[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.51]

[Page 248-249]
 
                        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 Dockets Management 
Branch. 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

[[Page 249]]

are available upon request and filed in FDA's Dockets Management Branch.
    (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.