83 FR 3737 - Determination of Regulatory Review Period for Purposes of Patent Extension; VRAYLAR
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 18 (January 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3737-3739 | |
| FR Document | 2018-01368 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Notices] [Pages 3737-3739] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01368] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-2443 and FDA-2016-E-2444] Determination of Regulatory Review Period for Purposes of Patent Extension; VRAYLAR 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 VRAYLAR 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. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by March 27, 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 25, 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 March 27, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 27, 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 [[Page 3738]] 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-2443 and FDA-2016-E-2444 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; VRAYLAR.'' 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 VRAYLAR (cariprazine). VRAYLAR is indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder. Subsequent to this approval, the USPTO received a patent term restoration application for VRAYLAR (U.S. Patent Nos. 7,737,142 and 7,943,621) from Forest Laboratories, LLC, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 7, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VRAYLAR 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 VRAYLAR is 3,742 days. Of this time, 2,709 days occurred during the testing phase of the regulatory review period, while 1,033 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: June 21, 2005. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on June 21, 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: November 19, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for VRAYLAR (NDA 204370) was initially submitted on November 19, 2012. 3. The date the application was approved: September 17, 2015. FDA has verified the applicant's claim that NDA 204370 was approved on September 17, 2015. [[Page 3739]] 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, this applicant seeks 905 or 275 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 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01368 Filed 1-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3737
and Clinical Pharmacology Advisory Commissioner or designee from among DEPARTMENT OF HEALTH AND
Committee by the Commissioner of authorities knowledgeable in the fields HUMAN SERVICES
Food and Drugs (the Commissioner). of pharmaceutical sciences
The Commissioner has determined that (pharmaceutical manufacturing, Food and Drug Administration
it is in the public interest to renew the bioequivalence research, laboratory [Docket Nos. FDA–2016–E–2443 and FDA–
Pharmaceutical Science and Clinical analytical techniques, pharmaceutical 2016–E–2444]
Pharmacology Advisory Committee for chemistry, physiochemistry,
an additional 2 years beyond the charter biochemistry, molecular biology, Determination of Regulatory Review
expiration date. The new charter will be immunology, microbiology) and clinical Period for Purposes of Patent
in effect until January 22, 2020. pharmacology (dose-response, Extension; VRAYLAR
DATES: Authority for the Pharmaceutical pharmacokinetics-pharmacodynamics,
Science and Clinical Pharmacology AGENCY: Food and Drug Administration,
modeling and simulation, HHS.
Advisory Committee will expire on pharmacogenomics, clinical trial design,
January 22, 2020, unless the ACTION: Notice.
pediatrics, and special populations and
Commissioner formally determines that innovative methods in drug
renewal is in the public interest. SUMMARY: The Food and Drug
development), biostatistics, related Administration (FDA or the Agency) has
FOR FURTHER INFORMATION CONTACT: Jay
biomedical and pharmacological determined the regulatory review period
Fajiculay, Division of Advisory specialties, current good manufacturing for VRAYLAR and is publishing this
Committee and Consultant
practices, and quality systems notice of that determination as required
Management, Center for Drug
implementation. Members will be by law. FDA has made the
Evaluation and Research, Food and
invited to serve for overlapping terms of determination because of the
Drug Administration, 10903 New
up to 4 years. Almost all non-Federal submission of applications to the
Hampshire Ave., Bldg. 31, Rm. 2417,
members of this committee serve as Director of the U.S. Patent and
Silver Spring, MD 20993–0002, 301–
Special Government Employees. The Trademark Office (USPTO), Department
796–9001, Fax: 301–847–8533, email:
core of voting members may include one of Commerce, for the extension of a
PSCP@fda.hhs.gov.
technically qualified member, selected patent which claims that human drug
SUPPLEMENTARY INFORMATION: Pursuant product.
to 41 CFR 102–3.65 and approval by the by the Commissioner or designee, who
Department of Health and Human is identified with consumer interests DATES: Anyone with knowledge that any
Services pursuant to 45 CFR part 11 and and is recommended by either a of the dates as published (see the
by the General Services Administration, consortium of consumer-oriented SUPPLEMENTARY INFORMATION section) are
FDA is announcing the renewal of the organizations or other interested incorrect may submit either electronic
Pharmaceutical Science and Clinical persons. In addition to the voting or written comments and ask for a
Pharmacology Advisory Committee (the members, the Committee may include redetermination by March 27, 2018.
