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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices 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:

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I. Background The Drug Price Competition and Patent Term Restoration Act of 1984
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 or biologic 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 SPINRAZA
nusinersen sodium. SPINRAZA is indicated for the treatment of spinal muscular atrophy in pediatric and adult patients. Subsequent to this approval, the USPTO received patent term restoration applications for SPINRAZA
U.S. Patent Nos. 7,838,657 and 8,110,560 from University of Massachusetts, and U.S. Patent Nos.
8,361,977 and 8,980,853 from Biogen
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MA Inc., and Cold Spring Harbor Laboratory, and the USPTO requested FDAs assistance in determining the patents eligibility for patent term restoration. In a letter dated February 8, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SPINRAZA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the products regulatory review period.
II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for SPINRAZA is 1,891 days. Of this time, 1,799 days occurred during the testing phase of the regulatory review period, while 92 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505i of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C.
355i became effective: October 22, 2011. FDA has verified the applicants claims that the date the investigational new drug application became effective was on October 22, 2011.
2. The date the application was initially submitted with respect to the human drug product under section 505
of the FD&C Act: September 23, 2016.
FDA has verified the applicants claims that the new drug application NDA for SPINRAZA NDA 209531 was initially submitted on September 23, 2016.
3. The date the application was approved: December 23, 2016. FDA has verified the applicants claims that NDA
209531 was approved on December 23, 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, these applicants seek 29 days, 210 days, 937 days, or 992 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 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
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comply with all the requirements of 60.30, including but not limited to:
Must be timely see DATES, must be filed in accordance with 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. 4142, 1984.
Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https www.regulations.gov at Docket No. FDA2013S0610. Submit written petitions two copies are required to the Dockets Management Staff HFA305, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 26, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202123719 Filed 102921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021D1031

Reporting Amount of Listed Drugs and Biological Products Under Section 510j3 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice of availability.

The Food and Drug Administration FDA or Agency is announcing the availability of a draft guidance for industry entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510j3 of the FD&C Act. This draft guidance addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Federal Food, Drug, and Cosmetic Act FD&C Act.
DATES: Submit either electronic or written comments on the draft guidance by January 3, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as follows:
SUMMARY:

E:FRFM01NON1.SGM

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