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52a. The collection of this information is authorized by 21 U.S.C. 379i and 379j. FDA will use the information to assess qualification as a small business, collect and process user fee payments, and facilitate debt collection under the Debt Collection Improvement Act. FDA may disclose information to courts and the Department of Justice in the context of litigation and requests for legal advice, to other Federal agencies in response to subpoenas issued by such agencies, to HHS and FDA employees a.

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