[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.55]

[Page 199-200]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20_PUBLIC INFORMATION--Table of Contents
 
                      Subpart C_Procedures and Fees
 
Sec.  20.55  Indexing trade secrets and confidential commercial or financial information.

    Whenever the Food and Drug Administration denies a request for a 
record

[[Page 200]]

or portion thereof on the grounds that the record or portion thereof is 
exempt from public disclosure as trade secret or confidential commercial 
or financial data and information under Sec.  20.61, and the person 
requesting the record subsequently contests the denial in the courts, 
the Food and Drug Administration will so inform the person affected, 
i.e., the person who submitted the record, and will require that such 
person intervene to defend the exempt status of the record. If a court 
requires the Food and Drug Administration to itemize and index such 
records, the Food and Drug Administration will so inform the person 
affected and will require that such person undertake the itemization and 
indexing of the records. If the affected person fails to intervene to 
defend the exempt status of the records and to itemize and index the 
disputed records, the Food and Drug Administration will take this 
failure into consideration in deciding whether that person has waived 
such exemption so as to require the Food and Drug Administration to 
promptly make the records available for public disclosure.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994. 
Redesignated at 68 FR 25286, May 12, 2003]