[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Rules and Regulations]
[Pages 21174-21176]
[FR Doc No: 2015-08885]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2014-0294; FRL-9926-29-Region-5]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; CO Monitoring

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to Indiana's monitoring requirements as a revision to the
State Implementation Plan (SIP). The SIP revision was submitted by
Indiana to EPA on January 22, 2014. Once approved, the SIP would
authorize emission units that combust sewage sludge to continuously
monitor carbon monoxide emissions, consistent with Federal
requirements.

DATES: This direct final rule will be effective June 16, 2015, unless
EPA receives adverse comments by May 18, 2015. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2014-0294, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2014-0294. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Matt Rau, Environmental Engineer, at
(312) 886-6524 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer,
Control Strategies Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we'',
``us'', or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this action?
II. What is EPA's analysis?
III. What action is EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is the background for this action?

    On January 22, 2014, Indiana submitted a request to EPA to revise
Title 326 of the Indiana Administration Code (IAC) Article 3--
Monitoring Requirements, Rule 5--Continuous Monitoring of Emissions,
Section 1--Applicability; Continuous Monitoring Requirements for
Applicable Pollutants.
    In the current SIP, 326 IAC 3-5-1(b)(6), requires sewage sludge
combustion units to continuously monitor total hydrocarbons, oxygen,
moisture, and temperature. The SIP revision provides the sewage sludge
combustion units the option to monitor carbon monoxide emissions as an
alternate to monitoring total hydrocarbons. In doing so, sources must
also comply with a 100 parts-per-million (ppm) total carbon monoxide
limit. The continuous carbon monoxide monitoring requirements are
specified at 326 IAC 3-5-1(b)(6)(A)(i) and (ii).
    The SIP revision is consistent with 40 CFR 503.40, the Federal
Standards for the Incineration of Sewage Sludge. This Federal
regulation, promulgated pursuant to the Clean Water Act, authorizes
sewage sludge combustion sources to continuously monitor carbon
monoxide as an alternative to continuously monitoring total
hydrocarbons emissions. The regulation requires that the carbon
monoxide monitoring be corrected for zero percent moisture and to seven
percent oxygen.

II. What is EPA's analysis?

    In its approval of 40 CFR 503.40, EPA determined that sewage sludge
incinerators are expected to meet the 100 ppm total hydrocarbon monthly
limit when the monthly average carbon monoxide concentration does not
exceed 100 ppm. See 59 FR 9099 (February 25, 1994). The Federal rule
requires that the continuous carbon monoxide monitor must be corrected
for zero percent moisture and to seven percent oxygen. The revision to
326 IAC 3-5-1 is consistent with the monitoring requirements in 40 CFR
503.40. EPA finds the requested revision to be approvable.

III. What action is EPA taking?

    EPA is approving a revision to 326 IAC 3-5-1 into the Indiana SIP.
The SIP revision would authorize emission units that combust sewage
sludge to continuously monitor carbon monoxide emissions, consistent
with Federal requirements.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective June 16, 2015
without further notice unless we receive relevant adverse written
comments by May 18, 2015. If we receive such comments, we will withdraw
this action before the effective date by publishing a subsequent
document that will withdraw the final action. All public comments
received will then be addressed in a subsequent final rule based on the
proposed action. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. If we do
not receive any comments, this action will be effective June 16, 2015.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Indiana
Regulations described in the amendments to 40 CFR part 52 set forth
below. EPA has made, and will continue to make, these documents
generally available electronically through www.regulations.gov and/or
in hard copy at the appropriate EPA office (see the ADDRESSES section
of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the CAA
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register.

 This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 16, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of this Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: April 2, 2015.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. In Sec.  52.770, the table in paragraph (c) is amended by revising
the entry for 3-5-1 under ``Article 3. Monitoring Requirements'',
``Rule 5. Continuous Monitoring of Emissions'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Indiana Regulations
----------------------------------------------------------------------------------------------------------------
                                                                  Indiana       EPA Approval
      Indiana citation                    Subject             effective date        date             Notes
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                       Article 3. Monitoring Requirements
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Rule 5. Continuous Monitoring of Emissions
----------------------------------------------------------------------------------------------------------------
3-5-1.......................  Applicability; continuous            1/15/2014  4/17/2015,       .................
                               monitoring requirements for                     [insert
                               applicable pollutants.                          Federal
                                                                               Register
                                                                               citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-08885 Filed 4-16-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76836-76838]
[FR Doc No: 2013-30185]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1619]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice invites comments on the information collection
provisions of FDA's regulations regarding current good manufacturing
practice (CGMP) for dietary supplements.

