Grant of Interim Extension of the Term of U.S. Patent No. 7,517,522; Recombinant ADAMTS13 (rADAMTS13), a Recombinant A Disintegrin and Metalloprotease With Thrombospondin Type-1 Motifs 13, 41932 [2023-13707]

Download as PDF 41932 Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices of Commerce shall promulgate regulations, as necessary and appropriate, to implement measures adopted by the International Commission for the Conservation of Atlantic Tunas (ICCAT). II. Method of Collection First-time VMS respondents must install a VMS unit and submit an activation checklist to NMFS via mail. Hail-out, hail-in, hourly position reports, and bluefin tuna catch reports must be submitted to NMFS electronically via the VMS communication system. First-time electronic monitoring respondents must have an electronic monitoring system installed by a NMFS contractor. Except when the hard drive is at capacity after one trip or otherwise stated by NMFS in writing, electronic monitoring data must be submitted after every other pelagic longline trip by mailing computer hard drives to the designated NMFS contractor. III. Data OMB Control Number: 0648–0372. Form Number(s): None. Type of Review: Regular submission (extension of a current information collection). Affected Public: Business or other forprofit organizations. Estimated Number of Respondents: 154. Estimated Time Per Response: 4 hours for initial VMS installation; 5 minutes per VMS initial activation checklist; 2 minutes per hail-out/hail-in declaration; 6 hours for initial electronic monitoring installation; 1 hour for camera boom installation; 5 minutes for pelagic longline bluefin tuna catch records; 1 minute for dockside review of bluefin tuna catch records; 1 hour for electronic monitoring data retrieval. Estimated Total Annual Burden Hours: 3,305 hours. Estimated Total Annual Cost to Public: $238,862. Respondent’s Obligation: Mandatory. Legal Authority: Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.), and the Atlantic Tunas Convention Act of 1975 (16 U.S.C. 971 et seq.). ddrumheller on DSK120RN23PROD with NOTICES1 IV. Request for Comments We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, VerDate Sep<11>2014 18:48 Jun 27, 2023 Jkt 259001 including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology. Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Sheleen Dumas, Department PRA Clearance Officer, Office of the Under Secretary for Economic Affairs, Commerce Department. [FR Doc. 2023–13752 Filed 6–27–23; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2023–0033] Grant of Interim Extension of the Term of U.S. Patent No. 7,517,522; Recombinant ADAMTS13 (rADAMTS13), a Recombinant A Disintegrin and Metalloprotease With Thrombospondin Type-1 Motifs 13 United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: The United States Patent and Trademark Office has issued an order granting a one-year interim extension of the term of U.S. Patent No. 7,517,522 (’522 patent). FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, Office of Patent Legal Administration, at 571– 272–0909 or ali.salimi@uspto.gov. SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 SUMMARY: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period is reasonably expected to extend beyond the expiration date of the patent. On June 15, 2023, The Regents of the University of Michigan, the owner of record of the ’522 patent, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of the ’522 patent. The ’522 patent claims a method of using the product recombinant ADAMTS13 (rADAMTS13), a recombinant A disintegrin and metalloprotease with thrombospondin type-1 motifs 13. The application for interim patent term extension indicates that a Biologics License Application No. 125795/0 was submitted to the Food and Drug Administration (FDA) on March 17, 2023, and that the FDA’s review thereof is ongoing. Review of the interim patent term extension application indicates that, except for permission to market or use the product commercially, the ’522 patent would be eligible for an extension of the patent term under 35 U.S.C. 156. Because it appears the approval phase of the regulatory review period will continue beyond the expiration date of the patent, i.e., June 30, 2023, interim extension of the ’522 patent’s term under 35 U.S.C. 156(d)(5) is appropriate. An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,517,522 is granted for a period of one year from the original expiration date of the ’522 patent. Robert Bahr, Deputy Commissioner for Patents, United States Patent and Trademark Office. [FR Doc. 2023–13707 Filed 6–27–23; 8:45 am] BILLING CODE 3510–16–P COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities: Notice of Intent to Extend Collection; 3038–0097; Process for Review of Swaps for Mandatory Clearing Commodity Futures Trading Commission. ACTION: Notice. AGENCY: The Commodity Futures Trading Commission (‘‘Commission’’ or ‘‘CFTC’’) is announcing an opportunity for public comment on the proposed renewal of a collection of certain SUMMARY: E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Page 41932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13707]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2023-0033]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,517,522; Recombinant ADAMTS13 (rADAMTS13), a Recombinant A 
Disintegrin and Metalloprotease With Thrombospondin Type-1 Motifs 13

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of interim patent term extension.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office has issued an 
order granting a one-year interim extension of the term of U.S. Patent 
No. 7,517,522 ('522 patent).

FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-0909 or 
[email protected].

SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the 
term of a patent may be extended for a period of up to five years, if 
the patent claims a product, or a method of making or using a product, 
that has been subject to certain defined regulatory review. 35 U.S.C. 
156(d)(5) generally provides that the term of such a patent may be 
extended for no more than five interim periods of up to one year each, 
if the approval phase of the regulatory review period is reasonably 
expected to extend beyond the expiration date of the patent.
    On June 15, 2023, The Regents of the University of Michigan, the 
owner of record of the '522 patent, timely filed an application under 
35 U.S.C. 156(d)(5) for an interim extension of the term of the '522 
patent. The '522 patent claims a method of using the product 
recombinant ADAMTS13 (rADAMTS13), a recombinant A disintegrin and 
metalloprotease with thrombospondin type-1 motifs 13. The application 
for interim patent term extension indicates that a Biologics License 
Application No. 125795/0 was submitted to the Food and Drug 
Administration (FDA) on March 17, 2023, and that the FDA's review 
thereof is ongoing.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the '522 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it appears the approval phase of the 
regulatory review period will continue beyond the expiration date of 
the patent, i.e., June 30, 2023, interim extension of the '522 patent's 
term under 35 U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 7,517,522 is granted for a period of one year from the 
original expiration date of the '522 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2023-13707 Filed 6-27-23; 8:45 am]
BILLING CODE 3510-16-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.