[Federal Register: October 14, 2005 (Volume 70, Number 198)]
[Proposed Rules]
[Page 60199-60202]
[DOCID:fr14oc05-25]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 403

[OW-2005-0024; 7980-3]
RIN 2040-AC58

Availability of and Procedures for Removal Credits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: Today's Advance Notice of Proposed Rulemaking (ANPRM) seeks
comment on two issues concerning the removal credits provisions in the
General Pretreatment Regulations. EPA requests comments on whether to
amend the list of pollutants for which removal credits are available to
add certain pollutants. The pollutants that the Agency would add are
those that EPA previously has determined, after an exposure and hazard
screening, would not require sewage sludge regulations. EPA is also
soliciting comment on options to amend the ``consistent removal''
provision in the removal credits regulations that would be consistent
with a decision of the U.S. Court of Appeals for the Third Circuit.

DATES: Comments must be received on or before December 13, 2005.

ADDRESSES: Submit your comments, identified by Docket ID No. OW-2005-
0024 by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the

on-line instructions for submitting comments.
    Agency Web site: http://www.epa.gov/edocket. EDOCKET, EPA's

electronic public docket and comment system, is EPA's preferred method
for receiving comments. Follow the on-line instructions for submitting
comments.
    E-mail<EMAIL_ADDRESS>Please specify Docket ID No. OW-2005-
0024 in the body of the message.
    Mail or Hand Delivery/Courier: Water Docket, Environmental
Protection Agency, Mailcode 4101T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, Attention Docket ID No. OW-2005-0024. Please
include a total of two copies. Hand deliveries/couriers are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. OW-2005-0024.
EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http://www.epa.gov/edocket
, 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 EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov websites are
``anonymous access'' systems, 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 e-mail comment directly to EPA without
going through EDOCKET or regulations.gov, your e-mail 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. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102). For additional instructions on submitting comments,
go to Section I.B1 of the preamble.
    Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Water Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC 20004. 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 Water Docket is (202)
566-2426.

FOR FURTHER INFORMATION CONTACT: Jennifer Chan, Water Permits Division,
Office of Wastewater Management (4203M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; phone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    Entities potentially affected by this action are governmental
entities responsible for implementation of the National Pretreatment
Program and industrial facilities subject to Pretreatment Standards and
requirements. These entities include:

------------------------------------------------------------------------
           Category                  Examples of regulated entities
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Local government.............  Publicly Owned Treatment Works (POTWs).
State government.............  States and Tribes acting as Pretreatment
                                Program Control Authorities or as
                                Approval Authorities.
Industry.....................  Industrial Users of POTWs.
Federal Government...........  EPA Regional Offices Acting as
                                Pretreatment Program Control Authorities
                                or as Approval Authorities.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your organization or facility is regulated by this action, you should
carefully examine the applicability criteria in 40 CFR 403.1 and 40 CFR
403.7. If you have questions about the applicability of this action to
a particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.

B. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. Overview of Removal Credits

A. What are the Existing Rules Relating to Removal Credits?

    Section 307(b)(1) of the Clean Water Act (CWA) directs EPA to
establish categorical Pretreatment Standards in order to prevent
interference with POTW operation and pass through of inadequately
treated pollutants. Because, in certain instances, POTWs could provide
some or all of the treatment of an Industrial User's wastewater that
would otherwise be required pursuant to the Pretreatment Standard, the
Act also authorizes a discretionary program for POTWs to grant
``removal credits'' to their Industrial Users. Removal credits are a
regulatory mechanism by which Industrial Users may discharge a
pollutant in quantities that exceed what would otherwise be allowed
under an applicable categorical Pretreatment Standard because it has
been determined that the POTW to which the Industrial User discharges
consistently removes the pollutant.
    Section 307(b)(1) establishes a three-part test that a POTW must
meet in order to obtain removal credit authority for a given pollutant.
Removal credits may be authorized only if (1) the POTW ``removes all or
any part of such toxic pollutant,'' (2) the POTW's ultimate Discharge
would ``not violate that effluent limitation or standard which would be
applicable to that toxic pollutant if it were discharged'' directly
rather than through a POTW, and (3) the POTW's Discharge would ``not
prevent sludge use and disposal by such [POTW] in accordance with
section [405] * * *'' (Sec. 307(b)). EPA promulgated removal credit
regulation that are codified at 40 CFR 403.7 (See 43 FR 27736, 46 FR
9404, 49 FR 31212, and 52 FR 42434).
    Under 40 CFR 403.7, POTWs are authorized to grant removal credits
if they meet the conditions outlined in 40 CFR 403.7(a)(3). One
condition is POTWs must demonstrate and continue to achieve
``consistent removal'' of the pollutant. ``Consistent removal'' is
defined at 40 CFR 403.7(b). Another condition is removal credits may
only be made available for pollutants that are listed in Appendix G,
Table I of Part 403 for the sludge use or disposal practice employed by
the POTW, when the requirements in 40 CFR Part 503 are met, or for
pollutants listed in Appendix G, Table II of this part when the
concentration for a pollutant in the sewage sludge does not exceed the
concentration for the pollutant in Appendix G, Table II. In addition,
removal credits may be made available for any pollutant in sewage
sludge when the POTW disposes all of its sewage sludge in a municipal
solid waste landfill unit that meets the criteria in 40 CFR Part 258.

