Source: https://www.federalregister.gov/documents/2001/03/23/01-7243/agency-information-collection-activities-proposed-collection-comment-request-patent-term-restoration
Timestamp: 2017-08-23 07:14:43
Document Index: 10031288

Matched Legal Cases: ['art 60', 'art 60', '§\u200960', '§\u200960', '§\u200960', '§\u200960', '§\u200960', '§\u200960', '§\u200960']

Submit written or electronic comments on the collection of information by May 22, 2001.
66 FR 16249
16249-16251 (3 pages)
Docket No. 01N-0114
01-7243
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions—Part 60 (21 CFR Part 60) (OMB Control No. 0910-0233)—Extension
https://www.federalregister.gov/d/01-7243 https://www.federalregister.gov/d/01-7243
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Start Printed Page 16250Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA’s patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with “due diligence.”
FDA’s patent extension activities are conducted under the authority of the Drug Price Competition and Patent Term Restoration Act of 1984 and the Animal Drug and Patent Term Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug, human biological, medical device, food additive, or color additive products regulated by FDA must undergo FDA safety, or safety and effectiveness, review before marketing is permitted. Where the product is covered by a patent, part of the patents’s term may be consumed during this review, which diminishes the value of the patent. In enacting 35 U.S.C. 156, Congress sought to encourage development of new, safer, and more effective medical and food additive products. It did so by authorizing the U.S. Patent Office (PTO) to extend the patent term by a portion of the time during which FDA’s safety and effectiveness review prevented marketing of the product. The length of the patent term extension is generally limited to a maximum of 5 years, and is calculated by PTO based on statutory formula. When a patent holder submits an application for patent term extension to PTO, PTO requests information from FDA, including the length of the regulatory review period for the patented product. If PTO concludes that the product is eligible for patent term extension, FDA publishes a notice that describes the length of the regulatory review period, and the dates used to calculate that period. Interested parties may request, under § 60.24, revision of the length of the regulatory review period, or may petition under § 60.30 to reduce the regulatory review period by any time where marketing approval was not pursued with “due diligence.” The statute defines due diligence as “that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.” As provided in § 60.30(c), a due diligence petition “shall set forth sufficient facts, including dates if possible, to merit an investigation by FDA of whether the applicant acted with due diligence.” Upon receipt of a due diligence petition, FDA reviews the petition and evaluates whether any change in the regulatory review period is necessary. If so, the corrected regulatory review period is published in the Federal Register. A due diligence petitioner not satisfied with FDA’s decision regarding the petition may, under § 60.40, request an informal hearing for reconsideration of the due diligence determination. Petitioners are likely to include persons or organizations having knowledge that FDA’s marketing permission for that product was not actively pursued throughout the regulatory review period. The information collection for which an extension of approval is being sought is the use of the statutorily created due diligence petition.
Since 1992, five requests for revision of the regulatory review period have been submitted under § 60.24. One regulatory review period has been altered. No due diligence petitions have been submitted to FDA under § 60.30, and consequently there have been no requests for hearings under § 60.40 regarding the decisions on such petitions.
60.30 0 0 0 0 0
Start Printed Page 16251
[FR Doc. 01-7243 Filed 3-22-01; 8:45 am]