[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: 21CFR515.30]

[Page 92]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 515--MEDICATED FEED MILL LICENSE--Table of Contents
 
                      Subpart C--Hearing Procedures
 
Sec.  515.30  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 of Food and Drugs (the Commissioner) to 
refuse to approve a medicated feed mill license application or to revoke 
the approval of a medicated feed mill license will specify the grounds 
upon which the Commissioner proposes to issue this order. On request of 
the applicant, the Commissioner will explain the reasons for the 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 the Commissioner is required to file a 
written appearance electing whether:
    (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, this 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, the applicant 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 
the medicated feed mill license should not be revoked, together with a 
well-organized and full-factual analysis of the information the 
applicant 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 information in the application and from the 
reasons and 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 revocation of approval of the application, the 
Commissioner will enter an order on this information, stating his/her 
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 
the Judge 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 the appearance.