[Federal Register Volume 69, Number 155 (Thursday, August 12, 2004)]
[Rules and Regulations]
[Pages 49807-49808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18407]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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)
----------------------------------------------------------------------------------------------------------------
(a) 21 U.S.C.
----------------------------------------------------------------------------------------------------------------
  (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
----------------------------------------------------------------------------------------------------------------
  (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
----------------------------------------------------------------------------------------------------------------
  (3) 333(b)(3)   Violation of certain        100,000        Per violation               2004      110,000
                   requirements of the
                   PDMA
----------------------------------------------------------------------------------------------------------------
  (4)             Violation of certain         15,000        Per violation               2004       16,500
   333(f)(1)(A)    requirements of the
                   Safe Medical Devices
                   Act (SMDA)
----------------------------------------------------------------------------------------------------------------
  (5)             Violation of certain      1,000,000        For the aggregate           2004    1,100,000
   333(f)(1)(A)    requirements of the                        of violations
                   SMDA
----------------------------------------------------------------------------------------------------------------
  (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)
----------------------------------------------------------------------------------------------------------------
  (7)             Violation of certain        250,000        Per ``any other             2004      275,000
   333(f)(2)(A)    requirements of the                        person''
                   FQPA
----------------------------------------------------------------------------------------------------------------
  (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
----------------------------------------------------------------------------------------------------------------

[[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)
----------------------------------------------------------------------------------------------------------------
  (10) 335b(a)    Violation of certain      1,000,000        Per violation for           2004    1,100,000
                   requirements of the                        ``any other
                   GDEA                                       person''
----------------------------------------------------------------------------------------------------------------
  (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)
----------------------------------------------------------------------------------------------------------------
  (12)            Violation of certain        300,000        For any related             2004      330,000
   360pp(b)(1)     requirements of the                        series of
                   RCHSA                                      violations
----------------------------------------------------------------------------------------------------------------
(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
----------------------------------------------------------------------------------------------------------------
  (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
----------------------------------------------------------------------------------------------------------------


    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