DATES: Submit either electronic or written comments on the collection
of information by February 18, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or

provide information to a third party. Section 3506(c)(2)(A) of the PRA
(44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111 (OMB Control Number 0910-0606)--Extension

    On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other
things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section
402(g)(2) of the FD&C Act provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practices for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
CGMP regulations for food and may not impose standards for which there
are no current, and generally available, analytical methodology.
Section 402(g)(1) of the FD&C Act states that a dietary supplement is
adulterated if ``it has been prepared, packed, or held under conditions
that do not meet current good manufacturing practice regulations.''
Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue
regulations necessary for the efficient enforcement of the FD&C Act. In
the Federal Register of June 25, 2007 (72 FR 34752) (the June 25, 2007,
final rule), FDA published a final rule that established, in part 111
(21 CFR part 111), the minimum CGMP necessary for activities related to
manufacturing, packaging, labeling, or holding dietary supplements to
ensure the quality of the dietary supplement.
    Records are an indispensable component of CGMP. The records
required by FDA's regulations in part 111 provide the foundation for
the planning, control, and improvement processes that constitute a
quality control system. Implementation of these processes in a
manufacturing operation serves as the backbone to CGMP. The records
show what is to be manufactured; what was, in fact, manufactured; and
whether the controls that the manufacturer put in place to ensure the
identity, purity, strength, and composition and limits on contaminants
and to prevent adulteration were effective. Further, records will show
whether and what deviations from control processes occurred, facilitate
evaluation and corrective action concerning these deviations
(including, where necessary, whether associated batches of product
should be recalled from the marketplace), and enable a manufacturer to
assure that the corrective action was effective. In addition, by
establishing recordkeeping requirements, FDA can ensure that industry
follows CGMP during manufacturing, packaging, labeling, or holding
operations. The regulations in part 111 establish the minimum
manufacturing practices necessary to ensure that dietary supplements
are manufactured, packaged, labeled, or held in a manner that will
ensure the quality of the dietary supplements during manufacturing,
packaging, labeling or holding operations.
    The recordkeeping requirements of the regulations include
establishing written procedures and maintaining records pertaining to:
(1) Personnel; (2) sanitation; (3) calibration of instruments and
controls; (4) calibration, inspection, or checks of automated,
mechanical, or electronic equipment; (5) maintaining, cleaning, and
sanitizing equipment and utensils and other contact surfaces; (6) water
used that may become a component of the dietary supplement; (7)
production and process controls; (8) quality control; (9) components,
packaging, labels and product received for packaging and labeling; (10)
master manufacturing and batch production; (11) laboratory operations;
(12) manufacturing operations; (13) packaging and labeling operations;
(14) holding and distributing operations; (15) returned dietary
supplements; and (16) product complaints.
    Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and repackagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses engaged in the dietary supplement
industry.
    The recordkeeping requirements of the regulations in part 111 are
set forth in each subpart. In Table 1 of this document we list the
annual burdens associated with recordkeeping, as described in the June
25, 2007, final rule. For some provisions listed in Table 1, we did not
estimate the number of records per recordkeeper because recordkeeping
occasions consist of frequent brief entries of dates, temperatures,
monitoring results, or documentation that specific actions were taken.
Information might be recorded a few times a day, week, or month. When
the records burden involves frequent brief entries, we entered 1 as the
default for the number of records per recordkeeper. For example, many
of the records listed under Sec.  111.35 in Table 1, such as Sec.
111.35(b)(2) (documentation, in individual equipment logs, of the date
of the use, maintenance, cleaning, and sanitizing of equipment),
involve many short sporadic entries over the course of the year,
varying across equipment and plants in the industry. We did not attempt
to estimate the actual number of recordkeeping occasions for these
provisions, but instead entered an estimate of the average number of
hours per year. We entered the default value of 1 as the number of
records per recordkeeper for these and similar provisions. For Sec.
111.35, the entry for number of records is 1 as a default representing
a large number of brief recordkeeping occasions.
    In many rows of Table 1 of this document, we list a burden under a
single provision that covers the written procedures or records
described in several provisions. For example, the burden of the batch
production records listed in Table 1 under Sec.  111.260 includes the
burden for records listed under Sec.  111.255 because the batch
production records must include those records.
    The number of records for batch production records (and other
records kept on a batch basis in Table 1 of this document) equals the
annual number of batches. The estimated burden for records kept by
batch includes both records kept for every batch and records kept for
some but not all batches. We use the annual number of batches as the
number of records that will not necessarily be kept for every batch,
such

