Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints, 6112-6116 [2014-02149]
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6112
Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Proposed Rules
provisions. We are taking this action in
response to requests for an extension to
allow interested persons more time to
comment given that in addition to the
proposed preventive control
requirements, the proposed current
good manufacturing practice (CGMP)
requirements are also new to the animal
food industry, unlike the human food
industry.
We also are taking this action to keep
the comment period for the information
collection provisions associated with
the rule consistent with the comment
period for the proposed rule.
DATES: FDA is extending the comment
period on the proposed rule and its
information collection provisions.
Submit either electronic or written
comments on the proposed rule and the
information collection by March 31,
2014.
You may submit comments,
identified by Docket No. FDA–2011–N–
0922 and/or Regulatory Information
Number (RIN) 0910–AG10, by any of the
following methods, except that
comments on information collection
issues under the PRA must be submitted
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget (OMB) (see the
‘‘Paperwork Reduction Act of 1995’’
section of this document).
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Written Submissions
Submit written submissions in the
following ways:
Mail/Hand delivery/Courier (for paper
submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name, Docket
No. FDA–2011–N–0922, and RIN 0910–
AG10 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 ‘‘Request for
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, found in brackets in the
heading of this document, into the
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‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to the proposed rule: Kim
Young, Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–2207.
With regard to the information
collection: Domini Bean, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400T, Rockville, MD 20850,
Domini.Bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 29,
2013, we published a proposed rule
entitled ‘‘Current Good Manufacturing
Practice and Hazard Analysis and RiskBased Preventive Controls for Food for
Animals’’ with a 120-day comment
period on the provisions of the
proposed rule and on the information
collection provisions that are subject to
review by OMB under the PRA (44
U.S.C. 3501–3520).
FDA has received requests for an
extension of the comment period on the
proposed rule. The requests conveyed
concern that the current 120-day
comment period does not allow time to
develop a meaningful response to the
proposed rule because, unlike the
human food industry, in addition to the
proposed preventive controls, the
proposed CGMPs are new to the animal
food industry. The requests also stated
an extended comment period would
allow interested persons an opportunity
to consider the interrelationship
between this proposed rule and the
proposed rules entitled ‘‘Foreign
Supplier Verification Programs for
Importers of Food for Humans and
Animals’’ (78 FR 45729, July 29, 2013)
and ‘‘Accreditation of Third-Party
Auditors/Certification Bodies to
Conduct Food Safety Audits and to
Issue Certifications’’ (78 FR 45782, July
29, 2013). FDA has considered the
requests and is granting an extension of
the comment period to March 31, 2014,
for the ‘‘Current Good Manufacturing
Practice and Hazard Analysis and RiskBased Preventive Controls for Food for
Animals’’ proposed rule to allow
interested persons additional time to
submit comments. We also are
extending the comment period for the
information collection provisions to
March 31, 2014, to make the comment
period for the information collection
provisions the same as the comment
period for the provisions of the
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proposed rule. To clarify, FDA is
requesting comment on all issues raised
by the proposed rule.
II. Paperwork Reduction Act of 1995
Interested persons may either submit
electronic comments regarding the
information collection to oira_
submission@omb.eop.gov or fax written
comments to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285. All
comments should be identified with the
title ‘‘Current Good Manufacturing
Practice and Hazard Analysis and RiskBased Preventive Controls for Food for
Animals.’’
III. Request for Comments
Interested persons may submit either
electronic comments regarding the
proposed rule to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments 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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02111 Filed 1–31–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
[Docket No. FDA–2014–N–0113]
Maximum Civil Money Penalty
Amounts; Civil Money Penalty
Complaints
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is publishing this
companion proposed rule to the direct
final rule, issuing a new regulation to
adjust for inflation the maximum civil
money penalty (CMP) amounts for the
various CMP authorities within our
jurisdiction and to amend the process
for initiating certain CMP administrative
actions. We are taking these actions to
comply with the Federal Civil Penalties
Inflation Adjustment Act of 1990
SUMMARY:
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Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Proposed Rules
(FCPIAA), as amended, and to
streamline our internal processes. The
last CMP adjustment was published in
the Federal Register of November 12,
2008, and the FCPIAA requires Federal
Agencies to adjust their CMPs at least
once every 4 years. We are using direct
final rulemaking for these actions
because the Agency expects that there
will be no significant adverse comment
on the rule.
