Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act, 66750-66754 [E8-26866]
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Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations
TABLE 1—SERVICE INFORMATION—Continued
Airbus service information
Revision
Date
Service Bulletin A340–53–4165 ......................................................................................................
Original ......................
September 19, 2007.
Material Incorporated by Reference
Avenue, SW., Renton, Washington; or at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
(202) 741–6030, or go to: https://
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code_of_federal_regulations/
ibr_locations.html.
this service information under 5 U.S.C.
552(a) and 1 CFR part 51.
(2) For service information identified in
this AD, contact Airbus, 1 Rond Point
Maurice Bellonte, 31707 Blagnac Cedex,
France; telephone +33 5 61 93 33 33; Internet
https://www.airbus.com.
(3) You may review copies at the FAA,
Transport Airplane Directorate, 1601 Lind
(i) You must use the service information
specified in Table 2 of this AD to do the
actions required by this AD, unless the AD
specifies otherwise.
(1) The Director of the Federal Register
approved the incorporation by reference of
TABLE 2—MATERIAL INCORPORATED BY REFERENCE
Airbus service information
Revision
Date
Mandatory Service Bulletin A330–53–3160 ....................................................................................
Mandatory Service Bulletin A330–53–3168 ....................................................................................
Mandatory Service Bulletin A340–53–4172 ....................................................................................
Mandatory Service Bulletin A340–53–4174 ....................................................................................
Service Bulletin A330–53–3159 ......................................................................................................
Service Bulletin A340–53–4165 ......................................................................................................
Original ......................
01 ..............................
Original ......................
01 ..............................
Original ......................
Original ......................
July 9, 2007.
February 15, 2008.
July 10, 2007.
February 15, 2008.
September 19, 2007.
September 19, 2007.
Issued in Renton, Washington, on October
20, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E8–25787 Filed 11–10–08; 8:45 am]
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described
previously, in the ADDRESSES portion of
this document under Electronic
Submissions.
Instructions: All submissions received
must include the agency name and
Docket No. FDA–2008–N–0561 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
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and/or go to the Division of Dockets
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Dockets Management (see ADDRESSES)
written or electronic comments
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
[Docket No. FDA–2008–N–0561]
Maximum Civil Money Penalty
Amounts and Compliance With the
Federal Civil Penalties Inflation
Adjustment Act
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Direct final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing 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. The last adjustment was
published in the Federal Register of
July 20, 2004 (69 FR 43299), and the
FCPIAA requires Federal agencies to
adjust their civil money penalties at
least once every 4 years. This rule does
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not adjust the civil money provisions
enacted by the Food and Drug
Administration Amendments Act of
2007 (FDAAA). We are using direct final
rulemaking for this action because the
agency expects that there will be no
significant adverse comment on the
rule. In the proposed rule section of this
issue of the Federal Register, we are
concurrently proposing and soliciting
comments on this rule. If significant
adverse comments are received, we will
withdraw this final rule and address the
comments in a subsequent final rule.
FDA will not provide additional
opportunity for comment.
DATES: This rule is effective March 27,
2009, without further notice, unless
FDA receives significant adverse
comment by January 26, 2009. If we
receive no timely significant adverse
comments, we will publish a document
in the Federal Register before February
25, 2009, confirming the effective date
of the direct final rule. If we receive any
timely significant adverse comments,
we will publish a document in the
Federal Register withdrawing this
direct final rule before March 27, 2009.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2008–N–
0561, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
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Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations
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.
FOR FURTHER INFORMATION CONTACT: Erik
Mettler, Office of Policy (HF–11), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3360.
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SUPPLEMENTARY INFORMATION:
I. Background
In general, the FCPIAA (28 U.S.C.
2461 note, as amended by the Debt
Collection Improvement Act of 1996 (31
U.S.C. 3701)) 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’’(28 U.S.C.
2461 note, section 5(b)).
The FCPIAA also prescribes a
rounding method based on the size of
the penalty after the calculated increase,
but states that the first 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’’ (28 U.S.C.
2461 note, section 3(2)).
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.
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In the Federal Register of July 20,
2004 (69 FR 43299), we published a
final rule that identified 14 civil
monetary penalties that fall within our
jurisdiction and are subject to
adjustments under the FCPIAA. The
final rule amended our regulations
governing civil money penalties
hearings found at part 17 (21 CFR part
17) to establish a new § 17.2 entitled
‘‘Maximum penalty amounts’’ to show
the maximum civil monetary penalty
amounts that were adjusted under the
FCPIAA. The final rule also revised
§ 17.1, which lists statutory provisions
authorizing civil money penalties
governed by the civil money penalty
regulations as of August 28, 1995,
updating the statutory citations.
