[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.120]

[Page 140-141]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 12--FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
 
                 Subpart G--Initial and Final Decisions
 
Sec. 12.120  Initial decision.


    (a) The presiding officer shall prepare and file an initial decision 
as soon as possible after the filing of briefs and oral argument.
    (b) The initial decision must contain--
    (1) Findings of fact based issued upon relevant, material, and 
reliable evidence of record;
    (2) Conclusions of law;
    (3) A discussion of the reasons for the findings and conclusions, 
including a discussion of the significant contentions made by any 
participant;
    (4) Citations to the record supporting the findings and conclusions;
    (5) An appropriate regulation or order supported by substantial 
evidence of record and based upon the findings of fact and conclusions 
of law; and
    (6) An effective date for the regulation or order.
    (c) The initial decision must refrain from disclosing specific 
details of matters specified in Sec. 10.20(j)(2)(i) (a) and (b), except 
as specifically authorized in a protective order issued pursuant to 
Sec. 10.20(j)(3).
    (d) The initial decision is to be filed with the Dockets Management 
Branch and served upon all participants. Once the initial decision is 
filed with the Dockets Management Branch, the presiding officer has no 
further jurisdiction over the matter, and any motions or requests filed 
with the Dockets Management Branch will be decided by the Commissioner.
    (e) The initial decision becomes the final decision of the 
Commissioner by operation of law unless a participant files exceptions 
with the Dockets Management Branch under Sec. 12.125(a) or the 
Commissioner files a notice of review under Sec. 12.125(f).
    (f) Notice that an initial decision has become the decision of the 
Commissioner without appeal to or review by the Commissioner will be 
published in

[[Page 141]]

the Federal Register, or the Commissioner may publish the decision when 
it is of widespread interest.