83 FR 53481 - Determination of Regulatory Review Period for Purposes of Patent Extension; NUPLAZID
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 205 (October 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 205 (October 23, 2018)
| Page Range | 53481-53483 | |
| FR Document | 2018-23057 |
[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)] [Notices] [Pages 53481-53483] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23057] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-E-3617, FDA-2017-E-3619, and FDA-2017-E-3618] Determination of Regulatory Review Period for Purposes of Patent Extension; NUPLAZID 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 NUPLAZID 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 December 24, 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 April 22, 2019. 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 December 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 24, 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''). [[Page 53482]] 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-2017-E-3617, FDA-2017-E-3619, and FDA-2017-E-3618 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; NUPLAZID.'' 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, NUPLAZID (pimavanserin tartrate). NUPLAZID is indicated for treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Subsequent to this approval, the USPTO received patent term restoration applications for NUPLAZID (U.S. Patent Nos. 7,601,740; 7,659,285; and 7,732,615) from ACADIA Pharmaceuticals Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 20, 2017, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of NUPLAZID 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 NUPLAZID is 4,557 days. Of this time, 4,315 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: November 9, 2003. FDA has verified the applicant's claim that the date the investigational new drug application became effective was November 9, 2003. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 1, 2015. FDA has verified the applicant's claim that the new drug application (NDA) for NUPLAZID (NDA 207-318) was initially submitted on September 1, 2015. 3. The date the application was approved: April 29, 2016. FDA has verified the applicant's claim that NDA 207-318 was approved on April 29, 2016. 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 1,197 days, 1,256 days, or 1,316 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 [[Page 53483]] 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: October 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23057 Filed 10-22-18; 8:45 am] BILLING CODE 4164-01-P
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FDA estimates that the confirmation to be for products subject to the Director of the U.S. Patent and
or updating of establishment registration deeming compliance period. Trademark Office (USPTO), Department
and product listing information as Based on FDA’s experience and the of Commerce, for the extension of a
required by section 905 of the FD&C Act actual number of product ingredient patent which claims that human drug
will take 10 minutes annually per listings submitted over the past 3 years, product.
confirmation or update per FDA estimates that 35 establishments
establishment. Based on FDA’s will each submit two reports (one every DATES: Anyone with knowledge that any
experience with current establishment 6 months). FDA also estimates that the of the dates as published (see the
registration and product listings confirmation or updating of product SUPPLEMENTARY INFORMATION section) are
submitted to the Agency, the Agency (ingredient) listing information required incorrect may submit either electronic
estimates that on average 3,578 by section 904(c) of the FD&C Act is or written comments and ask for a
establishments will each submit one expected to take 0.40 hour (24 minutes) redetermination by December 24, 2018.
confirmation or updated report each and will take 48 minutes annually for Furthermore, any interested person may
year, which is expected to take 0.16 two confirmations or updates per petition FDA for a determination
hour (10 minutes) for a total 572 burden establishment, for a total 28 burden regarding whether the applicant for
hours. hours. FDA estimates that obtaining a extension acted with due diligence
FDA estimates that we have received DUNS (data universal numbering during the regulatory review period by
most tobacco product ingredient system) number will take 30 minutes. April 22, 2019. See ‘‘Petitions’’ in the
submissions for large manufacturers of FDA assumes that all new establishment SUPPLEMENTARY INFORMATION section for
deemed products. Small manufacturers’ facilities that will be required to more information.
deadline for ingredient submissions is initially register under section 905 of
ADDRESSES: You may submit comments
November 2018. This is based on the the FD&C Act would obtain a DUNS
number. FDA estimates that up to 100 as follows. Please note that late,
counts we have to date (July 2018), untimely filed comments will not be
including statutorily regulated products establishments that would need to
obtain this number each year. The total considered. Electronic comments must
(based on information in our tracking be submitted on or before December 24,
system). industry burden to obtain a DUNS
number is 50 hours. 2018. The https://www.regulations.gov
FDA estimates that the submission of electronic filing system will accept
FDA estimates the total burden for
ingredient listings required by section comments until 11:59 p.m. Eastern Time
this collection to be 830 hours. We have
904(a)(1) of the FD&C Act for each at the end of December 24, 2018.
adjusted our burden estimate, which has
establishment will take 2 hours initially. Comments received by mail/hand
resulted in a decrease of 93,086 hours to
Because this burden estimate covers a delivery/courier (for written/paper
the currently approved burden. Based
timeframe of 3 years, we anticipate submissions) will be considered timely
on data we reviewed from the past 3
almost all section 904(a)(1) tobacco if they are postmarked or the delivery
years and projecting the number of
ingredient submissions to have been service acceptance receipt is on or
remaining establishments that have not
received before the expiration of the before that date.
registered and submitted product
current approval (prior to 11/8/2018 for
ingredient listings, we revised the Electronic Submissions
small manufacturers and large
number of respondents and burden
manufacturers, 5/8/18). We are Submit electronic comments in the
hours in this information collection.
estimating approximately 30 following way:
manufacturers may miss their deadline. Dated: October 17, 2018.
