[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55900-55902]
[FR Doc No: 2018-24442]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0253]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Drug and Biological Product Experience Reporting and Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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
December 10, 2018.

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:
202-395-7285, or emailed to [email protected]. All comments
should be identified with the OMB control number 0910-0230. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Postmarketing Adverse Drug and Biological Product Experience Reporting
and Recordkeeping

OMB Control Number 0910-0230--Revision

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) (FD&C Act) require that
marketed drugs be safe and effective. To monitor the safety and
efficacy of drugs that are on the market, FDA must be promptly informed
of adverse experiences associated with the use of marketed drugs. We
have issued regulations at Sec. Sec.  310.305 and 314.80 (21 CFR
310.305 and 314.80) to implement reporting and recordkeeping
requirements that enable us to take necessary action to protect the
public health from adverse drug experiences.
    All applicants who have received marketing approval of drug
products are required to report serious, unexpected adverse drug
experiences (15-day ``Alert reports''), as well as follow-up reports
(Sec.  314.80(c)(1)). This includes reports of all foreign or domestic
adverse experiences as well as those based on information from
applicable scientific literature and certain reports from postmarketing
studies. Section 314.80(c)(1)(iii) pertains to such reports submitted
by nonapplicants.
    Under Sec.  314.80(c)(2), applicants must provide periodic reports
of adverse drug experiences. A periodic report includes, for the
reporting interval, reports of serious, expected adverse drug
experiences and all nonserious adverse drug experiences and an index of
these reports, a narrative summary and analysis of adverse drug
experiences, an analysis of the 15-day Alert reports submitted during
the reporting interval, and a history of actions taken because of
adverse drug experiences. Under Sec.  314.80(j), applicants must keep
for 10 years records of all adverse drug experience reports known to
the applicant.
    For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as follow-up reports (Sec.
310.305(c)). Section 310.305(c)(5) pertains to the submission of
follow-up reports to reports forwarded to the manufacturers, packers,
and distributors by FDA. Under Sec.  310.305(g), each manufacturer,
packer, and distributor shall maintain for 10 years records of all
adverse drug experiences required to be reported.
    Section 760 of the Act (21 U.S.C. 379aa), also provides for
mandatory safety reporting for over-the-counter (OTC) human drug
products not subject to applications approved under section 505 of the
Act (new drug applications or abbreviated new drug applications). These
requirements apply to all OTC) drug products marketed without an
approved application, including those marketed under the OTC Drug
Monograph Review process (whether or not subject to a final monograph),
those marketed outside the monograph system, and including those that
have been discontinued from marketing but for which a report of an
adverse event was received. Under 21 CFR part 329.100 respondents must
submit section 760 reports in an electronic format.
    To assist respondents with implementation of section 760 we
developed the guidance document entitled ``Postmarketing Adverse Event
Reporting for Nonprescription Human Drug Products Marketed Without an
Approved Application.'' The guidance document discusses what should be
included in a serious adverse drug event report submitted under section
760(b)(1) of the FD&C Act (21 U.S.C. 379aa(b)(1)), including follow-up
reports under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and
how to submit these reports.
    Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires
that responsible persons maintain records of nonprescription adverse
event reports, whether or not the event is serious, for a period of 6
years. The guidance recommends that respondents maintain records of
efforts to obtain the minimum data elements for a report of a serious
adverse drug event and any follow-up reports. The information
collection associated with the guidance is currently approved under OMB
Control No. 0910-0636, however we are now consolidating it into this
collection.
    The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more diverse patient populations
exposed to the marketed drug provide the opportunity to collect
information on rare, latent, and long-term effects. Signals are
obtained from a variety of sources, including reports from patients,
treating physicians, foreign regulatory agencies, and clinical
investigators. Information derived from the adverse drug experience
reporting system contributes directly to increased public health
protection because the information enables us to make important changes
to the product's labeling (such as adding a new warning), to make
decisions about risk evaluation and mitigation strategies or the need
for postmarketing studies or clinical trials, and when necessary, to
initiate removal of a drug from the market.
    In the Federal Register of July 11, 2018 (83 FR 32132) we published
a 60-day notice requesting public comment on the proposed collection of
information approved under OMB Control No. 0910-0230. One comment from
an anonymous source referred us to attachments that were not
successfully transmitted. We are therefore unable to address this
comment. In the Federal Register of August 15, 2018 (83 FR 40520) we
published a 60-day notice requesting public comment on the collection
of information approved under OMB Control No 0910-0636. No comments
were received.
    Respondents to the collection of information are manufacturers,
packers, distributors, and applicants of FDA-regulated drug and
biological products. The following estimates are based on our knowledge
of adverse drug experience reporting, including the time needed to
prepare the reports and the number of reports submitted to the Agency.
    We estimate the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Reporting Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
310.305(c)(5)...................               3               1               3               1               3
314.80(c)(1)(iii)...............               5               1               5               1               5
314.80(c)(2)....................             810           17.19       13,923.90              60         835,434
Reports of serious adverse drug              283         687.099         194,449               6       1,166,694
 events (21 U.S.C. 379aa((b) and
 (c))...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       2,002,136
----------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec.   310.305(c)(1), (2), and (3), and Sec.   314.80(c)(1)(i) and (ii) is covered
  under OMB control number 0910-0645.
\2\ The capital costs or operating and maintenance costs associated with this collection of information are
  approximately $25,000 annually.

