[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: 21CFR20.61]
[Page 200-201]
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 D Exemptions
Sec. 20.61 Trade secrets and commercial or financial information which is
privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan,
formula, process, or device that is used for the making, preparing,
compounding, or processing of trade commodities and that can be said to
be the end product of either innovation or substantial effort. There
must be a direct relationship between the trade secret and the
productive process.
(b) Commercial or financial information that is privileged or
confidential means valuable data or information which is used in one's
business and is of a type customarily held in strict confidence or
regarded as privileged and not disclosed to any member of the public by
the person to whom it belongs.
(c) Data and information submitted or divulged to the Food and Drug
Administration which fall within the definitions of a trade secret or
confidential commercial or financial information are not available for
public disclosure.
(d) A person who submits records to the Government may designate
part or all of the information in such records as exempt from disclosure
under exemption 4 of the Freedom of Information Act. The person may make
this designation either at the time the records are submitted to the
Government or within a reasonable time thereafter. The designation must
be in writing. Where a legend is required by a request for proposals or
request for quotations, pursuant to 48 CFR 352.215-12, then that legend
is necessary for this purpose. Any such designation will expire 10 years
after the records were submitted to the Government.
(e) The procedures in this paragraph apply to records on which the
submitter has designated information as provided in paragraph (d) of
this section. These procedures also apply to records that were submitted
to the Food and Drug Administration when the agency has substantial
reason to believe that information in the records could reasonably be
considered exempt under exemption 4 of the Freedom of Information Act.
Certain exceptions to these procedures are set forth in paragraph (f) of
this section.
[[Page 201]]
(1) When the Food and Drug Administration receives a request for
such records and determines that disclosure may be required, the Food
and Drug Administration will make reasonable efforts to notify the
submitter about these facts. The notice will include a copy of the
request, and it will inform the submitter about the procedures and time
limits for submission and consideration of objections to disclosure. If
the Food and Drug Administration must notify a large number of
submitters, notification may be done by posting or publishing a notice
in a place where the submitters are reasonably likely to become aware of
it.
(2) The submitter has 5 working days from receipt of the notice to
object to disclosure of any part of the records and to state all bases
for its objections.
(3) The Food and Drug Administration will give consideration to all
bases that have been stated in a timely manner by the submitter. If the
Food and Drug Administration decides to disclose the records, the Food
and Drug Administration will notify the submitter in writing. This
notice will briefly explain why the agency did not sustain the
submitter's objections. The Food and Drug Administration will include
with the notice a copy of the records about which the submitter
objected, as the agency proposes to disclose them. The notice will state
that the Food and Drug Administration intends to disclose the records 5
working days after the submitter receives the notice unless a U.S.
District Court orders the agency not to release them.
(4) If a requester files suit under the Freedom of Information Act
to obtain records covered by this paragraph, the Food and Drug
Administration will promptly notify the submitter.
(5) Whenever the Food and Drug Administration sends a notice to a
submitter under paragraph (e)(1) of this section, the Food and Drug
Administration will notify the requester that the Food and Drug
Administration is giving the submitter a notice and an opportunity to
object. Whenever the Food and Drug Administration sends a notice to a
submitter under paragraph (e)(3) of this section, the Food and Drug
Administration will notify the requester of this fact.
(f) The notice requirements in paragraph (e) of this section do not
apply in the following situations:
(1) The Food and Drug Administration decided not to disclose the
records;
(2) The information has previously been published or made generally
available;
(3) Disclosure is required by a regulation issued after notice and
opportunity for public comment, that specifies narrow categories of
records that are to be disclosed under the Freedom of Information Act,
but in this case a submitter may still designate records as described in
paragraph (d) of this section, and in exceptional cases, the Food and
Drug Administration may, at its discretion, follow the notice procedures
in paragraph (e) of this section;
(4) The information requested has not been designated by the
submitter as exempt from disclosure when the submitter had an
opportunity to do so at the time of submission of the information or
within a reasonable time thereafter, unless the Food and Drug
Administration has substantial reason to believe that disclosure of the
information would result in competitive harm; or
(5) The designation appears to be obviously frivolous, but in this
case the Food and Drug Administration will still give the submitter the
written notice required by paragraph (e)(3) of this section (although
this notice need not explain our decision or include a copy of the
records), and the Food and Drug Administration will notify the requester
as described in paragraph (e)(5) of this section.
[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994]
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