[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Notices]
[Page 66638-66639]
[DOCID:fr16de09-65]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2009-0528; FRL-9092-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Industrial-Commercial-
Institutional Steam Generating Units, EPA ICR Number 1088.12, OMB
Control Number 2060-0072

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before January 15,
2010.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2009-0528, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Robert C. Marshall, Jr., Office of
Compliance, Mail code: 2223A, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-7021; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 30, 2009 (74 FR 38004), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2009-0528, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center 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 Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NSPS for Industrial-Commercial-Institutional Steam
Generating Units (40 CFR Part 60, Subpart Db).
    ICR Numbers: EPA ICR Number 1088.12, OMB Control Number 2060-0072.
    ICR Status: This ICR is scheduled to expire on February 28, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this

submission is pending at OMB. 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 OMB control number. The OMB
control numbers for EPA's regulations in title 40 of the CFR, after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, and displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Entities potentially affected by this action are the
owners or operators of industrial/commercial/institutional steam
generating units. The affected entities are subject to the General
Provisions of the New Source Performance Standards (NSPS) at 40 CFR
part 60, subpart A and any changes, or additions to the General
Provisions specified at 40 CFR part 60, subpart Db. Owners or operators
of the affected facilities must make an initial notification,
performance tests, and periodic reports, and maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. Reports, at a minimum, are required
semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 214
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Owners or operators of industrial/
commercial/institutional steam generating units.
    Estimated Number of Respondents: 1,500.
    Frequency of Response: Initially, occasionally, quarterly, and
semiannually.
    Estimated Total Annual Hour Burden: 771,889.
    Estimated Total Annual Cost: $94,838,557, which includes
$63,338,557 in labor costs, $9,000,000 in capital/startup costs, and
$22,500,000 in operation and maintenance (O&M) costs.
    Changes in the Estimates: The increase in burden from the most
recently approved ICR is due to adjustment. The total number of
respondents has increased from 1,185 to 1,500 which results in a
greater number of respondents, responses, and burden hours. The burden
also increased somewhat due to calculation errors in the previous ICR
that are corrected in this ICR. In addition, an increase in respondent
and Agency labor costs resulted from labor rate increases and the
inclusion of managerial and clerical labor hours. The previous ICR
showed only the technical hours.

    Dated: December 7, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-29892 Filed 12-15-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Notices]
[Page 68010-68012]
[DOCID:fr04no10-82]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-29493]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

October 29, 2010.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
October 2010. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>. An order granting each application will be
issued unless the SEC orders a hearing. Interested persons may request
a hearing on any application by writing to the SEC's Secretary at the
address below and serving the relevant applicant with a copy of the
request, personally or by mail. Hearing requests should be received by
the SEC by 5:30 p.m. on November 19, 2010, and should be accompanied by
proof of service on the applicant, in the form of an affidavit or, for
lawyers, a certificate of service. Hearing requests should state the
nature of the writer's interest, the reason for the request, and the
issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Evergreen Leaders Trust [File No. 811-8334]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has never made a public offering of
its securities and does not propose to make a public offering or engage
in business of any kind.
    Filing Dates: The application was filed on October 13, 2010, and
amended on October 25, 2010.
    Applicant's Address: 200 Berkeley St., Boston, MA 02116.

Federated Investment Portfolios [File No. 811-7461]; Federated
Investment Trust [File No. 811-7477]

    Summary: Applicants, a hub and spoke, respectively, in a hub and
spoke structure, seek orders declaring that they have ceased to be
investment companies. On September 25, 1998, Federated Investment Trust
redeemed all of its interests in Federated Investment Portfolios, whose
assets were distributed in-kind to Federated Investment Trust at net
asset value. Also, on September 25, 1998, Federated Investment Trust
transferred its assets to Federated Total Return Bond Fund, a series of
Federated Total Return Series,

Inc., based on net asset value. Applicants incurred no expenses in
connection with the reorganization and liquidation.
    Filing Dates: The applications were filed on August 3, 2010, and
amended on October 22, 2010.
    Applicants' Address: Federated Investors Funds, 4000 Ericsson Dr.,
Warrendale, PA 15086-7561.

Stone Harbor Credit Recovery Income Fund [File No. 811-22330]; Stone
Harbor Local Markets Income Fund [File No. 811-22068]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants have never made a public offering of their securities and do
not propose to make a public offering or engage in business of any
kind.
    Filing Dates: The applications were filed on September 16, 2010 and
September 20, 2010, respectively, and each was amended on October 14,
2010.
    Applicants' Address: ALPS Fund Services, Inc., 1290 Broadway, Suite
1100, Denver, CO 80203.

Pioneer Municipal and Equity Income Trust [File No. 811-21448]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Between
October 6, 2008 and October 24, 2008, applicant redeemed its auction
market preferred shares at $25,000 per share, plus an amount equal to
accumulated but unpaid dividends. On October 24, 2008, applicant
transferred its assets to Pioneer Tax Free Income Fund, based on net
asset value. Expenses of approximately $257,023 incurred in connection
with the reorganization were paid by applicant.
    Filing Dates: The application was filed on November 12, 2009, and
amended on September 29, 2010.
    Applicant's Address: 60 State St., Boston, MA 02109.

Torrey US Strategy Partners, LLC [File No. 811-21066]; Torrey
International Strategy Partners, LLC [File No. 811-21067]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company. On July
27, 2010, each applicant made a final liquidating distribution to its
shareholders, based on net asset value. Expenses of approximately
$128,797 and $37,004, respectively, incurred in connection with the
liquidations were paid by applicants. Applicants have retained $40,435
and $31,640, respectively, in cash to pay certain expected liabilities.
    Filing Date: The applications were filed on October 8, 2010.
    Applicants' Address: 45 East Putnam Ave., Suite 124, Greenwich, CT
06830.

Morgan Stanley Global Opportunity Bond Fund, Inc. [File No. 811-8460]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On January
25, 2010, applicant transferred its assets to Morgan Stanley Emerging
Markets Debt Fund, Inc., based on net asset value. Expenses of
approximately $169,949 incurred in connection with the reorganization
were paid by applicant and the acquiring fund.
    Filing Dates: The application was filed on October 4, 2010 and
amended on October 14, 2010.
    Applicant's Address: c/o Morgan Stanley Investment Management Inc.,
522 Fifth Ave., New York, NY 10036.

Emerging Markets Portfolio [File No. 811-8332]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On September 24, 2010, applicant made a
liquidating distribution to its shareholders, based on net asset value.
No expenses were incurred in connection with the liquidation.
    Filing Date: The application was filed on October 6, 2010.
    Applicant's Address: Two International Place, Boston, MA 02110.

Pennsylvania Avenue Funds [File No. 811-21253]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On June 7, 2010, applicant transferred its
assets to Quaker Event Arbitrage Fund, a series of Quaker Investment
Trust, based on net asset value. Expenses of $1,740 incurred in
connection with the reorganization were paid by applicant.
    Filing Date: The application was filed on October 7, 2010.
    Applicant's Address: 260 Water St., Brooklyn, NY 11201.

Wells Family of Real Estate Funds [File No. 811-8355]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 18, 2009, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $221,161 incurred in connection with the liquidation were
paid by Wells Asset Management, Inc., applicant's investment adviser.
    Filing Date: The application was filed on October 1, 2010.
    Applicant's Address: Wells Asset Management, Inc., 6200 The Corners
Parkway, Norcross, GA 30092.