as test results or material review and disposition records, because
such records are part of records, if they are necessary, that will be
kept for every batch.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                      Avg. burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14, records of personnel              15,000               4          60,000               1          60,000
 practices, including
 documentation of training......
111.23, records of physical               15,000               1          15,000             0.2           3,000
 plant sanitation practices,
 including pest control and
 water quality..................
111.35, records of equipment and             400               1             400            12.5           5,000
 utensils calibration and
 sanitation practices...........
111.95, records of production                250               1             250              45          11,250
 and process control systems....
111.140, records that quality                240            1163         279,120               1         279,120
 control personnel must make and
 keep...........................
111.180, records associated with             240            1163         279,120               1         279,120
 components, packaging, labels,
 and product received for
 packaging and labeling as a
 dietary supplement.............
111.210, requirements for what               240               1             240             2.5             600
 the master manufacturing record
 must include...................
111.260, requirements for what               145            1408         204,160               1         204,160
 the batch record must include..
111.325, records that quality                120               1             120              15           1,800
 control personnel must make and
 keep for laboratory operations.
111.375, records of the written              260               1             260               2             520
 procedures established for
 manufacturing operations.......
111.430, records of the written               50               1              50            12.6             630
 procedures for packaging and
 labeling operations............
111.475, records of product               15,000               1          15,000             0.4           6,000
 distribution and procedures for
 holding and distributing
 operations.....................
111.535, records for returned                110               4             440            13.5           5,940
 dietary supplements............
111.570, records regarding                   240             600         144,000             0.5          72,000
 product complaints.............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         929,140
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The average burden per recordkeeping estimates in Table 1 of this
document are based on those in the June 25, 2007, final rule, which
were based on our institutional experience with other CGMP requirements
and on data provided by Research Triangle Institute in the ``Survey of
Manufacturing Practices in the Dietary Supplement Industry'' cited in
that rule.
    The estimates in Table 1 of the number of firms affected by each
provision of part 111 are based on the percentage of manufacturers,
packagers, labelers, holders, distributors, and warehousers that
reported in the survey that they have not established written SOPs or
do not maintain records that were later required by the June 25, 2007,
final rule. Because we do not have survey results for general
warehouses, we entered the approximate number of facilities in that
category for those provisions covering general facilities. For the
dietary supplement industry, the survey estimated that 1,460 firms
would be covered by the final rule, including manufacturers, packagers,
labelers, holders, distributors, and warehousers. The time estimates
include the burden involved in documenting that certain requirements
are performed and in recordkeeping. We used an estimated annual batch
production of 1,408 batches per year to estimate the burden of
requirements that are related to the number of batches produced
annually, such as Sec.  111.260, ``What must the batch production
record include?'' The estimate of 1,408 batches per year is near the
midpoint of the number of annual batches reported by survey firms.
    The length of time that CGMP records must be maintained is set
forth in Sec.  111.605. Table 1 of this document reflects the estimated
burdens for written procedures, record maintenance, periodically
reviewing records to determine if they may be discarded, and for any
associated documentation for that activity for records that are
required under part 111. We have not included a separate estimate of
burden for those sections that require maintaining records in
accordance with Sec.  111.605, but have included those burdens under
specific provisions for keeping records. For example, Sec.  111.255(a)
requires that the batch production records be prepared every time a
batch is manufactured, and Sec.  111.255(d) requires that batch
production records be kept in accordance with Sec.  111.605. The
estimated burdens for both Sec.  111.255(a) and (d) are included under
Sec.  111.260 (what the batch record must include).

    Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30185 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74736-74737]
[FR Doc No: 2012-30240]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2012-0088]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated November 13, 2012, the San Diego Trolley Incorporated (SDTI) has
petitioned the Federal Railroad Administration (FRA) for a waiver of
compliance from certain provisions of the Federal railroad safety
regulations contained at 49 CFR 213.57-Curves; elevation and speed
limitations. FRA has assigned the petition Docket Number FRA-2012-0088.
    SDTI seeks a waiver of compliance from provisions regarding cant
deficiency contained at 49 CFR 213.57. Cant deficiency is a technical
term describing the imbalance of inner and outer wheel loads when a
rail vehicle traverses a curve. With the right combination of speed,
curvature, and superelevation (the amount the outer rail is elevated
above the inner rail), the loads on both inner and outer wheels will be
equal, i.e. balanced. The curving speed corresponding to this balanced
state is referred to as balance speed. At higher than the balance
speed, the centrifugal force will cause the outer wheel load to
increase and the inner wheel load to decrease. The manifestation of
this load imbalance is that a lateral throw will be sustained by the
passengers when the vehicle is traversing the curve. To counter the
imbalance, the superelevation on the curve would have to be increased.
The necessary amount of the increase in superelevation is the amount of
cant deficiency.
    SDTI intends to operate its SD100 and S70 light rail vehicles (LRV)
on curves at speeds that will generate a cant deficiency up to, but not
more than, 6 inches; but no more than the maximum authorized speed.
    In support of its petition, STDI has submitted a report for a cant
deficiency dynamic test that is to demonstrate that the LRVs can safely
be operated at the requested 6 inches cant deficiency.

    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey Ave.
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 31, 2013 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78) or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on December 10, 2012.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2012-30240 Filed 12-14-12; 8:45 am]
BILLING CODE 4910-06-P