[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.17]

[Page 185-186]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17--CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
Sec. 17.17  Summary decisions.

    (a) At any time after the filing of a complaint, a party may move, 
with or without supporting affidavits (which, for purposes of this part, 
shall include declarations under penalty of perjury), for a summary 
decision on any issue in the hearing. The other party may, within 30 
days after service of the motion, which may be extended for an 
additional 10 days for good cause, serve opposing affidavits or 
countermove for summary decision.
    The presiding officer may set the matter for argument and call for 
the submission of briefs.
    (b) The presiding officer shall grant the motion if the pleadings, 
affidavits, and other material filed in the record, or matters 
officially noticed, show that there is no genuine issue as to any 
material fact and that the party is entitled to summary decision as a 
matter of law.
    (c) Affidavits shall set forth only such facts as would be 
admissible in evidence and shall show affirmatively that the affiant is 
competent to testify to the matters stated. When a motion for summary 
decision is made and supported as provided in this regulation, a party 
opposing the motion may not rest on mere allegations or denials or 
general descriptions of positions and contentions; affidavits or other 
responses must set forth specific facts showing that there is a genuine 
issue of material fact for the hearing.
    (d) If, on motion under this section, a summary decision is not 
rendered on

[[Page 186]]

all issues or for all the relief asked, and if additional facts need to 
be developed, the presiding officer will issue an order specifying the 
facts that appear without substantial controversy and directing further 
evidentiary proceedings on facts still at issue. The facts specified not 
to be at issue shall be deemed established.
    (e) Except as provided in Sec. 17.18, a party may not obtain 
interlocutory review by the entity deciding the appeal (currently the 
DAB) of a partial summary decision of the presiding officer. A review of 
final summary decisions on all issues may be had through the procedure 
set forth in Sec. 17.47.