[Federal Register Volume 74, Number 35 (Tuesday, February 24, 2009)]
[Rules and Regulations]
[Page 8200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2008-N-0561]


Maximum Civil Money Penalty Amounts and Compliance With the 
Federal Civil Penalties Inflation Adjustment Act; 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 March 27, 2009, for the direct final rule that 
appeared in the Federal Register of November 12, 2008 (73 FR 66750). 
The direct final rule amends the agency's regulations to update the 
statutory citations regarding the new civil monetary penalties 
prescribed by the Food and Drug Administration Amendments Act of 2007 
(FDAAA), amends the regulations to include the new FDAAA penalties, and 
adjusts the preceding maximum civil penalty amounts for inflation as 
prescribed by the Federal Civil Penalties Inflation Adjustment Act of 
1990 (FCPIAA). This document confirms the effective date of the direct 
final rule.

DATES: Effective date confirmed: March 27,2009.

FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave, Bldg. 1, rm. 4305, 
Silver Spring, MD 20993, 301-796-4830.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 12, 2008 
(73 FR 66750), FDA published the ``Maximum Civil Money Penalty Amounts 
and Compliance With the Federal Civil Penalties Inflation Adjustment 
Act'' direct final rule and solicited comments concerning the direct 
final rule for a 75-day period ending March 27, 2009. The direct final 
rule revises Sec.  17.1 (21 CFR 17.1) to update the statutory citations 
regarding the new civil monetary penalties prescribed by FDAAA, and 
revises the table in Sec.  17.2 (21 CFR 17.2) to include the new FDAAA 
penalties, and adjusts the preceding maximum civil penalty amounts for 
inflation as prescribed by the FCPIAA. This was accomplished by 
revising the list of statutory monetary penalties in Sec.  17.1 to 
include the new penalties prescribed by the Federal Food, Drug, and 
Cosmetic Act, as amended by FDAAA in 2007. These new penalties have 
been added as new paragraphs (c) and (d). The table in Sec.  17.2 also 
has been amended to include the new penalties, and the adjusted maximum 
penalty amounts for the pre-FDAAA penalties have been updated to 
account for the inflation between June 2004 (the year of the last 
adjustment) and June 2007 as prescribed by FCPIAA.
    FDA also solicited comments concerning the changes for a 75-day 
period ending January 26, 2009, in a proposed rule published in the 
Federal Register of November 12, 2008 (73 FR 66811). FDA stated that 
the effective date of the direct final rule would be on March 27, 2009, 
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: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3831 Filed 2-23-09; 8:45 am]
BILLING CODE 4160-01-S