B. Third Circuit Court Decision

    The U.S. Court of Appeals for the Third Circuit in NRDC v. EPA, 790
F.2d 289 (3rd. Cir. 1986), struck down the 1984 provisions of EPA's
General Pretreatment regulations (49 FR 31212) concerning removal
credits on the grounds that EPA had not promulgated the comprehensive
sewage sludge regulations required by CWA section 405 sludge
regulations. In the course of the decision, the court also determined
that the definition of ``consistent removal'' in the regulations failed
to implement the requirements of the CWA. The court held that the
definition violated a statutory requirement that direct and indirect
dischargers be held to the same standards and that EPA's definition of
consistent POTW removal, i.e. removal that is achieved only 50% of the
time, violated section 307(b)(1) of the CWA.
    In 1987, the Agency replaced the 1984 ``consistent removal''
provision with the 1981 provision (46 FR 9404). See 52 FR 42434. On
February 19, 1993, EPA promulgated the first round of sewage sludge
regulations, 40 CFR Part 503, (58 FR 9248) and included those
pollutants regulated in 40 CFR Part 503 in Appendix G of 40 CFR Part
403, Table I, Regulated Pollutants in Part 503 Eligible for a Removal
Credit. Those pollutants not regulated in 40 CFR Part 503 and that the
Agency was no longer considering for the sewage sludge regulations were
included in Appendix G of 40 CFR Part 403, Table II, Additional
Pollutants Eligible for a Removal Credit.

C. What is the Status of EPA's Review of the Existing Part 503 Sewage
Sludge Regulations?

    The CWA requires EPA to review the sewage sludge regulations every
two years to identify additional toxic pollutants in sewage sludge that
may warrant regulation under section 405(d). Under a recent biennial
review cycle, EPA evaluated publicly available information on the
toxicity, persistence, concentration, mobility, and potential for
exposure of additional toxic pollutants in sewage sludge. In a late
2003 Federal Register notice, EPA outlined a final action plan (68 FR
75531) for reviewing its sewage sludge regulations in response to a
2002 National Research Council (NRC) report that identified a need to
update the scientific basis of Part 503. In that notice, EPA also
presented the results of its studies to identify additional toxic
pollutants that might be candidates for future sewage sludge
regulations. EPA identified fifteen pollutants from a list of 803
pollutants for further evaluation and possible regulation. These 15
pollutants, listed below, had a Hazard Quotient (HQ) equal to or
greater than one and thus failed the screening. The HQ is the ratio of
the magnitude of exposure of the receptor organism (humans, aquatic
organism) to the human health or ecological benchmark. EPA will obtain
updated concentration data and conduct a refined risk assessment using
the data to determine whether to propose amendments to Part 503.

 Acetone
 Anthracene
 Barium
 Beryllium
 Carbon disulfide
 Chloroaniline, 4-; p-Chloroaniline
 Diazinon
 Fluoranthene
 Manganese (from drinking water)
 Methyl ethyl ketone; 2-Butanone
 Nitrate (as Nitrate-nitrogen)
 Nitrite (as Nitrate-nitrogen)
 Phenol
 Pyrene
 Silver

The Federal Register notice (68 FR 75531, December 31, 2003) includes

timeframes for taking action on these pollutants. Once this action is
taken, Appendix G of the Pretreatment regulation would be modified to
add the additional pollutants if warranted. Additional biennial review
cycles will occur per section 405(d)(2)(C) of the CWA.
    EPA also determined that there was sufficient toxicological and
exposure data for 25 pollutants to conclude that these pollutants would
not require regulation under Part 503. (With respect to five of these
25 pollutants, EPA has reevaluated its determination because they are
undergoing current IRIS (Integrated Risk Information System) or Office
of Pesticide Program reassessment.) These 5 pollutants are listed
below:
     Benzoic acid
     Butyl benzyl phthalate
     Dichloroethene, 1, 2-trans-
     Dichloromethane; Methylene chloride
     Dioxane, 1,4-

The remaining 20 pollutants, listed in Section III.A., have undergone
EPA's rigorous exposure and hazard screening which includes a
probabilistic model of 14 potential pathways to humans and ecological
endpoints.

III. Solicitation of Comments

    This section of the ANPRM describes the two issues EPA is
soliciting comments on.
    1. Whether EPA should propose to amend the list of pollutants
eligible for removal credits to add the 20 pollutants for which the
Agency has completed an exposure and hazard screening.
    2. Whether there are any options to amend the ``consistent
removal'' provision in the removal credits regulations that would be
consistent with the earlier Third Circuit decision.

A. What Action Could EPA Take To Amend the List of Eligible Pollutants

    EPA did not propose any changes to the list of pollutants eligible
for removal credits or any modifications to the procedures for
obtaining removal credits in the 1999 proposed Pretreatment
Streamlining Rule (64 FR 39564). (EPA notes that the Agency did propose
to change the methodology used for adjusting removal credits to account
for system overflows in 40 CFR 403.7(h). See Section III.H. of today's
final Pretreatment Streamlining Rule.) A number of commenters asked EPA
to consider changes to the regulations to allow greater availability of
removal credits for a broader range of pollutants. More specifically,
these commenters suggested that EPA further streamline the regulations
to make removal credits available for pollutants EPA is no longer
considering for the sewage sludge regulations (40 CFR Part 503). EPA
notes that certain pollutants that it evaluated and is no longer
considering for the sewage sludge regulations are listed in Appendix G
of the 40 CFR Part 403, Table II and are eligible for removal credits.
Moreover, as explained above, EPA is at this time evaluating whether to
amend the sewage sludge regulations. During any resulting rulemaking,
interested parties may submit information and background data to EPA
that would support amendments to Appendix G to add additional
pollutants for which removal credits will be available.
    In addition, a POTW or Industrial User may petition the Agency to
establish a Part 503 standard or an amendment to Part 403, Appendix G
for a pollutant. The petition must contain documentation consistent
with the records of decision underlying current Appendix G listings.
Data must be included on the toxicity, fate effects, and environmental
transport properties of individual pollutants adequate to allow EPA to
construct a Part 503 numerical standard, or to allow EPA to make a
finding that the concentration of the pollutant in sewage sludge is not
sufficient to create a reasonable probability of negative human health
or environmental impact from that pollutant contained in the sewage
sludge considering the specific sewage sludge use or disposal practice
being employed by the POTW. See the Federal Register notice dated
December 31, 2003 (68 FR 75531) for the exposure and hazard assessment
needed for pollutant to be considered for removal credits.
    As discussed in section II.C. of the preamble, there are 20
pollutants that did not fail EPA's exposure and hazard screening. These
pollutants, listed below, could potentially qualify for removal
credits.