FDA is publishing this rule as a direct
final rule without prior proposal and
comment because we view this as a
noncontroversial amendment and
anticipate no significant adverse
comment. This rule incorporates
requirements specifically set forth in the
FCPIAA requiring FDA to issue a
regulation implementing inflation
adjustments for all its civil penalty
provisions. These technical changes,
required by law, do not substantively
alter the existing regulatory framework,
nor do they in any way affect the terms
under which civil penalties are assessed
by FDA. The formula for the amount of
the penalty adjustment is prescribed by
Congress in the FCPIAA, and these
changes are not subject to the exercise
of discretion by FDA. In addition, FDA
has made conforming changes to the
regulations, which have no substantive
effect, to reflect the new penalties
prescribed by Congress in FDAAA.
II. What Changes Did We Make?
We revised the list of statutory
monetary penalties in § 17.1 to include
the new penalties prescribed by the
Federal Food, Drug, and Cosmetic Act,
as amended by FDAAA in 2007. These
new penalties have been added as new
paragraphs (c) and (d). The table in
§ 17.2 has also been amended to include
the new penalties, and the adjusted
maximum penalty amounts for the preFDAAA penalties have been updated to
account for the inflation between June
2004 (the year of the last adjustment)
and June 2007 as prescribed by FCPIAA.
The per violation amount for 21 U.S.C.
333(f)(1)(A), the per violation per person
amount for 21 U.S.C. 360pp(b)(1), and
the per violation amount for 42 U.S.C.
263b(h)(3) have not been adjusted
because the rounding rules of FCPIAA
prevent an inflation adjustment in these
cases. The new FDAAA penalties have
also not been adjusted because Congress
only recently passed FDAAA on
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September 27, 2007. Finally, the
‘‘Description of the Violation’’ column
in the table in § 17.2 has been removed,
as it is unnecessary for purposes of
merely showing the adjustment in
penalty amounts.
III. What Does the Direct Final Rule
Do?
In brief, the direct final rule:
• Revises § 17.1 to update the
statutory citations regarding the new
civil monetary penalties prescribed by
FDAAA, and
• Revises the table in § 17.2 to
include the new FDAAA penalties, and
adjusts the pre-FDAAA maximum civil
penalty amounts for inflation as
prescribed by FCPIAA.
IV. 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.
V. Paperwork Reduction Act 1995
We conclude that the civil monetary
penalties adjustments in this final rule
are not subject to review 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.
VI. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
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, the
agency has 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.
VII. Analysis of Impacts
FDA has examined the impacts of the
final 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
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Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations
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). The agency
believes that this final rule is not a
significant regulatory action 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 final rule simply
adjusts the maximum amount of civil
monetary penalties administered by
FDA, and because the adjustment is
required by the FCPIAA, the agency
certifies that the final rule will not have
a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $130
million, using the most current (2007)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VIII. 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
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, 21 CFR part 17 is 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
redesignating paragraphs (c) through (g)
as paragraphs (e) through (i) and by
adding new paragraphs (c) and (d) to
read as follows:
■
§ 17.1
Scope.
*
*
*
*
*
(c) Section 303(f)(3) of the act
authorizing civil money penalties for
certain violations relating to the
submission of certifications and/or
clinical trial information to the clinical
trial data bank and section 303(f)(4) of
the act authorizing civil money
penalties for certain violations of the act
relating to postmarket studies, clinical
trial requirements, and risk evaluation
and mitigation strategies for drugs.
(d) Section 303(g)(1) of the act
authorizing civil money penalties for
certain violations of the act that relate
to dissemination of direct-to-consumer
advertisements for approved drugs or
biological products.
*
*
*
*
*
3. Section 17.2 is revised to read as
follows:
■
§ 17.2
Maximum penalty amounts.
The following table shows maximum
civil monetary penalties associated with
the statutory provisions authorizing
civil monetary penalties under the act or
the Public Health Service Act.
CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS
U.S.C. Section
Former Maximum
Penalty Amount
(in dollars)
Date of Last
Penalty Figure or
Adjustment
Assessment Method
Adjusted
Maximum
Penalty
Amount (in
dollars)
21 U.S.C.
55,000
For each of the first two violations in any 10-year period
2008
60,000
333(b)(2)(B)
1,100,000
For each violation after the second conviction in any 10year period
2008
1,200,000
333(b)(3)
110,000
Per violation
2008
120,000
333(f)(1)(A)
16,500
Per violation
2008
16,500 (not
adjusted)
333(f)(1)(A)
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333(b)(2)(A)
1,100,000
For the aggregate of violations
2008
1,200,000
333(f)(2)(A)
55,000
Per individual
2008
60,000
333(f)(2)(A)
275,000
Per ‘‘any other person’’
2008
300,000
333(f)(2)(A)
550,000
For all violations adjudicated in a single proceeding
2008
600,000
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66753
CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—
Continued
U.S.C. Section
Former Maximum
Penalty Amount
(in dollars)
Date of Last
Penalty Figure or
Adjustment
Assessment Method
Adjusted
Maximum
Penalty
Amount (in
dollars)
333(f)(3)(A)
10,000
For all violations adjudicated in a single proceeding
2007
10,000 (not
adjusted)
333(f)(3)(B)
10,000
For each day the violation is not corrected after a 30-day
period following notification until the violation is corrected
2007
10,000 (not
adjusted)
333(f)(4)(A)(i)
250,000
Per violation
2007
250,000
(not
adjusted)
333(f)(4)(A)(i)
1,000,000
For all violations adjudicated in a single proceeding
2007
1,000,000
(not
adjusted)
333(f)(4)(A)(ii)
250,000
For the first 30-day period (or any portion thereof) of
continued violation following notification
2007
250,000
(not
adjusted)
333(f)(4)(A)(ii)
1,000,000
For any 30-day period, where the amount doubles for
every 30-day period of continued violation after the
first 30-day period
2007
1,000,000
(not
adjusted)
333(f)(4)(A)(ii)
10,000,000
For all violations adjudicated in a single proceeding
2007
10,000,000
(not
adjusted)
333(g)(1)
250,000
For the first violation in any 3-year period
2007
250,000
(not
adjusted)
333(g)(1)
500,000
For each subsequent violation in any 3-year period
2007
500,000
(not
adjusted)
335b(a)
275,000
Per violation for an individual
2008
300,000
335b(a)
1,100,000
Per violation for ‘‘any other person’’
2008
1,200,000
360pp(b)(1)
1,100
Per violation per person
2008
1,100 (not
adjusted)
360pp(b)(1)
330,000
For any related series of violations
2008
355,000
263b(h)(3)
11,000
Per violation
2008
11,000 (not
adjusted)
300aa–28(b)(1)
110,000
Per occurrence
2008
120,000
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42 U.S.C.
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Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations
Dated: October 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–26866 Filed 11–12–08; 8:45 am]
DEPARTMENT OF DEFENSE
32 CFR Part 578
BILLING CODE 4160–01–S
Decorations, Medals, Ribbons, and
Similar Devices
Brenda S. Bowen,
Army Federal Register Liaison Officer.
[FR Doc. E8–26699 Filed 11–10–08; 8:45 am]
BILLING CODE 3710–08–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
21 CFR Part 101
[Docket No. FDA–2004–P–0205 (formerly
Docket No. 2004P–0464)]
Food Labeling: Health Claims; Calcium
and Osteoporosis, and Calcium,
Vitamin D, and Osteoporosis
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 appeared in the Federal
Register of Monday, September 29, 2008
(73 FR 56477). The final rule was
published with an inadvertent error in
the ‘‘Analysis of Economic Impacts’’
section. This document corrects that
error.
DATES: This correction is effective:
November 12, 2008.
FOR FURTHER INFORMATION CONTACT:
Jillonne Kevala, Office of Nutrition,
Labeling, and Dietary Supplements
(HFS–830), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1450.
SUPPLEMENTARY INFORMATION: In FR Doc.
E8–22730, appearing on page 56477 in
the Federal Register of September 29,
2008, the following correction is made:
1. On page 56481, in the second
column, starting in the forth line, the
sentence ‘‘Therefore, because of the
limited use of the current calcium and
osteoporosis health claim, the agency
certifies that the final rule will not have
a significant economic impact on a
substantial number of small entities.’’ is
corrected to read ‘‘Therefore, because of
the limited use of the current calcium
and osteoporosis health claim, the
agency believes that the final rule will
not have a significant economic impact
on a substantial number of small
entities.’’
