 21 CFR 10.30. comments until midnight Eastern Time Dockets Management Staff between 9
VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1](https://thefederalregister.org/doc/83_FR_4515/page/1.svg)
![Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices 4495
a.m. and 4 p.m., Monday through medical device, food additive, or color U.S.C. 355(i)) became effective: July 10,
Friday. additive) was subject to regulatory 2005. FDA has verified the applicant’s
• Confidential Submissions—To review by FDA before the item was claim that the date the investigational
submit a comment with confidential marketed. Under these acts, a product’s new drug application became effective
information that you do not wish to be regulatory review period forms the basis was on July 10, 2005.
made publicly available, submit your for determining the amount of extension
2. The date the application was
comments only as a written/paper an applicant may receive.
A regulatory review period consists of initially submitted with respect to the
submission. You should submit two
copies total. One copy will include the two periods of time: A testing phase and human drug product under section
information you claim to be confidential an approval phase. For human drug 505(b) of the FD&C Act: July 8, 2014.
with a heading or cover note that states products, the testing phase begins when FDA has verified the applicant’s claim
‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical that the NDA for CRESEMBA (NDA
CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes 207501) was initially submitted on July
Agency will review this copy, including effective and runs until the approval 8, 2014.
the claimed confidential information, in phase begins. The approval phase starts 3. The date the application was
its consideration of comments. The with the initial submission of an approved: March 6, 2015. FDA has
second copy, which will have the application to market the human drug verified the applicant’s claim that NDA
claimed confidential information product and continues until FDA grants 207501 was approved on March 6, 2015.
redacted/blacked out, will be available permission to market the drug product.
Although only a portion of a regulatory This determination of the regulatory
for public viewing and posted on
review period may count toward the review period establishes the maximum
https://www.regulations.gov. Submit
actual amount of extension that the potential length of a patent extension.
both copies to the Dockets Management
Staff. If you do not wish your name and Director of USPTO may award (for However, the USPTO applies several
contact information to be made publicly example, half the testing phase must be statutory limitations in its calculations
available, you can provide this subtracted as well as any time that may of the actual period for patent extension.
information on the cover sheet and not have occurred before the patent was In its applications for patent extension
in the body of your comments and you issued), FDA’s determination of the based on NDA 207501, this applicant
must identify this information as length of a regulatory review period for seeks 5 years or 1,264 days of patent
‘‘confidential.’’ Any information marked a human drug product will include all term extension.
as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B). III. Petitions
except in accordance with § 10.20 (21
CFR 10.20) and other applicable FDA has approved for marketing the
Anyone with knowledge that any of
disclosure law. For more information human drug product CRESEMBA
the dates as published are incorrect may
about FDA’s posting of comments to (isavuconazonium sulfate). CRESEMBA
is indicated for use in the treatment of submit either electronic or written
public dockets, see 80 FR 56469, comments and, under 21 CFR 60.24, ask
invasive aspergillosis and invasive
September 18, 2015, or access the for a redetermination (see DATES).
mucormycosis. Subsequent to this
information at: https://www.gpo.gov/ Furthermore, as specified in § 60.30 (21
approval, the USPTO received patent
fdsys/pkg/FR-2015-09-18/pdf/2015- CFR 60.30), any interested person may
term restoration applications for
23389.pdf. petition FDA for a determination
CRESEMBA as approved under NDA
Docket: For access to the docket to regarding whether the applicant for
207501 (U.S. Patent Nos. 6,812,238 and
read background documents or the extension acted with due diligence
7,459,561) from Basilea Pharmaceutica
electronic and written/paper comments during the regulatory review period. To
International Ltd., and the USPTO
received, go to https:// meet its burden, the petition must be
requested FDA’s assistance in
www.regulations.gov and insert the timely (see DATES), must be filed in
determining the patents’ eligibility for
docket number, found in brackets in the
patent term restoration. In a letter dated accordance with § 10.20, must contain
heading of this document, into the
July 28, 2016, FDA advised the USPTO sufficient facts to merit an FDA
‘‘Search’’ box and follow the prompts
that this human drug product had investigation, and must certify that a
and/or go to the Dockets Management
undergone a regulatory review period true and complete copy of the petition
Staff, 5630 Fishers Lane, Rm. 1061,
and that the approval of CRESEMBA has been served upon the patent
Rockville, MD 20852.
represented the first permitted applicant. (See H. Rept. 857, part 1, 98th
FOR FURTHER INFORMATION CONTACT: commercial marketing or use of the Cong., 2d sess., pp. 41–42, 1984.)
Beverly Friedman, Office of Regulatory product. Thereafter, the USPTO Petitions should be in the format
Policy, Food and Drug Administration, requested that FDA determine the specified in 21 CFR 10.30.
10903 New Hampshire Ave., Bldg. 51, product’s regulatory review period.
Rm. 6250, Silver Spring, MD 20993, Submit petitions electronically to
301–796–3600. II. Determination of Regulatory Review https://www.regulations.gov at Docket
SUPPLEMENTARY INFORMATION: Period No. FDA–2013–S–0610. Submit written
FDA has determined that the petitions (two copies are required) to the
I. Background Dockets Management Staff (HFA–305),
applicable regulatory review period for
The Drug Price Competition and CRESEMBA is 3,528 days. Of this time, Food and Drug Administration, 5630
Patent Term Restoration Act of 1984 Fishers Lane, Rm. 1061, Rockville, MD
sradovich on DSK3GMQ082PROD with NOTICES
3,286 days occurred during the testing
(Pub. L. 98–417) and the Generic phase of the regulatory review period, 20852.
Animal Drug and Patent Term while 242 days occurred during the Dated: January 26, 2018.
Restoration Act (Pub. L. 100–670) approval phase. These periods of time
Leslie Kux,
generally provide that a patent may be were derived from the following dates:
extended for a period of up to 5 years 1. The date an exemption under Associate Commissioner for Policy.
so long as the patented item (human section 505(i) of the Federal Food, Drug, [FR Doc. 2018–01892 Filed 1–30–18; 8:45 am]
drug product, animal drug product, and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P
VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 E:\FR\FM\31JAN1.SGM 31JAN1](https://thefederalregister.org/doc/83_FR_4515/page/2.svg)
Document Created: 2018-01-31 00:58:37
Document Modified: 2018-01-31 00:58:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 2, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 30, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 83 FR 4494 |
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