83 FR 6856 - Determination of Regulatory Review Period for Purposes of Patent Extension; BRIDION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 32 (February 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 32 (February 15, 2018)
| Page Range | 6856-6858 | |
| FR Document | 2018-03137 |
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)] [Notices] [Pages 6856-6858] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03137] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2524] Determination of Regulatory Review Period for Purposes of Patent Extension; BRIDION 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 BRIDION 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 August 14, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 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. [[Page 6857]] 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-2524 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; BRIDION.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product BRIDION (sugammadex sodium). BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. Subsequent to this approval, the USPTO received a patent term restoration application for BRIDION (U.S. Patent No. RE44733) from Merck Sharp & Dohme, B.V., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 23, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BRIDION 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 BRIDION is 4,265 days. Of this time, 1,297 days occurred during the testing phase of the regulatory review period, while 2,968 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: April 13, 2004. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on April 13, 2004. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: October 31, 2007. FDA has verified the applicant's claim that the new drug application (NDA) for BRIDION (NDA 022225) was initially submitted on October 31, 2007. 3. The date the application was approved: December 15, 2015. FDA has verified the applicant's claim that NDA 022225 was approved on December 15, 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 application for patent extension, this applicant seeks 1,826 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 [[Page 6858]] 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: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03137 Filed 2-14-18; 8:45 am] BILLING CODE 4164-01-P
![6856 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
permission to market the drug product. ADDYI (NDA 22–526) was initially ACTION: Notice.
Although only a portion of a regulatory submitted on October 27, 2009.
review period may count toward the 3. The date the application was SUMMARY: The Food and Drug
actual amount of extension that the approved: August 18, 2015. FDA has Administration (FDA or the Agency) has
Director of USPTO may award (for verified the applicant’s claims that NDA determined the regulatory review period
example, half the testing phase must be 22–526 was approved on August 18, for BRIDION and is publishing this
subtracted as well as any time that may 2015. notice of that determination as required
have occurred before the patent was This determination of the regulatory by law. FDA has made the
issued), FDA’s determination of the review period establishes the maximum determination because of the
length of a regulatory review period for potential length of a patent extension. submission of an application to the
a human drug product will include all However, the USPTO applies several Director of the U.S. Patent and
statutory limitations in its calculations Trademark Office (USPTO), Department
of the testing phase and approval phase
of the actual period for patent extension. of Commerce, for the extension of a
as specified in 35 U.S.C. 156(g)(1)(B).
In its applications for patent extension, patent which claims that human drug
FDA has approved for marketing the product.
human drug product ADDYI this applicant seeks 5 years of patent
(flibanserin). ADDYI is indicated for the term extension. DATES: Anyone with knowledge that any
treatment of premenopausal women III. Petitions of the dates as published (in the
with acquired, generalized hypoactive SUPPLEMENTARY INFORMATION section) are
Anyone with knowledge that any of incorrect may submit either electronic
sexual desire disorder as characterized the dates as published are incorrect may
by low sexual desire that causes a or written comments and ask for a
submit either electronic or written redetermination by April 16, 2018.
marked distress or interpersonal comments and, under 21 CFR 60.24, ask
difficulty and is NOT due to: (1) A co- Furthermore, any interested person may
for a redetermination (see DATES). petition FDA for a determination
existing medical or psychiatric Furthermore, as specified in § 60.30 (21
condition, (2) problems within the regarding whether the applicant for
CFR 60.30), any interested person may extension acted with due diligence
relationship, or (3) the effects of a petition FDA for a determination
medication or other drug substance. during the regulatory review period by
regarding whether the applicant for August 14, 2018. See ‘‘Petitions’’ in the
Subsequent to this approval, the USPTO extension acted with due diligence
received patent term restoration SUPPLEMENTARY INFORMATION section for
during the regulatory review period. To more information.