                             Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
310.305(g)......................              25               1              25              16             400
314.80(j).......................             352           1,870         658,240              16      10,531,840
Recordkeeping (21 U.S.C.<PHONE_NUMBER>         265,700               8       2,125,600
 379aa(e)(1))...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      12,657,840
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.

    Based on submissions received we have increased our burden estimate
for reporting under part 314.80(c)(2) and recordkeeping under part
314.80(j). Additionally, and as previously stated, we are consolidating
burden associated with reporting and recordkeeping under section 760 of
the FD&C Act. Based on our records, we received 194,449 total annual
reports from approximately 283 respondents for nonprescription drugs
marketed without an approved application. We estimate each submission
takes approximately 6 hours to prepare and submit. We estimate that
there are 265,700 records per year maintained by approximately 300
respondents, and that it takes 8 hours to maintain each record.

     Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24442 Filed 11-7-18; 8:45 am]
 BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1 Supporting Statement for a Request for OMB Review
under

The Paperwork Reduction Act

1	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title and Number of the Information Collection

		Title:	Notification of Substantial Risk of Injury to Health and the
Environment under TSCA Section 8(e)

		EPA ICR No.:    0794.12	OMB Control No.: 	2070-0046

	1(b)	Short Characterization

	Section 8(e) of the Toxic Substances Control Act (TSCA) states, “any
person who manufactures, [imports,] processes, or distributes in
commerce a chemical substance or mixture and who obtains information
which reasonably supports the conclusion that such substance or mixture
presents a substantial risk of injury to health or the environment shall
immediately inform the [EPA] Administrator of such information unless
such person has actual knowledge that the Administrator has been
adequately informed of such information.”  (15 U.S.C. 2607(e))

	From January 1977 through June 2005, EPA received 16,063 initial
section 8(e) submissions covering a large number of chemical substances
and mixtures on a wide range of chemical toxicity/exposure information.
This includes approximately 10,500 submissions EPA received following a
1992 Compliance Audit Program, described below in Part 2(a).  Although
EPA’s receipt of section 8(e) information does not necessarily trigger
immediate regulatory action under TSCA or other authorities administered
by EPA, all section 8(e) submissions receive screening level evaluations
by EPA’s Office of Pollution Prevention and Toxics (OPPT) to identify
priorities for further Agency action and appropriate referrals to other
programs.

	OPPT routinely disseminates section 8(e) data to EPA’s Program and
Regional Offices and other Federal agencies (e.g., NIOSH, OSHA, CPSC,
FDA, NTP) on newly discovered chemical hazards/risks.  Since June 2001,
OPPT has made these referrals primarily via e-mails of biweekly tables
summarizing all new section 8(e) submissions.  There is also public
outreach and information access to section 8(e) data through the TSCA
Public Docket, online data bases that include TSCA 8(e) records, as well
as through the TSCA 8(e) web page that includes all biweekly reports of
new 8(e) submissions back to June 2001 with PDF links to the
submissions.

