2018-09589. Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Direct final rule; withdrawal.

    SUMMARY:

    The Food and Drug Administration (FDA) published in the Federal Register of January 26, 2018, a direct final rule to amend the general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

    DATES:

    The direct final rule published at January 26, 2018 (83 FR 3586), is withdrawn effective May 7, 2018.

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    FOR FURTHER INFORMATION CONTACT:

    Melissa Segal, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

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    SUPPLEMENTARY INFORMATION:

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the direct final rule published on January 26, 2018 (83 FR 3586) is withdrawn.

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    Dated: May 1, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

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    [FR Doc. 2018-09589 Filed 5-4-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Effective Date:
5/7/2018
Published:
05/07/2018
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Rule
Action:
Direct final rule; withdrawal.
Document Number:
2018-09589
Dates:
The direct final rule published at January 26, 2018 (83 FR 3586), is withdrawn effective May 7, 2018.
Pages:
19936-19936 (1 pages)
Docket Numbers:
Docket No. FDA-2017-N-7007
RIN:
0910-AH49
SectionNoes:
PDF File:
2018-09589.pdf
CFR: (1)
21 CFR 600