[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR3.9]
[Page 59]
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. 3.9 Effect of letter of designation.
(a) The letter of designation constitutes an agency determination
that is subject to change only as provided in paragraph (b) of this
section.
(b) The product jurisdiction officer may change the designated
agency component with the written consent of the sponsor, or without its
consent to protect the public health or for other compelling reasons. A
sponsor shall be given 30 days written notice of any proposed
nonconsensual change in designated agency component. The sponsor may
request an additional 30 days to submit written objections, not to
exceed 15 pages, to the proposed change, and shall be granted, upon
request, a timely meeting with the product jurisdiction officer and
appropriate center officials. Within 30 days of receipt of the sponsor's
written objections, the product jurisdiction officer shall issue to the
sponsor, with copies to appropriate center officials, a written
determination setting forth a statement of reasons for the proposed
change in designated agency component. A nonconsensual change in the
designated agency component requires the concurrence of the Principal
Associate Commissioner.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]
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