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–26868 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
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Department of the Army
AGENCY:
Food and Drug Administration
Similar Devices, is removed in its
entirety.
Department of the Army, DOD.
DEPARTMENT OF COMMERCE
Final rule; removal.
SUMMARY: This action removes 32 CFR
Part 578, Decorations, Medals, Ribbons,
and Similar Devices. The Department of
the Army has determined that the rules
prescribing policy and criteria for
military awards and the administrative
instructions for processing military
awards are not required to be published
in the Code of Federal Regulations
(CFR) because they are not generally
applicable and have no legal effect per
44 U.S.C. 1505.
DATES:
Effective date November 12,
2008.
U.S. Army Human
Resources Command, ATTN: AHRC–
PDP–A, 200 Stovall Street, Alexandria,
VA 22332–0471.
ADDRESSES:
Mr.
Les Plooster, Policy Section, Military
Awards Branch, 703–325–4761.
FOR FURTHER INFORMATION CONTACT:
The
Deputy Chief of Staff, G–1, is the
proponent for the regulation represented
in 32 CFR Part 578. The objective of the
Department of the Army Military
Awards Program is to provide tangible
recognition for acts of valor, exceptional
service or achievement, special skills or
qualifications, and acts of heroism not
involving actual combat.
Implementation of the program is a
command responsibility, with the goal
of fostering mission accomplishment by
recognizing excellence of both military
and civilian members of the force and
motivating them to high levels of
performance and service. As such, the
program does not have the general
applicability and legal effect required to
publish rules pertaining to this program
in the Code of Federal Regulations.
SUPPLEMENTARY INFORMATION:
List of Subjects in 32 CFR Part 578
Decorations, Medals, Awards,
Military Personnel.
PART 578—[REMOVED]
Accordingly, for reasons stated in the
preamble, under the authority of Sec.
3012, Public Law 84–1028, 70A Stat.
157, and 10 U.S.C. 3013, 32 CFR Part
578, Decorations, Medals, Ribbons, and
■
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United States Patent and Trademark
Office
37 CFR Part 1
RIN 0651–AC28
[Docket No.: PTO–P–2008–0023]
Fiscal Year 2009 Changes to Patent
Cooperation Treaty Transmittal and
Search Fees
United States Patent and
Trademark Office, Commerce.
AGENCY:
ACTION:
Final rule.
SUMMARY: The United States Patent and
Trademark Office (Office) is amending
the rules of practice to adjust the
transmittal and search fees for
international applications filed under
the Patent Cooperation Treaty (PCT).
The Office is adjusting the PCT
transmittal and search fees to recover
the estimated average cost to the Office
of processing PCT international
applications and preparing international
search reports and written opinions for
PCT international applications.
Effective Date: The changes to 37
CFR 1.445 are effective on January 12,
2009 and are applicable to any
international application having a
receipt date that is on or after January
12, 2009.
DATES:
FOR FURTHER INFORMATION CONTACT:
Boris Milef, Legal Examiner, Office of
PCT Legal Administration, Office of the
Deputy Commissioner for Patent
Examination Policy, by telephone at
(571) 272–3288; or by mail addressed to:
Box Comments Patents, Commissioner
for Patents, P.O. Box 1450, Alexandria,
VA 22313–1450.
The PCT
enables United States applicants to file
one application (a PCT international
application) in a standardized format in
English in a Receiving Office (either the
United States Patent and Trademark
Office or the International Bureau of the
World Intellectual Property
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Rules and Regulations]
[Pages 66750-66754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26866]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
[Docket No. FDA-2008-N-0561]
Maximum Civil Money Penalty Amounts and Compliance With the
Federal Civil Penalties Inflation Adjustment Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing 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.
The last adjustment was published in the Federal Register of July 20,
2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust
their civil money penalties at least once every 4 years. This rule does
not adjust the civil money provisions enacted by the Food and Drug
Administration Amendments Act of 2007 (FDAAA). We are using direct
final rulemaking for this action because the agency expects that there
will be no significant adverse comment on the rule. In the proposed
rule section of this issue of the Federal Register, we are concurrently
proposing and soliciting comments on this rule. If significant adverse
comments are received, we will withdraw this final rule and address the
comments in a subsequent final rule. FDA will not provide additional
opportunity for comment.
