[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: 21CFR514.200]

[Page 87-88]
 
                        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 C--Hearing Procedures
 
Sec.  514.200  Contents of notice of opportunity for a hearing.


    (a) The notice to the applicant of opportunity for a hearing on a 
proposal by the Commissioner to refuse to approve an application or to 
withdraw the approval of an application will specify the grounds upon 
which he proposes to issue his order. On request of the applicant, the 
Commissioner will explain the reasons for his action. The notice of 
opportunity for a hearing will be published in the Federal Register and 
will specify that the applicant has 30 days after issuance of the notice 
within which he is required to file a written appearance electing 
whether:

[[Page 88]]

    (1) To avail himself of the opportunity for a hearing; or
    (2) Not to avail himself of the opportunity for a hearing.
    (b) If the applicant fails to file a written appearance in answer to 
the notice of opportunity for hearing, his failure will be construed as 
an election not to avail himself of the opportunity for the hearing, and 
the Commissioner without further notice may enter a final order.
    (c) If the applicant elects to avail himself of the opportunity for 
a hearing, he is required to file a written appearance requesting the 
hearing within 30 days after the publication of the notice, giving the 
reason why the application should not be refused or should not be 
withdrawn, together with a well-organized and full-factual analysis of 
the clinical and other investigational data he is prepared to prove in 
support of his opposition to the Commissioner's proposal. A request for 
a hearing may not rest upon mere allegations or denials, but must set 
forth specific facts showing there is a genuine and substantial issue of 
fact that requires a hearing. When it clearly appears from the data in 
the application and from the reasons and a factual analysis in the 
request for the hearing that no genuine and substantial issue of fact 
precludes the refusal to approve the application or the withdrawal of 
approval of the application (for example, no adequate and well-
controlled clinical investigations to support the claims of 
effectiveness have been identified), the Commissioner will enter an 
order on this data, stating his findings and conclusions. If a hearing 
is requested and is justified by the applicant's response to the notice 
of opportunity for a hearing, the issues will be defined, an 
Administrative Law Judge will be named, and he shall issue a written 
notice of the time and place at which the hearing will commence. In the 
case of denial of approval, such time shall be not more than 90 days 
after the expiration of such 30 days unless the Administrative Law Judge 
and the applicant otherwise agree; and, in the case of withdrawal of 
approval, such time shall be as soon as practicable.
    (d) The hearing will be open to the public; however, if the 
Commissioner finds that portions of the application which serve as a 
basis for the hearing contain information concerning a method or process 
entitled to protection as a trade secret, the part of the hearing 
involving such portions will not be public, unless the respondent so 
specifies in his appearance.

[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 1941, Jan. 13, 1978]