Hyperion Brookfield Collateralized Securities Fund, Inc. [File No. 811-
21466]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On August 6,
2010, applicant made a final liquidating distribution to its
shareholders, based on net asset value. Expenses of $38,500 incurred in
connection with the liquidation were paid by applicant.
    Filing Date: The application was filed on September 21, 2010.
    Applicant's Address: Three World Financial Center, 200 Vesey St.,
10th Floor, New York, NY 10281-1010.

ICAP Funds, Inc. [File No. 811-8850]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On February 26, 2010, each series of
applicant transferred its assets to the corresponding shell series of
MainStay Funds Trust, based on net asset value. Expenses of $108,347
incurred in connection with the reorganization were paid by applicant.
    Filing Date: The application was filed on October 8, 2010.
    Applicant's Address: 51 Madison Ave., New York, NY 10010.

Castle Convertible Fund, Inc. [File No. 811-2213]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On January 9,
2009, applicant transferred its assets to Alger Convertible Fund, a
series of The Alger Funds, based on net asset value. Expenses of
$120,000 incurred in connection with the reorganization were paid by
Fred Alger Management, Inc., applicant's investment adviser.
    Filing Date: The application was filed on October 14, 2010.
    Applicant's Address: 111 Fifth Ave., New York, NY 10003.

Templeton Capital Accumulator Fund [File No. 811-6198]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On May 20, 2005, applicant transferred its
assets to Templeton Growth Fund, Inc., based on net asset value.
Expenses of $376,699 incurred in connection with the

reorganization were paid one-quarter by the applicant, one-quarter by
Templeton Growth Fund, Inc., one-quarter by Templeton Investment
Counsel, LLC, the applicant's investment manager, and one-quarter by
Templeton Global Advisors Limited, Templeton Growth Fund, Inc.'s
investment manager.
    Filing Dates: The application was filed on August 11, 2010 and
amended on October 22, 2010.
    Applicant's Address: 500 East Broward Boulevard, Fort Lauderdale,
FL 33394-3091.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-27861 Filed 11-3-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Notices]
[Page 29200]
[FR Doc No: 2013-11916]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Benda Pharmaceutical, Inc. and China Shuangjii Cement Ltd., Order
of Suspension of Trading

May 15, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Benda Pharmaceutical, Inc. because it has not filed any periodic
reports since the period ended September 30, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
China Shuangji Cement Ltd. because it has not filed any periodic
reports since the period ended September 30, 2010.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on May 15, 2013, through 11:59 p.m.
EDT on May 29, 2013.

    By the Commission.
Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2013-11916 Filed 5-15-13; 4:15 pm]
BILLING CODE 8011-01-P


Make advance arrangements for reclamation	0.00	0.00	1.50	0.00	1.50
$104.12	$0.00	$0.55	26	40	$2,756.31

Prepare reclamation plan	0.00	0.10	0.30	1.34	1.74	$64.11	$0.00	$0.00	26
46	$1,688.23

Maintain reclamation plan on-site for a minimum of three years	0.00	0.00
0.00	0.05	0.05	$1.24	$0.00	$0.00	26	1	$32.65

Submit reclamation plan upon request	0.00	0.00	0.00	0.16	0.16	$3.95
$0.00	$0.44	42	7	$183.62

Management Standards (Labeling and Compliance)

Label containers in satellite accumulation area	0.00	0.00	0.50	0.00	0.50
$34.71	$0.00	$0.00	79	40	$2,742.09

Label containers in 360-day accumulation area	0.00	0.00	1.00	0.00	1.00
$69.41	$0.00	$0.00	79	79	$5,483.39

Prepare procedures to ensure waste is stored no more than one year and
maximum accumulation volume is two standard shipments	0.00	0.00	1.00
0.10	1.10	$71.88	$0.00	$0.00	26	29	$1,892.84

Document that storage procedures are satisfied	0.00	0.00	0.25	0.00	0.25
$17.35	$0.00	$0.00	79	20	$1,370.65

Large Quantity Generator

Personnel Training

Collect job-related data	0.00	0.00	0.00	0.50	0.50	$12.35	$0.00	$0.00	6	3
$68.63

Maintain information at facility	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00
$0.00	6	1	$13.73

Contingency Plan and Planning Procedures

Collect data required in contingency plan	0.00	0.00	2.00	1.00	3.00
$163.53	$0.00	$0.00	6	17	$908.78

Document whether authorities decline arrangement	0.00	0.00	0.00	0.10
0.10	$2.47	$0.00	$0.00	6	1	$13.73

Write contingency plan	0.00	0.00	6.00	2.00	8.00	$465.89	$0.00	$0.00	6	44
$2,589.08

Maintain contingency plan	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.00	6	1
$13.73

Submit contingency plan to relevant emergency centers	0.00	0.00	0.00
0.16	0.16	$3.95	$0.00	$4.07	6	1	$44.57

Amend contingency plan when appropriate	0.00	0.00	1.00	1.00	2.00	$94.12
$0.00	$0.11	6	11	$523.66

Emergency Procedures

Collect information required in emergency report	0.00	0.00	1.00	1.00
2.00	$94.12	$0.00	$0.00	6	11	$523.05

Write emergency report	0.17	0.00	1.00	0.00	1.17	$92.12	$0.00	$0.00	6	7
$511.94

Call OSC or notify NRC; notify local authorities if advisable	0.00	0.10
0.90	0.00	1.00	$72.65	$0.00	$10.38	6	6	$461.42

Notice of Compliance

Collect information required in emergency report	0.00	0.00	0.50	0.50
1.00	$47.06	$0.00	$0.00	6	6	$261.53

Write emergency notification report	0.17	0.00	0.50	0.50	1.17	$69.76
$0.00	$0.00	6	7	$387.68

Submit report to Regional Administrator	0.00	0.00	0.00	0.16	0.16	$3.95
$0.00	$0.99	6	1	$27.45

Compile information demonstrating compliance	0.00	0.00	0.50	0.50	1.00
$47.06	$0.00	$0.00	6	6	$261.53

Small Quantity Generator

Personnel Training

Collect job-related data	0.00	0.00	0.00	0.50	0.50	$12.35	$0.00	$0.00	2	1
$28.93

Maintain information at facility	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00
$0.00	2	0	$5.79

Emergency Procedures

Observe scene of hazardous waste discharge	0.00	0.00	0.50	0.00	0.50
$34.71	$0.00	$0.00	2	1	$81.32

Report by phone requested data for NRC	0.00	0.00	0.50	0.00	0.50	$34.71
$0.00	$5.19	2	1	$93.47

Document that local officials declines to enter into arrangements for
coordinating response	0.00	0.00	0.10	0.00	0.10	$6.94	$0.00	$0.00	2	0
$16.26

Providing post emergency information by phone	0.00	0.00	0.00	0.10	0.10
$2.47	$0.00	$0.00	2	0	$5.79

Notice of Compliance

Collect information required in emergency report	0.00	0.00	0.33	0.33
0.67	$31.37	$0.00	$0.00	2	1	$65.92

Write emergency notification report	0.11	0.00	0.33	0.33	0.78	$46.51
$0.00	$0.00	2	2	$97.73

Submit report to Regional Administrator	0.00	0.00	0.00	0.11	0.11	$2.64
$0.00	$0.99	2	0	$7.63

Compile information demonstrating compliance	0.00	0.00	0.33	0.33	0.67
$31.37	$0.00	$0.00	2	1	$65.92

Manifest Requirements

Respondents will be required to complete manifests under existing
requirements of ICR 801: Requirements for Generators, Transporters, &
Waste Management Facilities Under the RCRA Hazardous Waste Manifest
System. This burden is calculated in Exhibit 3.