     Acetophenone
     Azinphos methyl
     Biphenyl, 1,1-
     Chlorobenzene; Phenyl chloride
     Chlorobenzilate
     Chlorpyrifos
     Cresol, o-; 2-Methylphenol
     Endrin
     Ethyl p-nitrophenyl phenylphosphororthioate; EPN; Sanox
     Hexachlorocyclohexane, alpha-
     Hexachlorocyclohexane, beta-
     Isobutyl alcohol
     Methyl isobutyl ketone (MIBK); Methyl-2-pentanone, 4-
     Naled
     N-Nitrosdiphenylamine
     Trichlorofluoromethane
     Trichlorophenoxy propionic acid, 2-2,4,5-; Silvex
     Trichlororphenoxyacetic acid, 2,4,5-; 2,4,5-T
     Trifluralin
     Xylenes (mixture)

    EPA could develop upper concentrations for these pollutants and add
them to Appendix G of 40 CFR Part 403, Table II through an amendment to
the Pretreatment rule. EPA requests comment on whether the addition of
any of these 20 pollutants to Appendix G would be helpful to POTWs and
IUs in applying for removal credits. Depending on the response, EPA
would then consider whether to develop a schedule for proposing an
amendment to Appendix G of 40 CFR Part 403, Table II.

B. Consistent Removal Demonstration

    EPA did not propose any changes to how a POTW demonstrates
``consistent removal'' in the 1999 Proposed Pretreatment Streamlining
Rule and did not receive comment on this issue. However, in a draft
2004 Report to Congress on the Costs and Benefits of Federal Regulation
prepared by the Office of Management and Budget (OMB), OMB requested
public nominations of specific regulations, guidance documents and
paperwork requirements that, if reformed, could result in lower costs,
greater effectiveness, enhanced competitiveness, more regulatory
certainty and increased flexibility. These nominations, along with
agency responses, were compiled in OMB's March, 2005 report on
Regulatory Reform of the U.S. Manufacturing Sector. One of the reform
nominations that OMB received suggested that the procedures POTWs must
follow to get authority for removal credits are unduly burdensome and
thus make removal credits unduly difficult to obtain. The commenter
asserted that the required testing procedures do not accurately reflect
the actual pollutant removal capability of the POTW and cited as
example the requirement under 40 CFR 403.7(b) which requires that the
POTW calculate the removal rate based on the average of the lowest half
of the removal measurements taken according to listed procedures. The
commenter recommended revisions to more accurately reflect the total
removal by the POTW, and modifications to facilitate the granting of
authority when justified.
    With respect to the commenter's concern about ``consistent
removal'', EPA notes that its options are constrained by the Third
Circuit's

decision. However, EPA is requesting comment on whether there are any
options to amend the consistent removal provision that would simplify
or improve the process for obtaining removal credits that would be
consistent with the restrictions previously established by the court.

    Dated: September 27, 2005.
Stephen L. Johnson,
Administrator.
[FR Doc. 05-20000 Filed 10-13-05; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Page 58063]
[FR Doc No: 2023-18237]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0079]

Agency Information Collection Activities; Renewal of an Approved
Information Collection: Request for Revocation of Authority Granted

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The FMCSA requests
approval to renew an ICR titled, ``Request for Revocation of Authority
Granted.'' There were 0 comments received.

DATES: Comments on this notice must be received on or before September
25, 2023.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Jeff Secrist, Office of Registration
and Safety Information, DOT, FMCSA, West Building 6th Floor, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001;<PHONE_NUMBER>;
[email protected].

SUPPLEMENTARY INFORMATION:
    Title: Request for Revocation of Authority Granted.
    OMB Control Number: 2126-0018.
    Type of Request: Renewal of a currently-approved ICR.
    Respondents: For-hire motor carriers, freight forwarders, and
property brokers.
    Estimated Number of Respondents: 8,699.
    Estimated Time per Response: 15 minutes (0.25 hours).
    Expiration Date: September 30, 2023.
    Frequency of Response: Other (As needed).
    Estimated Total Annual Burden: 2,175.

Background

    FMCSA registers for-hire motor carriers of regulated commodities
under 49 U.S.C. 13902, surface freight forwarders under 49 U.S.C.
13903, and property brokers under 49 U.S.C. 13904. Each registration is
effective from the date specified under 49 U.S.C. 13905 (c). Subsection
(d) of 49 U.S.C. 13905 also provides that on application of the
registrant, the Secretary may amend or revoke a registration, and hence
the registrant's operating authority. Form OCE-46 allows these
registrants to apply voluntarily for revocation of their operating
authority or parts thereof. If the registrant fails to maintain
evidence of the required level of insurance coverage on file with
FMCSA, its operating authority will be revoked involuntarily. Although
the effect of both types of revocation is the same, some registrants
prefer to request voluntary revocation. For various business reasons, a
registrant may request revocation of some part, but not all, of its
operating authority. This information collection, which supports the
DOT Strategic Goal of Safety, is being revised to reflect modified
estimates of burden hours and costs. For respondents, the program
adjustment has resulted in increased total burden hours and an increase
in respondent costs. The burden hour increase is due to an estimated
increase in the number of annual filings of Form OCE-46 from 5,901 to
8,699 per year, resulting in an increase of 2,798 responses and 700
burden hours. The estimated annual labor cost for industry resulting
from submitting Form OCE-46 is $67,287, an increase of $17,760. The
total annual respondent cost has increased by $7,992. This increase is
due to the increase in the number of respondents filing paper forms.
While the online submission option exists, FMCSA still estimates that
approximately 2,310 respondents will continue to file the form by mail,
which incurs notarization and postage fees. For the Federal Government,
the program costs have increased by $19,707 due to the increase in the
number of forms received by FMCSA.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued under the authority of 49 CFR 1.87.
Thomas P. Keane,
Associate Administrator, Office of Research and Registration.
[FR Doc. 2023-18237 Filed 8-23-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: February 7, 2006 (Volume 71, Number 25)]
[Notices]
[Page 6297]
[DOCID:fr07fe06-62]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 19a-1; SEC File No. 270-240; OMB Control No. 3235-0216

