
[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Rules and Regulations]
[Pages 32643-32644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2014-N-0113]


Maximum Civil Money Penalty Amounts; Civil Money Penalty 
Complaints; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; Confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of June 18, 2014, for the direct final rule that 
appeared in the Federal Register of February 3, 2014. The direct final 
rule revises the regulations to update the table to adjust the 
preceding maximum civil penalty amounts for inflation as prescribed by 
the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). 
The direct final rule also revises the regulations to amend the process 
for initiating certain civil money penalty (CMP) administrative 
actions. This document confirms the effective date of the direct final 
rule.

DATES: Effective date of the direct final rule published in the Federal 
Register of February 3, 2014 (79 FR 6088), confirmed: June 18, 2014.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20903, 301-796-4830.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 3, 2014 
(79 FR 6088), FDA published the direct final rule Maximum Civil Money 
Penalty Amounts; Civil Money Penalty Complaints. The direct final rule 
revises the table in 21 CFR 17.2 to adjust the preceding maximum CMP 
amounts for inflation as prescribed by FCPIAA. The adjusted CMPs have 
been updated to

[[Page 32644]]

account for the inflation as prescribed by FCPIAA. The direct final 
rule also revises 21 CFR 17.5(a) to provide authority for the Chief 
Counsel to delegate the responsibility for initiating a CMP 
administrative action against a tobacco retailer.
    FDA also solicited comments concerning the changes for a 75-day 
period ending April 21, 2014, in a proposed rule that published in the 
Federal Register of February 3, 2014 (79 FR 6112). FDA stated that the 
effective date of the direct final rule would be June 18, 2014, 60 days 
after the end of the comment period, unless any significant adverse 
comment was submitted to FDA during the comment period. FDA did not 
receive any significant adverse comments.

    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act and the Public Health Service Act, and under authority delegated 
to the Commissioner of Food and Drugs, 21 CFR part 17 is amended. 
Accordingly, the amendments issued thereby are effective.

    Dated: June 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13165 Filed 6-5-14; 8:45 am]
BILLING CODE 4160-01-P


