[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: 21CFR25.50]

[Page 248]
 
                        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. 25.50  General information.


    (a) To the extent actions are not protected from disclosure by 
existing law applicable to the agency's operation, FDA will involve the 
public in preparing and implementing its NEPA procedures and will 
provide public notice of NEPA-related hearings, public meetings, and the 
availability of environmental documents.
    (b) Many FDA actions involving investigations, review, and approval 
of applications, and premarket notifications for human drugs, animal 
drugs, biologic products, and devices are protected from disclosure 
under the Trade Secret Act, 18 U.S.C. 1905, and 301(j) of the act. These 
actions are also protected from disclosure under FDA's regulations 
including part 20, Secs. 312.130(a), 314.430(b), 514.11(b), 514.12(a), 
601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of this 
chapter. Even the existence of applications for human drugs, animal 
drugs, biologic products, and devices is protected from disclosure under 
these regulations. Therefore, unless the existence of applications for 
human drugs, animal drugs, biologic products, or premarket notification 
for devices has been made publicly available, the release of the 
environmental document before approval of human drugs, animal drugs, 
biologic products, and devices is inconsistent with statutory 
requirements imposed on FDA. Appropriate environmental documents, 
comments, and responses will be included in the administrative record to 
the extent allowed by applicable laws.