DATES: Submit either electronic or
written comments on the proposed rule
by April 21, 2014. If FDA receives any
significant adverse comments, the
Agency will publish a document in the
Federal Register withdrawing the direct
final rule within 30 days after the
comment period ends. FDA will then
proceed to respond to comments under
this proposed rule using the usual
notice and comment procedures.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2014–N–
0113, 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.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2014–N–0113 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, 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.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 301–796–4830.
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The last
CMP adjustment was published in the
Federal Register of November 12, 2008
(73 FR 66750).
SUPPLEMENTARY INFORMATION:
I. Background
A. CMP Amounts
FDA is amending § 17.2 (21 CFR 17.2)
to update the maximum CMP amounts.
In general, FCPIAA requires Federal
Agencies to issue regulations to adjust
for inflation each CMP provided by law
within their jurisdiction. (28 U.S.C.
2461 note, as amended by the Debt
Collection Improvement Act of 1996 (31
U.S.C. 3701)). FCPIAA directs Agencies
to adjust the CMP provided by law 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 the
Consumer Price Index for the month of
June of the calendar year preceding the
adjustment, exceeds 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)).
FCPIAA also prescribes a rounding
method based on the size of the penalty
after the calculated increase, but states
that the adjustment of a CMP may not
exceed 10 percent of the penalty.
FCPIAA defines a CMP as any penalty,
fine, or other sanction that is for a
specific monetary amount as provided
by Federal law, or has a maximum
amount provided for by Federal law,
and is assessed or enforced by an agency
pursuant to Federal law, and 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)).
B. CMP Complaints
Currently, under § 17.5(a) (21 CFR
17.5(a)), CMP complaints against
retailers of tobacco products may only
be signed by attorneys in FDA’s Office
of the Chief Counsel (OCC). Given the
routine nature of many of these CMPs,
FDA is amending this regulation to
permit the Chief Counsel to designate
other FDA staff, such as those in FDA’s
Center for Tobacco Products, to sign a
tobacco retailer CMP complaint.
Based on FDA’s experience, the large
majority of the tobacco retailer
complaints to date have involved
alleged violations of the requirement to
not sell cigarettes and smokeless
tobacco to any person younger than 18
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6113
years of age or to verify age in
accordance with 21 CFR 1140.14(b).
These complaints have almost always
been straightforward, they involve
simple fact patterns, and they do not
require a complex legal analysis. Over
time, such CMP complaints have
increased in volume, and we anticipate
that the volume will continue to be
relatively high.
We have determined that, with certain
limitations and controls, non-attorney
staff outside OCC can carry out the
function of reviewing the evidence and
signing the tobacco retailer CMP
complaints in appropriate
circumstances. The proposed
amendment to § 17.5(a) would give this
decisionmaking authority to the Chief
Counsel, who could ensure the
authority to sign complaints is only
given to appropriate staff and under
appropriate circumstances. Under the
proposal, the Chief Counsel would have
the authority to set and revise
limitations and controls, and to
broaden, limit, or rescind any
authorizations to sign tobacco retailer
CMP complaints.
The limitations could include, for
example, limiting the delegation to
situations where the CMP amount is
below a certain dollar value; the CMP
involves specified tobacco retailer
charges that OCC has determined are
routine and predictable and do not
require a complex legal analysis; and
involve charges for which FDA has
developed OCC-approved templates,
parameters, and procedures. The
controls could include, for example, an
audit or other quality review.
This proposed rule incorporates
requirements specifically set forth in the
FCPIAA requiring FDA to issue a
regulation implementing inflation
adjustments for all its CMP 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 CMPs 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. The amendment to § 17.5(a)
changes an internal process.
This proposed rule is a companion to
the direct final rule published elsewhere
in this issue of the Federal Register.