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collections of information summarized below. The Commission plans to
submit these existing collections of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Section 19(a) [15 U.S.C. 80a-19(a)] of the Investment Company Act
of 1940 (the ``Act'') makes it unlawful for any registered investment
company to pay any dividend or similar distribution from any source
other than the company's net income, unless the payment is accompanied
by a written statement to the company's shareholders which adequately
discloses the sources of the payment. Section 19(a) authorizes the
Commission to prescribe the form of such statement by rule.
    Rule 19a-1 [17 CFR 270.19a-1] under the Act, entitled ``Written
Statement to Accompany Dividend Payments by Management Companies,''
sets forth specific requirements for the information that must be
included in statements made pursuant to section 19(a) by or on behalf
of management companies.\1\ The rule requires that the statement
indicate what portions of distribution payments are made from net
income, net profits and paid-in capital. When any part of the payment
is made from net profits, rule 19a-1 also requires that the statement
disclose certain other information relating to the appreciation or
depreciation of portfolio securities. If an estimated portion is
subsequently determined to be significantly inaccurate, a correction
must be made on a statement made pursuant to section 19(a) or in the
first report to shareholders following the discovery of the inaccuracy.
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    \1\ Section 4(3) of the Act [15 U.S.C. 80a-4(3)] defines
``management company'' as ``any investment company other than a face
amount certificate company or a unit investment trust.''
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    The purpose of rule 19a-1 is to afford fund shareholders adequate
disclosure of the sources from which distribution payments are made.
The rule is intended to prevent shareholders from confusing income
dividends with distributions made from capital sources. Absent rule
19a-1, shareholders might receive a false impression of fund gains.
    Based on a review of filings made with the Commission, the staff
estimates that approximately 3,000 portfolios of registered investment
companies that are management companies may be subject to rule 19a-1
each year, and that each portfolio on average mails two statements per
year to meet the requirements of the rule.\2\ The staff further
estimates that the time needed to make the determinations required by
the rule and to prepare the statement required under the rule is
approximately 1.5 hours per statement. The total annual burden for all
portfolios therefore is estimated to be approximately 9,000 burden
hours.
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    \2\ A few portfolios make monthly distributions from sources
other than net income, so the rule requires them to send out a
statement 12 times a year. Other portfolios never make such
distributions.
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    The staff estimates that approximately one-third of the total
annual burden (3,000 hours) would be incurred by a senior
administrative officer with an average hourly wage rate of
approximately $158 per hour, and approximately two-thirds of the annual
burden (6,000 hours) would be incurred by senior clerical staff with an
average hourly wage rate of $25 per hour.\3\ The staff therefore
estimates that the aggregate annual cost of complying with the
paperwork requirements of the rule is approximately $624,000 ((3,000
hours x $158) + (6,000 hours x $25)).
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    \3\ All hourly rates in this Supporting Statement are derived
from the average annual salaries reported for employees outside of
New York City in Securities Industry Association, Management and
Professional Earnings in the Securities Industry (2003) and
Securities Industry Association, Office Salaries in the Securities
Industry (2003).
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    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules. Compliance with the collection of information
required by rule 19a-1 is mandatory for management companies that make
statements to shareholders pursuant to section 19(a) of the Act.
Responses will not be kept confidential. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid control number.
    Written comments are invited on: (a) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burdens
of the collections of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collections of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Office of Information Technology, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549.

    Dated: January 31, 2006.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-1622 Filed 2-6-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56715-56717]
[FR Doc No: 2013-22312]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0577]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements for
Submission of Labeling for Human Prescription Drugs and Biologics in
Electronic Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
15, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0530.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Requirements for Submission of Labeling for Human Prescription Drugs
and Biologics in Electronic Format--(OMB Control Number 0910-0530)--
Extension

