[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: 21CFR514.110]

[Page 81-82]
 
                        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 B--Administrative Actions on Applications
 
Sec.  514.110  Reasons for refusing to file applications.

    (a) The date of receipt of an application for a new animal drug 
shall be the date on which the application shall be deemed to be filed.
    (b) An application for a new animal drug shall not be considered 
acceptable for filing for any of the following reasons:
    (1) It does not contain complete and accurate English translations 
of any pertinent part in a foreign language.
    (2) Fewer than three copies are submitted.
    (3) It is incomplete on its face in that it is not properly 
organized and indexed.
    (4) On its face the information concerning required matter is so 
inadequate that the application is clearly not approvable.
    (5) The new animal drug is to be manufactured, prepared, propagated, 
compounded, or processed in whole or in part in any State in an 
establishment that has not been registered or exempted from registration 
under the provisions of section 510 of the act.
    (6) The sponsor does not reside or maintain a place of business 
within the United States and the application has not been countersigned 
by an attorney, agent, or other representative of the applicant, which 
representative resides in the United States and has been duly authorized 
to act on behalf of the applicant and to receive communications on all 
matters pertaining to the application.
    (7) The new animal drug is a drug subject to licensing under the 
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 
U.S.C. 151 et seq.). Such applications will be referred to

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the U.S. Department of Agriculture for action.
    (8) It fails to include, with respect to each nonclinical laboratory 
study contained in the application, either a statement that the study 
was conducted in compliance with the good laboratory practice 
regulations set forth in part 58 of this chapter, or, if the study was 
not conducted in compliance with such regulations, a brief statement of 
the reasons for the noncompliance.
    (9) [Reserved]
    (10) The applicant fails to submit a complete environmental 
assessment under Sec.  25.40 of this chapter or fails to provide 
sufficient information to establish that the requested action is subject 
to categorical exclusion under Sec.  25.30 or Sec.  25.33 of this 
chapter.
    (c) If an application is determined not to be acceptable for filing, 
the applicant shall be notified within 30 days of receipt of the 
application and shall be given the reasons therefore.
    (d) If the applicant disputes the findings that his application is 
not acceptable for filing, he may make written request that the 
application be filed over protest, in which case it will be filed as of 
the day originally received.

[40 FR 13825, Mar. 27, l975, as amended at 50 FR 7517, Feb. 22, 1985; 50 
FR 16668, Apr. 26, 1985; 62 FR 40600, July 29, 1997]