This companion proposed rule and the
direct final rule are identical in
substance. This companion proposed
rule will provide the procedural
framework to proceed with standard
notice-and-comment rulemaking in the
event the direct final rule receives
significant adverse comment and is
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withdrawn. The comment period for the
companion proposed rule runs
concurrently with the comment period
of the direct final rule. Any comments
received under the companion proposed
rule will be treated as comments
regarding the direct final rule and vice
versa.
A significant adverse comment is one
that explains why the rule would be
inappropriate, including challenges to
the rule’s underlying premise or
approach, or would be ineffective or
unacceptable without change. A
comment recommending a rule change
in addition to this rule will not be
considered a significant adverse
comment unless the comment states
why this rule would be ineffective
without the additional change.
If no significant adverse comment is
received in response to the direct final
rule, no further action will be taken
related to the companion proposed rule.
Instead, we will publish a confirmation
notice in the Federal Register within 30
days after the comment period ends. We
intend the direct final rule to become
effective 30 days after publication of the
confirmation notice.
If we receive significant adverse
comments, we will withdraw the direct
final rule. We will proceed to respond
to all the comments received regarding
the direct final rule, treating those
comments as comments to this proposed
rule. The Agency will address the
comments in the subsequent final rule.
We will not provide additional
opportunity for comment. If we receive
a significant adverse comment that
applies to part of the rule and that part
may be severed from the remainder of
the rule, we may adopt as final those
parts of the rule that are not the subject
of significant adverse comment.
For additional background
information, see the corresponding
direct final rule published elsewhere in
this issue of the Federal Register.
This proposed rule:
• Revises the table in § 17.2 to adjust
the maximum CMP amounts for
inflation as prescribed by FCPIAA.
• Revises § 17.5(a) to provide
authority for the Chief Counsel to
delegate the responsibility for initiating
a CMP administrative action against a
tobacco retailer.
II. Environmental Impact
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
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the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
III. Paperwork Reduction Act
This proposed rule contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
IV. Federalism
FDA has analyzed this proposed 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.
V. Analysis of Impacts
FDA has examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Orders 12866 and 13563
direct 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). The Agency
believes that this proposed rule is not a
significant regulatory action under
Executive Order 12866.
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
simply adjusts the maximum amount of
CMPs administered by FDA, the
adjustment is required by the FCPIAA,
and the proposed rule makes a change
to FDA’s internal processes, the Agency
certifies that the proposed rule will not
have a significant economic impact on
a substantial number of small entities.
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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 $141
million, using the most current (2012)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this proposed rule, when finalized, to
result in any 1-year expenditure that
would meet or exceed this amount.
VI. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments 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, and
will be posted to the docket 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, FDA proposes 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 17.2 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
Federal Food, Drug, and Cosmetic Act
or the Public Health Service Act.
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6115
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.
60,000
1,200,000
333(b)(3) .............................
333(f)(1)(A) .........................
333(f)(1)(A) .........................
333(f)(2)(A) .........................
333(f)(2)(A) .........................
333(f)(2)(A) .........................
333(f)(3)(A) .........................
333(f)(3)(B) .........................
120,000
16,500
1,200,000
55,000
300,000
600,000
10,000
10,000
333(f)(4)(A)(i) ......................
333(f)(4)(A)(i) ......................
333(f)(4)(A)(ii) .....................
250,000
1,000,000
250,000
333(f)(4)(A)(ii) .....................
1,000,000
333(f)(4)(A)(ii) .....................
333(f)(9)(A) .........................
333(f)(9)(A) .........................
333(f)(9)(B)(i)(I) ...................
333(f)(9)(B)(i)(I) ...................
333(f)(9)(B)(i)(II) ..................
10,000,000
15,000
1,000,000
250,000
1,000,000
250,000
333(f)(9)(B)(i)(II) ..................
1,000,000
333(f)(9)(B)(i)(II) ..................
333(f)(9)(B)(ii)(I) ..................
333(f)(9)(B)(ii)(I) ..................
333(f)(9)(B)(ii)(II) .................
10,000,000
250,000
1,000,000
250,000
333(f)(9)(B)(ii)(II) .................
1,000,000
333(f)(9)(B)(ii)(II) .................
