E9-3831. 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.

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 § 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 § 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 § 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 § 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.