21 CFR 230.70
§ 230.70 Supplements and other changes to a granted certification.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 230.70, § 230.70 Supplements and other changes to a granted certification, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86138
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Full text
(a) The applicant must submit a supplement if any information in the certification request changes after the request has been deemed granted, including, but not limited to, the addition of a new facility manufacturing the designated medical gas, a change in contact information, or a change in the corporate name.
(b) Each supplement must include a signed, completed request for certification form with the updated information in accordance with § 230.50. The updated information must be submitted no later than 30 calendar days after the date the change occurred.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.