333(g)(1) .............................
333(g)(1) .............................
333 note ..............................
10,000,000
250,000
500,000
250
333 note ..............................
500
333 note ..............................
2,000
333 note ..............................
5,000
333 note ..............................
10,000
333 note ..............................
250
333 note ..............................
500
333 note ..............................
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333(b)(2)(A) ........................
333(b)(2)(B) ........................
1,000
333 note ..............................
2,000
333 note ..............................
5,000
333 note ..............................
10,000
335b(a) ...............................
335b(a) ...............................
360pp(b)(1) .........................
300,000
1,200,000
1,100
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For each of the first two violations in any 10-year period ...
For each violation after the second conviction in any 10year period.
Per violation ..........................................................................
Per violation ..........................................................................
For the aggregate of violations ............................................
Per individual ........................................................................
Per ‘‘any other person’’ ........................................................
For all violations adjudicated in a single proceeding ...........
For all violations adjudicated in a single proceeding ...........
For each day the violation is not corrected after a 30-day
period following notification until the violation is corrected.
Per violation ..........................................................................
For all violations adjudicated in a single proceeding ...........
For the first 30-day period (or any portion thereof) of continued violation following notification.
For any 30-day period, where the amount doubles for
every 30-day period of continued violation after the first
30-day violation.
For all violations adjudicated in a single proceeding ...........
Per violation ..........................................................................
For all violations adjudicated in a single proceeding ...........
Per violation ..........................................................................
For all violations adjudicated in a single proceeding ...........
For the first 30-day period (or any portion thereof) of continued violation following notification.
For any 30-day period, where the amount doubles for
every 30-day period of continued violation after the first
30-day violation.
For all violations adjudicated in a single proceeding ...........
Per violation ..........................................................................
For all violations adjudicated in a single proceeding ...........
For the first 30-day period (or any portion thereof) of continued violation following notification.
For any 30-day period, where the amount doubles for
every 30-day period of continued violation after the first
30-day violation.
For all violations adjudicated in a single proceeding ...........
For the first violation in any 3-year period ...........................
For each subsequent violation in any 3-year period ............
For the second violation (following a first violation with a
warning) within a 12-month period by a retailer with an
approved training program.
For the third violation within a 24-month period by a retailer with an approved training program.
For the fourth violation within a 24-month period by a retailer with an approved training program.
For the fifth violation within a 36-month period by a retailer
with an approved training program.
For the sixth or subsequent violation within a 48-month period by a retailer with an approved training program.
For the first violation by a retailer without an approved
training program.
For the second violation within a 12-month period by a retailer without an approved training program.
For the third violation within a 24-month period by a retailer without an approved training program.
For the fourth violation within a 24-month period by a retailer without an approved training program.
For the fifth violation within a 36-month period by a retailer
without an approved training program.
For the sixth or subsequent violation within a 48-month period by a retailer without an approved training program.
Per violation for an individual ...............................................
Per violation for ‘‘any other person’’ .....................................
Per violation per person .......................................................
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03FEP1
2013
2013
65,000
1,275,000
2013
2008
2013
2013
2013
2013
2013
2013
130,000
16,500
1,275,000
60,000
325,000
650,000
11,000
11,000
2013
2013
2013
275,000
1,075,000
275,000
2013
1,075,000
2013
2009
2013
2013
2013
2013
10,850,000
15,000
1,050,000
275,000
1,050,000
275,000
2013
1,050,000
2013
2013
2013
2013
10,525,000
275,000
1,050,000
275,000
2013
1,050,000
2013
2013
2013
2009
10,525,000
275,000
550,000
250
2009
500
2009
2,000
2009
5,000
2013
11,000
2009
250
2009
500
2013
1,100
2009
2,000
2009
5,000
2013
11,000
2013
2013
2008
325,000
1,275,000
1,100
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CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—
Continued
U.S.C. section
Former
maximum
penalty
amount
(in dollars)
360pp(b)(1) .........................
355,000
Date of
last penalty
figure or
adjustment
Assessment method
For any related series of violations ......................................