TSDFs

Continuation of RCRA Permits

Read the regulations	2.00	1.00	1.00	0.00	4.00	$438.32	$0.00	$0.00	19	76
$8,284.25

Complete and submit Part B renewal application	5.00	15.00	80.00	12.00
112.00	$8,044.51	$0.00	$0.44	19	2,117	$152,049.56

Revisions to the Generator-Controlled Exclusion for Hazardous Secondary
Materials (Option 3)

Recordkeeping and Speculative Accumulation

Large Quantity Generators

Label containers in satellite accumulation area with start date	0.00
0.00	0.50	0.00	0.50	$34.71	$0.00	$0.00	60	30	$2,099.85

Label containers in accumulation area with start date	0.00	0.00	1.00
0.00	1.00	$69.41	$0.00	$0.00	60	60	$4,199.10

Inventory logs must demonstrate that at least 75% by weight or volume of
material being recycled is transferred to a different site for recycling
in a calendar year	0.00	0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	60	15
$1,049.62

Small Quantity Generators

Label containers in satellite accumulation area with start date	0.00
0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	26	6	$442.48

Label containers in accumulation area with start date	0.00	0.00	0.25
0.00	0.25	$17.35	$0.00	$0.00	26	6	$442.48

Inventory logs must demonstrate that at least 75% by weight or volume of
material being recycled is transferred to a different site for recycling
in a calendar year.	0.00	0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	26	6
$442.48

Recordkeeping for the Tolling Provision

Tolling contractor must maintain at its facility for no less than three
years records of all hazardous secondary materials received pursuant to
the written contract with the tolling manufacturer.	0.00	0.00	0.00	0.05
0.05	$1.24	$0.00	$0.00	29	1	$35.42

Tolling manufacturer must maintain at its facility for no less than
three years records of hazardous secondary materials shipped pursuant to
its written contract with the tolling contractor.	0.00	0.00	0.00	0.05
0.05	$1.24	$0.00	$0.00	29	1	$35.42

Revisions to the Definition of Legitimacy (Option 4)

Legitimacy Codified for All Recycling

Legitimacy Documentation

Prepare documentation and certification statement - using in-house
employee audit	0.00	2.00	14.00	4.00	20.00	$1,274.24	$0.00	$646.66	1,139
22,784	$2,188,331.97

Prepare documentation and certification statement - using outside vendor
0.00	2.00	4.00	0.00	6.00	$481.29	$0.00	$3,233.31	1,139	6,835
$4,231,754.87

Prepare documentation and certification statement - using readily
available information	0.00	2.00	4.00	0.00	6.00	$481.29	$0.00	$0.00	1,139
6,835	$548,296.26

Repeat at least every three years - using in-house employee audit	0.00
2.00	14.00	4.00	20.00	$1,274.24	$0.00	$646.66	0	0	$0.00

Repeat at least every three years - using outside vendor	0.00	2.00	4.00
0.00	6.00	$481.29	$0.00	$3,233.31	0	0	$0.00

Repeat at least every three years - using readily available information
0.00	2.00	4.00	0.00	6.00	$481.29	$0.00	$0.00	0	0	$0.00

Maintain for a minimum of three years documentation and certification
0.00	0.00	0.00	0.05	0.05	$1.24	$0.00	$0.00	3,418	171	$4,237.91

Make documentation and certification available upon request by a
regulatory authority within 72 hours, or within a longer period of time
as specified by the regulatory authority	0.00	0.00	0.00	0.10	0.10	$2.47
$0.00	$0.44	615	62	$1,790.17

All Legitimacy Factors Mandatory

Legitimacy Petition

Prepare and submit a legitimacy petition	4.00	4.00	130.00	8.00	146.00
$10,162.84	$0.00	$22.83	103	14,969	$1,044,336.75

Sampling and analytical costs for hazardous secondary material
characterization	0.00	0.00	2.00	0.00	2.00	$138.83	$0.00	$306.09	103	205
$45,617.65

Revisions to Solid Waste Variances and Non-Waste Determinations (Option
5)

Re-Application if Material No Longer Meets Relevant Variance Criteria

Prepare and submit a re-application	0.00	0.00	75.00	0.00	75.00	$5,206.01
$0.00	$25.87	4	300	$20,927.52

Re-Application if Material No Longer Meets Relevant Non-Waste
Determination Criteria

Prepare and submit a re-application	2.00	2.00	65.00	4.00	73.00	$5,081.42
$0.00	$25.87	3	204	$14,300.41

Re-Notification

Update and submit notification by March 1 of each even numbered year
thereafter 	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	4	0	$10.67

Update and submit notification that the hazardous secondary materials
are no longer managed in accordance with the solid waste variances and
non-waste determinations	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	0.6
0	$1.60

Variance From Classification as a Solid Waste (260.31(c) and 260.33(a))

Provide information on whether the degree of partial reclamation the
material has undergone is substantial.	0.00	0.00	40.00	0.00	40.00
$2,776.54	$0.00	$25.87	4	160	$11,209.64

Provide information on whether the partially-reclaimed material has
sufficient economic value that it will be purchased for final
reclamation	0.00	0.00	16.00	0.00	16.00	$1,110.62	$0.00	$0.00	4	64
$4,442.48

Describe whether the partially-reclaimed material is a viable substitute
for a product or intermediate, produced from virgin or raw materials,
which feeds subsequent production steps.	0.00	0.00	40.00	0.00	40.00
$2,776.54	$0.00	$0.00	4	160	$11,106.16

Examine whether there is a guaranteed end market for the
partially-reclaimed material	0.00	0.00	20.00	0.00	20.00	$1,388.27	$0.00
$0.00	4	80	$5,553.08

Describe whether the partially-reclaimed material is handled to minimize
loss	0.00	0.00	6.00	0.00	6.00	$416.48	$0.00	$0.00	4	24.00	$1,665.92

Change to Non-Waste Determination

Demonstrate respondent cannot or should not meet the existing DSW
exclusions	0.00	0.00	20.00	0.00	20.00	$1,388.27	$0.00	$0.00	7	140
$9,717.89

Re-Manufacturing Exclusion (Option 6)

Petition Process

Prepare and submit petition to add certain chemicals, industries, and/or
chemical function uses to the re-manufacturing criteria	4.00	4.00	130.00
8.00	146.00	$10,162.84	$0.00	$22.83	0.04	5.84	$407.43

Sampling and analytical costs for hazardous secondary material
characterization	0.00	0.00	2.00	0.00	2.00	$138.83	$0.00	$306.09	0.04
0.08	$17.80

Additional Exclusion Conditions

Generator

Notification

Prepare and submit a notification prior to re-use under the
re-manufacturing exclusion.	0.00	0.10	0.30	0.10	0.50	$33.48	$0.00	$0.44
1	1	$45.23

Update and submit notification by March 1 of each even numbered year
thereafter 	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	1	0	$3.88

Update and submit notification that the hazardous secondary materials
are no longer managed in accordance with the re-manufacturing exclusion
0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	0.2	0	$0.58

Re-manufacturing Plan

Make advance arrangements with re-manufacturer	0.00	0.00	1.50	0.00	1.50
$104.12	$0.00	$0.55	1	2	$139.56