applications for ADDYI (U.S. Patent meet its burden, the petition must
Nos. 7,151,103 and 7,420,057) from ADDRESSES: You may submit comments
comply with all the requirements of as follows. Please note that late,
Sprout Pharmaceuticals, Inc., and the § 60.30, including but not limited to:
USPTO requested FDA’s assistance in untimely filed comments will not be
Must be timely (see DATES), must be considered. Electronic comments must
determining the patents’ eligibility for filed in accordance with § 10.20, must
patent term restoration. In a letter dated be submitted on or before April 16,
contain sufficient facts to merit an FDA 2018. The https://www.regulations.gov
September 23, 2016, FDA advised the investigation, and must certify that a
USPTO that this human drug product electronic filing system will accept
true and complete copy of the petition comments until midnight Eastern Time
had undergone a regulatory review has been served upon the patent
period and that the approval of ADDYI at the end of April 16, 2018. Comments
applicant. (See H. Rept. 857, part 1, 98th received by mail/hand delivery/courier
represented the first permitted Cong., 2d sess., pp. 41–42, 1984.)
commercial marketing or use of the (for written/paper submissions) will be
Petitions should be in the format considered timely if they are
product. Thereafter, the USPTO specified in 21 CFR 10.30.
requested that FDA determine the postmarked or the delivery service
Submit petitions electronically to acceptance receipt is on or before that
product’s regulatory review period. https://www.regulations.gov at Docket date.
II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written
Period petitions (two copies are required) to the Electronic Submissions
Dockets Management Staff (HFA–305), Submit electronic comments in the
FDA has determined that the Food and Drug Administration, 5630 following way:
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal:
ADDYI is 6,852 days. Of this time, 4,730 20852. https://www.regulations.gov. Follow the
days occurred during the testing phase instructions for submitting comments.
Dated: February 9, 2018.
and 2,122 days occurred during the Comments submitted electronically,
Leslie Kux,
approval phase. These periods of time including attachments, to https://
were derived from the following dates: Associate Commissioner for Policy.
www.regulations.gov will be posted to
1. The date an exemption under [FR Doc. 2018–03130 Filed 2–14–18; 8:45 am]
the docket unchanged. Because your
section 505(i) of the Federal Food, Drug, BILLING CODE 4164–01–P
comment will be made public, you are
and Cosmetic Act (FD&C Act) (21 U.S.C. solely responsible for ensuring that your
355(i)) became effective: November 15, comment does not include any
1996. FDA has verified Sprout DEPARTMENT OF HEALTH AND
HUMAN SERVICES confidential information that you or a
Pharmaceuticals, Inc. claims that third party may not wish to be posted,
November 15, 1996, is the date the Food and Drug Administration such as medical information, your or
investigational new drug application
sradovich on DSK3GMQ082PROD with NOTICES
anyone else’s Social Security number, or
became effective. [Docket No. FDA–2016–E–2524] confidential business information, such
2. The date the application was as a manufacturing process. Please note
Determination of Regulatory Review
initially submitted with respect to the that if you include your name, contact
Period for Purposes of Patent
human drug product under section 505 information, or other information that
Extension; BRIDION
of the FD&C Act: October 27, 2009. FDA identifies you in the body of your
has verified the applicant’s claims that AGENCY: Food and Drug Administration, comments, that information will be
the new drug application (NDA) for HHS. posted on https://www.regulations.gov.
VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1](https://thefederalregister.org/doc/83_FR_6888/page/1.svg)
![6858 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
CFR 60.30), any interested person may extension acted with due diligence Instructions: All submissions received
petition FDA for a determination during the regulatory review period by must include the Docket No. FDA–
regarding whether the applicant for August 14, 2018. See ‘‘Petitions’’ in the 2015–E–1179 for ‘‘Determination of
extension acted with due diligence SUPPLEMENTARY INFORMATION section for Regulatory Review Period for Purposes
during the regulatory review period. To more information. of Patent Extension; AVEED.’’ Received
meet its burden, the petition must ADDRESSES: You may submit comments comments, those filed in a timely
comply with all the requirements of as follows. Please note that late, manner (see ADDRESSES), will be placed
§ 60.30, including but not limited to: untimely filed comments will not be in the docket and, except for those
must be timely (see DATES), must be considered. Electronic comments must submitted as ‘‘Confidential
filed in accordance with § 10.20, must be submitted on or before April 16, Submissions,’’ publicly viewable at
contain sufficient facts to merit an FDA 2018. The https://www.regulations.gov https://www.regulations.gov or at the
investigation, and must certify that a electronic filing system will accept Dockets Management Staff between 9
true and complete copy of the petition comments until midnight Eastern Time a.m. and 4 p.m., Monday through
has been served upon the patent at the end of April 16, 2018. Comments Friday.
