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Public Disclosure and Environmental Assessment

Public Disclosure and Environmental Assessment. Public Disclosure. Questions: (a) should we disclose to the public that we are considering an import tolerance for a new animal drug? If so, (b) when, (c) how, and (d) in how much detail?. Public Disclosure.

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Public Disclosure and Environmental Assessment

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  1. Public Disclosure andEnvironmental Assessment

  2. Public Disclosure Questions: (a) should we disclose to the public that we are considering an import tolerance for a new animal drug? If so, (b) when, (c) how, and (d) in how much detail?

  3. Public Disclosure • 21 CFR 514.11 (b) - The existence of an NADA file will not be disclosed by the Food and Drug Administration before an approval has been published in the FEDERAL REGISTER, unless it has previously been publicly disclosed or acknowledged.

  4. Environmental Assessment Question: Will the establishment of import tolerances have a significant effect on the environment?

  5. Environmental Assessment • 21 CFR 25.20 - Actions requiring preparation of an environmental assessment. (m) Approval of NADA’s, abbreviated applications, supplements, and actions on INAD’s, unless excluded under 25.33 (a), (c), (d), (e).

  6. Environmental Assessment • 21 CFR 25.33 - Categorical Exclusions • (a) … if the action does not increase the use of the drug. • (c) … for substances that occur naturally in the environment… • (d) “low environmental exposure” • (e) Action on an INAD.

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