Prepare re-manufacturing plan jointly with re-manufacturer	0.00	0.10
0.30	1.34	1.74	$64.11	$0.00	$0.00	1	2	$85.48

Maintain re-manufacturing plan	0.00	0.00	0.00	0.05	0.05	$1.24	$0.00
$0.00	1	0	$1.65

Submit re-manufacturing plan upon request	0.00	0.00	0.00	0.16	0.16	$3.95
$0.00	$0.44	2	0	$9.30

Record of Shipments and Confirmations of Receipts

Maintain records of shipments for a period of three years from the dates
of shipments.	0.00	0.00	0.00	0.05	0.05	$1.24	$0.00	$0.00	14	1	$17.51

Maintain records of confirmations of receipts for a period of three
years from the dates of shipments.	0.00	0.00	0.00	0.05	0.05	$1.24	$0.00
$0.00	14	1	$17.51

Management in Tanks and Containers

Label or record in a log materials being stored in tanks and containers
prior to re-manufacturing	0.00	0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	4
1	$69.40

Technical Standards

Respondents will be required to comply with technical standards covered
by existing EPA ICR 1572: Hazardous Waste Specific Unit Requirements and
Special Waste Processes and Types. This burden is calculated in Exhibit
3.

NESHAP Standards

Respondents will be required to comply with air pollution standards
covered by existing EPA ICRs 820: Hazardous Waste Generator Standards
and 1593: Air Emission Standards for Tanks, Surface Impoundment and
Containers. This burden is calculated in Exhibit 3.

No Speculative Accumulation

Label containers in satellite accumulation area with start date	0.00
0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	0	0	$0.00

Label containers in accumulation area with start date	0.00	0.00	0.25
0.00	0.25	$17.35	$0.00	$0.00	0	0	$0.00

Inventory logs must demonstrate that at least 75% by weight or volume of
material being recycled is transferred to a different site for recycling
in a calendar year.	0.00	0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	0	0
$0.00

Re-Manufacturer

Notification

Prepare and submit a notification prior to re-use under the
re-manufacturing exclusion.	0.00	0.10	0.30	0.10	0.50	$33.48	$0.00	$0.44
1	1	$45.23

Update and submit notification by March 1 of each even numbered year
thereafter 	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	1	0	$3.88

Update and submit notification that the hazardous secondary materials
are no longer managed in accordance with the re-manufacturing exclusion.
0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	0.2	0	$0.58

Re-manufacturing Plan

Make advance arrangements with hazardous secondary material generator
0.00	0.00	1.50	0.00	1.50	$104.12	$0.00	$0.55	1	2	$139.56

Prepare re-manufacturing plan jointly with generator	0.00	0.10	0.30	1.34
1.74	$64.11	$0.00	$0.00	1	2	$85.48

Maintain re-manufacturing plan	0.00	0.00	0.00	0.05	0.05	$1.24	$0.00
$0.00	1	0	$1.65

Submit re-manufacturing plan upon request	0.00	0.00	0.00	0.16	0.16	$3.95
$0.00	$0.44	2	0	$9.30

Record of Shipments and Confirmations of Receipts

Maintain records of shipments for a period of three years from the dates
of shipments.	0.00	0.00	0.00	0.05	0.05	$1.24	$0.00	$0.44	14	1	$23.72

Management in Tanks and Containers

Label or record in a log materials being stored in tanks and containers
prior to re-manufacturing	0.00	0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	4
1	$69.40

Technical Standards

Respondents will be required to comply with technical standards covered
by existing EPA ICR 1572: Hazardous Waste Specific Unit Requirements and
Special Waste Processes and Types. This burden is calculated in Exhibit
3.

NESHAP Standards

Respondents will be required to comply with air pollution standards
covered by existing EPA ICRs 820: Hazardous Waste Generator Standards
and 1593: Air Emission Standards for Tanks, Surface Impoundment and
Containers. This burden is calculated in Exhibit 3.

No Speculative Accumulation

Label containers in satellite accumulation area with start date	0.00
0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	0	0	$0.00

Label containers in accumulation area with start date	0.00	0.00	0.25
0.00	0.25	$17.35	$0.00	$0.00	0	0	$0.00

Inventory logs must demonstrate that at least 75% by weight or volume of
material being recycled is transferred to a different site for recycling
in a calendar year.	0.00	0.00	0.25	0.00	0.25	$17.35	$0.00	$0.00	0	0
$0.00

Revisions to Other Recycling Exclusions and Exemptions (Option 7), i.e.,
Pre-2008 DSW Exclusions

Contained Standard

Read the regulations	0.00	1.00	2.50	0.00	3.50	$275.35	$0.00	$0.00	1,774
6,208	$488,379.12

Notification

Prepare and submit a notification prior to operating under exclusion
0.00	0.10	0.30	0.10	0.50	$33.48	$0.00	$0.44	1,774	887	$60,162.77

Update and submit notification by March 1 of each even numbered year
thereafter 	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	1,774	177
$5,161.37

Update and submit notification that the hazardous secondary materials
are no longer managed in accordance with the exclusion	0.00	0.00	0.00
0.10	0.10	$2.47	$0.00	$0.44	266	27	$774.21

Recordkeeping for Speculative Accumulation

Prepare procedures ensuring waste is stored no more than one year	0.00
0.00	1.00	0.10	1.10	$71.88	$0.00	$0.00	1,774	1,951	$127,491.16

Document that storage procedures are satisfied	0.00	0.00	0.25	0.00	0.25
$17.35	$0.00	$0.00	5,321	1,330	$92,319.35

Prepare a description of waste generation and waste management practices
	0.00	0.00	1.50	0.10	1.60	$106.59	$0.00	$0.00	1,774	2,838	$189,055.13

Document that the unit is emptied at least once a year	0.00	0.00	1.00
0.40	1.40	$79.30	$0.00	$0.00	5,321	7,449	$421,955.30

Label containers in accumulation area with start date	0.00	0.00	1.00
0.00	1.00	$69.41	$0.00	$0.00	5,321	5,321	$369,330.61

Label containers in satellite accumulation area with start date	0.00
0.00	0.50	0.00	0.50	$34.71	$0.00	$0.00	5,321	2,661	$184,691.91

Total (New Requirements)	 	 	 	 	 	 	 	 	 	84,590	$10,277,107

Exhibit 2

Estimated Annual Respondent Hour and Cost Burden – Existing
Requirements

Revisions to the Definition of Solid Waste*

	 	Hours and Costs Per Respondent	Total Hours and Costs

Legal	Managerial	Technical	Clerical	Hours/  Activity	Labor
Costs/Activity	Capital Costs	O&M Costs	No. of Respond./ Activities	Total
Hours/Year	Total Cost/Year

	Notification for Generator-Controlled Exclusion

	Prepare and submit a notification prior to recycling	0.00	0.10	0.30
0.10	0.50	$33.48	$0.00	$0.44	29	14	$972.37

	Update and submit notification by March 1 of each even numbered year
thereafter 	0.00	0.00	0.00	0.10	0.10	$2.47	$0.00	$0.44	29	3	$83.42

	Update and submit notification that the hazardous secondary materials
are no longer managed in accordance with the exclusion	0.00	0.00	0.00
0.10	0.10	$2.47	$0.00	$0.44	4.3	0	$12.51

	Certifications for Hazardous Secondary Material Generated and Reclaimed
Under the Control of the Generator

