[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
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 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
[[Page 200]]
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]
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