2	NEED FOR AND USE OF THE COLLECTION

	2(a)  	Need/Authority for the Collection

	Section 8(e) of TSCA continues to be an important and useful tool for
early warning and identification of potential substantial risk
situations allowing EPA and others to focus their limited resources on
chemicals or mixtures of highest concern.  The submission of  section
8(e) information makes it possible for the Agency and others to learn
quickly about potential new chemical hazards/risks posed by exposure to
chemical substances, to conduct more complete assessments and, if
needed, effective action to eliminate or reduce such risks in a timely
manner.

	The statutory authority for this information collection is section 8(e)
of TSCA (U.S. Public Law 94-469; 90 Stat. 2029; 15 U.S.C. 2607(e)).  No
formal rule-making by the Agency was required to implement section 8(e),
in that section 8(e) was a self-activating reporting provision of TSCA
that became immediately effective on January 1, 1977 (the effective date
of the Act).  However, in order to facilitate compliance with section
8(e), EPA clarified the kinds of information that constitute substantial
risk information, specified the types of information exempt from the
reporting requirements, and outlined standard reporting procedures, in
published proposed guidance (42 FR 45362; September 9, 1977).  After
holding several public meetings and considering the public comments on
the proposed section 8(e) guidance, the Agency published its final
“Statement of Interpretation and Enforcement Policy; Notification of
Substantial Risk” (43 FR 11110; March 16, 1978).  In June 1991, EPA
published a “Section 8(e) Reporting Guide” to further assist the
regulated community in complying with section 8(e).  The 1991 Reporting
Guide references examples of  submitted information and EPA’s comments
on these submissions to help persons subject to section 8(e) better
understand the types of information that are reportable under section
8(e).  The 1991 Guide also includes dose ranges and exposure factors to
consider in determining the section 8(e) reportability of acute
lethality data.

	In February of 1991, the Agency initiated a voluntary section 8(e)
“Compliance Audit Program” (CAP).  This compliance program, which
followed several section 8(e) enforcement cases indicating that some
companies were not complying with section 8(e) reporting requirements,
was designed to 1) achieve EPA’s goal of obtaining any outstanding
section 8(e) data, and 2) provide maximum encouragement to companies to
voluntarily audit their files for section 8(e)-reportable information.
The section 8(e) CAP involved consent agreements/orders pursuant to
section 15 of TSCA, stipulated monetary penalties and an overall penalty
ceiling.  123 companies elected to participate voluntarily in the
Agency’s section 8(e) CAP activity.  The CAP was terminated on May 15,
1996 and settlements with CAP participants were announced on October 15,
1996.

	In implementing the section 8(e) CAP, EPA determined that there was a
need to suspend and refine those portions of the 1978 section 8(e)
Policy Statement that deal specifically with the reportability of
chemical releases to the environment and the detection of toxic
chemicals in environmental media.  On July 13, 1993 (58 FR 37735), EPA
published proposed guidance on the detection of toxic chemicals in
environmental media.  EPA received comments from 49 companies and
industry associations.  Based on the submitted comments and a number of
meetings with industry representatives, EPA revised the proposed
guidance and made it available for additional public comment through a
notice in the Federal Register published on March 20, 1995 (60 FR
14756).  In response, EPA received an additional 22 comments.  While the
comments offered additional refinements to the revised guidance, their
basic tenor was that industry was in support of the changes.

	Beginning in 1996, there was an ongoing collaboration between EPA and
industry to develop a question and answer (Q&A) document to promote
industry understanding of and compliance with the Agency’s anticipated
revised section 8(e) reporting criteria for environmental release and
contamination information.  The intent was to make the Q&A publicly
available before the revised guidance was published.  However, the
finalized Q&A document was not yet available when the revised guidance,
“TSCA Section 8(e); Notification of Substantial Risk; Policy
Clarification and Reporting Guidance” (68 FR 33129-33139), was
published on June 3, 2003.  The revised guidance included a
re-publication of the 1978 Policy Statement and incorporated revisions
that address the reporting of information on the release of chemical
substances to the environment and the detection of toxic chemicals in
environmental media.  Also included in the June 2003 Reporting Guidance
is a change in the deadline for reporting “substantial risk”
information to the Agency (from 15 working days to 30 calendar days) and
the circumstances under which certain information need not be reported
to EPA under section 8(e) of TSCA.  In a subsequent Federal Register
Notice, “TSCA Section 8(e) Reporting Guidance; Correction,
Clarification of Applicability, and Announcement Regarding the Issuance
(of) Questions and Answers” (70 FR 2162-2164), EPA announced certain
corrections to the June 2003 Reporting Guidance (due to transcription
errors from the 1978 Policy Statement that appeared in the June 2003
Guidance), stated that the applicability date for the June 2003 Guidance
Document was the publication date, and announced the availability on the
TSCA 8(e) web page (http://www.epa.gov/oppt/tsca8e) of a Q&A document on
the section 8(e) reportability of releases of chemical substances to the
environment and the detection of toxic chemicals in environmental media.
 This Q&A document included only a few of the items drafted earlier by
industry stakeholders with EPA participation, but EPA will be adding
Q&As to the TSCA 8(e) web page on environmental releases and other
aspects of section 8(e) reporting following further comment and review.

	2(b)  	Use/Users of the Data

	Since 1977, the Agency and members of the chemical industry have
devoted significant efforts in fulfilling their respective
responsibilities under section 8(e).  Since January 1, 1977, 16,063
initial section 8(e) notices (includes CAP and non-CAP submissions)
covering a broad range of toxicity and exposure-related data on a wide
range of chemicals and chemical mixtures have been received by the
Agency, screened, and received follow-up attention as needed.

	All incoming section 8(e) submissions are reviewed by EPA shortly after
receipt.  The initial processing of section 8(e) submissions includes a
screening level evaluation of the submitted data.  Such evaluations are
not risk assessments, nor do they consider other available toxicity data
on the chemical or exposure-related information on the chemical/mixture
being reviewed.  The results of screening level evaluations are used for
priority-setting to select cases for more detailed assessment, as well
as to identify referrals to other Offices and Agencies.

	EPA utilizes section 8(e) submission information for hazard/risk
identification purposes in the initial stages of the TSCA chemical
screening and review program.  Section 8(e) data are also used in
ongoing EPA hazard and exposure assessments of both existing and new
chemicals, in the SIDS international testing program, in the High
Production Volume (HPV) Challenge Program, and in support of regulation
development under TSCA, e.g., development of chemical testing rules
under section 4 of TSCA, as well as regulation development under other
authorities administered by the Agency.  In addition, section 8(e)
submissions have been the basis for chemical advisories to communicate
potential health risks and the need for exposure controls, as well as
for chemical summaries to identify data availability for chemical hazard
and exposure assessment.

	Regardless of the type of section 8(e) follow-up action or activity
taken, all reported information not claimed as TSCA confidential
business information is made available to other EPA Program and Regional
Offices, other Federal Agencies and others (e.g., chemical industry,
trade unions, environmental groups, general public, international
community) who may be interested in the subject chemical or mixture.
EPA Offices and other federal agencies routinely utilize section 8(e)
data in implementing their regulatory programs.  The principal vehicles
for making the information publicly available are the TSCATS database,
the TSCA Docket, and the TSCA section 8(e) web page at   HYPERLINK
"http://www.epa.gov/opptintr/tsca8e"  http://www.epa.gov/opptintr/tsca8e
.  The TSCA 8(e) web page includes all published section 8(e) guidance
and full text copies of all new section 8(e) submissions.