	Prepare the certification	0.00	0.02	0.00	0.08	0.10	$4.01	$0.00	$0.00	61
6	$245.95

	Non-Waste Determination

	Application for Non-Waste Determination

	Prepare and submit an application	4.00	4.00	130.00	8.00	146.00
$10,162.84	$0.00	$22.83	7	1,022	$71,299.69

	Re-Application for Non-Waste Determination

	Prepare and submit a re-application	2.00	2.00	65.00	4.00	73.00
$5,081.42	$0.00	$22.83	0	0	$0.00

	Total (Existing Requirements)	 	 	 	 	 	 	 	 	 	1,046
$72,613.94

Exhibit 3

Estimated Annual Respondent Hour and Cost Burden - New and Existing
Paperwork Requirements

Revisions to the Definition of Solid Waste*

 	ICR Number	Hours/Year	Labor Cost/Year	Capital Cost/Year	O&M Cost/Year
Total Cost/Year

Respondent Paperwork Requirements

Paperwork Requirements for this ICR

2011 Revisions to the RCRA Definition of Solid Waste	2310.02	84,590
$5,820,813	$0	$4,456,294	$10,277,107

Continuing requirements under the 2008 Revisions to the RCRA Definition
of Solid Waste	2310.01	1,046	$72,427	$0	$187	$72,614

New Paperwork Requirements under Existing ICRs

Requirements for Generators, Transporters, and Waste Management
Facilities under the RCRA Hazardous Waste Manifest System	801	478
$14,589	$0 	$37 	$14,626

Hazardous Waste Generator Standards	820	7	$261	$0 	$0 	$261

Hazardous Waste Specific Unit Requirements and Special Waste Processes
and Types	1572	297	$11,152	$0 	$512	$11,663

Air Emission Standards for Tanks, Surface Impoundment and Containers
1593	458	$44,743 	$0 	$8,099	$52,842

Total Respondent Burden	 	86,876 	$5,963,985 	$0 	$4,465,129
$10,429,113

* Table includes rounding error.

Exhibit 4

Estimated Annual Agency Hour and Cost Burden

Revisions to the Definition of Solid Waste*

	 	Hours and Costs Per Agency Activity	Total Hours and Costs

	Legal	Managerial 	Technical	Clerical	 Hours/  Activity	Labor
Costs/Activity	Capital Costs	 O&M Costs	No. of Agency Activities	Total
Hours/Year	Total Cost/Year

Information Collection Activity	$70.07	$65.36	$56.30	$26.74

	Alternative Subtitle C Regulation for Hazardous Recyclable Materials
For Offsite Transfer Recycling Exclusion (Option 2)

Notification

Receive, Review and File Initial Notifications 	0.00	0.00	0.08	0.05	0.13
$5.84	$0.00	$0.44	26	3	$165.37

Receive, Review and File Biennial Notifications 	0.00	0.00	0.08	0.05
0.13	$5.84	$0.00	$0.44	26	3	$165.37

Receive, Review and File Discontinuation Notifications 	0.00	0.00	0.08
0.05	0.13	$5.84	$0.00	$0.44	4	1	$24.81

Reclamation Plan

Receive, Review and File Advance Arrangement Documents 	0.00	0.50	0.00
0.20	0.70	$38.03	$0.00	$0.00	42	29	$1,590.69

Large Quantity Generator

Emergency Procedures

Review submitted release report information	0.00	0.00	0.50	0.00	0.50
$28.15	$0.00	$0.00	6	3	$156.44

Enter information into database tracking all releases	0.00	0.00	0.50
0.50	1.00	$41.52	$0.00	$0.00	6	6	$230.74

Transmit information to respective response authorities	0.00	0.00	0.25
0.25	0.50	$20.76	$0.00	$0.00	6	3	$115.37

Notice of Compliance

Receive, review and file notification of compliance regarding affected
release area.	0.00	0.00	4.00	0.00	4.00	$225.19	$0.00	$0.00	6	22
$1,251.44

Small Quantity Generator

Emergency Procedures

Review submitted release report information	0.00	0.00	0.50	0.00	0.50
$28.15	$0.00	$0.00	2	1	$65.95

Enter information into database tracking all releases	0.00	0.00	0.50
0.50	1.00	$41.52	$0.00	$0.00	2	2	$97.27

Transmit information to respective response authorities	0.00	0.00	0.25
0.25	0.50	$20.76	$0.00	$0.00	2	1	$48.63

Notice of Compliance

Receive, review and file notification of compliance regarding affected
release area.	0.00	0.00	4.00	0.00	4.00	$225.19	$0.00	$0.00	2	8	$473.20

Manifest Requirements

The Agency will be required to review additional manifests under
existing requirements of ICR 801: Requirements for Generators,
Transporters, & Waste Management Facilities Under the RCRA Hazardous
Waste Manifest System. This burden is calculated in Exhibit 6.

TSDFs

Continuation of  RCRA permits

Review the permit application	0.00	1.00	20.00	0.00	21.00	$1,191.29	$0.00
$0.00	19	397	$22,515.38

Enter information into database	0.00	0.00	0.00	0.10	0.10	$2.67	$0.00
$0.00	19	2	$50.46

Revisions to the Definition of Legitimacy (Option 4)

Legitimacy Codified for All Recycling

Legitimacy Documentation

Evaluate Legitimacy Documentation 	2.00	2.00	31.25	4.00	39.25	$2,137.08
$0.00	$0.00	615	24,146	$1,314,688.87

All Legitimacy Factors Mandatory

Evaluate Legitimacy Petitions 	8.00	8.00	125.00	16.00	157.00	$8,548.34
$0.00	$0.00	103	16,097	$876,461.30

Revisions to Solid Waste Variances and Non-Waste Determinations (Option
5)

Re-Application  if Material No Longer Meets Relevant Variance Criteria

Receive, Review and File Re-Application	8.00	8.00	125.00	16.00	157.00
$8,548.34	$0.00	$0.00	4	628	$34,193.36

   Re-Application  if Material No Longer Meets Relevant  Non-Waste
Criteria

Receive, Review and File Re-Application	8.00	8.00	125.00	16.00	157.00
$8,548.34	$0.00	$0.00	3	440	$23,935.35

Re-Notification

Receive, Review and File Biennial Notifications 	0.00	0.00	0.08	0.05
0.13	$5.84	$0.00	$0.44	4	0	$23.03

Receive, Review and File Discontinuation Notifications 	0.00	0.00	0.08
0.05	0.13	$5.84	$0.00	$0.44	1	0	$3.45

EPA provides online public access to a list (including supporting
documentation) of facilities receiving non-waste determinations	0.00
0.25	1.00	0.10	1.35	$75.31	$0.00	$0.00	4	5	$276.14

Revisions to Partial Reclamation Variance

Variance from Classification as a Solid Waste (260.31(c) and 260.33(a))

Review the variance demonstration	0.00	2.20	18.16	0.00	20.36	$1,166.14
$0.00	$0.00	4	81	$4,664.56

Request additional information if necessary	0.00	0.00	0.55	1.65	2.20
$75.08	$0.00	$0.00	4	9	$300.32

Deliberate and issue draft determination	3.85	1.65	25.31	2.20	33.01
$1,861.30	$0.00	$0.00	4	132	$7,445.20

Publicize draft determination	0.00	0.00	1.65	4.40	6.05	$210.54	$0.00
$0.00	4	24	$842.16