Adjusted
maximum
penalty
amount
(in dollars)
2013
375,000
2008
2013
11,000
130,000
42 U.S.C.
263b(h)(3) ...........................
300aa–28(b)(1) ...................
1 Not
11,000
120,000
adjusted.
3. In § 17.5, revise paragraph (a) to
read as follows:
■
§ 17.5
Complaint.
(a) The Center with principal
jurisdiction over the matter involved
shall begin all administrative civil
money penalty actions by serving on the
respondent(s) a complaint signed by the
Office of the Chief Counsel attorney for
the Center and by filing a copy of the
complaint with the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. For a civil
money penalty action against retailers of
tobacco products, the complaint may be
signed by any Agency employee
designated by the Chief Counsel.
*
*
*
*
*
Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02149 Filed 1–31–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 507
[Docket No. FDA–2013–N–1043]
Draft Qualitative Risk Assessment of
Risk of Activity/Animal Food
Combinations for Activities (Outside
the Farm Definition) Conducted in a
Facility Co-Located on a Farm;
Availability; Extension of Comment
Period
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Per violation ..........................................................................
Per occurrence .....................................................................
AGENCY:
Food and Drug Administration,
HHS.
Notification; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for a
document we made available for public
SUMMARY:
VerDate Mar<15>2010
16:26 Jan 31, 2014
Jkt 232001
comment in the Federal Register of
October 29, 2013 (78 FR 64428) (the
draft RA). We are taking this action to
make the comment period for the draft
RA conform to the comment period for
proposed rule entitled ‘‘Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Food for Animals’’ (the
proposed preventive controls rule for
food for animals).
DATES: FDA is extending the comment
period on the draft RA. Submit either
electronic or written comments by
March 31, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2013–N–
1043 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:
Mail/Hand delivery/Courier (for paper
submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2013–N–1043. 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 ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov, and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kim
Young, Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–2207.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 29,
2013, we published a notification with
a 120-day comment period announcing
the availability of, and requesting
comment on, a document entitled ‘‘Draft
Qualitative Risk Assessment of Risk of
Activity/Animal Food Combinations for
Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on
a Farm’’ (the draft RA). The purpose of
the draft RA is to provide a sciencebased risk analysis of those activity/
animal food combinations that would be
considered low risk.
We conducted this draft RA to satisfy
requirements of the FDA Food Safety
Modernization Act (FSMA) to conduct a
science-based risk analysis and to
consider the results of that analysis in
rulemaking that is required by FSMA.
In the Federal Register of October 29,
2013, we announced that we had used
the results of the draft RA to propose to
exempt certain animal food facilities
(i.e., those that are small or very small
businesses that are engaged only in
specific types of on-farm manufacturing,
processing, packing, or holding
activities identified in the draft RA as
low-risk activity/animal food
combinations) from the proposed
requirements of the Federal Food, Drug,
and Cosmetic Act for hazard analysis
and risk-based preventive controls (the
proposed preventive controls rule).
Interested persons were originally given
until February 26, 2014, to comment on
the proposed preventive controls rule.
FDA has received requests for an
extension of the comment period on the
proposed preventive controls rule for
E:\FR\FM\03FEP1.SGM
03FEP1
]]>Agencies
[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Proposed Rules]
[Pages 6112-6116]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02149]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
[Docket No. FDA-2014-N-0113]
Maximum Civil Money Penalty Amounts; Civil Money Penalty
Complaints
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing this
companion proposed rule to the direct final rule, issuing a new
regulation to adjust for inflation the maximum civil money penalty
(CMP) amounts for the various CMP authorities within our jurisdiction
and to amend the process for initiating certain CMP administrative
actions. We are taking these actions to comply with the Federal Civil
Penalties Inflation Adjustment Act of 1990
[[Page 6113]]
(FCPIAA), as amended, and to streamline our internal processes. The
last CMP adjustment was published in the Federal Register of November
12, 2008, and the FCPIAA requires Federal Agencies to adjust their CMPs
at least once every 4 years. We are using direct final rulemaking for
these actions because the Agency expects that there will be no
significant adverse comment on the rule.
DATES: Submit either electronic or written comments on the proposed
rule by April 21, 2014. If FDA receives any significant adverse
comments, the Agency will publish a document in the Federal Register
withdrawing the direct final rule within 30 days after the comment
period ends. FDA will then proceed to respond to comments under this
proposed rule using the usual notice and comment procedures.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0113, 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:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0113 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, 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.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20903, 301-796-4830.
SUPPLEMENTARY INFORMATION: The last CMP adjustment was published in the
Federal Register of November 12, 2008 (73 FR 66750).
I. Background
A. CMP Amounts
FDA is amending Sec. 17.2 (21 CFR 17.2) to update the maximum CMP
amounts. In general, FCPIAA requires Federal Agencies to issue
regulations to adjust for inflation each CMP provided by law within
their jurisdiction. (28 U.S.C. 2461 note, as amended by the Debt
Collection Improvement Act of 1996 (31 U.S.C. 3701)). FCPIAA directs
Agencies to adjust the CMP provided by law 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 the Consumer Price Index for the
month of June of the calendar year preceding the adjustment, exceeds
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)).
FCPIAA also prescribes a rounding method based on the size of the
penalty after the calculated increase, but states that the adjustment
of a CMP may not exceed 10 percent of the penalty. FCPIAA defines a CMP
as any penalty, fine, or other sanction that is for a specific monetary
amount as provided by Federal law, or has a maximum amount provided for
by Federal law, and is assessed or enforced by an agency pursuant to
Federal law, and 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)).
B. CMP Complaints
Currently, under Sec. 17.5(a) (21 CFR 17.5(a)), CMP complaints
against retailers of tobacco products may only be signed by attorneys
in FDA's Office of the Chief Counsel (OCC). Given the routine nature of
many of these CMPs, FDA is amending this regulation to permit the Chief
Counsel to designate other FDA staff, such as those in FDA's Center for
Tobacco Products, to sign a tobacco retailer CMP complaint.
Based on FDA's experience, the large majority of the tobacco
retailer complaints to date have involved alleged violations of the
requirement to not sell cigarettes and smokeless tobacco to any person
younger than 18 years of age or to verify age in accordance with 21 CFR
1140.14(b). These complaints have almost always been straightforward,
they involve simple fact patterns, and they do not require a complex
legal analysis. Over time, such CMP complaints have increased in
volume, and we anticipate that the volume will continue to be
relatively high.
We have determined that, with certain limitations and controls,
non-attorney staff outside OCC can carry out the function of reviewing
the evidence and signing the tobacco retailer CMP complaints in
appropriate circumstances. The proposed amendment to Sec. 17.5(a)
would give this decisionmaking authority to the Chief Counsel, who
could ensure the authority to sign complaints is only given to
appropriate staff and under appropriate circumstances. Under the
proposal, the Chief Counsel would have the authority to set and revise
limitations and controls, and to broaden, limit, or rescind any
authorizations to sign tobacco retailer CMP complaints.
The limitations could include, for example, limiting the delegation
to situations where the CMP amount is below a certain dollar value; the
CMP involves specified tobacco retailer charges that OCC has determined
are routine and predictable and do not require a complex legal
analysis; and involve charges for which FDA has developed OCC-approved
templates, parameters, and procedures. The controls could include, for
example, an audit or other quality review.
This proposed rule incorporates requirements specifically set forth
in the FCPIAA requiring FDA to issue a regulation implementing
inflation adjustments for all its CMP 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 CMPs 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. The
amendment to Sec. 17.5(a) changes an internal process.
This proposed rule is a companion to the direct final rule
published elsewhere in this issue of the Federal Register. This
companion proposed rule and the direct final rule are identical in
substance. This companion proposed rule will provide the procedural
framework to proceed with standard notice-and-comment rulemaking in the
event the direct final rule receives significant adverse comment and is
[[Page 6114]]
withdrawn. The comment period for the companion proposed rule runs
concurrently with the comment period of the direct final rule. Any
comments received under the companion proposed rule will be treated as
comments regarding the direct final rule and vice versa.
A significant adverse comment is one that explains why the rule
would be inappropriate, including challenges to the rule's underlying
premise or approach, or would be ineffective or unacceptable without
change. A comment recommending a rule change in addition to this rule
will not be considered a significant adverse comment unless the comment
states why this rule would be ineffective without the additional
change.
If no significant adverse comment is received in response to the
direct final rule, no further action will be taken related to the
companion proposed rule. Instead, we will publish a confirmation notice
in the Federal Register within 30 days after the comment period ends.
We intend the direct final rule to become effective 30 days after
publication of the confirmation notice.
If we receive significant adverse comments, we will withdraw the
direct final rule. We will proceed to respond to all the comments
received regarding the direct final rule, treating those comments as
comments to this proposed rule. The Agency will address the comments in
the subsequent final rule. We will not provide additional opportunity
for comment. If we receive a significant adverse comment that applies
to part of the rule and that part may be severed from the remainder of
the rule, we may adopt as final those parts of the rule that are not
the subject of significant adverse comment.
For additional background information, see the corresponding direct
final rule published elsewhere in this issue of the Federal Register.
This proposed rule:
Revises the table in Sec. 17.2 to adjust the maximum CMP
amounts for inflation as prescribed by FCPIAA.
Revises Sec. 17.5(a) to provide authority for the Chief
Counsel to delegate the responsibility for initiating a CMP
administrative action against a tobacco retailer.
II. Environmental Impact
The Agency has determined under 21 CFR 25.33 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.
III. Paperwork Reduction Act
This proposed rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
IV. Federalism
FDA has analyzed this proposed 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.
V. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct 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). The Agency believes that this proposed rule is not a
significant regulatory action under Executive Order 12866.
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 simply adjusts the maximum
amount of CMPs administered by FDA, the adjustment is required by the
FCPIAA, and the proposed rule makes a change to FDA's internal
processes, the Agency certifies that the proposed 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 $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule, when finalized, to result in any 1-year expenditure that
would meet or exceed this amount.
VI. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket 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, FDA proposes that 21 CFR part 17 be
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 17.2 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 Federal Food, Drug, and Cosmetic Act or the Public
Health Service Act.
[[Page 6115]]
Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Former maximum Adjusted
penalty Date of last maximum
U.S.C. section amount (in Assessment method penalty figure penalty amount
dollars) or adjustment (in dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
333(b)(2)(A)................................ 60,000 For each of the first two violations in any 10-year 2013 65,000
period.
333(b)(2)(B)................................ 1,200,000 For each violation after the second conviction in any 2013 1,275,000
10-year period.
333(b)(3)................................... 120,000 Per violation.......................................... 2013 130,000
333(f)(1)(A)................................ 16,500 Per violation.......................................... 2008 16,500
333(f)(1)(A)................................ 1,200,000 For the aggregate of violations........................ 2013 1,275,000
333(f)(2)(A)................................ 55,000 Per individual......................................... 2013 60,000
333(f)(2)(A)................................ 300,000 Per ``any other person''............................... 2013 325,000
333(f)(2)(A)................................ 600,000 For all violations adjudicated in a single proceeding.. 2013 650,000
333(f)(3)(A)................................ 10,000 For all violations adjudicated in a single proceeding.. 2013 11,000
333(f)(3)(B)................................ 10,000 For each day the violation is not corrected after a 30- 2013 11,000
day period following notification until the violation
is corrected.
333(f)(4)(A)(i)............................. 250,000 Per violation.......................................... 2013 275,000
333(f)(4)(A)(i)............................. 1,000,000 For all violations adjudicated in a single proceeding.. 2013 1,075,000
333(f)(4)(A)(ii)............................ 250,000 For the first 30-day period (or any portion thereof) of 2013 275,000
continued violation following notification.
333(f)(4)(A)(ii)............................ 1,000,000 For any 30-day period, where the amount doubles for 2013 1,075,000
every 30-day period of continued violation after the
first 30-day violation.
