83 FR 4221 - Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Aapplication 207500
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 20 (January 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 20 (January 30, 2018)
| Page Range | 4221-4222 | |
| FR Document | 2018-01645 |
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)] [Notices] [Pages 4221-4222] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01645] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1582; FDA-2016-E-1236] Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA--New Drug Aapplication 207500 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) 207500 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 207500. 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-1582 and FDA-2016-E-1236 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA--NDA 207500.'' 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 [[Page 4222]] 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 207500 (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 July 10, 2005, is the date the investigational new drug application (IND) became effective. 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 new drug application (NDA) for CRESEMBA (NDA 207500) 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 207500 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 207500, 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 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 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01645 Filed 1-29-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices 4221
approval phase. These periods of time Dated: January 24, 2018. Electronic Submissions
were derived from the following dates: Leslie Kux, Submit electronic comments in the
1. The date an exemption under Associate Commissioner for Policy. following way:
section 505(i) of the Federal Food, Drug, [FR Doc. 2018–01637 Filed 1–29–18; 8:45 am] • Federal eRulemaking Portal:
and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P https://www.regulations.gov. Follow the
355(i)) became effective: October 29, instructions for submitting comments.
2009. FDA has verified the applicant’s Comments submitted electronically,
claim that the date the investigational DEPARTMENT OF HEALTH AND including attachments, to https://
new drug application became effective HUMAN SERVICES www.regulations.gov will be posted to
was on October 29, 2009. the docket unchanged. Because your
Food and Drug Administration comment will be made public, you are
2. The date the application was
initially submitted with respect to the solely responsible for ensuring that your
human drug product under section [Docket Nos. FDA–2016–E–1582; FDA– comment does not include any
505(b) of the FD&C Act: December 22, 2016–E–1236] confidential information that you or a
2014. FDA has verified the applicant’s third party may not wish to be posted,
Determination of Regulatory Review
claim that the new drug application such as medical information, your or
Period for Purposes of Patent
(NDA) for UPTRAVI (NDA 207947) was anyone else’s Social Security number, or
Extension; CRESEMBA—New Drug
initially submitted on December 22, confidential business information, such
Aapplication 207500
2014. as a manufacturing process. Please note
3. The date the application was AGENCY: Food and Drug Administration, that if you include your name, contact
approved: December 21, 2015. FDA has HHS. information, or other information that
verified the applicant’s claim that NDA ACTION: Notice. identifies you in the body of your
207947 was approved on December 21, comments, that information will be
2015. SUMMARY: The Food and Drug posted on https://www.regulations.gov.
Administration (FDA or the Agency) has • If you want to submit a comment
This determination of the regulatory
determined the regulatory review period with confidential information that you
review period establishes the maximum
for CRESEMBA as approved under new do not wish to be made available to the
potential length of a patent extension.
drug application (NDA) 207500 and is public, submit the comment as a
However, the USPTO applies several
publishing this notice of that written/paper submission and in the
statutory limitations in its calculations
determination as required by law. FDA manner detailed (see ‘‘Written/Paper
of the actual period for patent extension.
has made the determination because of Submissions’’ and ‘‘Instructions’’).
In its application for patent extension,
this applicant seeks 1,305 days of patent the submission of applications to the Written/Paper Submissions
term extension. Director of the U.S. Patent and
Trademark Office (USPTO), Department Submit written/paper submissions as
III. Petitions of Commerce, for the extension of a follows:
patent which claims that human drug • Mail/Hand delivery/Courier (for
Anyone with knowledge that any of written/paper submissions): Dockets
product as approved under NDA
the dates as published are incorrect may Management Staff (HFA–305), Food and
207500.
submit either electronic or written Drug Administration, 5630 Fishers
comments and, under 21 CFR 60.24, ask DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
for a redetermination (see DATES). of the dates as published (in the • For written/paper comments
Furthermore, as specified in § 60.30 (21 SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
CFR 60.30), any interested person may incorrect may submit either electronic Staff, FDA will post your comment, as
petition FDA for a determination or written comments and ask for a well as any attachments, except for
regarding whether the applicant for redetermination by April 2, 2018. information submitted, marked and
extension acted with due diligence Furthermore, any interested person may identified, as confidential, if submitted
during the regulatory review period. To petition FDA for a determination as detailed in ‘‘Instructions.’’