This is based on estimates of how many Leslie Kux, • Federal eRulemaking Portal:
large manufacturers we are aware of that Associate Commissioner for Policy. https://www.regulations.gov. Follow the
have missed their deadline. Because this [FR Doc. 2018–23056 Filed 10–22–18; 8:45 am] instructions for submitting comments.
burden estimate covers 3 years, we are BILLING CODE 4164–01–P
Comments submitted electronically,
dividing by 3, to yield 10 respondents including attachments, to https://
as a yearly average for this estimate. www.regulations.gov will be posted to
Therefore, FDA estimates that 10 DEPARTMENT OF HEALTH AND the docket unchanged. Because your
establishments will initially submit one HUMAN SERVICES comment will be made public, you are
report annually at 2 hours per report, for solely responsible for ensuring that your
a total of 20 hours. Food and Drug Administration comment does not include any
Submissions under 904(c) of the [Docket Nos. FDA–2017–E–3617, FDA– confidential information that you or a
FD&C Act are for any new product that 2017–E–3619, and FDA–2017–E–3618] third party may not wish to be posted,
is not yet on the market (e.g., if on the such as medical information, your or
market due to deeming compliance Determination of Regulatory Review anyone else’s Social Security number, or
period), newly deemed product Period for Purposes of Patent confidential business information, such
manufacturers should have submitted Extension; NUPLAZID as a manufacturing process. Please note
under section 904(a)(1) of the FD&C Act. that if you include your name, contact
AGENCY: Food and Drug Administration, information, or other information that
This includes any statutorily regulated HHS.
product that would receive a marketing identifies you in the body of your
ACTION: Notice. comments, that information will be
authorization and any new deemed
product not subject to the deeming SUMMARY: The Food and Drug posted on https://www.regulations.gov.
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compliance period. For deemed product Administration (FDA or the Agency) has • If you want to submit a comment
categories, while we anticipate receiving determined the regulatory review period with confidential information that you
a large number of premarket for NUPLAZID and is publishing this do not wish to be made available to the
applications, there is a portion of these notice of that determination as required public, submit the comment as a
applicants who will have reported their by law. FDA has made the written/paper submission and in the
ingredients under section 904(a)(1) as determination because of the manner detailed (see ‘‘Written/Paper
most of these submissions are expected submission of applications to the Submissions’’ and ‘‘Instructions’’).
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regarding whether the applicant for planning to achieve these goals through Therefore, there is a need for a better
extension acted with due diligence increased interactive engagement with understanding of premarket testing
during the regulatory review period. To manufacturers of OCT devices. FDA expectations for OCT devices and
meet its burden, the petition must intends to use the voluntary OCT 510(k) dialogue between FDA and OCT
comply with all the requirements of Pilot Program to assess whether the manufacturers in order to reduce the
§ 60.30, including but not limited to: individual testing recommendations need for additional data requests during
Must be timely (see DATES), must be provided through the pre-submission the 510(k) submission review.
filed in accordance with § 10.20, must process and increased interactive
engagement improve the premarket II. Description of the Voluntary OCT
contain sufficient facts to merit an FDA
review process and reduce the overall 510(k) Pilot Program
investigation, and must certify that a
true and complete copy of the petition total time to decision (TTD), a shared FDA intends to achieve the goals of
has been served upon the patent FDA-industry commitment goal, in the voluntary OCT 510(k) Pilot Program,
applicant. (See H. Rept. 857, part 1, 98th support of the Medical Device User Fee that are described in Section III, by: (1)
Cong., 2d sess., pp. 41–42, 1984.) Amendments of 2017. Communicating and obtaining feedback
Petitions should be in the format DATES: FDA is seeking participation in related to individual recommendations
specified in 21 CFR 10.30. the voluntary OCT 510(k) Pilot Program regarding non-clinical and clinical
Submit petitions electronically to beginning October 23, 2018. See the evaluation of OCT devices; and (2)
https://www.regulations.gov at Docket ‘‘Voluntary OCT 510(k) Pilot Program facilitating discussion between FDA and
No. FDA–2013–S–0610. Submit written Procedures’’ section for instructions on individual OCT device manufacturers
petitions (two copies are required) to the how to submit a request to participate. regarding these risk-based testing
Dockets Management Staff (HFA–305), The voluntary OCT 510(k) Pilot Program recommendations. Specifically,
Food and Drug Administration, 5630 will select the first nine eligible participants in the voluntary OCT
Fishers Lane, Rm. 1061, Rockville, MD participants. 510(k) Pilot Program will have the
20852. FOR FURTHER INFORMATION CONTACT: Brad
opportunity to discuss premarket
Dated: October 17, 2018. Cunningham, Center for Devices and performance testing recommendations
Leslie Kux, Radiological Health, Food and Drug for their OCT device in an interactive
Administration, 10903 New Hampshire format (by phone or in-person meeting)
Associate Commissioner for Policy.
