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Civil Money Penalties Hearings; Maximum Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act; Correction

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that published in the Federal Register of July 20, 2004 (69 FR 43299). The document issued a regulation to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities within our jurisdiction. The document published with some errors and this document corrects those errors.

DATES:

The rule is effective September 20, 2004.

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FOR FURTHER INFORMATION CONTACT:

Joyce A. Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville MD, 20857, 301-827-7010.

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SUPPLEMENTARY INFORMATION:

In FR Doc. 04-16388, appearing on page 43299 in the Federal Register of Tuesday, July 20, 2004, the following corrections are made:

[Corrected]

1. On pages 43301 and 43302, in the last column of the table (in dollars), paragraphs (a)(4), (a)(11), and (a)(12) are corrected to read: 16,500, 1,100, and 330,000, respectively. For the convenience of the reader, the table is republished in its entirety:

Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts

U.S.C. SectionDescription of ViolationFormer Maximum Penalty Amount (in dollars)Assessment MethodDate of Last PenaltyAdjusted Maximum Penalty Amount (in dollars)
(a) 21 U.S.C.
(1) 333(b)(2)(A)Violation of certain requirements of the Prescription Drug Marketing Act (PDMA)50,000For each of the first two violations in any 10-year period200455,000
(2) 333(b)(2)(B)Violation of certain requirements of the PDMA1,000,000For each violation after the second conviction in any 10-year period20041,100,000
(3) 333(b)(3)Violation of certain requirements of the PDMA100,000Per violation2004110,000
(4) 333(f)(1)(A)Violation of certain requirements of the Safe Medical Devices Act (SMDA)15,000Per violation200416,500
(5) 333(f)(1)(A)Violation of certain requirements of the SMDA1,000,000For the aggregate of violations20041,100,000
(6) 333(f)(2)(A)Violation of certain requirements of the Food Quality Protection Act of 1996 (FQPA)50,000Per individual200455,000
(7) 333(f)(2)(A)Violation of certain requirements of the FQPA250,000Per “any other person”2004275,000
(8) 333(f)(2)(A)Violation of certain requirements of the FQPA500,000For all violations adjudicated in a single proceeding2004550,000
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(9) 335b(a)Violation of certain requirements of the Generic Drug Enforcement Act of 1992 (GDEA)250,000Per violation for an individual2004275,000
(10) 335b(a)Violation of certain requirements of the GDEA1,000,000Per violation for “any other person”20041,100,000
(11) 360pp(b)(1)Violation of certain requirements of the Radiation Control for Health and Safety Act of 1968 (RCHSA)1,000Per violation per person20041,100
(12) 360pp(b)(1)Violation of certain requirements of the RCHSA300,000For any related series of violations2004330,000
(b) 42 U.S.C.
(1) 263b(h)(3)Violation of certain requirements of the Mammography Quality Standards Act of 1992 and the Mammography Quality Standards Act of 199810,000Per violation200411,000
(2) 300aa-28(b)(1)Violation of certain requirements of the National Childhood Vaccine Injury Act of 1986100,000Per occurrence2004110,000
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Dated: August 5, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 04-18407 Filed 8-11-04; 8:45 am]

BILLING CODE 4160-01-S