    FDA is requesting that OMB extend approval under the Paperwork
Reduction Act (44 U.S.C. 3501-3520) for the information collection
resulting from the requirement that the content of labeling for
prescription drug products be submitted to FDA electronically in a form
that FDA can process, review, and archive. This requirement was set
forth in the final rule entitled ``Requirements for Submission of
Labeling for Human Prescription Drugs and Biologics in Electronic
Format'' (December 11, 2003; 68 FR 69009), which amended FDA
regulations governing the format in which certain labeling is required
to be submitted for FDA review with new drug applications (NDAs) (21
CFR 314.50(l)(1)(i)), including supplemental NDAs, abbreviated new drug
applications (ANDAs) (21 CFR 314.94(d)(1)(ii)), including supplemental
ANDAs, and annual reports (21 CFR 314.81(b)(2)(iii)(b)) (the final rule
also applied to certain BLAs, but the information collection for these
requirements is not part of this OMB approval request).
    This OMB approval request is only for the burden associated with
the electronic submission of the content of labeling. The burden for
submitting labeling as part of NDAs, ANDAs, supplemental NDAs and
ANDAs, and annual reports, has been approved by OMB under control
number 0910-0001.
    We estimate that it should take applicants approximately 1.25 hours
to convert the content of labeling from Word or PDF to structured
labeling format (SPL) format. The main task involved in this conversion
is copying the content from one document (Word or PDF) to another
(SPL). Over the past few years, several enhancements have been made to
SPL authoring software which significantly reduces the burden and time
needed to generate well-formed SPL documents. SPL authors may now copy
a paragraph from a Word or PDF document and paste the text into the
appropriate section of an SPL document. In those cases where an SPL
author needs to create a table, the table text may be copied from the
Word or PDF document and pasted into each table cell in the SPL
document, eliminating the need to retype any information. Enhancements
have also been made to the software for conversion vendors. Conversion
software vendors have designed tools which will import the Word version
of the content of labeling and, within minutes, automatically generate
the SPL document (a few formatting edits may have to be made).
    Based on the number of content of labeling submissions received
during the past few years, we estimate that approximately 5,750 content
of labeling submissions are made annually with original NDAs, ANDAs,
supplemental NDAs and ANDAs, and annual reports by approximately 500
applicants. Therefore, the total annual hours to convert the content of
labeling from Word or PDF to SPL format would be approximately 7,187.50
hours.
    Concerning costs, we conclude that there are no capital costs or
operating and maintenance costs associated with this collection of
information. In May 2009, FDA issued a guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Listing.'' The guidance describes how to
electronically create and submit SPL files using defined code sets and
codes for establishment registration and drug listing information,
including labeling. The information collection resulting from this
guidance, discussed in the Federal Register of January 8, 2009 (74 FR
816), has been approved by OMB under control number 0910-0045. As
discussed in the January 8, 2009, Federal Register notice, to create an
SPL file and submit it to FDA, a registrant would need the following
tools: A computer, appropriate software, access to the Internet,
knowledge of terminology and standards, and access to FDA's electronic
submission gateway (ESG). Registrants (and most individuals) have
computers and Internet access available for their use. If a business
does not have an available computer or access to the Internet, free use
of computers and the Internet are usually available at public
facilities, e.g., a community library. In addition, there should be no
additional costs associated with obtaining the appropriate software. In
2008, FDA collaborated with GlobalSubmit to make available free SPL
authoring software that SPL authors may utilize to create new SPL
documents or edit previous versions. (Information on obtaining this
software is explained in section IV.A of the guidance ``Providing
Regulatory Submissions in Electronic Format--Drug Establishment
Registration and Listing.'') In addition to the software, FDA also
provides technical assistance and other resources, code sets and codes,
and data standards regarding SPL files.
    After the SPL file is created, the registrant would upload the file
through the ESG, as explained in the January 8, 2009, Federal Register
notice. A digital certificate is needed to use the ESG. The digital
certificate binds together the owner's name and a pair of electronic
keys (a public key and a private key) that can be used to encrypt and
sign documents. A fee of up to $20 is charged for the digital
certificate and the registrant may need to renew the certificate not
less than annually. We are not calculating this fee as a cost for this
extension because all applicants who submit content of labeling are
also subject to the drug establishment registration and listing
requirements and would have already acquired the digital certificate as
a result of the May 2009 guidance on drug establishment registration
and listing.
    In the Federal Register of May 30, 2013 (78 FR 32392), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. There were two comments received. Both
comments disagreed with FDA's estimate of 1.25 hours for converting the
content of labeling to SPL format. One comment said it would take 4 to
12 hours for experienced users to develop the initial well-formed SPL
and 4-5 hours for an SPL update, and that these estimates vary
depending on the complexity of the labeling metadata

and whether changes are necessary. The comment said that FDA also needs
to account for the time required for validating the SPL extensible
markup language (XML) file, including the need for using at least one
XML validation tool to ensure that the SPL file set is well-formed and
error-free. The comment said that copying table cells to create an SPL
file is time consuming and prone to errors, and that software tools do
not allow users to copy and paste the text and render it as intended in
SPL. The comment said that most users need to apply applicable
formatting to tables, which leads to longer conversion timelines, and
that manually creating the SPL file and proofing the document is time-
consuming.
    One comment said that updating the SPL file for submission to FDA
when a non-annotated or partially annotated MS Word document is
received from FDA requires a significant amount of time to identify the
changes to the labeling. The comment said that although SPL is a useful
and necessary format it involves extra time and costs for staying
current with changes in terminology and software versions, and for
conversion from another format when FDA requests documents in both MS
Word and SPL. The comment said that maintaining multiple formats of
labeling, negotiating FDA comments, and documenting agreements to final
labeling is time-consuming.
    A comment requested that FDA use a single, electronic file format
for receipt, review, and revision of labeling. The comment said that
companies currently receive information from FDA during its review of
labeling in many formats, including MS Word (both editable and hard-
formatted), faxes, texts, in emails, or other scanned documents with
handwritten comments. The comment noted that each iteration of the MS
Word document may need to be converted to SPL for submission, and that
managing the same activities for two different formats doubles the
work-load and causes incremental costs to be incurred by companies. The
comment also said that there should be better document management
(e.g., version control, tracking changes, and validation) of the MS
Word documents. A comment said that the staffing, expertise, and
technical support necessary to independently determine the need for a
labeling change is costly.
    One comment preferred the use of MS Word for labeling revisions and
negotiations with FDA, and said that until FDA is able to revise
labeling using only SPL it should not require an SPL submission until
14 days post-approval.
    Concerning the need for a digital certificate to use the ESG, one
comment said that companies may need to renew the certificate ``not
less than annually.'' The comment said that FDA should maintain an
accurate list of acceptable digital certificate vendors and communicate
the list to stakeholders via a formal process, as well as issue
appropriate notice of changes. The comment noted that some companies
received messages from FDA that one of the vendors listed as an
approved certificate vendor was not acceptable for use for submissions
to FDA, and, as a result, the companies purchased multiple certificates
from different vendors in order to use the ESG.
    A comment requested clarification concerning the type of filing
needed or anticipated by FDA to make an appropriate labeling decision.
The comment said that the Federal Register notice is not clear about
what type of filing is needed ``other than a CBE [change being
effected], which will not allow the Agency adequate time to review if
the label change is solely linked to one manufacturer or if it is
indeed a product related safety concern applicable to an entire class
of pharmaceuticals.''
    FDA appreciates the comments. We will respond to the issues raised
in the comments and amend this collection if necessary as soon as we
have gathered sufficient information to address the cost issues
specified in the comments. The public will have an opportunity to
comment on our response at that time.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
 Content of labeling submissions in NDAs, ANDAs, supplemental NDAs      Number of      responses per     Total annual    Average burden    Total hours
                   and ANDAs, and annual reports                       respondents        response        responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                500            11.50             5750             1.25         7,187.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22312 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71791-71793]
[FR Doc No: 2015-29368]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2015-0224; FRL-9939-16-OAR]

