[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.108]

[Page 145-146]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
   Subpart D--FDA Action on Applications and Abbreviated Applications
 
Sec. 314.108  New drug product exclusivity.

    (a) Definitions. The following definitions of terms apply to this 
section:
    Active moiety means the molecule or ion, excluding those appended 
portions of the molecule that cause the drug to be an ester, salt 
(including a salt with hydrogen or coordination bonds), or other 
noncovalent derivative (such as a complex, chelate, or clathrate) of the 
molecule, responsible for the physiological or pharmacological action of 
the drug substance.
    Approved under section 505(b) means an application submitted under 
section 505(b) and approved on or after October 10, 1962, or an 
application that was ``deemed approved'' under section 107(c)(2) of Pub. 
L. 87-781.
    Clinical investigation means any experiment other than a 
bioavailability study in which a drug is administered or dispensed to, 
or used on, human subjects.
    Conducted or sponsored by the applicant with regard to an 
investigation means that before or during the investigation, the 
applicant was named in Form FDA-1571 filed with FDA as the sponsor of 
the investigational new drug application under which the investigation 
was conducted, or the applicant or the applicant's predecessor in 
interest, provided substantial support for the investigation. To 
demonstrate ``substantial support,'' an applicant must either provide a 
certified statement from a certified public accountant that the 
applicant provided 50 percent or more of the cost of conducting the 
study or provide an explanation why FDA should consider the applicant to 
have conducted or sponsored the study if the applicant's financial 
contribution to the study is less than 50 percent or the applicant did 
not sponsor the investigational new drug. A predecessor in interest is 
an entity, e.g., a corporation, that the applicant has taken over, 
merged with, or purchased, or from which the applicant has purchased all 
rights to the drug. Purchase of nonexclusive rights to a clinical 
investigation after it is completed is not sufficient to satisfy this 
definition.
    Date of approval means the date on the letter from FDA stating that 
the new drug application is approved, whether or not final printed 
labeling or other materials must yet be submitted as long as approval of 
such labeling or materials is not expressly required. ``Date of 
approval'' refers only to a final approval and not to a tentative 
approval that may become effective at a later date.
    Essential to approval means, with regard to an investigation, that 
there are no other data available that could support approval of the 
application.
    FDA means the Food and Drug Administration.
    New chemical entity means a drug that contains no active moiety that 
has been approved by FDA in any other application submitted under 
section 505(b) of the act.

[[Page 146]]

    New clinical investigation means an investigation in humans the 
results of which have not been relied on by FDA to demonstrate 
substantial evidence of effectiveness of a previously approved drug 
product for any indication or of safety for a new patient population and 
do not duplicate the results of another investigation that was relied on 
by the agency to demonstrate the effectiveness or safety in a new 
patient population of a previously approved drug product. For purposes 
of this section, data from a clinical investigation previously submitted 
for use in the comprehensive evaluation of the safety of a drug product 
but not to support the effectiveness of the drug product would be 
considered new.
    (b) Submission of and effective date of approval of an abbreviated 
new drug application submitted under section 505(j) of the act or a 
505(b)(2) application. (1) [Reserved]
    (2) If a drug product that contains a new chemical entity was 
approved after September 24, 1984, in an application submitted under 
section 505(b) of the act, no person may submit a 505(b)(2) application 
or abbreviated new drug application under section 505(j) of the act for 
a drug product that contains the same active moiety as in the new 
chemical entity for a period of 5 years from the date of approval of the 
first approved new drug application, except that the 505(b)(2) 
application or abbreviated application may be submitted after 4 years if 
it contains a certification of patent invalidity or noninfringement 
described in Sec. 314.50(i)(1)(i)(A)(4) or Sec. 314.94(a)(12)(i)(A)(4).
    (3) The approval of a 505(b)(2) application or abbreviated 
application described in paragraph (b)(2) of this section will become 
effective as provided in Sec. 314.107(b)(1) or (b)(2), unless the owner 
of a patent that claims the drug, the patent owner's representative, or 
exclusive licensee brings suit for patent infringement against the 
applicant during the 1-year period beginning 48 months after the date of 
approval of the new drug application for the new chemical entity and 
within 45 days after receipt of the notice described at Sec. 314.52 or 
Sec. 314.95, in which case, approval of the 505(b)(2) application or 
abbreviated application will be made effective as provided in 
Sec. 314.107(b)(3).
    (4) If an application:
    (i) Was submitted under section 505(b) of the act;
    (ii) Was approved after September 24, 1984;
    (iii) Was for a drug product that contains an active moiety that has 
been previously approved in another application under section 505(b) of 
the act; and
    (iv) Contained reports of new clinical investigations (other than 
bioavailability studies) conducted or sponsored by the applicant that 
were essential to approval of the application, the agency will not make 
effective for a period of 3 years after the date of approval of the 
application the approval of a 505(b)(2) application or an abbreviated 
new drug application for the conditions of approval of the original 
application, or an abbreviated new drug application submitted pursuant 
to an approved petition under section 505(j)(2)(C) of the act that 
relies on the information supporting the conditions of approval of an 
original new drug application.
    (5) If a supplemental application:
    (i) Was approved after September 24, 1984; and
    (ii) Contained reports of new clinical investigations (other than 
bioavailability studies) that were conducted or sponsored by the 
applicant that were essential to approval of the supplemental 
application, the agency will not make effective for a period of 3 years 
after the date of approval of the supplemental application the approval 
of a 505(b)(2) application or an abbreviated new drug application for a 
change, or an abbreviated new drug application submitted pursuant to an 
approved petition under section 505(j)(2)(C) of the act that relies on 
the information supporting a change approved in the supplemental new 
drug application.

[59 FR 50368, Oct. 3, 1994]