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Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices 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 September 7, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 7, 2021.
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.

ADDRESSES:

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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 elses 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 HFA305, 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
2019E5322 and FDA2019E5323
for Determination of Regulatory Review Period for Purposes of Patent Extension; PIQRAY. Received
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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, 2404027500.
Confidential SubmissionsTo 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 10.20 21
CFR 10.20 and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/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, 2404027500.
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, 3017963600.
SUPPLEMENTARY INFORMATION:
I. Background The Drug Price Competition and Patent Term Restoration Act of 1984

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Pub. L. 98417 and the Generic Animal Drug and Patent Term Restoration Act Pub. L. 100670
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 products 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, FDAs 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. 156g1B.
FDA has approved for marketing the human drug product, PIQRAY
alpelisib. PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptorpositive, human epidermal growth factor receptor 2-negative, PIK3CAmutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Subsequent to this approval, the USPTO received patent term restoration applications for PIQRAY U.S. Patent Nos. 8,277,462 and 8,476,268 from Novartis AG and the USPTO requested FDAs assistance in determining the patents eligibility for patent term restoration. In a letter dated December 23, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of PIQRAY
represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the products regulatory review period.

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