California State Nonroad Engine Pollution Control Standards; In-
Use Diesel-Fueled Transport Refrigeration Units (TRUs) and TRU
Generator Sets and Facilities Where TRUs Operate; Request for Within-
the-Scope and Full Authorization; Opportunity for Public Hearing and
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The California Air Resources Board (CARB) has notified the
Environmental Protection Agency (EPA) that it has adopted amendments to
its In-Use Diesel-Fueled Transport Refrigeration Units (TRUs) and TRU
Generator Sets and Facilities Where TRUs Operate (together ``2011 TRU
Amendments'') regulation. By letter dated March 2, 2015, CARB asked
that EPA authorize these amendments pursuant to section 209(e) of the
Clean Air Act. CARB seeks confirmation that certain 2011 TRU Amendments
are within the scope of prior authorizations issued by EPA, or, in the
alternative, that such amendments merit full authorization. CARB also
seeks a full authorization for other 2011 TRU Amendments. This notice
announces that EPA has tentatively scheduled a public hearing to
consider California's authorization request for the 2011 TRU Amendments
and that EPA is now accepting written comment on the request.

DATES: EPA has tentatively scheduled a public hearing concerning CARB's
request on January 6, 2016, at 10 a.m. ET. EPA will hold a hearing only
if any party notifies EPA by December 15, 2015 to express interest in
presenting the Agency with oral testimony. Parties wishing to present
oral testimony at the public hearing should provide written notice to
David Dickinson at the email address noted below. If EPA receives a
request for a public hearing, that hearing will be held at the William
Jefferson Clinton Building (North), Room 5528 at 1200 Pennsylvania Ave.
NW., Washington, DC 20460. If EPA does not receive a request for a
public hearing, then EPA will not hold a hearing, and instead will
consider CARB's request based on written submissions to the docket. Any
party may submit written comments until February 8, 2016.
    Any person who wishes to know whether a hearing will be held may
call David Dickinson at<PHONE_NUMBER> on or after December 16, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2015-0224, by one of the following methods:
     Online at http://www.regulations.gov: Follow the Online
Instructions for Submitting Comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket, Docket ID No. EPA-HQ-OAR-
2015-0224, U.S. Environmental Protection Agency, Mail code: 6102T, 1200
Pennsylvania Avenue NW., Washington, DC 20460. Please include a total
of two copies.
     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC
20460. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Online Instructions for Submitting Comments: Direct your comments
to Docket ID No. EPA-HQ-OAR-2015-0224. EPA's policy is that all
comments we receive will be included in the public docket without
change and may be made available online at http://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 http://www.regulations.gov or email. The http://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 http://www.regulations.gov, your
email address will automatically be 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. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    EPA will make available for public inspection materials submitted
by CARB, written comments received from any interested parties, and any
testimony given at the public hearing. Materials relevant to this
proceeding are contained in the Air and Radiation Docket and
Information Center, maintained in Docket ID No. EPA-HQ-OAR-2015-0224.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the Air and
Radiation Docket in the EPA Headquarters Library, EPA West Building,
Room 3334, located at 1301 Constitution Avenue NW., Washington, DC. The
Public Reading Room is open to the public on all federal government
work days from 8:30 a.m. to 4:30 p.m.; generally, it is open Monday
through Friday, excluding holidays. The telephone number for the
Reading Room is<PHONE_NUMBER>. The Air and Radiation Docket and
Information Center's Web site is http://www.epa.gov/oar/docket.html.
The electronic mail (email) address for the Air and Radiation Docket
is<EMAIL_ADDRESS>the telephone number is<PHONE_NUMBER>, and
the fax number is<PHONE_NUMBER>. An electronic version of the public
docket is available through the federal government's electronic public
docket and comment system. You may access EPA dockets at http://www.regulations.gov. After opening the http://www.regulations.gov Web
site, enter, in the ``Enter Keyword or ID'' fill-in box to view
documents in the record. Although a part of the official docket, the
public docket does not include Confidential Business Information
(``CBI'') or other information whose disclosure is restricted by
statute.
    EPA's Office of Transportation and Air Quality also maintains a Web
page that contains general information on its review of California
waiver and authorization requests. Included on that page are links to
prior waiver and authorization Federal Register notices. The page can
be accessed at http://www.epa.gov/otaq/cafr.htm.

