Rules and Regulations. Final rule; correction

Agency: Food and Drug Administration, HHS
Action: Final rule; correction
Citation: FR Doc. 04-18407 · Docket No. 2003N-0308 · 21 CFR 17

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.

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: § 17.2 [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. 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]