[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.50]

[Page 272-273]
 
                        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

[[Page 273]]

the act. These actions are also protected from disclosure under FDA's 
regulations including part 20, Sec. Sec. 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.