83 FR 6031 - Determination of Regulatory Review Period for Purposes of Patent Extension; DALVANCE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 29 (February 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 29 (February 12, 2018)
| Page Range | 6031-6033 | |
| FR Document | 2018-02768 |
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)] [Notices] [Pages 6031-6033] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02768] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-1685] Determination of Regulatory Review Period for Purposes of Patent Extension; DALVANCE 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 DALVANCE 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 13, 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 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 13, 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. 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 13, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. 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-2015-E-1685 for ''Determination of Regulatory Review Period for Purposes of Patent Extension; DALVANCE.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential [[Page 6032]] 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 DALVANCE (dalbavancin). DALVANCE is indicated for acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram- positive microorganisms. Subsequent to this approval, the USPTO received a patent term restoration application for DALVANCE (U.S. Patent No. 6,900,175) from Vicuron Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 2, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of DALVANCE 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 DALVANCE is 5,033 days. Of this time, 1,592 days occurred during the testing phase of the regulatory review period, while 3,441 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: August 13, 2000. The applicant claims August 11, 2000, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 13, 2000, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 21, 2004. FDA has verified the applicant's claim that the new drug application (NDA) for DALVANCE (NDA 21883) was initially submitted on December 21, 2004. 3. The date the application was approved: May 23, 2014. FDA has verified the applicant's claim that NDA 21883 was approved on May 23, 2014. 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 1,612 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 6033]] Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02768 Filed 2-9-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 6031
its consideration of comments. The assessing the impact of packaging, considered timely if they are
second copy, which will have the storage, and disposal options in both the postmarked or the delivery service
claimed confidential information premarket and postmarket settings; and acceptance receipt is on or before that
redacted/blacked out, will be available ways in which FDA could encourage the date. Furthermore, any interested
for public viewing and posted on development and assessment of person may petition FDA for a
https://www.regulations.gov. Submit packaging, storage, and disposal options determination regarding whether the
both copies to the Dockets Management for opioids that have the potential to applicant for extension acted with due
Staff. If you do not wish your name and enhance opioid safety. The notice diligence during the regulatory review
contact information to be made publicly requested comments by February 12, period by August 13, 2018. See
available, you can provide this 2018; FDA is extending the comment ‘‘Petitions’’ in the SUPPLEMENTARY
information on the cover sheet and not period until March 16, 2018. The INFORMATION section for more
in the body of your comments and you Agency believes this extension allows information.
must identify this information as adequate time for interested persons to
‘‘confidential.’’ Any information marked submit comments. Electronic Submissions
as ‘‘confidential’’ will not be disclosed Dated: February 7, 2018. Submit electronic comments in the
except in accordance with 21 CFR 10.20 Leslie Kux,
following way:
and other applicable disclosure law. For • Federal eRulemaking Portal:
Associate Commissioner for Policy.
more information about FDA’s posting https://www.regulations.gov. Follow the
[FR Doc. 2018–02803 Filed 2–9–18; 8:45 am] instructions for submitting comments.
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access BILLING CODE 4164–01–P Comments submitted electronically,
the information at: https://www.gpo.gov/ including attachments, to https://
fdsys/pkg/FR-2015-09-18/pdf/2015- www.regulations.gov will be posted to
DEPARTMENT OF HEALTH AND the docket unchanged. Because your
23389.pdf. HUMAN SERVICES
Docket: For access to the docket to comment will be made public, you are
read background documents or the Food and Drug Administration solely responsible for ensuring that your
electronic and written/paper comments comment does not include any
received, go to https:// [Docket No. FDA–2015–E–1685] confidential information that you or a
www.regulations.gov and insert the third party may not wish to be posted,
Determination of Regulatory Review such as medical information, your or
docket number, found in brackets in the
Period for Purposes of Patent anyone else’s Social Security number, or
heading of this document, into the
Extension; DALVANCE confidential business information, such
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management AGENCY: Food and Drug Administration, as a manufacturing process. Please note
Staff, 5630 Fishers Lane, Rm. 1061, HHS. that if you include your name, contact
Rockville, MD 20852. ACTION: Notice. information, or other information that
FOR FURTHER INFORMATION CONTACT: identifies you in the body of your
Irene Z. Chan, Food and Drug SUMMARY: The Food and Drug comments, that information will be
Administration, 10903 New Hampshire Administration (FDA or the Agency) has posted on https://www.regulations.gov.
Ave., Bldg. 22, Rm. 4420, Silver Spring, determined the regulatory review period • If you want to submit a comment
MD, 20993–0002, 301–796–3962, for DALVANCE and is publishing this with confidential information that you
Irene.Chan2@fda.hhs.gov; or Michelle notice of that determination as required do not wish to be made available to the
Eby, Food and Drug Administration, by law. FDA has made the public, submit the comment as a
10903 New Hampshire Ave., Bldg. 22, determination because of the written/paper submission and in the
Rm. 4422, Silver Spring, MD, 20993– submission of an application to the manner detailed (see ‘‘Written/Paper
0002, 301–796–4714, Michelle.Eby@ Director of the U.S. Patent and Submissions’’ and ‘‘Instructions’’).
fda.hhs.gov. Trademark Office (USPTO), Department
of Commerce, for the extension of a Written/Paper Submissions
SUPPLEMENTARY INFORMATION: patent which claims that human drug Submit written/paper submissions as
In the Federal Register of October 31, product. follows:
2017 (82 FR 50429), FDA published a • Mail/Hand delivery/Courier (for
notice announcing a public workshop DATES: Anyone with knowledge that any
written/paper submissions): Dockets
entitled ‘‘Packaging, Storage, and of the dates as published (in the
Management Staff (HFA–305), Food and
Disposal Options to Enhance Opioid SUPPLEMENTARY INFORMATION section) are
Drug Administration, 5630 Fishers
Safety—Exploring the Path Forward,’’ incorrect may submit either electronic
Lane, Rm. 1061, Rockville, MD 20852.
