[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: 21CFR20.43]

[Page 203-204]
 
                        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. 20.43  Waiver or reduction of fees.

    (a) Standard. The Associate Commissioner for Public Affairs 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

[[Page 204]]

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 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]