[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR3.8]

[Page 24-25]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 3--PRODUCT JURISDICTION--Table of Contents
 
   Subpart A--Assignment of Agency Component for Review of Premarket 
                              Applications
 
Sec. 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

[[Page 25]]

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 
Sec. 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.