FOR FURTHER INFORMATION CONTACT: David Dickinson, Attorney-Advisor,
Transportation and Climate Division, Office of Transportation and Air
Quality, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., (6405J), Washington, DC 20460. Telephone:<PHONE_NUMBER>. Fax:
(202) 343-2804. Email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. California's TRU Regulations; Within-the-Scope Request and Request
for Full Authorization

    CARB's TRU regulations require TRU engines to meet in-use standards
that vary by horsepower (hp) range and have two levels of emissions
stringency (LETRU and ULETRU--low-emission and ultra-low emission
transportation refrigeration units, respectively) that are phased in
over time.\1\ The 2011 Amendments provide owners of 2001 through 2003
model year (MY) TRU engines that complied with the LETRU in-use
performance standards by specified compliance deadlines a one-year
extension of the deadline to comply with the more stringent ULETRU in-
use performance standards.\2\ The 2011 Amendments also clarify manual
recordkeeping requirements for electric standby-equipped TRUs and
ultimately require automated electronic tracking system requirements
for such TRUs; establish requirements for businesses that arrange,
hire, contract, or dispatch the transport of goods in TRU-equipped
trucks, trailers or containers; and address other issues that arose
during the initial implementation of the TRU regulation.\3\
---------------------------------------------------------------------------

    \1\ CARB's amended regulation is codified at California Code of
Regulations (CCR), title 13, section 2477. EPA granted California a
full authorization for the initial TRU regulation in 2009 (74 FR
3030 (January 16, 2009)). EPA confirmed California's 2010 amendments
were within the scope of the initial TRU authorization in 2013 (78
FR 38970 (June 28, 2013)).
    \2\ The 2011 TRU Amendments also provide an extension of
applicable compliance dates should compliant technology not be
available.
    \3\ For a complete description of CARB's amended TRU regulation
and the provisions which CARB seeks EPA's authorization see CARB's
incoming request to EPA (and accompanying documents) submitted to
the public docket at EPA-HQ-OAR-2015-0224.
---------------------------------------------------------------------------

    By letter dated March 2, 2015, CARB submitted a request to EPA
pursuant to section 209(e) of the Clean Air Act (CAA or the Act) for
confirmation that its 2011 Amendments fall within the scope of EPA's
previous authorizations, or, in the alternate, a full authorization for
those amendments. Included in the within-the-scope request are the 2011
Amendments that (1) extend the ULETRU compliance date for MY 2003 and
older TRUs that complied with the LETRU standard by specified dates;
(2) extend compliance dates when compliant technology is unavailable or
delayed for certain reasons; (3) establish new exemptions; \4\ and (4)
allow in-use performance standards and associated compliance deadlines
to be based on the year the TRU was manufactured instead of the TRU
engine model year. CARB also seeks within-the-scope confirmation that
certain amendments to its accompanying enforcement procedures are
within the scope of prior EPA authorizations.\5\ CARB seeks a full
authorization for a subset of the 2011 Amendments that set forth
requirements for repowering TRUs with new replacement engines and that
allow owners to repower TRUs with rebuilt engines meeting certain
requirements. CARB also seeks a full authorization for a series
amendments to the TRU accompanying enforcement procedures.\6\
---------------------------------------------------------------------------

    \4\ These new exemptions are listed in section II G of CARB's
authorization request, EPA-HQ-OAR-2015-0224-0002 at p. 12-13.
    \5\ These amendments to the TRU accompanying enforcement
procedures are listed in CARB's authorization request, EPA-HQ-OAR-
2015-0244-0002 at p. 24.
    \6\ These amendments to the TRU accompanying enforcement
procedures are listed in CARB's authorization request, EPA-HQ-OAR-
2015-0224-0002 at p. 25.
---------------------------------------------------------------------------

II. Clean Air Act Nonroad Engine and Vehicle Authorizations

    Section 209(e)(1) of the CAA prohibits states and local governments
from adopting or attempting to enforce any standard or requirement
relating to the control of emissions from certain types of new nonroad
vehicles or engines. The Act also preempts states from adopting and
enforcing standards and other requirements related to the control of
emissions from other types of new nonroad vehicles or engines as well
as non-new nonroad engines or vehicles. Section 209(e)(2), however,
requires the Administrator, after notice and opportunity for public
hearing, to authorize California to adopt and enforce standards and
other requirements relating to the control of emissions from such
preempted vehicles or engines if California determines that California
standards will be, in the aggregate, at least as protective of public
health and welfare as applicable Federal standards. However, EPA shall
not grant such authorization if it finds that (1) the determination of
California is arbitrary and capricious; (2) California does not need
such California standards to meet compelling and extraordinary
conditions; or (3) California standards and accompanying enforcement
procedures are not consistent with [CAA section 209].\7\ In addition,
other states with air quality attainment plans may adopt and enforce
such regulations if the standards and the implementation and
enforcement procedures are identical to California's standards. On July
20, 1994, EPA promulgated a rule that sets forth, among other things,
regulations providing the criteria, as found in section 209(e)(2),
which EPA must consider before granting any California authorization
request for new nonroad engine or vehicle emission standards.\8\ EPA
revised these regulations in 1997.\9\ As stated in the preamble to the
1994 rule, EPA has historically interpreted the section
209(e)(2)(A)(iii) ``consistency'' inquiry to require, at minimum, that
California standards and enforcement procedures be consistent with
section 209(a), section 209(e)(1), and section 209(b)(1)(C) (as EPA has
interpreted that subsection in the context of section 209(b) motor
vehicle waivers).\10\
---------------------------------------------------------------------------

    \7\ EPA's review of California regulations under section 209 is
not a broad review of the reasonableness of the regulations or its
compatibility with all other laws. Sections 209(b) and 209(e) of the
Clean Air Act limit EPA's authority to deny California requests for
waivers and authorizations to the three criteria listed therein. As
a result, EPA has consistently refrained from denying California's
requests for waivers and authorizations based on any other criteria.
In instances where the U.S. Court of Appeals has reviewed EPA
decisions declining to deny waiver requests based on criteria not
found in section 209(b), the Court has upheld and agreed with EPA's
determination. See Motor and Equipment Manufacturers Ass'n v.
Nichols, 142 F.3d 449, 462-63, 466-67 (D.C. Cir.1998), Motor and
Equipment Manufacturers Ass'n v. EPA, 627 F.2d 1095, 1111, 1114-20
(D.C. Cir. 1979). See also 78 FR 58090, 58120 (September 20, 2013).
    \8\ 59 FR 36969 (July 20, 1994).
    \9\ 62 FR 67733 (December 30, 1997). The applicable regulations,
now in 40 CFR part 1074, subpart B, Sec.  1074.105, provide:
    (a) The Administrator will grant the authorization if California
determines that its standards will be, in the aggregate, at least as
protective of public health and welfare as otherwise applicable
federal standards.
    (b) The authorization will not be granted if the Administrator
finds that any of the following are true:
    (1) California's determination is arbitrary and capricious.
    (2) California does not need such standards to meet compelling
and extraordinary conditions.
    (3) The California standards and accompanying enforcement
procedures are not consistent with section 209 of the Act.
    (c) In considering any request to authorize California to adopt
or enforce standards or other requirements relating to the control
of emissions from new nonroad spark-ignition engines smaller than 50
horsepower, the Administrator will give appropriate consideration to
safety factors (including the potential increased risk of burn or
fire) associated with compliance with the California standard.
    \10\ 59 FR 36969 (July 20, 1994).
---------------------------------------------------------------------------

