[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: 21CFR3.7]
[Page 58-59]
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. 3.7 Request for designation.
(a) Who should file: the sponsor of:
(1) Any combination product the sponsor believes is not covered by
an intercenter agreement; or
(2) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation
before filing any application for premarket review, whether an
application for marketing approval or a required investigational notice.
Sponsors are encouraged to file a request for designation as soon as
there is sufficient information for the agency to make a determination.
(c) What to file: an original and two copies of the request for
designation must be filed. The request for designation must not exceed
15 pages, including attachments, and must set forth:
(1) The identity of the sponsor, including company name and address,
establishment registration number, company contact person and telephone
number.
(2) A description of the product, including:
(i) Classification, name of the product and all component products,
if applicable;
(ii) Common, generic, or usual name of the product and all component
products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has
received premarket approval, is marketed as not being subject to
premarket approval, or has received an investigational exemption, the
identity of the sponsors, and the status of any discussions or
agreements between the sponsors regarding the use of this product as a
component of a new combination product.
(v) Chemical, physical, or biological composition;
(vi) Status and brief reports of the results of developmental work,
including animal testing;
(vii) Description of the manufacturing processes, including the
sources of all components;
(viii) Proposed use or indications;
(ix) Description of all known modes of action, the sponsor's
identification of the single mode of action that provides the most
important therapeutic action of the product, and the basis for that
determination.
(x) Schedule and duration of use;
(xi) Dose and route of administration of drug or biologic;
(xii) Description of related products, including the regulatory
status of those related products; and
(xiii) Any other relevant information.
(3) The sponsor's recommendation as to which agency component should
have primary jurisdiction based on the mode of action that provides the
most important therapeutic action of the combination product. If the
sponsor cannot determine with reasonable certainty which mode of action
provides the most important therapeutic action of the combination
product, the sponsor's recommendation must be based on the assignment
algorithm set forth in Sec. 3.4(b) and an assessment of the assignment
of other combination products the sponsor wishes FDA to consider during
the assignment of its combination product.
(d) Where to file: all communications pursuant to this subpart shall
be addressed to the attention of the product jurisdiction officer. Such
a request, in its mailing cover should be plainly marked ``Request for
Designation.'' Concurrent submissions of electronic
[[Page 59]]
copies of Requests for Designation may be addressed to
combination@fda.gov.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003;
70 FR 49861, Aug. 25, 2005]
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