Committee). The Committee is a up to three non-voting members who are Furthermore, any interested person may
discretionary Federal advisory identified with industry interests. petition FDA for a determination
committee established to provide advice regarding whether the applicant for
Further information regarding the extension acted with due diligence
to the Commissioner. The Committee most recent charter and other
advises the Commissioner or designee during the regulatory review period by
information can be found at https:// July 25, 2018. See ‘‘Petitions’’ in the
in discharging responsibilities as they
www.fda.gov/AdvisoryCommittees/ SUPPLEMENTARY INFORMATION section for
relate to helping to ensure safe and
CommitteesMeetingMaterials/Drugs/ more information.
effective drugs for human use and, as
AdvisoryCommitteeforPharmaceutical ADDRESSES: You may submit comments
required, any other product for which
FDA has regulatory responsibility. ScienceandClinicalPharmacology/ as follows. Please note that late,
The Committee reviews and evaluates default.htm or by contacting the untimely filed comments will not be
scientific, clinical, and technical issues Designated Federal Officer (see FOR considered. Electronic comments must
related to the safety and effectiveness of FURTHER INFORMATION CONTACT). In light be submitted on or before March 27,
drug products for use in the treatment of the fact that no change has been made 2018. The https://www.regulations.gov
of a broad spectrum of human diseases, to the committee name or description of electronic filing system will accept
the quality characteristics which such duties, no amendment will be made to comments until midnight Eastern Time
drugs purport or are represented to 21 CFR 14.100. at the end of March 27, 2018. Comments
have, and as required, any other product This document is issued under the received by mail/hand delivery/courier
for which FDA has regulatory Federal Advisory Committee Act (5 (for written/paper submissions) will be
responsibility, and makes appropriate U.S.C. app.). For general information considered timely if they are
recommendations to the Commissioner. related to FDA advisory committees, postmarked or the delivery service
The Committee may also review Agency please visit us at https://www.fda.gov/ acceptance receipt is on or before that
sponsored intramural and extramural AdvisoryCommittees/default.htm. date.
biomedical research programs in
Dated: January 19, 2018. Electronic Submissions
support of FDA’s drug regulatory
responsibilities and its critical path Leslie Kux, Submit electronic comments in the
initiatives related to improving the Associate Commissioner for Policy. following way:
daltland on DSKBBV9HB2PROD with NOTICES
efficacy and safety of drugs and [FR Doc. 2018–01377 Filed 1–25–18; 8:45 am]
• Federal eRulemaking Portal:
improving the efficiency of drug https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P
development. instructions for submitting comments.
The Committee shall consist of a core Comments submitted electronically,
of 14 voting members including two including attachments, to https://
Chairpersons. Members and www.regulations.gov will be posted to
Chairpersons are selected by the the docket unchanged. Because your
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![Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3739
This determination of the regulatory ACTION:Notice of availability; extension Management Staff (HFA–305), Food and
review period establishes the maximum of comment period. Drug Administration, 5630 Fishers
potential length of a patent extension. Lane, Rm. 1061, Rockville, MD 20852.
However, the USPTO applies several SUMMARY: The Food and Drug • For written/paper comments
statutory limitations in its calculations Administration (FDA or the Agency) is submitted to the Dockets Management
of the actual period for patent extension. extending the comment period for the Staff, FDA will post your comment, as
In its applications for patent extension, notice of availability that appeared in well as any attachments, except for
this applicant seeks 905 or 275 days of the Federal Register of November 29, information submitted, marked and
patent term extension. 2017. In the notice of availability, FDA identified, as confidential, if submitted
requested comments on draft guidance as detailed in ‘‘Instructions.’’