meet its burden, the petition must regarding whether the applicant for Instructions: All submissions received
comply with all the requirements of extension acted with due diligence must include the Docket Nos. FDA–
§ 60.30, including but not limited to: during the regulatory review period by 2016–E–1582 and FDA–2016–E–1236
Must be timely (see DATES), must be July 30, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory
filed in accordance with § 10.20, must SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
contain sufficient facts to merit an FDA more information. Extension; CRESEMBA—NDA 207500.’’
investigation, and must certify that a ADDRESSES: You may submit comments Received comments, those filed in a
true and complete copy of the petition as follows. Please note that late, timely manner (see ADDRESSES), will be
has been served upon the patent untimely filed comments will not be placed in the docket and, except for
applicant. (See H. Rept. 857, part 1, 98th considered. Electronic comments must those submitted as ‘‘Confidential
Cong., 2d sess., pp. 41–42, 1984.) be submitted on or before April 2, 2018. Submissions,’’ publicly viewable at
Petitions should be in the format The https://www.regulations.gov https://www.regulations.gov or at the
specified in 21 CFR 10.30. electronic filing system will accept Dockets Management Staff between 9
Submit petitions electronically to comments until midnight Eastern Time a.m. and 4 p.m., Monday through
daltland on DSKBBV9HB2PROD with NOTICES
https://www.regulations.gov at Docket at the end of April 2, 2018. Comments Friday.
No. FDA–2013–S–0610. Submit written received by mail/hand delivery/courier • Confidential Submissions—To
petitions (two copies are required) to the (for written/paper submissions) will be submit a comment with confidential
Dockets Management Staff (HFA–305), considered timely if they are information that you do not wish to be
Food and Drug Administration, 5630 postmarked or the delivery service made publicly available, submit your
Fishers Lane, Rm. 1061, Rockville, MD acceptance receipt is on or before that comments only as a written/paper
20852. date. submission. You should submit two
VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1](https://thefederalregister.org/doc/83_FR_4241/page/1.svg)
![4222 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices
copies total. One copy will include the A regulatory review period consists of human drug product under section
information you claim to be confidential two periods of time: A testing phase and 505(b) of the FD&C Act: July 8, 2014.
with a heading or cover note that states an approval phase. For human drug FDA has verified the applicant’s claim
‘‘THIS DOCUMENT CONTAINS products, the testing phase begins when that the new drug application (NDA) for
CONFIDENTIAL INFORMATION.’’ The the exemption to permit the clinical CRESEMBA (NDA 207500) was initially
Agency will review this copy, including investigations of the drug becomes submitted on July 8, 2014.
the claimed confidential information, in effective and runs until the approval
phase begins. The approval phase starts 3. The date the application was
its consideration of comments. The
second copy, which will have the with the initial submission of an approved: March 6, 2015. FDA has
claimed confidential information application to market the human drug verified the applicant’s claim that NDA
redacted/blacked out, will be available product and continues until FDA grants 207500 was approved on March 6, 2015.
for public viewing and posted on permission to market the drug product. This determination of the regulatory
https://www.regulations.gov. Submit Although only a portion of a regulatory review period establishes the maximum
both copies to the Dockets Management review period may count toward the potential length of a patent extension.
Staff. If you do not wish your name and actual amount of extension that the However, the USPTO applies several
contact information to be made publicly Director of USPTO may award (for statutory limitations in its calculations
available, you can provide this example, half the testing phase must be of the actual period for patent extension.
information on the cover sheet and not subtracted as well as any time that may In its applications for patent extension
in the body of your comments and you have occurred before the patent was based on NDA 207500, this applicant
must identify this information as issued), FDA’s determination of the
seeks 5 years or 1,264 days of patent
‘‘confidential.’’ Any information marked length of a regulatory review period for
term extension.
as ‘‘confidential’’ will not be disclosed a human drug product will include all
except in accordance with § 10.20 (21 of the testing phase and approval phase III. Petitions
CFR 10.20) and other applicable as specified in 35 U.S.C. 156(g)(1)(B).
