[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: 21CFR25.52]

[Page 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. 25.52  Environmental impact statements.

    (a) If FDA determines that an EIS is necessary for an action 
involving investigations or approvals for drugs, animal drugs, biologic 
products, or devices, an EIS will be prepared but will become available 
only at the time of the approval of the product. Disclosure will be made 
in accordance with 40 CFR 1506.6 and part 20 of this chapter. The EIS 
will in all other respects conform to the requirements for EIS's as 
specified in 40 CFR part 1502 and 1506.6(f).
    (b) Comments on the EIS may be submitted after the approval of the 
drug, animal drug, biologic product, or device. Those comments can form 
the basis for the agency to consider beginning an action to withdraw the 
approval of applications for a drug, animal drug, or biologic product, 
or to withdraw premarket notifications or premarket approval 
applications for devices.
    (c) In those cases where the existence of applications and premarket 
notifications for drugs, animal drugs, biologic products, or devices has 
already been disclosed before the agency approves the action, the agency 
will make diligent effort (40 CFR 1506.6) to involve the public in 
preparing and implementing the NEPA procedures for EIS's while following 
its own disclosure requirements including those listed in part 20, 
Secs. 312.130(b), 314.430(d), 514.11(d), 514.12(b), 601.51(d), 
807.95(e), 812.38(b), and 814.9(d) of this chapter.
    (d) Draft and final EIS's, comments, and responses will be included 
in the administrative record and will be available from the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.