[Title 21 CFR 1401.3]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter III - OFFICE OF NATIONAL DRUG CONTROL POLICY]
[Part 1401 - PUBLIC AVAILABILITY OF INFORMATION]
[Sec. 1401.3 - Definitions.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1401.3Sec. 1401.3FOOD AND DRUGSOFFICE OF NATIONAL DRUG CONTROL POLICYPUBLIC AVAILABILITY OF INFORMATION
Sec. 1401.3  Definitions.

    For the purpose of this part:
    (a) All the terms defined in the Freedom of Information Act apply.
    (b) Commercial-use request means a request from or on behalf of one 
who seeks information for a cause or purpose that furthers the 
commercial, trade or profit interests of the requester or the person or 
institution on whose behalf the request is made. In determining whether 
a requester properly belongs in this category, ONDCP will consider the 
intended use of the information.
    (c) Direct costs means the expense actually expended to search, 
review, or duplicate in response to a FOIA request. For example, direct 
costs include 116% of the salary of the employee performing work and the 
actual costs incurred while operating equipment.
    (d) Duplicate means the process of making a copy of a document. Such 
copies may take the form of paper, microform, audio-visual materials, or 
machine-readable documentation. ONDCP will provide a copy of the 
material in a form that is usable by the requester.
    (e) Educational institution means preschool, a public or private 
elementary or secondary school, an institution of undergraduate higher 
education, an institution of graduate higher education, an institution 
of professional education, or an institution of vocational education 
that operates a program or programs of scholarly research.

[[Page 172]]

    (f) Noncommercial scientific institution means an institution that 
is not operated on a commercial basis as that term is defined in this 
section, and that is operated solely for the purpose of conducting 
scientific research not intended to promote any particular product or 
industry.
    (g) Records and any other terms used in this part in reference to 
information includes any information that would be an agency record 
subject to the requirements of this part when maintained in any format, 
including electronic format.
    (h) Representative of the news media means any person actively 
gathering news for an entity that is organized and operated to publish 
or broadcast news to the public. News is information about current 
events or information that would be of interest to the public. Examples 
of the news media include television or radio stations that broadcast to 
the public at large and publishers of news periodicals that make their 
products available to the general public for purchase or subscription. 
Freelance journalists may be regarded as working for the news media 
where they demonstrate a reasonable basis for expecting publication 
through that organization, even though not actually employed by it.
    (i) Request means a letter or other written communication seeking 
records or information under FOIA.
    (j) Review means the process of examining documents that are located 
during a search to determine if any portion should lawfully be withheld. 
It is the processing of determining disclosability.
    (k) Search means to review, manually or by automated means, agency 
records for the purpose of locating those records responsive to a 
request.