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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter APart 3Subpart A → §3.8

Title 21: Food and Drugs
Subpart A—Assignment of Agency Component for Review of Premarket Applications

§3.8   Letter of designation.

(a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request for designation determined to be incomplete will be returned to the applicant with a request for the missing information. The sponsor of an accepted request for designation will be notified of the filing date.

(b) Within 60 days of the filing date of a request for designation, the product jurisdiction officer will issue a letter of designation to the sponsor, with copies to the centers, specifying the agency component designated to have primary jurisdiction for the premarket review and regulation of the product at issue, and any consulting agency components. The product jurisdiction officer may request a meeting with the sponsor during the review period to discuss the request for designation. If the product jurisdiction officer has not issued a letter of designation within 60 days of the filing date of a request for designation, the sponsor's recommendation of the center with primary jurisdiction, in accordance with §3.7(c)(3), shall become the designated agency component.

(c) Request for reconsideration by sponsor: If the sponsor disagrees with the designation, it may request the product jurisdiction officer to reconsider the decision by filing, within 15 days of receipt of the letter of designation, a written request for reconsideration not exceeding 5 pages. No new information may be included in a request for reconsideration. The product jurisdiction officer shall review and act on the request in writing within 15 days of its receipt.

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