	EPA’s proactive implementation of section 8(e) has also resulted in
heightened corporate awareness of the potential risk of injury posed by
exposure to chemical substances.  This increased corporate awareness has
led to a variety of voluntary corporate actions designed to protect
human health and/or the environment.  Many companies have reported to
EPA that the following types of risk reduction/pollution prevention
measures were initiated in direct response to the submitted chemical
toxicity and/or exposure data:

Notification of workers, customers and others;

Revision of product labels and Material Safety Data Sheets;

Modification of manufacturing, processing, and/or handling;

Ceasing production/use either temporarily or permanently;

Initiation of additional toxicity or exposure studies to further define
potential risks.

3	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA

	3(a)  	Non-Duplication

	There is no other source of data that can be used in place of the data
submitted to EPA under the section 8(e) statutory reporting requirement.
 The “substantial risk” information required to be reported to EPA
is unpublished information not already known to the Agency.  In
addition, information need not be submitted under section 8(e) if the
information has been reported already to EPA pursuant to another
mandatory information reporting requirement of TSCA or some other
authority administered or delegated to the States by EPA.  In the June
3, 2003 Reporting Guidance, the Agency clarified the circumstances under
which certain information need not be reported to EPA under section 8(e)
of TSCA.  This is expected to result in some additional reduction of the
overall respondent reporting burden for section 8(e).

	3(b)  	Public Notice Required Prior to ICR Submission to OMB

	  SEQ CHAPTER \h \r 1 Prior to submission to OMB, this ICR will be made
available to the public for comment through a Federal Register notice.
The public will have 60 days to provide comments.  Any comments received
will be given consideration when completing the supporting statement
that is submitted to OMB.

	3(c) 	Consultations

	EPA personnel have participated in numerous public meetings and other
fora to discuss the section 8(e) Policy Statement and the Agency’s
implementation of section 8(e).  Large EPA-sponsored public meetings at
which section 8(e) was a primary topic of discussion were held in 1978,
1986, 1987, 1990 and 1992 with chemical industry representatives and
other interested parties.  EPA staff also met on numerous occasions with
members of the chemical industry to discuss section 8(e) in the context
of the section 8(e) Compliance Audit Program.  In addition, EPA staff
have participated in more than 30 industry-sponsored meetings at which
section 8(e) of TSCA was the major or primary topic of discussion.

	EPA proposed amendments to the section 8(e) policy statement in 1993
and again in 1995.  The proposed amendments dealt specifically with
clarifications on reporting requirements for occurrences of
environmental exposure or contamination.  The Agency received numerous
public comments on these proposed amendments and developed a “Comment
and Response Document for Revised Policy Statement of Section 8(e) of
TSCA” (OPPT-2002-0067-0002) to record these comments and the
Agency’s responses (see Attachment 3).  EPA has also collaborated with
industry in preparing a question and answer document dealing with
revisions to the 1978 Policy Statement and from 1994 to the present
section 8(e) has been on the agenda of the “Living with TSCA”
conferences held annually for all TSCA stakeholders.

	  SEQ CHAPTER \h \r 1 Under 5 CFR 1320.8(d)(1) OMB requires agencies to
consult with potential ICR respondents and data users about specific
aspects of ICRs before submitting an original or renewal ICR to OMB for
review and approval.  In accordance with this regulation, EPA will
pursue additional consultations with interested parties during the
development of the renewal of this collection.

	3(d)  	Effects of Less Frequent Collection

	TSCA section 8(e) reporting is not cyclical, but rather is
self-implementing.  The statute states that persons covered under the
section 8(e) reporting requirement shall immediately notify the EPA
Administrator upon obtaining reportable information.  As stated
previously, section 8(e) continues to be an extremely important and
useful EPA tool for early identification of potential substantial risk
situations and allows the Agency as well as others to focus their
resources on those chemicals or mixtures of highest concern.  The
consequences of EPA’s not receiving section 8(e) data immediately
following receipt by a respondent are serious.  The Agency would be
prevented from learning about and publicizing new information about
substantial risks to health or environmental injury posed by exposure to
chemical substances and/or mixtures.  Further, EPA would not be in a
position to adequately assess and, if necessary, take action to
effectively eliminate or reduce such risks in an expeditious manner.