Ave., Bldg. 66, Rm. 2430, Silver Spring, with the FDA review team, including
[FR Doc. 2018–23057 Filed 10–22–18; 8:45 am]
MD 20993, 301–796–6620, email: engineers, medical officers, and
BILLING CODE 4164–01–P managers. FDA will interactively
Bradley.Cunningham@fda.hhs.gov.
communicate and solicit feedback on its
SUPPLEMENTARY INFORMATION:
individual testing recommendations to
DEPARTMENT OF HEALTH AND I. Background yield a mutual, clear understanding of
HUMAN SERVICES the information necessary to
OCT devices are devices for viewing,
Food and Drug Administration imaging, measurement, and analysis of demonstrate substantial equivalence in
ocular structures and may be used to aid a 510(k) submission for the OCT device
[Docket No. FDA–2018–N–3623]
in the detection and management of and to streamline 510(k) submission and
various ocular diseases. These devices review.
Fostering Medical Innovation: Participation eligibility in this
Voluntary Pilot Program To Streamline are classified under 21 CFR 886.1570
and are assigned the product code OBO; voluntary OCT 510(k) Pilot Program is
Review of Premarket Notification determined based on the factors listed
(510(k)) Submissions for Ophthalmic they are Class II devices requiring
premarket notification (510(k)) prior to in Section IV. Due to resource
Optical Coherence Tomography constraints, we intend to limit this
Devices marketing. In their 510(k) submission,
for purposes of premarket clearance, voluntary pilot program to the first nine
AGENCY: Food and Drug Administration, manufacturers must demonstrate eligible participants.
HHS. substantial equivalence to a legally To evaluate success of the voluntary
ACTION: Notice. marketed predicate in terms of intended OCT 510(k) Pilot Program, we intend to
use, technological characteristics, and assess 510(k) TTD and feedback on the
SUMMARY: The Food and Drug performance. This is typically achieved pre-submission and 510(k) processes
Administration’s (FDA) Center for through evaluation of non-clinical and/ from participants in the pilot program.
Devices and Radiological Health, Office or clinical data, among other This voluntary pilot program is
of Device Evaluation recognizes that an information. limited to OCT devices, not already
efficient, risk-based approach to Currently, there are no FDA- cleared for marketing through 510(k),
regulating ophthalmic Optical recognized consensus standards or which could be classified under 21 CFR
Coherence Tomography (OCT) published guidance documents 886.1570.
technology will foster innovation available that describe performance III. Goals of the Voluntary OCT 510(k)
designed to improve ophthalmic testing recommendations for OCT Pilot Program
healthcare. To make premarket review devices. As such, 510(k) submissions,
of OCT devices more efficient, we are when initially submitted to FDA, often FDA has the following goals for the
announcing a new voluntary OCT do not include adequate testing to voluntary OCT 510(k) Pilot Program:
Premarket Notification (510(k)) Pilot support substantial equivalence. This is 1. Improve consistency and
khammond on DSK30JT082PROD with NOTICES
Program, designed to develop and refine evidenced by consistent requests for predictability of the 510(k) premarket
individual premarket testing additional information (including new review process for OCT devices.
recommendations for OCT devices data and analyses) across OCT 510(k) 2. Reduce TTD for OCT 510(k)
through the pre-submission process to submissions, which are unforeseen by submissions, noting that ‘‘FDA and
yield more consistent premarket manufacturers and may greatly applicants share the responsibility for
submissions and improve predictability contribute to an increase in TTD for an achieving this objective of reducing the
of the 510(k) review process. We are individual 510(k) submission. average Total Time to Decision, while
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Document Created: 2018-10-23 04:14:48
Document Modified: 2018-10-23 04:14:48
| 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 December 24, 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 April 22, 2019. 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 53481 |
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