DATES: This rule is effective March 27, 2009, without further notice,
unless FDA receives significant adverse comment by January 26, 2009. If
we receive no timely significant adverse comments, we will publish a
document in the Federal Register before February 25, 2009, confirming
the effective date of the direct final rule. If we receive any timely
significant adverse comments, we will publish a document in the Federal
Register withdrawing this direct final rule before March 27, 2009.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0561, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No. FDA-2008-N-0561 for this rulemaking. All comments
received may be posted without change to https://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Interested persons may submit to the Division of Dockets
Management (see ADDRESSES) written or electronic comments
[[Page 66751]]
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.
FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
In general, the FCPIAA (28 U.S.C. 2461 note, as amended by the Debt
Collection Improvement Act of 1996 (31 U.S.C. 3701)) 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''(28 U.S.C.
2461 note, section 5(b)).
The FCPIAA also prescribes a rounding method based on the size of
the penalty after the calculated increase, but states that the first
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'' (28
U.S.C. 2461 note, section 3(2)).
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.
In the Federal Register of July 20, 2004 (69 FR 43299), we
published a final rule that identified 14 civil monetary penalties that
fall within our jurisdiction and are subject to adjustments under the
FCPIAA. The final rule amended our regulations governing civil money
penalties hearings found at part 17 (21 CFR part 17) to establish a new
Sec. 17.2 entitled ``Maximum penalty amounts'' to show the maximum
civil monetary penalty amounts that were adjusted under the FCPIAA. The
final rule also revised Sec. 17.1, which lists statutory provisions
authorizing civil money penalties governed by the civil money penalty
regulations as of August 28, 1995, updating the statutory citations.
FDA is publishing this rule as a direct final rule without prior
proposal and comment because we view this as a noncontroversial
amendment and anticipate no significant adverse comment. This rule
incorporates requirements specifically set forth in the FCPIAA
requiring FDA to issue a regulation implementing inflation adjustments
for all its civil penalty provisions. These technical changes, required
by law, do not substantively alter the existing regulatory framework,
nor do they in any way affect the terms under which civil penalties are
assessed by FDA. The formula for the amount of the penalty adjustment
is prescribed by Congress in the FCPIAA, and these changes are not
subject to the exercise of discretion by FDA. In addition, FDA has made
conforming changes to the regulations, which have no substantive
effect, to reflect the new penalties prescribed by Congress in FDAAA.
II. What Changes Did We Make?
We revised the list of statutory monetary penalties in Sec. 17.1
to include the new penalties prescribed by the Federal Food, Drug, and
Cosmetic Act, as amended by FDAAA in 2007. These new penalties have
been added as new paragraphs (c) and (d). The table in Sec. 17.2 has
also been amended to include the new penalties, and the adjusted
maximum penalty amounts for the pre-FDAAA penalties have been updated
to account for the inflation between June 2004 (the year of the last
adjustment) and June 2007 as prescribed by FCPIAA. The per violation
amount for 21 U.S.C. 333(f)(1)(A), the per violation per person amount
for 21 U.S.C. 360pp(b)(1), and the per violation amount for 42 U.S.C.
263b(h)(3) have not been adjusted because the rounding rules of FCPIAA
prevent an inflation adjustment in these cases. The new FDAAA penalties
have also not been adjusted because Congress only recently passed FDAAA
on September 27, 2007. Finally, the ``Description of the Violation''
column in the table in Sec. 17.2 has been removed, as it is
unnecessary for purposes of merely showing the adjustment in penalty
amounts.
III. What Does the Direct Final Rule Do?
In brief, the direct final rule:
Revises Sec. 17.1 to update the statutory citations
regarding the new civil monetary penalties prescribed by FDAAA, and
Revises the table in Sec. 17.2 to include the new FDAAA
penalties, and adjusts the pre-FDAAA maximum civil penalty amounts for
inflation as prescribed by FCPIAA.
IV. 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.
V. Paperwork Reduction Act 1995
We conclude that the civil monetary penalties adjustments in this
final rule are not subject to review 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.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has 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, the agency has 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.
VII. Analysis of Impacts
FDA has examined the impacts of the final 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
[[Page 66752]]
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). The agency
believes that this final rule is not a significant regulatory action
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 final rule simply adjusts the maximum
amount of civil monetary penalties administered by FDA, and because the
adjustment is required by the FCPIAA, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VIII. 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
List of Subjects in 21 CFR Part 17
Administrative practice and procedure, Penalties.