disclosure law. For more information FDA has approved for marketing the Anyone with knowledge that any of
about FDA’s posting of comments to human drug product CRESEMBA the dates as published are incorrect may
public dockets, see 80 FR 56469, (isavuconazonium sulfate). CRESEMBA submit either electronic or written
September 18, 2015, or access the is indicated for use in the treatment of comments and, under 21 CFR 60.24, ask
information at: https://www.gpo.gov/ invasive aspergillosis and invasive for a redetermination (see DATES).
fdsys/pkg/FR-2015-09-18/pdf/2015- mucormycosis. Subsequent to this Furthermore, as specified in § 60.30 (21
23389.pdf. approval, the USPTO received patent CFR 60.30), any interested person may
term restoration applications for petition FDA for a determination
Docket: For access to the docket to CRESEMBA as approved under NDA
read background documents or the regarding whether the applicant for
207500 (U.S. Patent Nos. 6,812,238 and extension acted with due diligence
electronic and written/paper comments 7,459,561) from Basilea Pharmaceutica
received, go to https:// during the regulatory review period. To
International Ltd., and the USPTO
www.regulations.gov and insert the meet its burden, the petition must
requested FDA’s assistance in
docket number, found in brackets in the comply with all the requirements of
determining the patents’ eligibility for
heading of this document, into the patent term restoration. In a letter dated § 60.30, including but not limited to:
‘‘Search’’ box and follow the prompts July 28, 2016, FDA advised the USPTO Must be timely (see DATES), must be
and/or go to the Dockets Management that this human drug product had filed in accordance with § 10.20, must
Staff, 5630 Fishers Lane, Rm. 1061, undergone a regulatory review period contain sufficient facts to merit an FDA
Rockville, MD 20852. and that the approval of CRESEMBA investigation, and must certify that a
FOR FURTHER INFORMATION CONTACT: represented the first permitted true and complete copy of the petition
Beverly Friedman, Office of Regulatory commercial marketing or use of the has been served upon the patent
Policy, Food and Drug Administration, product. Thereafter, the USPTO applicant. (See H. Rept. 857, part 1, 98th
10903 New Hampshire Ave., Bldg. 51, requested that FDA determine the Cong., 2d sess., pp. 41–42, 1984.)
Rm. 6250, Silver Spring, MD 20993, product’s regulatory review period. Petitions should be in the format
301–796–3600. specified in 21 CFR 10.30.
II. Determination of Regulatory Review
SUPPLEMENTARY INFORMATION: Period Submit petitions electronically to
https://www.regulations.gov at Docket
I. Background FDA has determined that the
applicable regulatory review period for No. FDA–2013–S–0610. Submit written
The Drug Price Competition and CRESEMBA is 3,528 days. Of this time, petitions (two copies are required) to the
Patent Term Restoration Act of 1984 3,286 days occurred during the testing Dockets Management Staff (HFA–305),
(Pub. L. 98–417) and the Generic phase of the regulatory review period, Food and Drug Administration, 5630
Animal Drug and Patent Term while 242 days occurred during the Fishers Lane, Rm. 1061, Rockville, MD
Restoration Act (Pub. L. 100–670) approval phase. These periods of time 20852.
generally provide that a patent may be were derived from the following dates: Dated: January 24, 2018.
extended for a period of up to 5 years 1. The date an exemption under Leslie Kux,
so long as the patented item (human section 505(i) of the Federal Food, Drug,
drug product, animal drug product, and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
daltland on DSKBBV9HB2PROD with NOTICES
medical device, food additive, or color U.S.C. 355(i)) became effective: July 10, [FR Doc. 2018–01645 Filed 1–29–18; 8:45 am]
additive) was subject to regulatory 2005. FDA has verified the applicant’s BILLING CODE 4164–01–P
review by FDA before the item was claim that July 10, 2005, is the date the
marketed. Under these acts, a product’s investigational new drug application
regulatory review period forms the basis (IND) became effective.
for determining the amount of extension 2. The date the application was
an applicant may receive. initially submitted with respect to the
VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 9990 E:\FR\FM\30JAN1.SGM 30JAN1](https://thefederalregister.org/doc/83_FR_4241/page/2.svg)
Document Created: 2018-10-26 10:10:11
Document Modified: 2018-10-26 10:10:11
| 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 4221 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR