Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints, 6088-6092 [2014-02150]
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Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Rules and Regulations
(i) The minimum use altitude
specified for the coupled approach
mode selected;
(ii) 50 feet; or
(iii) An altitude specified by
Administrator.
(3) For autopilots with an AFM
specified negligible or zero altitude loss
for an autopilot approach mode
malfunction, the greater of—
(i) 50 feet; or
(ii) An altitude specified by
Administrator.
(4) If executing an autopilot coupled
go-around or missed approach using a
certificated and functioning autopilot in
accordance with paragraph (e) in this
section.
(e) Go-Around/Missed Approach. No
person may engage an autopilot during
a go-around or missed approach below
the minimum engagement altitude
specified for takeoff and initial climb in
paragraph (b) in this section. An
autopilot minimum use altitude does
not apply to a go-around/missed
approach initiated with an engaged
autopilot. Performing a go-around or
missed approach with an engaged
autopilot must not adversely affect safe
obstacle clearance.
(f) Landing. Notwithstanding
paragraph (d) of this section, autopilot
minimum use altitudes do not apply to
autopilot operations when an approved
automatic landing system mode is being
used for landing. Automatic landing
systems must be authorized in an
operations specification issued to the
operator.
PART 135—OPERATING
REQUIREMENTS: COMMUTER AND
ON DEMAND OPERATIONS AND RULE
GOVERNING PERSONS ON BOARD
SUCH AIRCRAFT
5. The authority citation for part 135
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 41706,
40113, 44701–44702, 44705, 44709, 44711–
44713, 44715–44717, 44722, 45101–45105.
■
6. Revise § 135.93 to read as follows:
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§ 135.93 Minimum altitudes for use of
autopilot.
(a) Definitions. For purpose of this
section—
(1) Altitudes for takeoff/initial climb
and go-around/missed approach are
defined as above the airport elevation.
(2) Altitudes for enroute operations
are defined as above terrain elevation.
(3) Altitudes for approach are defined
as above the touchdown zone elevation
(TDZE), unless the altitude is
specifically in reference to DA (H) or
MDA, in which case the altitude is
defined by reference to the DA(H) or
MDA itself.
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(b) Takeoff and initial climb. No
person may use an autopilot for takeoff
or initial climb below the higher of 500
feet or an altitude that is no lower than
twice the altitude loss specified in the
Airplane Flight Manual (AFM), except
as follows—
(1) At a minimum engagement
altitude specified in the AFM; or
(2) At an altitude specified by the
Administrator, whichever is greater.
(c) Enroute. No person may use an
autopilot enroute, including climb and
descent, below the following—
(1) 500 feet;
(2) At an altitude that is no lower than
twice the altitude loss specified in the
AFM for an autopilot malfunction in
cruise conditions; or
(3) At an altitude specified by the
Administrator, whichever is greater.
(d) Approach. No person may use an
autopilot at an altitude lower than 50
feet below the DA(H) or MDA for the
instrument procedure being flown,
except as follows—
(1) For autopilots with an AFM
specified altitude loss for approach
operations—
(i) An altitude no lower than twice the
specified altitude loss if higher than 50
feet below the MDA or DA(H);
(ii) An altitude no lower than 50 feet
higher than the altitude loss specified in
the AFM, when the following
conditions are met—
(A) Reported weather conditions are
less than the basic VFR weather
conditions in § 91.155 of this chapter;
(B) Suitable visual references
specified in § 91.175 of this chapter
have been established on the instrument
approach procedure; and
(C) The autopilot is coupled and
receiving both lateral and vertical path
references;
(iii) An altitude no lower than the
higher of the altitude loss specified in
the AFM or 50 feet above the TDZE,
when the following conditions are
met—
(A) Reported weather conditions are
equal to or better than the basic VFR
weather conditions in § 91.155 of this
chapter; and
(B) The autopilot is coupled and
receiving both lateral and vertical path
references; or
(iv) A greater altitude specified by the
Administrator.
(2) For autopilots with AFM specified
approach altitude limitations, the
greater of—
(i) The minimum use altitude
specified for the coupled approach
mode selected;
(ii) 50 feet; or
(iii) An altitude specified by
Administrator.
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(3) For autopilots with an AFM
specified negligible or zero altitude loss
for an autopilot approach mode
malfunction, the greater of—
(i) 50 feet; or
(ii) An altitude specified by
Administrator.
(4) If executing an autopilot coupled
go-around or missed approach using a
certificated and functioning autopilot in
accordance with paragraph (e) in this
section.
(e) Go-Around/Missed Approach. No
person may engage an autopilot during
a go-around or missed approach below
the minimum engagement altitude
specified for takeoff and initial climb in
paragraph (b) in this section. An
autopilot minimum use altitude does
not apply to a go-around/missed
approach initiated with an engaged
autopilot. Performing a go-around or
missed approach with an engaged
autopilot must not adversely affect safe
obstacle clearance.
(f) Landing. Notwithstanding
paragraph (d) of this section, autopilot
minimum use altitudes do not apply to
autopilot operations when an approved
automatic landing system mode is being
used for landing. Automatic landing
systems must be authorized in an
operations specification issued to the
operator.
(g) This section does not apply to
operations conducted in rotorcraft.
Issued under authority provided by 49
U.S.C. 106(f) and 44701(a)(5) in Washington,
DC, on December 24, 2013.
Michael P. Huerta,
Administrator.
[FR Doc. 2014–02123 Filed 1–31–14; 8:45 am]
BILLING CODE 4910–13–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:
Direct final rule.
The Food and Drug
Administration (FDA) is 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
SUMMARY:
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administrative actions. We are taking
these actions to comply with the Federal
Civil Penalties Inflation Adjustment Act
of 1990 (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. 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 June 18,
2014, without further notice, unless
FDA receives significant adverse
comment by April 21, 2014. If we
receive no timely significant adverse
comments, we will publish a document
in the Federal Register before May 19,
2014, 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 June 18, 2014.
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.
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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
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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 § 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 penalty 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,
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6089
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 § 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.
FDA is publishing this rule as a direct
final rule without prior proposal and
comment because we view these as
noncontroversial amendments 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 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
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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 direct final 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
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
III. Paperwork Reduction Act
This final 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 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.
V. Analysis of Impacts
FDA has examined the impacts of the
final 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 final 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 final rule simply
adjusts the maximum amount of CMPs
administered by FDA as required by the
FCPIAA, and because the proposed rule
makes a change to FDA’s internal
processes, 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 $141
million, using the most current (2012)
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.
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, 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 17.2 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.
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
333(b)(2)(B) .......................
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333(b)(2)(A) .......................
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) ........................
120,000
16,500
1,200,000
55,000
300,000
600,000
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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
10-year period.
Per violation ...............................................................
Per violation ...............................................................
For the aggregate of violations ..................................
Per individual .............................................................
Per ‘‘any other person’’ ..............................................
For all violations adjudicated in a single proceeding
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2013
65,000.
2013
1,275,000.
2013
2008
2013
2013
2013
2013
130,000.
16,500 (not adjusted).
1,275,000.
60,000.
325,000.
650,000.
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6091
CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—
Continued
U.S.C. Section
Former
maximum
penalty
amount
(in dollars)
333(f)(3)(A) ........................
333(f)(3)(B) ........................
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 ............................
1,000
333 note ............................
2,000
333 note ............................
5,000
333 note ............................
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Date of last
penalty figure
or adjustment
Assessment method
10,000
335b(a) ..............................
335b(a) ..............................
360pp(b)(1) .......................
360pp(b)(1) .......................
300,000
1,200,000
1,100
355,000
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 48month 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 48month period by a retailer without an approved
training program.
Per violation for an individual ....................................
Per violation for ‘‘any other person’’ ..........................
Per violation per person ............................................
For any related series of violations ...........................
Adjusted maximum
penalty amount
(in dollars)
2013
2013
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 (not adjusted).
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 (not adjusted).
2009
500 (not adjusted).
2009
2,000 (not adjusted).
2009
5,000 (not adjusted).
2013
11,000.
2009
250 (not adjusted).
2009
500 (not adjusted).
2013
1,100.
2009
2,000 (not adjusted).
2009
5,000 (not adjusted).
2013
11,000.
2013
2013
2008
2013
325,000.
1,275,000.
1,100 (not adjusted).
375,000.
2008
2013
11,000 (not adjusted).
130,000.
42 U.S.C.
263b(h)(3) .........................
300aa–28(b)(1) .................
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11,000
120,000
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Per violation ...............................................................
Per occurrence ..........................................................
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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. 2014–02150 Filed 1–31–14; 8:45 am]
BILLING CODE 4160–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0210; FRL–9394–2]
αlpha-Alkyl-w-Hydroxypoly
(Oxypropylene) and/or Poly
(Oxyethylene) Polymers Where the
Alkyl Chain Contains a Minimum of Six
Carbons etc.; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
tkelley on DSK3SPTVN1PROD with RULES
VerDate Mar<15>2010
16:01 Jan 31, 2014
Jkt 232001
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0210, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
A. Does this action apply to me?
This regulation establishes an
exemption from the requirement of a
tolerance for residues of a-alkyl-whydroxypoly (oxypropylene) and/or
poly (oxyethylene) polymers where the
alkyl chain contains a minimum of six
carbons, and a-alkyl-w-hydroxypoly
(oxypropylene) and/or poly
(oxyethylene) polymers where the alkyl
chain contains a minimum of six
carbons and a minimum number
average molecular weight (in amu) 1,100
(hereinafter referred to as ‘‘AAAs’’ (alkyl
alcohol alkoxylates) when used as an
inert ingredient as a surfactant in
pesticide formulations in growing crops
without limitations. Akzo Nobel Surface
Chemistry submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an
amendment to an existing requirement
of a tolerance. This regulation
eliminates the need to establish a
SUMMARY:
maximum permissible level for residues
of AAAs.
DATES: This regulation is effective
February 3, 2014. Objections and
requests for hearings must be received
on or before April 4, 2014, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2013–0210 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before April 4, 2014. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2013–0210, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of August 5,
2009 (74 FR 38935) (FRL–8430–1), EPA
issued a final rule, announcing the
establishment of a tolerance exemption
pursuant to a pesticide petition (PP
9E7534) by The Joint Inerts Task Force
(JITF), Cluster Support Team Number 1
(CST1), c/o CropLife America, 1156
15th Street NW., Suite 400, Washington,
DC 20005. The petition requested that
40 CFR 180.910, 40 CFR 180.930, 40
CFR 180.940a, and 40 CFR 180.960 be
E:\FR\FM\03FER1.SGM
03FER1
]]>Agencies
[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Rules and Regulations]
[Pages 6088-6092]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02150]
=======================================================================
-----------------------------------------------------------------------
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: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is 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
[[Page 6089]]
administrative actions. We are taking these actions to comply with the
Federal Civil Penalties Inflation Adjustment Act of 1990 (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. 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 June 18, 2014, without further notice,
unless FDA receives significant adverse comment by April 21, 2014. If
we receive no timely significant adverse comments, we will publish a
document in the Federal Register before May 19, 2014, 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 June 18, 2014.
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 penalty 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.
FDA is publishing this rule as a direct final rule without prior
proposal and comment because we view these as noncontroversial
amendments 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 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
[[Page 6090]]
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 direct final 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 final 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 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.
V. Analysis of Impacts
FDA has examined the impacts of the final 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 final 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 final rule simply adjusts the maximum
amount of CMPs administered by FDA as required by the FCPIAA, and
because the proposed rule makes a change to FDA's internal processes,
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 $141 million, using the most current (2012) 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.
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, 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 17.2 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.
Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
----------------------------------------------------------------------------------------------------------------
Former
maximum Date of last Adjusted maximum
U.S.C. Section penalty Assessment method penalty figure penalty amount (in
amount (in or adjustment dollars)
dollars)
----------------------------------------------------------------------------------------------------------------
21 U.S.C.
----------------------------------------------------------------------------------------------------------------
333(b)(2)(A)..................... 60,000 For each of the first 2013 65,000.
two violations in any
10-year period.
333(b)(2)(B)..................... 1,200,000 For each violation after 2013 1,275,000.
the second conviction
in any 10-year period.
333(b)(3)........................ 120,000 Per violation........... 2013 130,000.
333(f)(1)(A)..................... 16,500 Per violation........... 2008 16,500 (not
adjusted).
333(f)(1)(A)..................... 1,200,000 For the aggregate of 2013 1,275,000.
violations.
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 2013 650,000.
adjudicated in a single
proceeding.