Hold hearing, if required	0.00	0.55	22.01	1.65	24.21	$1,319.15	$0.00
$0.00	4	97	$5,276.60

Review comments and make final determination	2.20	1.65	23.11	2.20	29.16
$1,621.84	$0.00	$0.00	4	117	$6,487.36

Change to Non-Waste Determination

Evaluate and approve/deny re-application	8.00	8.00	125.00	16.00	157.00
$8,548.34	$0.00	$0.00	7	1,099	$59,838.38

Re-Manufacturing Exclusion (Option 6)

Petition Process

Review the petition	8.00	8.00	125.00	16.00	157.00	$8,548.34	$0.00	$0.00
0.04	6	$341.93

Request additional information if necessary	0.00	0.00	0.55	1.65	2.20
$75.08	$0.00	$0.00	0.04	0	$3.00

Deliberate and issue draft determination	3.85	1.65	25.31	2.20	33.01
$1,861.30	$0.00	$0.00	0.04	1	$74.45

Publicize draft determination	0.00	0.00	1.65	4.40	6.05	$210.54	$0.00
$0.00	0.04	0	$8.42

Hold hearing, if required	0.00	0.55	22.01	1.65	24.21	$1,319.15	$0.00
$0.00	0.04	1	$52.77

Review comments and make final determination	2.20	1.65	23.11	2.20	29.16
$1,621.84	$0.00	$0.00	0.04	1	$64.87

Additional Exclusion Conditions

Generator

Notification

Receive, Review and File Initial Notifications 	0.00	0.00	0.08	0.05	0.13
$5.84	$0.00	$0.44	1	0	$8.37

Receive, Review and File Biennial Notifications 	0.00	0.00	0.08	0.05
0.13	$5.84	$0.00	$0.44	1	0	$8.37

Receive, Review and File Discontinuation Notifications 	0.00	0.00	0.08
0.05	0.13	$5.84	$0.00	$0.44	0	0	$1.26

Technical Standards

Agency will be required to conduct activities associated with technical
standards covered by existing EPA ICR 1572: Hazardous Waste Specific
Unit Requirements and Special Waste Processes and Types for additional
facilities. This burden is calculated in Exhibit 6.

NESHAP Standards

Agency will be required to conduct activities associated with pollution
standards covered by existing EPA ICRs 820: Hazardous Waste Generator
Standards and 1593: Air Emission Standards for Tanks, Surface
Impoundment and Containers. This burden is calculated in Exhibit 6.

Re-Manufacturer

Notification

Receive, Review and File Initial Notifications 	0.00	0.00	0.08	0.05	0.13
$5.84	$0.00	$0.44	1	0	$8.37

Receive, Review and File Biennial Notifications 	0.00	0.00	0.08	0.05
0.13	$5.84	$0.00	$0.44	1	0	$8.37

Receive, Review and File Discontinuation Notifications 	0.00	0.00	0.08
0.05	0.13	$5.84	$0.00	$0.44	0	0	$1.26

Technical Standards

Agency will be required to conduct activities associated with technical
standards covered by existing EPA ICR 1572: Hazardous Waste Specific
Unit Requirements and Special Waste Processes and Types for additional
facilities. This burden is calculated in Exhibit 6.

NESHAP Standards

Agency will be required to conduct activities associated with pollution
standards covered by existing EPA ICRs 820: Hazardous Waste Generator
Standards and 1593: Air Emission Standards for Tanks, Surface
Impoundment and Containers. This burden is calculated in Exhibit 6.

Revisions to Other Recycling Exclusions and Exemptions (Option 7), i.e.,
pre-2008 DSW exclusions

Contained Standard

Notification

Receive, Review and File Initial Notifications	0.00	0.00	0.08	0.05	0.13
$5.84	$0.00	$0.44	1,774	231	$11,138.63

Receive, Review and File Biennial Notifications 	0.00	0.00	0.08	0.05
0.13	$5.84	$0.00	$0.44	1,774	231	$11,138.63

Receive, Review and File Discontinuation Notifications 	0.00	0.00	0.08
0.05	0.13	$5.84	$0.00	$0.44	266	35	$1,670.79

Recordkeeping for Speculative Accumulation

Notification

Receive, review, and file the notifications	0.00	0.00	0.08	0.05	0.13
$5.84	$0.00	$0.00	0	0	$0.00

Total (New Requirements)	 	 	 	 	 	 	 	 	 	43,863	$2,385,917

Exhibit 5

Estimated Annual Agency Hour and Cost Burden – Existing Requirements

Revisions to the Definition of Solid Waste*

	 	Hours and Costs Per Agency Activity	Total Hours and Costs

	Legal	Managerial 	Technical	Clerical	 Hours/  Activity	Labor
Costs/Activity	Capital Costs	 O&M Costs	No. of Agency Activities	Total
Hours/Year	Total Cost/Year

Notification for Generator-Controlled Exclusion

Receive, Review and File Initial Notifications	0.00	0.00	0.08	0.05	0.13
$5.84	$0.00	$0.44	29	4	$180

Receive, Review and File Biennial Notifications 	0.00	0.00	0.08	0.05
0.13	$5.84	$0.00	$0.44	29	4	$180

Receive, Review and File Discontinuation Notifications 	0.00	0.00	0.08
0.05	0.13	$5.84	$0.00	$0.44	4	1	$27

Non-Waste Determinations

Application for Non-Waste Determination

Evaluate and approve/deny application	8.00	8.00	125.00	16.00	157.00
$8,548.34	$0.00	$0.00	7	1,099	$59,838

Re-Application for Non-Waste Determination

Evaluate and approve/deny re-application	8.00	8.00	125.00	16.00	157.00
$8,548.34	$0.00	$0.00	0	0	$0.00

Total (Existing Requirements)

1,107	  $60,225

Exhibit 6

Estimated Annual Agency Hour and Cost Burden - New and Existing
Paperwork Requirements

Revisions to the Definition of Solid Waste*

 	ICR Number	Hours/Year	Labor Cost/Year	Capital Cost/Year	O&M Cost/Year
Total Cost/Year

Agency Paperwork Requirements

Paperwork Requirements for this ICR

2011 Revisions to the RCRA Definition of Solid Waste	2310.02	43,863
$2,384,210	$0	$1,707	$2,385,917

Continuing requirements under 2008 Revisions to the RCRA Definition of
Solid Waste	2310.01	1,107	$60,198	$0	$27	$60,225

New Paperwork Requirements under Existing ICRs

Requirements for Generators, Transporters, and Waste Management
Facilities under the RCRA Hazardous Waste Manifest System	801	2	$81	$0
$0	$81

Hazardous Waste Generator Standards	820	4	$134	$0	$0	$134

Hazardous Waste Specific Unit Requirements and Special Waste Processes
and Types	1572	1	$46	$0	$0	$46

Air Emission Standards for Tanks, Surface Impoundment and Containers
1593	5	$221	$0 	$0 	$221

Total Agency Burden	 	44,982 	$2,444,889 	$0 	$1,734 	$2,446,623

* Table includes rounding error.

 The two types of non-waste determinations are (1) a determination for
hazardous secondary materials reclaimed in a continuous industrial
process and (2) a determination for hazardous secondary materials that
are indistinguishable in all relevant aspects from a product or
intermediate.

 Based on EPA’s research indicating that an airline fare of $600 is
representative of a roundtrip flight within the EPA also found that
respondents can purchase an audit report of a reclaimer for about
$3,000.

