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20-08361-01 621400 US Department of Health and Human Services (F.A.)

Accession Number: ML20191A026

Date Released: Wednesday, February 10, 2021

Package Contents

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• ML20269A387 - US Department of Health and Human Services, letter dated September 25, 2020, RE: Request for Additional Information (5 page(s), 9/25/2020)
• ML20363A005 - U.S. Department of Health and Human Services, ltr dated 12/23/2020, RE: Request for Amended Certification of Financial Assurance and Statement of Intent (2 page(s), 12/23/2020)
• ML20365A062 - U.S. Department of Health and Human Services, ltr dtd 12/23/2020, RE: Request for Amendened Certification of Financial Assurance and Statement of Intent (2 page(s), 12/23/2020)
• ML21029A164 - U.S. Department of Health and Human Services, emails dated December 23, 2020, January 04, 2021, and January 5, 2021 RAI and RAI Response (4 page(s), 1/5/2021)
• ML21040A472 - U.S. Department of Health and Human Services, Food and Drug Administration, Acceptance of Notification of Financial Assurance, Mail Control No. 621400 (3 page(s), 2/2/2021)