III. Petitions for industry and FDA staff entitled Instructions: All submissions received
Anyone with knowledge that any of ‘‘Select Updates for Recommendations must include the Docket No. FDA–
the dates as published are incorrect may for Clinical Laboratory Improvement 2017–D–5570 for ‘‘Select Updates for
submit either electronic or written Amendments of 1988 (CLIA) Waiver Recommendations for Clinical
comments and, under 21 CFR 60.24, ask Applications for Manufacturers of In Laboratory Improvement Amendments
for a redetermination (see DATES). Vitro Diagnostic Devices.’’ The Agency of 1988 (CLIA) Waiver Applications for
Furthermore, as specified in § 60.30 (21 is taking this action in response to a Manufacturers of In Vitro Diagnostic
CFR 60.30), any interested person may request for an extension to allow Devices; Draft Guidance for Industry
petition FDA for a determination interested persons additional time to and Food and Drug Administration
regarding whether the applicant for submit comments. Staff; Availability.’’ Received comments
extension acted with due diligence DATES: FDA is extending the comment will be placed in the docket and, except
during the regulatory review period. To period on the document published for those submitted as ‘‘Confidential
meet its burden, the petition must November 29, 2017 (82 FR 56607). Submissions,’’ publicly viewable at
comply with all the requirements of Submit either electronic or written https://www.regulations.gov or at the
§ 60.30, including but not limited to: comments on the draft guidance by Dockets Management Staff between 9
Must be timely (see DATES), must be March 30, 2018, to ensure that the a.m. and 4 p.m., Monday through
filed in accordance with § 10.20, must Agency considers your comment on this Friday.
draft guidance before it begins work on • Confidential Submissions—To
contain sufficient facts to merit an FDA
the final version of the guidance. submit a comment with confidential
investigation, and must certify that a
ADDRESSES: You may submit comments information that you do not wish to be
true and complete copy of the petition
on any guidance at any time as follows: made publicly available, submit your
has been served upon the patent
comments only as a written/paper
applicant. (See H. Rept. 857, part 1, 98th Electronic Submissions submission. You should submit two
Cong., 2d sess., pp. 41–42, 1984.) copies total. One copy will include the
Petitions should be in the format Submit electronic comments in the
following way: information you claim to be confidential
specified in 21 CFR 10.30.
• Federal eRulemaking Portal: with a heading or cover note that states
Submit petitions electronically to https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov at Docket instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
No. FDA–2013–S–0610. Submit written Comments submitted electronically, Agency will review this copy, including
petitions (two copies are required) to the including attachments, to https:// the claimed confidential information, in
Dockets Management Staff (HFA–305), www.regulations.gov will be posted to its consideration of comments. The
Food and Drug Administration, 5630 the docket unchanged. Because your second copy, which will have the
Fishers Lane, Rm. 1061, Rockville, MD comment will be made public, you are claimed confidential information
20852. solely responsible for ensuring that your redacted/blacked out, will be available
Dated: January 19, 2018. comment does not include any for public viewing and posted on
Leslie Kux, confidential information that you or a https://www.regulations.gov. Submit
Associate Commissioner for Policy. third party may not wish to be posted, both copies to the Dockets Management
[FR Doc. 2018–01368 Filed 1–25–18; 8:45 am] such as medical information, your or Staff. If you do not wish your name and
anyone else’s Social Security number, or contact information to be made publicly
BILLING CODE 4164–01–P
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not
DEPARTMENT OF HEALTH AND that if you include your name, contact in the body of your comments and you
HUMAN SERVICES information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
Food and Drug Administration comments, that information will be as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
[Docket No. FDA–2017–D–5570] • If you want to submit a comment and other applicable disclosure law. For
with confidential information that you more information about FDA’s posting
Select Updates for Recommendations do not wish to be made available to the of comments to public dockets, see 80
for Clinical Laboratory Improvement public, submit the comment as a FR 56469, September 18, 2015, or access
Amendments of 1988 Waiver written/paper submission and in the the information at: https://www.gpo.gov/
Applications for Manufacturers of In manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
daltland on DSKBBV9HB2PROD with NOTICES
Vitro Diagnostic Devices; Draft Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Guidance for Industry and Food and Docket: For access to the docket to
Written/Paper Submissions read background documents or the
Drug Administration Staff; Availability;
Extension of Comment Period Submit written/paper submissions as electronic and written/paper comments
follows: received, go to https://
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
HHS. written/paper submissions): Dockets docket number, found in brackets in the
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Document Created: 2018-10-26 10:05:55
Document Modified: 2018-10-26 10:05:55
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by March 27, 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 25, 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 3737 |
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