applicant. (See H. Rept. 857, part 1, 98th received by mail/hand delivery/courier • Confidential Submissions—To
Cong., 2d sess., pp. 41–42, 1984.) (for written/paper submissions) will be submit a comment with confidential
Petitions should be in the format considered timely if they are information that you do not wish to be
specified in 21 CFR 10.30. postmarked or the delivery service made publicly available, submit your
Submit petitions electronically to acceptance receipt is on or before that comments only as a written/paper
https://www.regulations.gov at Docket date. submission. You should submit two
No. FDA–2013–S–0610. Submit written copies total. One copy will include the
petitions (two copies are required) to the Electronic Submissions information you claim to be confidential
Dockets Management Staff (HFA–305), Submit electronic comments in the with a heading or cover note that states
Food and Drug Administration, 5630 following way: ‘‘THIS DOCUMENT CONTAINS
Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
20852. https://www.regulations.gov. Follow the Agency will review this copy, including
Dated: February 9, 2018. instructions for submitting comments. the claimed confidential information, in
Leslie Kux, Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
Associate Commissioner for Policy.
www.regulations.gov will be posted to claimed confidential information
[FR Doc. 2018–03137 Filed 2–14–18; 8:45 am]
the docket unchanged. Because your redacted/blacked out, will be available
BILLING CODE 4164–01–P
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
DEPARTMENT OF HEALTH AND
confidential information that you or a Staff. If you do not wish your name and
HUMAN SERVICES
third party may not wish to be posted, contact information to be made publicly
Food and Drug Administration such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
[Docket No. FDA–2015–E–1179] in the body of your comments and you
confidential business information, such
as a manufacturing process. Please note must identify this information as
Determination of Regulatory Review ‘‘confidential.’’ Any information marked
Period for Purposes of Patent that if you include your name, contact
information, or other information that as ‘‘confidential’’ will not be disclosed
Extension; AVEED except in accordance with § 10.20 (21
identifies you in the body of your
AGENCY: Food and Drug Administration, comments, that information will be CFR 10.20) and other applicable
HHS. posted on https://www.regulations.gov. disclosure law. For more information
ACTION: Notice. • If you want to submit a comment about FDA’s posting of comments to
with confidential information that you public dockets, see 80 FR 56469,
SUMMARY: The Food and Drug do not wish to be made available to the September 18, 2015, or access the
Administration (FDA or the Agency) has public, submit the comment as a information at: https://www.gpo.gov/
determined the regulatory review period written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
for AVEED and is publishing this notice manner detailed (see ‘‘Written/Paper 23389.pdf.
of that determination as required by Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
law. FDA has made the determination read background documents or the
because of the submission of an Written/Paper Submissions electronic and written/paper comments
application to the Director of the U.S. Submit written/paper submissions as received, go to https://
Patent and Trademark Office (USPTO), follows: www.regulations.gov and insert the
Department of Commerce, for the • Mail/Hand delivery/Courier (for docket number, found in brackets in the
extension of a patent which claims that written/paper submissions): Dockets heading of this document, into the
human drug product. Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers and/or go to the Dockets Management
of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION section) are • For written/paper comments Rockville, MD 20852.
incorrect may submit either electronic submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
or written comments and ask for a Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
redetermination by April 16, 2018. well as any attachments, except for Policy, Food and Drug Administration,
Furthermore, any interested person may information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
petition FDA for a determination identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
regarding whether the applicant for as detailed in ‘‘Instructions.’’ 301–796–3600.
VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1](https://thefederalregister.org/doc/83_FR_6888/page/3.svg)
Document Created: 2018-02-15 00:21:10
Document Modified: 2018-02-15 00:21:10
| 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 16, 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 August 14, 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 6856 |
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