 “Regulatory Impact Analysis, EPA’s 2011 Proposed Revisions to the
Industrial Recycling Exclusions of the RCRA Definition of Solid
Waste,” Mark Eads (EPA) and David Gustafson (DPRA Incorporated), 09
March 2011.

 Data published by EPA indicate that, as of April 26, 2011, 49
facilities had submitted notifications to EPA claiming either onsite
recycling exclusions, same-company transfer exclusions, and/or offsite
transfer exclusions (  HYPERLINK
"http://www.epa.gov/waste/hazard/dsw/notify-sum.pdf"
http://www.epa.gov/waste/hazard/dsw/notify-sum.pdf ).  Based on these
data, it is assumed that 49 industrial facilities will have submitted
DSW exclusion notifications under the 2008 DSW final rule by June 30,
2011. Given that these notifications were submitted to EPA over an
approximate two-and-a-half year period (i.e., between its December 28,
2008 effective date, and April 26, 2011), the rate of new notifications
every year is estimated to be 21 facilities per year (i.e., 49
facilities divided by 2.33 years = 21 facilities per year). This rate of
notification is assumed to continue on an annual basis beginning in
2009, through our period of analysis (2015-2017) and in subsequent
years.

 This ICR differs from the 2011 RIA for this rulemaking with regard to
this calculation. The RIA analyzes the rule's impact over a much longer
time horizon of 50 years, during which EPA believes the number of
facilities operating under each exclusion will eventually diverge from
its current pace due to the disparity in the number of facilities
eligible for each exclusion.

 Ibid.

 Of the 277 facilities eligible for the generator-based exclusion, 92
(33.2%) utilize offsite tolling.

 The ICR covers the period 2015-2017, during which an average of 168
facilities will notify, based on these assumptions (projected from
2009).

 This ICR differs from the 2011 RIA for this rulemaking with regard to
this calculation. The RIA analyzes the rule's impact over a much longer
time horizon of 50 years, during which EPA believes the number of
facilities operating under each exclusion will eventually diverge from
its current pace due to the disparity in the number of facilities
eligible for each exclusion.

 Ibid.

 The total count of 3,996 facilities excludes 660 CESQGs, as CESQGs are
not expected to apply under the Alternative Subtitle C Standard for
Hazardous Recyclable Materials.

 The total count of 3,996 facilities excludes 660 CESQGs, as CESQGs are
not expected to apply under the Alternative Subtitle C Standard for
Hazardous Recyclable Materials.

 Ibid.

 This estimate is the average of the low and high estimates of variance
re-applications given in the RIA (zero and eight, respectively).

 This estimate is the average of the low and high estimates of the
percentage of applicants that will petition given in the 2011 RIA (zero
and ten, respectively).

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  PAGE  i

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  PAGE  57


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Rules and Regulations]
[Pages 43582-43585]
[FR Doc No: 2011-18391]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308)

Cardiovascular Devices; Classification of Electrocardiograph
Electrodes

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
electrocardiograph electrode, intended to acquire and transmit the
electrical signal at the body surface to a processor that produces an
electrocardiogram (ECG) or vectorcardiogram, into class II (special
controls). FDA is also exempting this device from the premarket
notification requirement.

DATES: This rule is effective August 22, 2011.

FOR FURTHER INFORMATION CONTACT: Sharon Lappalainen, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1238, Silver Spring, MD 20993, 301-796-
6322.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Pub. L. 101-629), the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), and the Medical
Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-
250), established a comprehensive system for the regulation

of medical devices intended for human use. Section 513 of the FD&C Act
(21 U.S.C. 360c) established three categories (classes) of devices,
defined by the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    Under section 513 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after it takes the following steps: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
    Devices that were not in commercial distribution before May 28,
1976, generally referred to as postamendments devices, are classified
automatically under section 513(f) of the FD&C Act into class III
without any FDA rulemaking process. Those devices remain in class III
until FDA does the following: (1) Reclassifies the device into class I
or II; (2) issues an order classifying the device into class I or II in
accordance with section 513(f)(2) of the FD&C Act; or (3) issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a legally marketed device that
has been classified into class I or class II.
    The Agency determines whether new devices are substantially
equivalent to previously marketed devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807 of the regulations. FDAMA added a new
section 510(m) to the FD&C Act. New section 510(m) provides that a
class II device may be exempted from the premarket notification
requirements under section 510(k) of the FD&C Act, if the Agency
determines that premarket notification is not necessary to assure the
safety and effectiveness of the device. FDA has determined that
premarket notification is not necessary to assure the safety and
effectiveness of electrocardiograph electrodes.
    Under the 1976 amendments, class II devices were defined as devices
for which there was insufficient information to show that general
controls themselves would provide reasonable assurance of safety and
effectiveness, but for which there was sufficient information to
establish performance standards to provide such assurance. SMDA
broadened the definition of class II devices to mean those devices for
which the general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there
is sufficient information to establish special controls to provide such
assurance, including performance standards, postmarket surveillance,
patient registries, development and dissemination of guidelines,
recommendations, and any other appropriate actions FDA deems necessary
(section 513(a)(1)(B) of the FD&C Act). Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of the guidance
document that will serve as the special control for this device. This
action is being taken under the FD&C Act, as amended by the 1976
amendments, SMDA, FDAMA, and MDUFMA.

II. Regulatory History of the Device

    In the Federal Register of October 4, 2007 (72 FR 56702; Docket No.
2007N-0308), FDA proposed to classify electrocardiograph electrodes,
intended to acquire and transmit the electrical signal at the body
surface to a processor that produces an electrocardiogram (ECG) or
vectorcardiogram, into class II. FDA also proposed to exempt this
device from premarket notification requirements. FDA invited interested
persons to comment on the proposed regulation by January 2, 2008. FDA
received seven comments on the proposed rule.

III. Summary of Final Rule

    FDA is amending the classification regulation for
electrocardiograph electrodes into class II, by making this device
exempt from 510(k) premarket notification requirements and subject to
the new special controls described in the special controls guidance
document entitled ``Guidance for Industry and Food and Drug
Administration Staff: Class II Special Controls Guidance Document:
Electrocardiograph Electrodes.''
    As described in that special controls guidance document, the
special controls include the following:
     Documentation of device description, which includes
compliance with 21 CFR 820.181(a) to maintain a device master record;
     Documentation of performance characteristics, which
includes documentation on biocompatibility, electrical performance,
adhesive performance, shelf life, reuse, electrodes intended for use in
specified procedures, sterility, and, with respect to electrode lead
wires and patient cables, compliance with 21 CFR part 898; and
     Specific labeling, including indications for use,
cautions, precautions, and adverse reactions.

Manufacturers must comply with the special controls as identified in
that special controls guidance document, either by meeting the
recommendations in the guidance document or by some other means that
provides equivalent assurance of safety and effectiveness.

