[Federal Register: August 12, 2004 (Volume 69, Number 155)]
[Rules and Regulations]
[Page 49807-49808]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au04-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
[Docket No. 2003N-0308]
Civil Money Penalties Hearings; Maximum Penalty Amounts and
Compliance With the Federal Civil Penalties Inflation Adjustment Act;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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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:
Sec. 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
----------------------------------------------------------------------------------------------------------------
Former Maximum Date of Adjusted Maximum
U.S.C. Section Description of Penalty Amount Assessment Method Last Penalty Amount
Violation (in dollars) Penalty (in dollars)
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(a) 21 U.S.C.
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(1) Violation of certain 50,000 For each of the 2004 55,000
333(b)(2)(A) requirements of the first two
Prescription Drug violations in any
Marketing Act (PDMA) 10-year period
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(2) Violation of certain 1,000,000 For each violation 2004 1,100,000
333(b)(2)(B) requirements of the after the second
PDMA conviction in any
10-year period
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(3) 333(b)(3) Violation of certain 100,000 Per violation 2004 110,000
requirements of the
PDMA
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(4) Violation of certain 15,000 Per violation 2004 16,500
333(f)(1)(A) requirements of the
Safe Medical Devices
Act (SMDA)
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(5) Violation of certain 1,000,000 For the aggregate 2004 1,100,000
333(f)(1)(A) requirements of the of violations
SMDA
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(6) Violation of certain 50,000 Per individual 2004 55,000
333(f)(2)(A) requirements of the
Food Quality
Protection Act of
1996 (FQPA)
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(7) Violation of certain 250,000 Per ``any other 2004 275,000
333(f)(2)(A) requirements of the person''
FQPA
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(8) Violation of certain 500,000 For all violations 2004 550,000
333(f)(2)(A) requirements of the adjudicated in a
FQPA single proceeding
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[[Page 49808]]
(9) 335b(a) Violation of certain 250,000 Per violation for 2004 275,000
requirements of the an individual
Generic Drug
Enforcement Act of
1992 (GDEA)
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(10) 335b(a) Violation of certain 1,000,000 Per violation for 2004 1,100,000
requirements of the ``any other
GDEA person''
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(11) Violation of certain 1,000 Per violation per 2004 1,100
360pp(b)(1) requirements of the person
Radiation Control for
Health and Safety Act
of 1968 (RCHSA)
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(12) Violation of certain 300,000 For any related 2004 330,000
360pp(b)(1) requirements of the series of
RCHSA violations
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(b) 42 U.S.C.
----------------------------------------------------------------------------------------------------------------
(1) 263b(h)(3) Violation of certain 10,000 Per violation 2004 11,000
requirements of the
Mammography Quality
Standards Act of 1992
and the Mammography
Quality Standards Act
of 1998
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(2) 300aa- Violation of certain 100,000 Per occurrence 2004 110,000
28(b)(1) requirements of the
National Childhood
Vaccine Injury Act of
1986
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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