[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: 21CFR25.51]
[Page 244]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 25 ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
Subpart E Public Participation and Notification of Environmental
Documents
Sec. 25.51 Environmental assessments and findings of no significant impact.
(a) Data and information that are protected from disclosure by 18
U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the
portion of environmental documents that is made public. When such data
and information are pertinent to the environmental review of a proposed
action, an applicant or petitioner shall submit such data and
information separately in a confidential section and shall summarize the
confidential data and information in the EA to the extent possible.
(b) FONSI's and EA's will be available to the public in accordance
with 40 CFR 1506.6 as follows:
(1) When the proposed action is the subject of a notice of proposed
rulemaking or a notice of filing published in the Federal Register, the
notice shall state that no EIS is necessary and that the FONSI and the
EA are available for public inspection at FDA's Division of Dockets
Management. If the responsible agency official is unable to complete
environmental consideration of the proposed action before a notice of
filing of a food or color additive petition is required to be published
under the act, and if the subsequent environmental analysis leads to the
conclusion that no EIS is necessary, the final regulation rather than
the notice of filing shall state that no EIS is necessary and that the
FONSI and the EA are available upon request and filed in FDA's Division
of Dockets Management.
(2) For actions for which notice is not published in the Federal
Register, the FONSI and the EA shall be made available to the public
upon request according to the procedures in 40 CFR 1506.6.
(3) For a limited number of actions, the agency may make the FONSI
and EA available for public review (including review by State and
areawide information clearinghouses) for 30 days before the agency makes
its final determination whether to prepare an EIS and before the action
may begin, as described in 40 CFR 1501.4(e). This procedure will be
followed when the proposed action is, or is closely similar to, one that
normally requires an EIS or when the proposed action is one without
precedent.
[[Page 245]]
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