which was held on December 11–12, or written comments and ask for a • For written/paper comments
2017. That notice requested comments redetermination by April 13, 2018. See submitted to the Dockets Management
on the role of packaging, storage, and ‘‘Petitions’’ in the SUPPLEMENTARY Staff, FDA will post your comment, as
disposal options within the larger INFORMATION section for more
well as any attachments, except for
landscape of activities aimed at information. information submitted, marked and
addressing abuse, misuse, or ADDRESSES: You may submit comments identified, as confidential, if submitted
inappropriate access of prescription as follows. Please note that late, as detailed in ‘‘Instructions.’’
opioid drug products (opioids); guiding untimely filed comments will not be Instructions: All submissions received
principles and considerations for the considered. Electronic comments must must include the Docket No. FDA–
daltland on DSKBBV9HB2PROD with NOTICES
design of packaging, storage, and be submitted on or before April 13, 2015–E–1685 for ’’Determination of
disposal options for opioids; integrating 2018. The https://www.regulations.gov Regulatory Review Period for Purposes
packaging, storage, and disposal options electronic filing system will accept of Patent Extension; DALVANCE.’’
into existing health care and pharmacy comments until midnight Eastern Time Received comments, those filed in a
systems, including both open and at the end of April 13, 2018. Comments timely manner (see ADDRESSES), will be
closed health care systems; data needs received by mail/hand delivery/courier placed in the docket and, except for
and how to address challenges in (for written/paper submissions) will be those submitted as ‘‘Confidential
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![Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 6033
Dated: February 7, 2018. Comments submitted electronically, second copy, which will have the
Leslie Kux, including attachments, to https:// claimed confidential information
Associate Commissioner for Policy. www.regulations.gov will be posted to redacted/blacked out, will be available
[FR Doc. 2018–02768 Filed 2–9–18; 8:45 am] the docket unchanged. Because your for public viewing and posted on
BILLING CODE 4164–01–P comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND confidential information that you or a contact information to be made publicly
HUMAN SERVICES third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
Food and Drug Administration anyone else’s Social Security number, or in the body of your comments and you
[Docket No. FDA–2015–E–2079] confidential business information, such must identify this information as
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Determination of Regulatory Review that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Period for Purposes of Patent information, or other information that except in accordance with § 10.20
Extension; BRAVECTO identifies you in the body of your (21 CFR 10.20) and other applicable
comments, that information will be disclosure law. For more information
AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. about FDA’s posting of comments to
HHS. • If you want to submit a comment public dockets, see 80 FR 56469,
ACTION: Notice. with confidential information that you September 18, 2015, or access the
do not wish to be made available to the information at: https://www.gpo.gov/
SUMMARY: The Food and Drug public, submit the comment as a
Administration (FDA or the Agency) has fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
determined the regulatory review period
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
for BRAVECTO and is publishing this
Submissions’’ and ‘‘Instructions’’). read background documents or the
notice of that determination as required
by law. FDA has made the Written/Paper Submissions electronic and written/paper comments
determination because of the received, go to https://
Submit written/paper submissions as
submission of an application to the www.regulations.gov and insert the
follows:
docket number, found in brackets in the
Director of U.S. Patent and Trademark • Mail/Hand delivery/Courier (for
Office (USPTO), Department of heading of this document, into the
written/paper submissions): Dockets
Commerce, for the extension of a patent ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
which claims that animal drug product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any
Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (see the • For written/paper comments Rockville, MD 20852.
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration,
redetermination by April 13, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600.
regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION:
extension acted with due diligence must include the Docket No. FDA–
2015–E–2079 for ‘‘Determination of I. Background
during the regulatory review period by
August 13, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Patent Extension; BRAVECTO.’’ Patent Term Restoration Act of 1984
more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term
as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670)
untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be
considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years
be submitted on or before April 13, https://www.regulations.gov or at the so long as the patented item (human
2018. The https://www.regulations.gov Dockets Management Staff between drug product, animal drug product,
electronic filing system will accept 9 a.m. and 4 p.m., Monday through medical device, food additive, or color
comments until midnight Eastern Time Friday. additive) was subject to regulatory
at the end of April 13, 2018. Comments • Confidential Submissions—To review by FDA before the item was
received by mail/hand delivery/courier submit a comment with confidential marketed. Under these acts, a product’s
(for written/paper submissions) will be information that you do not wish to be regulatory review period forms the basis
considered timely if they are made publicly available, submit your for determining the amount of extension
postmarked or the delivery service comments only as a written/paper an applicant may receive.
acceptance receipt is on or before that submission. You should submit two A regulatory review period consists of
date. copies total. One copy will include the two periods of time: A testing phase and
daltland on DSKBBV9HB2PROD with NOTICES
information you claim to be confidential an approval phase. For animal drug
Electronic Submissions with a heading or cover note that states products, the testing phase begins on
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the earlier date when either a major
following way: CONFIDENTIAL INFORMATION.’’ The environmental effects test was initiated
• Federal eRulemaking Portal: Agency will review this copy, including for the drug or when an exemption
https://www.regulations.gov. Follow the the claimed confidential information, in under section 512(j) of the Federal Food,
instructions for submitting comments. its consideration of comments. The Drug, and Cosmetic Act (FD&C Act) (21
VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/83_FR_6060/page/3.svg)
Document Created: 2018-11-01 08:42:46
Document Modified: 2018-11-01 08:42:46
| 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 13, 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 6031 |
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