---
kind: "section"
citation: "21 C.F.R. § 25.44"
title: "21"
number: "25.44"
heading: "Lead and cooperating agencies."
url: "https://uscodex.org/cfr/21/25.44"
---

# §25.44. Lead and cooperating agencies.


For actions requiring the preparation of an EIS, FDA and other affected Federal agencies will agree which will be the lead agency and which will be the cooperating agencies. The responsibilities of lead agencies and cooperating agencies are described in the CEQ regulations (40 CFR [1501.5](/cfr/40/1501.5.md) and [1501.6](/cfr/40/1501.6.md), respectively). If an action affects more than one center within FDA, the Commissioner of Food and Drugs will designate one of these units to be responsible for coordinating the preparation of any required environmental documentation.


## Notes

### Authority

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.

### Source

Source: 62 FR 40592, July 29, 1997, unless otherwise noted.