[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: 21CFR17.47]

[Page 193-194]
 
                        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. 17.47  Appeals.

    (a) Either the Center or any respondent may appeal an initial 
decision, including a decision not to withdraw a default judgment, or a 
decision granting summary decision to the Commissioner of Food and Drugs 
or other entity the Commissioner designates to decide the appeal. The 
Commissioner has currently designated the Departmental Appeals Board 
(DAB) to decide appeals under this part. Parties may appeal to the DAB 
by filing a notice of appeal with the DAB, rm. 637-D, Hubert H. Humphrey 
Bldg., 200 Independence Ave. SW., Washington, DC 20201, and the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, in accordance with this 
section.
    (b)(1) A notice of appeal may be filed at any time within 30 days 
after the presiding officer issues an initial decision or decision 
granting summary decision.
    (2) The Commissioner or the entity designated by the Commissioner to 
hear appeals may, within his or her discretion, extend the initial 30-
day period for an additional period of time if the Center or any 
respondent files a request for an extension within the initial 30-day 
period and shows good cause.
    (c) A notice of appeal shall be accompanied by a written brief of no 
greater length than that allowed for the posthearing brief. The notice 
must identify specific exceptions to the initial decision, must support 
each exception with citations to the record, and must explain the basis 
for each exception.
    (d) The opposing party may file a brief of no greater length than 
that allowed for the posthearing brief in opposition to exceptions 
within 30 days of receiving the notice of appeal and accompanying brief, 
unless such time period is extended by the Commissioner or the entity 
designated by the Commissioner to hear appeals on request of the 
opposing party for good cause shown. Any brief in opposition to 
exceptions shall be filed with the Dockets Management Branch and the DAB 
(addresses above).
    (e) The appellant may file a reply brief not more than 10 pages in 
length within 10 days of being served with appellee's brief.
    (f) There is no right to appear personally before the Commissioner 
of Food and Drugs or other entity deciding the appeal (currently the 
DAB).
    (g) The entity deciding the appeal will consider only those issues 
raised before the presiding officer, except that the appellee may make 
any argument based on the record in support of the initial decision or 
decision granting summary decision.
    (h) If on appeal the entity deciding the appeal considers issues not 
adequately briefed by the parties, the entity may ask for additional 
briefing. However, no such additional briefs will be considered unless 
so requested.
    (i) If any party demonstrates to the satisfaction of the entity 
deciding the appeal (currently the DAB) that additional evidence not 
presented at the hearing is relevant and material and that there were 
reasonable grounds for the failure to adduce such evidence at the 
hearing, the entity deciding the appeal may remand the matter to the 
presiding officer for consideration of the additional evidence.
    (j) The Commissioner of Food and Drugs or other entity deciding the 
appeal (currently the DAB) will issue a decision on the appeal within 60 
days,

[[Page 194]]

if practicable, of the due date for submission of the appellee's brief. 
In the decision, the entity deciding the appeal may decline to review 
the case, affirm the initial decision or decision granting summary 
decision (with or without an opinion), or reverse the initial decision 
or decision granting summary decision, or increase, reduce, reverse, or 
remand any civil money penalty determined by the presiding officer in 
the initial decision. If the entity deciding the appeal declines to 
review the case, the initial decision or the decision granting summary 
decision shall constitute the final decision of FDA and shall be final 
and binding on the parties 30 days after the declination by the entity 
deciding the appeal.
    (k) The standard of review on a disputed issue of fact is whether 
the initial decision is supported by substantial evidence on the whole 
record. The standard of review on a disputed issue of law is whether the 
initial decision is erroneous.