IV. Discussion of Comments

    The public comments received in response to the proposed rule
addressed issues pertaining to labeling, the scope of the devices
subject to the classification rule, and testing as follows:
    Regarding labeling, the comments requested the mandatory product
labeling of all adhesive coated disposable electrocardiograph
electrodes and the establishment of template labeling with which
electrocardiograph electrodes should comply. In response, FDA has
revised the labeling section of the special controls guidance document;
however, FDA has not established template labeling.
    Regarding the scope of the devices subject to the notice, the
comments requested a products-based definition or listing of examples
to flesh out the ``type'' of devices that are consistent with Agency
intent, requested a clarification of the type of sensor that is
included in the scope of the classification, and requested a
clarification if the list of environmental conditions is intended to be
an exclusive list. In response, FDA has revised the special controls
guidance document to clarify what the scope of this classification rule
includes and excludes and to clarify what labeling should be reported
regarding conditions of use.
    Regarding testing, the comments requested clarification of the
shelf life, storage condition testing, and human clinical testing
required to establish sensitivity and irritation for all adhesives. In
response, FDA has revised the special controls guidance document to
clarify testing for shelf life and has clarified the testing for
biocompatibility.
    FDA is adopting in final form the assessment of the risks to public
health stated in the proposed rule published on October 4, 2007, and
agrees that the risk of electrical shock should also be taken

into account for purposes of this assessment. The guidance document has
been revised accordingly. FDA is issuing this final rule which
classifies the generic type of device, electrocardiograph electrode,
into class II subject to special controls.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under the Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because manufacturers are already substantially in
compliance with the recommendations in the guidance document and
exemption from the premarket notification requirements for the devices
following the specific measures recommended in the special control will
simplify the entry to market for other manufacturers, the Agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities. In addition, this
final rule will not impose costs of $100 million or more on either the
private sector or state, local, and tribal governments in the
aggregate, and therefore a written statement under section 202(a) of
the Unfunded Mandates Reform Act of 1995 is not required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The specific measures recommended largely reflect current
practices. With most manufacturers complying with most of the
recommendations in the guidance document, any additional burden brought
about by the final rule and guidance will likely be small.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe* * * a Federal statute to preempt State
law only where the statute contains an express preemption provision or
there is some other clear evidence that the Congress intended
preemption of State law, or where the exercise of State authority
conflicts with the exercise of Federal authority under the Federal
statute.'' Federal law includes an express preemption provision that
preempts certain state requirements ``different from or in addition
to'' certain Federal requirements applicable to devices. 21 U.S.C.
360k. See Medtronic v. Lohr, 518 U.S. 470 (1996); and Riegel v.
Medtronic, 552 U.S. 312 (2008). The special controls established by
this final rule create ``requirements'' to address each identified risk
to health presented by these specific medical devices under 21 U.S.C.
360k, even though product sponsors may have flexibility in how they
meet those requirements Cf. Papike v. Tambrands, Inc., 107 F.3d 737,
740-42 (9th Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520) is not required.
    This final rule designates a guidance document as a special
control. FDA also concludes that the special control guidance document
does not contain new information collection provisions that are subject
to review and clearance by OMB under the PRA.

IX. Electronic Access

    For access to the docket to read references or the public comments
received, go to http://www.regulations.gov or go to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. A hard copy of any
document can be obtained by submitting a Freedom of Information Act
request to the Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857.

X. References

    The following references have been placed on display in the
Division of Dockets Management (see section IX of this document) and
may be seen by interested persons between 9 a.m. and 4 p.m., Monday
through Friday, or can be obtained in hardcopy by submitting a Freedom
of Information Act request to the Division of Freedom of Information
(see section IX of this document). (FDA has verified the Web site
address, but we are not responsible for any subsequent changes to the
Web site after this document publishes in the Federal Register.)

1. ``Class II Special Controls Guidance Document: Electrocardiograph
Electrodes.''
2. ANSI/AAMI/ISO 10993-1, ``Biological Evaluation of Medical
Devices--Part 1: Evaluation and Testing.''
3. ISO 10993-5, ``Biological Evaluation of Medical Devices--Part 5:
Tests for In Vitro Cytotoxicity.''
4. ISO 10993-10, ``Biological Evaluation of Medical Devices--Part
10: Tests for Irritation and Delayed Type Hypersensitivity.''
5. ANSI/AAMI EC12, ``Disposable ECG Electrodes.''
6. AAMI/ANSI/ISO ST79, ``Comprehensive Guide to Steam Sterilization
and Sterility Assurance in Health Care Facilities.''
7. ``Updated 520(k) Sterility Review Guidance K90-1.''
8. IEC 601-1.56.3(c), ``Medical Electrical Equipment--Part 1,
General Requirements for Safety.''
9. ANSI/AAMI EC53, ``ECG Cables and Leadwires.''
10. FDA Guidance 89-4203, ``Labeling--Regulatory Requirements for
Medical Devices,'' available at http://www.fda.gov/cdrh/dsma/470.pdf.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Revise paragraph (b) in Sec.  870.2360 to read as follows:

Sec.  870.2360  Electrocardiograph electrode.

* * * * *
    (b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec.  870.9. The
special control for this device is the FDA guidance document entitled
``Class II Special Controls Guidance Document: Electrocardiograph
Electrodes.'' See Sec.  870.1(e) for availability information of
guidance documents.

    Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18391 Filed 7-20-11; 8:45 am]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE  OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM							DATE: 2 October 2009

SUBJECT:	Reply to Formal Response Concerning Use of Two Avian
Reproduction Studies to Fulfill Notice of Registration Requirement for
Chlorophacinone

FROM:	Andrew Shelby, Physical Scientist

		Environmental Fate and Effects Division, Environmental Risk Branch II

THRU:	Tom Bailey, Branch Chief

		Environmental Fate and Effects Division, Environmental Risk Branch II

TO:		Dan Peacock, Biologist

		Registration Division, Insecticide Rodenticide Branch

	The Agency has reviewed the request to waive the avian reproduction
study data requirement for chlorophacinone submitted by Liphatech Inc.
The Agency is unable to accept the two studies suggested to fulfill this
requirement for the reasons outlined below.

	The first suggested study was “Subacute and Subchronic Toxicity of
Chlorophacinone in Japanese Quail” (MRID 47323201) published in the
Archives of Experimental Veterinary Medicine.  While we reserve the
discretion to include open literature studies in our risk assessments,
we cannot accept this open literature study as a replacement for the
avian reproduction study requirement.  Over 90% of the avian
reproduction endpoints are not measured.  Though total mass of eggs and
eggs per hen are measured, embryo survival endpoints, hatching endpoints
and hatchling survival endpoints are not determined.  Finally, raw data
is not included disallowing independent validation of the results.

The second suggested study was “Avian Reproduction Study with
Difenacoum in the Japanese Quail” (MRID 46799101).  Chlorophacinone
and difenacoum are very distinct chemicals.  Treating difenacoum as a
surrogate chemical is inappropriate and cannot be justified without an
acceptable bridging strategy.  Disparate chemical structures preclude
the acceptance of this study for fulfilling the avian reproduction data
gap for chlorophacinone.

	Please refer to OPPTS Harmonized Test Guideline 850.2300 for a more
thorough explanation as to how to fulfill this data requirement.  The
Agency welcomes constructive comments and suggestions through the
registration process.  However, your formal response does not satisfy
conditions of our May 13, 2009 Notice of Registration to your company.
For further consideration of this new use registration of Rozol,
acceptable avian reproduction studies on two species must be submitted
in accordance with registration timelines.


[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Page 28127]
[FR Doc No: 2021-11009]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4593-DR; Docket ID FEMA-2021-0001]

Washington; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Washington (FEMA-4593-DR), dated April 8, 2021, and
related determinations.

DATES: This amendment was issued May 14, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Washington is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 8, 2021.

    Cowlitz County and the Puyallup Tribe of Indians for Public
Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-11009 Filed 5-24-21; 8:45 am]
BILLING CODE 9111-23-P