    In order to be consistent with section 209(a), California's nonroad
standards and enforcement procedures must not apply to new motor
vehicles or new motor vehicle engines. To be consistent with section
209(e)(1), California's nonroad standards and enforcement procedures
must not attempt to regulate

engine categories that are permanently preempted from state regulation.
To determine consistency with section 209(b)(1)(C), EPA typically
reviews nonroad authorization requests under the same ``consistency''
criteria that are applied to motor vehicle waiver requests. Pursuant to
section 209(b)(1)(C), the Administrator shall not grant California a
motor vehicle waiver if she finds that California ``standards and
accompanying enforcement procedures are not consistent with [section
202(a)]'' of the Act. Previous decisions granting waivers and
authorizations have noted that state standards and enforcement
procedures are inconsistent with section 202(a) if: (1) There is
inadequate lead time to permit the development of the necessary
technology giving appropriate consideration to the cost of compliance
within that time, or (2) the federal and state testing procedures
impose inconsistent certification requirements.\11\
---------------------------------------------------------------------------

    \11\ Id. See also 78 FR 58090, 58092 (September 20, 2013).
---------------------------------------------------------------------------

    If California amends regulations that EPA has already authorized,
California can seek EPA confirmation that the amendments are within the
scope of the previous authorization. A within-the-scope confirmation,
without a full authorization review, is permissible if three conditions
are met.\12\ First, the amended regulations must not undermine
California's determination that its standards, in the aggregate, are as
protective of public health and welfare as applicable federal
standards. Second, the amended regulations must not affect consistency
with section 202(a) of the Act. Third, the amended regulations must not
raise any ``new issues'' affecting EPA's prior authorizations.
---------------------------------------------------------------------------

    \12\ See 78 FR 38970, 38972 (June 28, 2013).
---------------------------------------------------------------------------

    In considering whether to grant authorizations for accompanying
enforcement procedures tied to standards for which an authorization has
already been granted, EPA addresses questions as to whether the
enforcement procedures undermine California's determination that its
standards are as protective of public health and welfare as applicable
federal standards, and whether the enforcement procedures are
consistent with section 202(a).\13\
---------------------------------------------------------------------------

    \13\ See CAA section 209(e)(2)(A)(i) and (iii), 42 U.S.C.
7543(e)(2)(A) (i) and (iii).
---------------------------------------------------------------------------

III. EPA's Request for Comments

    As stated above, EPA is offering the opportunity for a public
hearing, and is requesting written comment on issues relevant to a
within-the-scope analysis and a full authorization analysis.
Specifically, we request comment on whether the 2011 Amendments (1)
undermine California's previous determination that its standards, in
the aggregate, are at least as protective of public health and welfare
as comparable federal standards; (2) affect the consistency of
California's requirements with section 209 of the Act; or (3) raise any
other new issues affecting EPA's previous waiver or authorization
determinations.
    Should any party believe that the amendments are not within the
scope of the previous authorizations, EPA also requests comment on
whether the 2011 Amendments meet the criteria for a full authorization.
Specifically, we request comment on: (a) Whether CARB's determination
that its standards, in the aggregate, are at least as protective of
public health and welfare as applicable federal standards is arbitrary
and capricious; (b) whether California needs such standards to meet
compelling and extraordinary conditions; and (c) whether California's
standards and accompanying enforcement procedures are consistent with
section 209 of the Act.

IV. Procedures for Public Participation

    If a hearing is held, the Agency will make a verbatim record of the
proceedings. Interested parties may arrange with the reporter at the
hearing to obtain a copy of the transcript at their own expense.
Regardless of whether a public hearing is held, EPA will keep the
record open until February 8, 2016. Upon expiration of the comment
period, the Administrator will render a decision on CARB's request
based on the record from the public hearing, if any, all relevant
written submissions, and other information that she deems pertinent.
All information will be available for inspection at the EPA Air Docket
No. EPA-HQ-OAR-2015-0224.
    Persons with comments containing proprietary information must
distinguish such information from other comments to the greatest extent
possible and label it as ``Confidential Business Information'' (CBI).
If a person making comments wants EPA to base its decision on a
submission labeled as CBI, then a non-confidential version of the
document that summarizes the key data or information should be
submitted to the public docket. To ensure that proprietary information
is not inadvertently placed in the public docket, submissions
containing such information should be sent directly to the contact
person listed above and not to the public docket. Information covered
by a claim of confidentiality will be disclosed by EPA only to the
extent allowed, and according to the procedures set forth in 40 CFR
part 2. If no claim of confidentiality accompanies the submission when
EPA receives it, EPA will make it available to the public without
further notice to the person making comments.

    Dated: November 9, 2015.
Christopher Grundler,
Director, Office of Transportation and Air Quality, Office of Air and
Radiation.
[FR Doc. 2015-29368 Filed 11-16-15; 8:45 am]
 BILLING CODE 6560-50-P