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.
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.
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:
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. Section | Description of Violation | Former Maximum Penalty Amount (in dollars) | Assessment Method | Date of Last Penalty | Adjusted 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) | 50,000 | For each of the first two violations in any 10-year period | 2004 | 55,000 |
| (2) 333(b)(2)(B) | Violation of certain requirements of the PDMA | 1,000,000 | For each violation after the second conviction in any 10-year period | 2004 | 1,100,000 |
| (3) 333(b)(3) | Violation of certain requirements of the PDMA | 100,000 | Per violation | 2004 | 110,000 |
| (4) 333(f)(1)(A) | Violation of certain requirements of the Safe Medical Devices Act (SMDA) | 15,000 | Per violation | 2004 | 16,500 |
| (5) 333(f)(1)(A) | Violation of certain requirements of the SMDA | 1,000,000 | For the aggregate of violations | 2004 | 1,100,000 |
| (6) 333(f)(2)(A) | Violation of certain requirements of the Food Quality Protection Act of 1996 (FQPA) | 50,000 | Per individual | 2004 | 55,000 |
| (7) 333(f)(2)(A) | Violation of certain requirements of the FQPA | 250,000 | Per “any other person” | 2004 | 275,000 |
| (8) 333(f)(2)(A) | Violation of certain requirements of the FQPA | 500,000 | For all violations adjudicated in a single proceeding | 2004 | 550,000 |
| (9) 335b(a) | Violation of certain requirements of the Generic Drug Enforcement Act of 1992 (GDEA) | 250,000 | Per violation for an individual | 2004 | 275,000 |
| (10) 335b(a) | Violation of certain requirements of the GDEA | 1,000,000 | Per violation for “any other person” | 2004 | 1,100,000 |
| (11) 360pp(b)(1) | Violation of certain requirements of the Radiation Control for Health and Safety Act of 1968 (RCHSA) | 1,000 | Per violation per person | 2004 | 1,100 |
| (12) 360pp(b)(1) | Violation of certain requirements of the RCHSA | 300,000 | For any related series of violations | 2004 | 330,000 |
| (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 1998 | 10,000 | Per violation | 2004 | 11,000 |
| (2) 300aa-28(b)(1) | Violation of certain requirements of the National Childhood Vaccine Injury Act of 1986 | 100,000 | Per occurrence | 2004 | 110,000 |
Dated: August 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18407 Filed 8-11-04; 8:45 am]
BILLING CODE 4160-01-S