[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR514.15]

[Page 73]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  514.15  Untrue statements in applications.

    Among the reasons why an application for a new animal drug or animal 
feed bearing or containing a new animal drug may contain an untrue 
statement of a material fact are:
    (a) Differences in:
    (1) Conditions of use prescribed, recommended, or suggested by the 
applicant for the product from the conditions of such use stated in the 
application;
    (2) Articles used as components of the product from those listed in 
the application;
    (3) Composition of the product from that stated in the application;
    (4) Methods used in or the facilities and controls used for the 
manufacture, processing, or packing of the product from such methods, 
facilities, and controls described in the application;
    (5) Labeling from the specimens contained in the application; or
    (b) The unexplained omission in whole or in part from an application 
or from an amendment or supplement to an application or from any record 
or report required under the provisions of section 512 of the act and 
Sec.  510.300 or Sec.  510.301 of this chapter of any information 
obtained from:
    (1) Investigations as to the safety, effectiveness, identity, 
strength, quality, or purity of the drug, made by the applicant on the 
drug, or
    (2) Investigations or experience with the product that is the 
subject of the application, or any related product, available to the 
applicant from any source if such information is pertinent to an 
evaluation of the safety, effectiveness, identity, strength, quality, or 
purity of the drug, when such omission would bias an evaluation of the 
safety or effectiveness of the product.
    (c) Any nonclinical laboratory study contained in the application 
was not conducted in compliance with the good laboratory practice 
regulations as set forth in part 58 of this chapter, and the application 
fails to include a brief statement of the reason for the noncompliance.

[40 FR 13825, Mar. 27, 1975, as amended at 49 FR 7226, Feb. 28, 1984; 50 
FR 7517, Feb. 22, 1985]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.15 was 
amended in paragraph (b) by removing ``Sec.  510.300'' and adding in its 
place ``Sec.  514.80'', effective June 30, 2003.