[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: 21CFR514.100]

[Page 79-80]
 
                        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.  514.100  Evaluation and comment on applications.

    (a) After the filed application has been evaluated, the applicant 
will be furnished written comment on any apparent deficiencies in the 
application.
    (b) When the description of the methods used in, and the facilities 
and controls used for, the manufacture, processing, and packing of such 
new animal drug appears adequate on its face, but it is not feasible to 
reach a conclusion as to the safety and effectiveness of the new animal 
drug solely from consideration of this description, the applicant may be 
notified that an establishment inspection is required to verify their 
adequacy.
    (c) A request for samples of a new animal drug or any edible tissues 
and byproducts of animals treated with such a drug, shall specify the 
quantity deemed adequate to permit tests of analytical methods to 
determine their adequacy for regulatory purposes. The request should be 
made as early in the 180-day period as possible to assure timely 
completion. The date used for computing the 180-day limit for the 
purposes of section 512(c) of the act shall be moved forward 1 day for 
each day after the mailing date of the request until all of the 
requested samples are received. If the samples are not received within 
90 days after the request, the application will be considered withdrawn 
without prejudice.
    (d) The information contained in an application may be insufficient 
to determine whether a new animal drug is safe or effective in use if it 
fails to include (among other things) a statement showing whether such 
drug is to be limited to prescription sale and exempt under section 
502(f) of the act from the requirement that its labeling bear adequate 
directions for lay use. If such drug is to be exempt, the information 
may also be insufficient if:
    (1) The specimen labeling proposed fails to bear adequate 
information for professional use including indications, effects, 
dosages, routes, methods, and frequency and duration of administration 
and any relevant hazards, contraindications, side effects, and 
precautions under which practitioners licensed by law to administer such 
drug can use the drug for the purposes for which it is intended, 
including all purposes for which it is to be advertised, or represented, 
in accordance with Sec.  201.105 of this chapter, and information 
concerning hazards, contraindications, side effects, and precautions 
relevant with respect to any uses for which such drug is to be 
prescribed.
    (2) The application fails to show that the labeling and advertising 
of such drug will offer the drug for use only under those conditions for 
which it is offered in the labeling that is part of the application.
    (3) The application fails to show that all labeling that furnishes 
or purports to furnish information for professional use of such drug 
will contain, in the same language and emphasis, the information for use 
including indications,

[[Page 80]]

effects, dosages, routes, methods, and frequency and duration of 
administration and any relevant warnings, hazards, contraindications, 
side effects, and precautions, which is contained in the labeling that 
is part of the application in accordance with Sec.  201.105 of this 
chapter.
    (e) The information contained in an application will be considered 
insufficient to determine whether a new animal drug is safe and 
effective for use when there is a refusal or failure upon written notice 
to furnish inspectors authorized by the Food and Drug Administration an 
adequate opportunity to inspect the facilities, controls, and records 
pertinent to the application.
    (f) On the basis of preliminary consideration of an application or 
supplemental application containing typewritten or other draft labeling 
in lieu of final printed labeling, an applicant may be informed that 
such application is approvable when satisfactory final printed labeling 
identical in content to such draft copy is submitted.
    (g) When an application has been found incomplete on the basis of a 
need for the kind of information described in Sec.  514.6, such 
application shall be considered withdrawn without prejudice to future 
filing on the date of issuance of the letter citing the inadequacies 
contained in the application, unless within 30 days the sponsor chooses 
to avail himself of the opportunity for hearing as prescribed by Sec.  
514.111.