[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: 21CFR20.46]
[Page 197-198]
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. 20.46 Waiver or reduction of fees.
(a) Standard. The Assistant Commissioner for Public Affairs (or
delegatee) will waive or reduce the fees that would otherwise be charged
if disclosure of the information meets both of the following tests:
(1) Is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of
the Government; and
(2) It is not primarily in the commercial interest of the requester.
These two tests are explained in paragraphs (b) and (c) of this section.
(b) Public interest. Disclosure of information satisfies the first
test only if it furthers the specific public interest of being likely to
contribute significantly to public understanding of Government
operations or activities, regardless of any other public interest it may
further. In analyzing this question, the Food and Drug Administration
will consider the following factors:
(1) Whether the records to be disclosed pertain to the operations or
activities of the Federal Government;
(2) Whether disclosure of the records would reveal any meaningful
information about Government operations or activities that is not
already public knowledge;
(3) Whether disclosure will advance the understanding of the general
public as distinguished from a narrow segment of interested persons.
Under this factor, the Food and Drug Administration may consider whether
the requester is in a position to contribute to public understanding.
For example, the Food and Drug Administration may consider whether the
requester has such knowledge or expertise as may be necessary to
understand the information, and whether the requester's intended use of
the information would be likely to disseminate the information to the
public. An unsupported claim to be doing research for a book or article
does not demonstrate that likelihood, while such a claim by a
representative of the news media is better evidence; and
(4) Whether the contribution to public understanding will be a
significant one, i.e., will the public's understanding of the
Government's operations be substantially greater as a result of the
disclosure.
(c) Not primarily in the requester's commercial interest. If
disclosure passes the test of furthering the specific public interest
described in paragraph (b) of this section, the Food and Drug
Administration will determine whether disclosure also furthers the
requester's commercial interest and, if so, whether this effect
outweighs the advancement of that public interest. In applying this
second test, the Food and Drug Administration will consider the
following factors:
(1) Whether disclosure would further a commercial interest of the
requester, or of someone on whose behalf the requester is acting.
Commercial interests include interests relating to business, trade, and
profit. Both profit and nonprofit-making corporations have commercial
interests, as well as individuals, unions, and other associations. The
interest of a representative of the news media in using the information
for news dissemination purposes will not be considered a commercial
interest.
(2) If disclosure would further a commercial interest of the
requester, whether that effect outweighs the advancement of the public
interest as defined in paragraph (b) of this section.
(d) Deciding between waiver and reduction. If the disclosure of the
information requested passes both tests described in paragraphs (b) and
(c) of this
[[Page 198]]
section, the Food and Drug Administration will normally waive fees.
However, in some cases the Food and Drug Administration may decide only
to reduce the fees. For example, the Food and Drug Administration may do
this when disclosure of some but not all of the requested records passes
the tests.
(e) Procedure for requesting a waiver or reduction. A requester must
request a waiver or reduction of fees at the same time as the request
for records. The requester should explain why a waiver or reduction is
proper under the factors set forth in paragraphs (a) through (d) of this
section. Only the Associate Commissioner for Public Affairs may make the
decision whether to waive or reduce the fees. If the Food and Drug
Administration does not completely grant the request for a waiver or
reduction, the denial letter will designate a review official. The
requester may appeal the denial to that official. The appeal letter
should address reasons for the Associate Commissioner's decision that
are set forth in the denial letter.
[59 FR 534, Jan. 5, 1994. Redesignated and amended at 68 FR 25286,
25287, May 12, 2003]
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