333(f)(4)(A)(ii)............................ 10,000,000 For all violations adjudicated in a single proceeding.. 2013 10,850,000
333(f)(9)(A)................................ 15,000 Per violation.......................................... 2009 15,000
333(f)(9)(A)................................ 1,000,000 For all violations adjudicated in a single proceeding.. 2013 1,050,000
333(f)(9)(B)(i)(I).......................... 250,000 Per violation.......................................... 2013 275,000
333(f)(9)(B)(i)(I).......................... 1,000,000 For all violations adjudicated in a single proceeding.. 2013 1,050,000
333(f)(9)(B)(i)(II)......................... 250,000 For the first 30-day period (or any portion thereof) of 2013 275,000
continued violation following notification.
333(f)(9)(B)(i)(II)......................... 1,000,000 For any 30-day period, where the amount doubles for 2013 1,050,000
every 30-day period of continued violation after the
first 30-day violation.
333(f)(9)(B)(i)(II)......................... 10,000,000 For all violations adjudicated in a single proceeding.. 2013 10,525,000
333(f)(9)(B)(ii)(I)......................... 250,000 Per violation.......................................... 2013 275,000
333(f)(9)(B)(ii)(I)......................... 1,000,000 For all violations adjudicated in a single proceeding.. 2013 1,050,000
333(f)(9)(B)(ii)(II)........................ 250,000 For the first 30-day period (or any portion thereof) of 2013 275,000
continued violation following notification.
333(f)(9)(B)(ii)(II)........................ 1,000,000 For any 30-day period, where the amount doubles for 2013 1,050,000
every 30-day period of continued violation after the
first 30-day violation.
333(f)(9)(B)(ii)(II)........................ 10,000,000 For all violations adjudicated in a single proceeding.. 2013 10,525,000
333(g)(1)................................... 250,000 For the first violation in any 3-year period........... 2013 275,000
333(g)(1)................................... 500,000 For each subsequent violation in any 3-year period..... 2013 550,000
333 note.................................... 250 For the second violation (following a first violation 2009 250
with a warning) within a 12-month period by a retailer
with an approved training program.
333 note.................................... 500 For the third violation within a 24-month period by a 2009 500
retailer with an approved training program.
333 note.................................... 2,000 For the fourth violation within a 24-month period by a 2009 2,000
retailer with an approved training program.
333 note.................................... 5,000 For the fifth violation within a 36-month period by a 2009 5,000
retailer with an approved training program.
333 note.................................... 10,000 For the sixth or subsequent violation within a 48-month 2013 11,000
period by a retailer with an approved training program.
333 note.................................... 250 For the first violation by a retailer without an 2009 250
approved training program.
333 note.................................... 500 For the second violation within a 12-month period by a 2009 500
retailer without an approved training program.
333 note.................................... 1,000 For the third violation within a 24-month period by a 2013 1,100
retailer without an approved training program.
333 note.................................... 2,000 For the fourth violation within a 24-month period by a 2009 2,000
retailer without an approved training program.
333 note.................................... 5,000 For the fifth violation within a 36-month period by a 2009 5,000
retailer without an approved training program.
333 note.................................... 10,000 For the sixth or subsequent violation within a 48-month 2013 11,000
period by a retailer without an approved training
program.
335b(a)..................................... 300,000 Per violation for an individual........................ 2013 325,000
335b(a)..................................... 1,200,000 Per violation for ``any other person''................. 2013 1,275,000
360pp(b)(1)................................. 1,100 Per violation per person............................... 2008 1,100
[[Page 6116]]
360pp(b)(1)................................. 355,000 For any related series of violations................... 2013 375,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
42 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
263b(h)(3).................................. 11,000 Per violation.......................................... 2008 11,000
300aa-28(b)(1).............................. 120,000 Per occurrence......................................... 2013 130,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Not adjusted.
0
3. In Sec. 17.5, revise paragraph (a) to read as follows:
Sec. 17.5 Complaint.
(a) The Center with principal jurisdiction over the matter involved
shall begin all administrative civil money penalty actions by serving
on the respondent(s) a complaint signed by the Office of the Chief
Counsel attorney for the Center and by filing a copy of the complaint
with the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For a
civil money penalty action against retailers of tobacco products, the
complaint may be signed by any Agency employee designated by the Chief
Counsel.
* * * * *
Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02149 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P
