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[FDA] Over-the-Counter Monograph Drug User Fee
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2021-01-08 20:05:00
http://en.icmcert.com/bbs/board7_3/268646 URL COPY
2020.12.29일 발표된 OTC Monograph Drug User Fee 규정이
2021.01.06일 취소되었습니다.

아래는 FDA 공지사항 전문이며 첨부파일도 참고바랍니다.
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The Notice, published in the Federal Register on December 29, 2020 (85 FR 85646), is withdrawn as of January 6, 2021.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Notice, Docket No. FDA-2020-N-2246, as published in the Federal Register on December 29, 2020, (85 FR 85646), is hereby withdrawn.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.

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