[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Notices]
[Page 550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2246]


Withdrawal of FDA Notice Regarding Fee Rates Under the Over-the-
Counter Monograph Drug User Fee Program for Fiscal Year 2021

AGENCY: Department of Health and Human Services (HHS), Food and Drug 
Administration (FDA).

ACTION: Notice; withdrawal.

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SUMMARY: The Department of Health and Human Services is issuing this 
Notice to withdraw FDA's December 29, 2020 Federal Register Notice 
entitled Fee Rates Under the Over-the-Counter Monograph User Fee 
Program for Fiscal Year 2021 because FDA lacked the delegated authority 
to issue the Notice. The Department is further informing the public 
that FDA has been ordered to cease further collection efforts related 
to the Over-the-Counter Drug Monograph User Fee Program until further 
action is announced in the Federal Register.

DATES: The Notice, published in the Federal Register on December 29, 
2020 (85 FR 85646), is withdrawn as of January 6, 2021.

FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61075, Beltsville, MD 20705-4304, 240-402 4585.

SUPPLEMENTARY INFORMATION: On December 29, 2020, FDA published a Notice 
in the Federal Register entitled Fee Rates Under the Over-the-Counter 
Monograph User Fee Program for Fiscal Year 2021. 85 FR 85646. The 
Notice purports to implement certain user fee provisions contained in 
the Coronavirus Aid, Relief, and Economic Security Act (``CARES Act''), 
Public Law 116-136, 134 Stat. 281 (March 27, 2020). The Notice was 
issued without approval of the Secretary. For this reason, the Notice, 
Docket No. FDA-2020-N-2246, as published in the Federal Register on 
December 29, 2020, (85 FR 85646), is hereby withdrawn.
    FDA has also been ordered to cease collections activities related 
to the Over-the-Counter Monograph User Fee Program (``OMUFA'') until, 
with the approval of the Secretary, the Department issues further 
direction concerning FDA's administration of OMUFA which provides the 
public with notice and opportunity for comment.

    Dated: December 31, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-00030 Filed 1-4-21; 4:15 pm]
BILLING CODE 4164-01-P


