[Federal Register: December 1, 2003 (Volume 68, Number 230)]
[Proposed Rules]
[Page 67094-67097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de03-23]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 67094]]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing a new
regulation to adjust for inflation the maximum civil money penalty
amounts for the various civil money penalty authorities within our
jurisdiction. We are taking this action to comply with the Federal
Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended.
DATES: Submit written or electronic comments by February 17, 2004.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0587.
SUPPLEMENTARY INFORMATION:
I. Why Are We Revising Our Civil Money Penalty Rules?
In general, the FCPIAA (28 U.S.C. 2461, as amended by the Debt
Collection Improvement Act of 1996) requires Federal agencies to issue
regulations to adjust for inflation each civil monetary penalty
provided by law within their jurisdiction. The FCPIAA directs agencies
to adjust the civil monetary penalties by October 23, 1996, and to make
additional adjustments at least once every 4 years thereafter. The
adjustments are based on changes in the cost of living, and the FCPIAA
defines the cost of living adjustment as:
* * * the percentage (if any) for each civil monetary penalty by
which--
(1) the Consumer Price Index for the month of June of the
calendar year preceding the adjustment, exceeds
(2) the Consumer Price Index for the month of June of the
calendar year in which the amount of such civil monetary penalty was
last set or adjusted pursuant to law.
The FCPIAA also prescribes a rounding method based on the amount of
the calculated increases, but states that the initial adjustment of a
civil monetary penalty may not exceed 10 percent of the penalty.
The FCPIAA defines a civil monetary penalty as:
* * * any penalty, fine, or other sanction that--
(A)(i) is for a specific monetary amount as provided by Federal
law; or
(ii) has a maximum amount provided for by Federal law; and
(B) is assessed or enforced by an agency pursuant to Federal
law; and
(C) is assessed or enforced pursuant to an administrative
proceeding or a civil action in the Federal Courts * * *.
Congress enacted the FCPIAA, in part, because it found that the
impact of civil monetary penalties had been reduced by inflation and
that reducing the impact of civil monetary penalties had weakened their
deterrent effect.
We have identified 14 civil monetary penalties that fall within our
jurisdiction and are subject to adjustments under the FCPIAA. The
following table lists those penalties, their maximum penalty amounts,
assessment methods, the dates that the penalties were last set or
adjusted, and the adjusted penalty amount. The affected civil monetary
penalties provisions are sections 303, 307, and 539 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 333, 335b, and 360pp)
and sections 354 and 2128 of the Public Health Service Act (PHS Act)
(42 U.S.C. 263b and 300aa-28).
Table 1.--Civil Monetary Penalties Authorities Administered by FDA and
Adjusted Maximum Penalty Amounts
------------------------------------------------------------------------
Current Date of Adjusted
Maximum Last Maximum
U.S.C. Description Penalty Assessment Penalty Penalty
Section of Violation Amount (in Method Figure or Amount (in
dollars) Adjustment dollars)
------------------------------------------------------------------------
21 U.S.C.
------------------------------------------------------------------------
333(b) Violation of 50,000 For each 1988 55,000
(2)(A certain of the
) requirements first two
of the violation
Prescription s in any
Drug 10-year
Marketing period
Act (PDMA)
------------------------------------------------------------------------
333(b) Violation of 1,000,000 For each 1988 1,100,000
(2)(B certain violation
) requirements after the
of the PDMA second
convictio
n in any
10-year
period
------------------------------------------------------------------------
333(b) Violation of 100,000 Per 1988 110,000
(3) certain violation
requirements
of the PDMA
------------------------------------------------------------------------
333(f) Violation of 15,000 Per 1990 15,000
(1)(A certain violation
) requirements
of the Safe
Medical
Devices Act
(SMDA)
------------------------------------------------------------------------
[[Page 67095]]
333(f) Violation of 1,000,000 For the 1990 1,100,000
(1)(A certain aggregate
) requirements of
of the SMDA violation
s
------------------------------------------------------------------------
333(f) Violation of 50,000 Per 1996 55,000
(2)(A certain individua
) requirements l
of the Food
Quality
Protection
Act of 1996
(FQPA)
------------------------------------------------------------------------
333(f) Violation of 250,000 Per ``any 1996 275,000
(2)(A certain other
) requirements person''
of the FQPA
------------------------------------------------------------------------
333(f) Violation of 500,000 For all 1996 550,000
(2)(A certain violation
) requirements s
of the FQPA adjudicat
ed in a
single
proceedin
g
------------------------------------------------------------------------
335b(a Violation of 250,000 Per 1992 275,000
) certain violation
requirements for an
of the individua
Generic Drug l
Enforcement
Act of 1992
(GDEA)
------------------------------------------------------------------------
335b(a Violation of 1,000,000 Per 1992 1,100,000
) certain violation
requirements for ``any
of the GDEA other
person''
------------------------------------------------------------------------
360pp( Violation of 1,000 Per 1968 1,000
b)(1) certain violation
requirements per
of the person
Radiation
Control for
Health and
Safety Act
of 1968
(RCHSA)
