83 FR 19936 - Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 88 (May 7, 2018)

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.

[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Page 19936]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09589]



[[Page 19936]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 600

[Docket No. FDA-2017-N-7007]
RIN 0910-AH49


Removal of Certain Time of Inspection and Duties of Inspector 
Regulations for Biological Products; Withdrawal

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3586), is withdrawn effective May 7, 2018.

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.

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3586) is withdrawn.

    Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09589 Filed 5-4-18; 8:45 am]
BILLING CODE 4164-01-P