0
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, 21 CFR part 17 is amended as follows:
PART 17--CIVIL MONEY PENALTIES HEARINGS
0
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.
0
2. Section 17.1 is amended by redesignating paragraphs (c) through (g)
as paragraphs (e) through (i) and by adding new paragraphs (c) and (d)
to read as follows:
Sec. 17.1 Scope.
* * * * *
(c) Section 303(f)(3) of the act authorizing civil money penalties
for certain violations relating to the submission of certifications
and/or clinical trial information to the clinical trial data bank and
section 303(f)(4) of the act authorizing civil money penalties for
certain violations of the act relating to postmarket studies, clinical
trial requirements, and risk evaluation and mitigation strategies for
drugs.
(d) Section 303(g)(1) of the act authorizing civil money penalties
for certain violations of the act that relate to dissemination of
direct-to-consumer advertisements for approved drugs or biological
products.
* * * * *
0
3. Section 17.2 is revised 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 act or the Public Health Service Act.
Civil Monetary Penalties Authorities Administered by FDA and Adjusted
Maximum Penalty Amounts
------------------------------------------------------------------------
Former Adjusted
Maximum Date of Last Maximum
U.S.C. Penalty Assessment Penalty Figure Penalty
Section Amount (in Method or Adjustment Amount (in
dollars) dollars)
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21 U.S.C.
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333(b)(2 55,000 For each of the 2008 60,000
)(A) first two
violations in
any 10-year
period
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333(b)(2 1,100,000 For each 2008 1,200,000
)(B) violation after
the second
conviction in
any 10-year
period
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333(b)(3 110,000 Per violation 2008 120,000
)
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333(f)(1 16,500 Per violation 2008 16,500 (not
)(A) adjusted)
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333(f)(1 1,100,000 For the 2008 1,200,000
)(A) aggregate of
violations
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333(f)(2 55,000 Per individual 2008 60,000
)(A)
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333(f)(2 275,000 Per ``any other 2008 300,000
)(A) person''
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333(f)(2 550,000 For all 2008 600,000
)(A) violations
adjudicated in
a single
proceeding
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[[Page 66753]]
333(f)(3 10,000 For all 2007 10,000 (not
)(A) violations adjusted)
adjudicated in
a single
proceeding
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333(f)(3 10,000 For each day the 2007 10,000 (not
)(B) violation is adjusted)
not corrected
after a 30-day
period
following
notification
until the
violation is
corrected
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333(f)(4 250,000 Per violation 2007 250,000
)(A)(i) (not
adjusted)
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333(f)(4 1,000,000 For all 2007 1,000,000
)(A)(i) violations (not
adjudicated in adjusted)
a single
proceeding
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333(f)(4 250,000 For the first 30- 2007 250,000
)(A)(ii day period (or (not
) any portion adjusted)
thereof) of
continued
violation
following
notification
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333(f)(4 1,000,000 For any 30-day 2007 1,000,000
)(A)(ii period, where (not
) the amount adjusted)
doubles for
every 30-day
period of
continued
violation after
the first 30-
day period
------------------------------------------------------------------------
333(f)(4 10,000,000 For all 2007 10,000,000
)(A)(ii violations (not
) adjudicated in adjusted)
a single
proceeding
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333(g)(1 250,000 For the first 2007 250,000
) violation in (not
any 3-year adjusted)
period
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333(g)(1 500,000 For each 2007 500,000
) subsequent (not
violation in adjusted)
any 3-year
period
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335b(a) 275,000 Per violation 2008 300,000
for an
individual
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335b(a) 1,100,000 Per violation 2008 1,200,000
for ``any other
person''
------------------------------------------------------------------------
360pp(b) 1,100 Per violation 2008 1,100 (not
(1) per person adjusted)
------------------------------------------------------------------------
360pp(b) 330,000 For any related 2008 355,000
(1) series of
violations
------------------------------------------------------------------------
42 U.S.C.
------------------------------------------------------------------------
263b(h)( 11,000 Per violation 2008 11,000 (not
3) adjusted)
------------------------------------------------------------------------
300aa-28 110,000 Per occurrence 2008 120,000
(b)(1)
------------------------------------------------------------------------
[[Page 66754]]
Dated: October 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26866 Filed 11-12-08; 8:45 am]
BILLING CODE 4160-01-S