[[Page 6091]]
333(f)(3)(A)..................... 10,000 For all violations 2013 11,000.
adjudicated in a single
proceeding.
333(f)(3)(B)..................... 10,000 For each day the 2013 11,000.
violation is not
corrected after a 30-
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 2013 1,075,000.
adjudicated in a single
proceeding.
333(f)(4)(A)(ii)................. 250,000 For the first 30-day 2013 275,000.
period (or any portion
thereof) of continued
violation following
notification.
333(f)(4)(A)(ii)................. 1,000,000 For any 30-day period, 2013 1,075,000.
where the amount
doubles for every 30-
day period of continued
violation after the
first 30-day violation.
333(f)(4)(A)(ii)................. 10,000,000 For all violations 2013 10,850,000.
adjudicated in a single
proceeding.
333(f)(9)(A)..................... 15,000 Per violation........... 2009 15,000 (not
adjusted).
333(f)(9)(A)..................... 1,000,000 For all violations 2013 1,050,000.
adjudicated in a single
proceeding.
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 2013 1,050,000.
adjudicated in a single
proceeding.
333(f)(9)(B)(i)(II).............. 250,000 For the first 30-day 2013 275,000.
period (or any portion
thereof) of continued
violation following
notification.
333(f)(9)(B)(i)(II).............. 1,000,000 For any 30-day period, 2013 1,050,000.
where the amount
doubles for 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 2013 10,525,000.
adjudicated in a single
proceeding.
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 2013 1,050,000.
adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(II)............. 250,000 For the first 30-day 2013 275,000.
period (or any portion
thereof) of continued
violation following
notification.
333(f)(9)(B)(ii)(II)............. 1,000,000 For any 30-day period, 2013 1,050,000.
where the amount
doubles for 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 2013 10,525,000.
adjudicated in a single
proceeding.
333(g)(1)........................ 250,000 For the first violation 2013 275,000.
in any 3-year period.
333(g)(1)........................ 500,000 For each subsequent 2013 550,000.
violation in any 3-year
period.
333 note......................... 250 For the second violation 2009 250 (not adjusted).
(following a first
violation with a
warning) within a 12-
month period by a
retailer with an
approved training
program.
333 note......................... 500 For the third violation 2009 500 (not adjusted).
within a 24-month
period by a retailer
with an approved
training program.
333 note......................... 2,000 For the fourth violation 2009 2,000 (not
within a 24-month adjusted).
period by a retailer
with an approved
training program.
333 note......................... 5,000 For the fifth violation 2009 5,000 (not
within a 36-month adjusted).
period by a retailer
with an approved
training program.
333 note......................... 10,000 For the sixth or 2013 11,000.
subsequent violation
within a 48-month
period by a retailer
with an approved
training program.
333 note......................... 250 For the first violation 2009 250 (not adjusted).
by a retailer without
an approved training
program.
333 note......................... 500 For the second violation 2009 500 (not adjusted).
within a 12-month
period by a retailer
without an approved
training program.
333 note......................... 1,000 For the third violation 2013 1,100.
within a 24-month
period by a retailer
without an approved
training program.
333 note......................... 2,000 For the fourth violation 2009 2,000 (not
within a 24-month adjusted).
period by a retailer
without an approved
training program.
333 note......................... 5,000 For the fifth violation 2009 5,000 (not
within a 36-month adjusted).
period by a retailer
without an approved
training program.
333 note......................... 10,000 For the sixth or 2013 11,000.
subsequent violation
within a 48-month
period by a retailer
without an approved
training program.
335b(a).......................... 300,000 Per violation for an 2013 325,000.
individual.
335b(a).......................... 1,200,000 Per violation for ``any 2013 1,275,000.
other person''.
360pp(b)(1)...................... 1,100 Per violation per person 2008 1,100 (not
adjusted).
360pp(b)(1)...................... 355,000 For any related series 2013 375,000.
of violations.
----------------------------------------------------------------------------------------------------------------
42 U.S.C.
----------------------------------------------------------------------------------------------------------------
263b(h)(3)....................... 11,000 Per violation........... 2008 11,000 (not
adjusted).
300aa-28(b)(1)................... 120,000 Per occurrence.......... 2013 130,000.
----------------------------------------------------------------------------------------------------------------
[[Page 6092]]
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. 2014-02150 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P