------------------------------------------------------------------------
360pp( Violation of 300,000 For any 1968 325,000
b)(1) certain related
requirements series of
of the RCHSA violation
s
------------------------------------------------------------------------
42 U.S.C.
------------------------------------------------------------------------
263b(h Violation of 10,000 Per 1992 10,000
)(3) certain violation
requirements
of the
Mammography
Quality
Standards
Act of 1992
and the
Mammography
Quality
Standards
Act of 1998
------------------------------------------------------------------------
300aa- Violation of 100,000 Per 1986 110,000
28(b) certain occurrenc
(1) requirements e
of the
National
Childhood
Vaccine
Injury Act
of 1986
------------------------------------------------------------------------
In several cases, the adjusted civil monetary penalty was subject
to the FCPIAA's provision restricting the initial adjustment to no more
than 10 percent of the penalty. In several other cases, the adjusted
civil monetary penalty did not change from the current civil monetary
penalty.
II. What Would the Proposed Rule Do?
The proposal would amend our civil money penalties hearing
regulations in part 17 (21 CFR part 17) to establish a new Sec. 17.2,
entitled ``Maximum Penalty Amounts,'' to show the current maximum civil
monetary penalty amounts that were adjusted under the FCPIAA. Proposed
Sec. 17.2 would be similar to the table shown in section I of this
document, except that the proposal would use a yet-to-be-determined
date as the ``Date of Last Penalty Figure or Adjustment'' because that
date would reflect a final rule's effective date and, at this time, we
cannot predict when we would issue a final rule.
We would revise the table in Sec. 17.2, as required by the FCPIAA,
at least once every 4 years.
The proposal would also revise Sec. 17.1 which lists, in part,
statutory provisions that authorize civil money penalties that are
governed by the civil money penalty regulations. The proposed revision
would simply update the statutory citations because some provisions
have been renumbered since the last time we amended Sec. 17.1.
We also note that section 351(d)(2) of the PHS Act (42 U.S.C.
262(d)(2)) authorizes a civil monetary penalty for certain violations
of the PHS Act. We have omitted section 351(d)(2) of the PHS Act from
this proposal because, unlike the other civil monetary penalty
provisions, section 351(d)(2) of the PHS Act is self-adjusting so that
the maximum civil monetary penalty amount increases annually. Section
351(d)(2) of the PHS Act, when first enacted in 1986, provided for a
maximum civil penalty of up to $100,000 per day of violation. By using
the adjustment formula prescribed in section 351(d)(2) of the PHS Act,
we calculate the adjusted maximum civil penalty amount for section
351(d)(2) of the PHS Act to be $151,637.28 per day of violation.
III. Environmental Impact
We have determined under 21 CFR 25.30(a) and (h) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Paperwork Reduction Act 1995
We tentatively conclude that the civil monetary penalties
adjustments in this proposed rule are not subject to review
[[Page 67096]]
by the Office of Management and Budget because they do not constitute a
``collection of information'' under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The adjustments do not require disclosure of any
information to FDA, third parties, or the public.
V. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, we have concluded that
the rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.
VI. Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
order and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule would simply adjust the
maximum amount of civil monetary penalties administered by FDA, and
because the adjustment is required by the FCPIAA, we certify that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
VII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 17
Administrative practice and procedure, Penalties.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 17 be
amended as follows:
PART 17--CIVIL MONEY PENALTIES HEARINGS
1. The authority citation for 21 CFR part 17 continues to read as
follows:
Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.
2. Section 17.1 is amended by revising paragraph (a), redesignating
paragraphs (d) through (f) as paragraphs (e) through (g), adding new
paragraph (d), and revising newly redesignated paragraphs (e), (f), and
(g) to read as follows:
Sec. 17.1 Scope.
* * * * *
(a) Section 303(b)(2) and (b)(3) of the Federal Food, Drug, and
Cosmetic Act (the act) authorizing civil money penalties for certain
violations of the act that relate to prescription drug marketing
practices.
* * * * *
(d) Section 539(b)(1) of the act authorizing civil money penalties
for certain violations of the act that relate to electronic products.
