Source: https://www.federalregister.gov/documents/2004/05/19/04-11252/agency-information-collection-activities-proposed-collection-comment-request-patent-term-restoration
Timestamp: 2018-04-25 07:57:04
Document Index: 727169116

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

Submit written or electronic comments on the collection of information by July 19, 2004.
69 FR 28929
28929-28930 (2 pages)
Docket No. 2004N-0204
04-11252
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions (21 CFR Part 60)—(OMB Control Number 0910-0233—Extension)
https://www.federalregister.gov/d/04-11252 https://www.federalregister.gov/d/04-11252
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 Paperwork 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 Patent and Trademark Office (PTO) may add a portion of FDA's 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 drugs, animal drugs, 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 patent'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 Start Printed Page 28930additive products. It did so by authorizing 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 a statutory formula. When a patent holder submits an application for patent term extension to PTO, that agency 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 document in the Federal Register, which describes the length of the regulatory review period, and the dates used to calculate that period. Interested parties may request, under § 60.24 (21 CFR 60.24), revision of the length of the regulatory review period, or may petition under § 60.30 (21 CFR 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 (21 CFR 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, seven requests for revision of the regulatory review period have been submitted under § 60.24. Three regulatory review periods have been altered. Two due diligence petitions have been submitted to FDA under § 60.30. There have been no requests for hearings under § 60.40 regarding the decisions on such petitions.
60.24(a) 7 1 7 100 700
60.30 2 0 2 50 100
60.40 0 0 0 0 0
[FR Doc. 04-11252 Filed 5-18-04; 8:45 am]