21 CFR 25.44
§ 25.44 Lead and cooperating agencies.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 25.44, § 25.44 Lead and cooperating agencies, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83436
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Full text
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 and 1501.6, 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.