(e) Section 351(d)(2) of the Public Health Service Act (the PHS
Act) authorizing civil money penalties for violations of biologic
recall orders.
(f) Section 354(h)(3) of the PHS Act, as amended by the Mammography
Quality Standards Act of 1992 and the Mammography Quality Standards Act
of 1998, authorizing civil money penalties for failure to obtain a
certificate and failure to comply with established standards, among
other things.
(g) Section 2128(b)(1) of the PHS Act authorizing civil money
penalties for intentionally destroying, altering, falsifying, or
concealing any record or report required to be prepared, maintained, or
submitted by vaccine manufacturers under section 2128 of the PHS Act.
3. Section 17.2 is added to read as follows:
Sec. 17.2 Maximum penalty amounts.
The following table shows maximum civil monetary penalties
associated with the statutory provisions authorizing civil monetary
penalties under the Federal Food, Drug, and Cosmetic Act or the Public
Health Service Act.
Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
----------------------------------------------------------------------------------------------------------------
Current Adjusted
Maximum Date of Last Maximum
U.S.C. Section Description of Violation Penalty Assessment Method Penalty Penalty
Amount (in Figure or Amount (in
dollars) Adjustment\1\ dollars)
----------------------------------------------------------------------------------------------------------------
(a) 21 U.S.C.
----------------------------------------------------------------------------------------------------------------
(1) 333(b)(2)(A) Violation of certain 50,000 For each of the first ---- 55,000
requirements of the two violations in any
Prescription Drug 10-year period
Marketing Act (PDMA)
----------------------------------------------------------------------------------------------------------------
(2) 333(b)(2)(B) Violation of certain 1,000,000 For each violation ---- 1,100,000
requirements of the PDMA after the second
conviction in any 10-
year period
----------------------------------------------------------------------------------------------------------------
[[Page 67097]]
(3) 333(b)(3) Violation of certain 100,000 Per violation ---- 110,000
requirements of the PDMA
----------------------------------------------------------------------------------------------------------------
(4) 333(f)(1)(A) Violation of certain 15,000 Per violation ---- 15,000
requirements of the Safe
Medical Devices Act
(SMDA)
----------------------------------------------------------------------------------------------------------------
(5) 333(f)(1)(A) Violation of certain 1,000,000 For the aggregate of ---- 1,100,000
requirements of the SMDA violations
----------------------------------------------------------------------------------------------------------------
(6) 333(f)(2)(A) Violation of certain 50,000 Per individual ---- 55,000
requirements of the Food
Quality Protection Act of
1996 (FQPA)
----------------------------------------------------------------------------------------------------------------
(7) 333(f)(2)(A) Violation of certain 250,000 Per ``any other ---- 275,000
requirements of the FQPA person''
----------------------------------------------------------------------------------------------------------------
(8) 333(f)(2)(A) Violation of certain 500,000 For all violations ---- 550,000
requirements of the FQPA adjudicated in a
single proceeding
----------------------------------------------------------------------------------------------------------------
(9) 335b(a) Violation of certain 250,000 Per violation for an ---- 275,000
requirements of the individual
Generic Drug Enforcement
Act of 1992 (GDEA)
----------------------------------------------------------------------------------------------------------------
(10) 335b(a) Violation of certain 1,000,000 Per violation for ``any ---- 1,100,000
requirements of the GDEA other person''
----------------------------------------------------------------------------------------------------------------
(11) 360pp(b)(1) Violation of certain 1,000 Per violation per ---- 1,000
requirements of the person
Radiation Control for
Health and Safety Act of
1968 (RCHSA)
----------------------------------------------------------------------------------------------------------------
(12) 360pp(b)(1) Violation of certain 300,000 For any related series ---- 325,000
requirements of the RCHSA of violations
----------------------------------------------------------------------------------------------------------------
(b) 42 U.S.C.
----------------------------------------------------------------------------------------------------------------
(1) 263b(h)(3) Violation of certain 10,000 Per violation ---- 10,000
requirements of the
Mammography Quality
Standards Act of 1992 and
the Mammography Quality
Standards Act of 1998
----------------------------------------------------------------------------------------------------------------
(2) 300aa-28(b)(1) Violation of certain 100,000 Per occurrence ---- 110,000
requirements of the
National Childhood
Vaccine Injury Act of
1986
----------------------------------------------------------------------------------------------------------------
\1\ Dates to-be-determined by the effective date of a final rule.
Dated: October 11, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29741 Filed 11-28-03; 8:45 am]
BILLING CODE 4160-01-S