	3(e)  	General Guidelines

	The required reporting that takes place under section 8(e) does not
appear to exceed the Paperwork Reduction Act-imposed guidelines that are
found at 5 CFR 1320.6.

	3(f)  	Confidentiality

	Any person submitting a notice to EPA under section 8(e) may assert a
claim of business confidentiality covering information contained in the
submission.  Any information covered by a claim will be disclosed by EPA
only to the extent and by means of the procedures set forth at 40 CFR
Part 2.  If no confidentiality claim accompanies a section 8(e) notice,
the submission is placed in the TSCA Docket and is available to the
public without further notice to the submitting organization.  The
Agency has established and actively implements well-publicized standard
procedures for the handling and safeguarding of information claimed as
TSCA Confidential Business Information (TSCA CBI).

	3(g)  	Sensitive Questions

	Under section 8(e), EPA does not seek submission of information with
regard to sexual behavior or attitudes, religious beliefs, or other
matters usually considered to be of a private nature.

4	RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)  	Respondents/NAICS Codes

	A statutory section 8(e) reporting obligation can be incurred by any
person who manufactures, imports, processes or distributes a
TSCA-covered chemical substance or mixture.  EPA’s section 8(e) Policy
Statement defines the term “person” broadly to include “any
natural person, corporation, firm, company, joint-venture, partnership,
sole proprietorship, association, or any other business entity, any
State or political subdivision thereof, any municipality, any interstate
body and any department, agency, instrumentality of the Federal
Government.”  Although this definition is quite broad in terms of
subject persons, section 8(e) reporting obligations are most typically
incurred by companies engaged in activities classified by NAICS Codes
325 - Chemicals and Allied Products Manufacturers and 32411- Petroleum
Refining.

	4(b)  	Information Requested

	(i)  	Data Items

	There is no required collection instrument or reporting form on which
section 8(e) information must be submitted to EPA; however, the section
8(e) Policy Statement requires all respondents to ensure that a written
section 8(e) notice:

is sent to EPA by a method verifying the Agency’s receipt;

states that it is being submitted under section 8(e) of TSCA;

contains the name, address, job title, phone number and signature of the
person reporting, and the name and address of the establishment with
which the person is associated;

identifies the chemical substance(s) or mixture including, if known, the
Chemical Abstract Service (CAS) Registry Number(s);

summarizes adverse health/environmental effects being reported including
a description of the nature and extent of the risk; and

contains the specific source/summary of the supporting data.

	EPA is continuing its efforts to implement optional electronic
reporting of section 8(e) submissions to increase processing efficiency
for both the Agency and the regulated community.

	(ii) 	Respondent Activities

	The overall purpose of section 8(e) reporting is to ensure that new
information that reasonably supports a conclusion that a chemical
substance or mixture presents a “substantial risk” of injury to
health or the environment is brought to EPA’s attention immediately
upon discovery.  It should be noted again that section 8(e) applies to
all chemical manufacturers, importers, processors, and distributors and
applies also to information that a subject person possesses or about
which that person has knowledge.  Although compliance with section 8(e)
does not require subject persons to search for information or to make
extraordinary efforts to acquire information, section 8(e) does apply to
information that is “obtained” (i.e., information that a person
possesses or about which that person knows).  Following a review of
existing information and a decision that such information is of the type
required under section 8(e), respondents must notify EPA in writing
immediately.  EPA’s June 2003 Reporting Guidance defines the term
“immediately” in the context of written section 8(e) reports to mean
within 30 calendar days of the date on which the information was
obtained; the immediate reporting of an emergency incident of
environmental contamination by a toxic substance is defined as a phone
report to EPA or to the National Response Center as soon as a person
knows about the incident.

5	INFORMATION COLLECTION - EPA ACTIVITIES, COLLECTION METHODOLOGY AND
INFORMATION MANAGEMENT

	5(a)  	Agency Activities

	As explained in additional detail in the following sections, the
Agency’s section 8(e) activities involve answering general and
specific section 8(e)-related questions, development and maintenance of
computerized information tracking (including data extraction, entry and
quality assurance/control), microfilming, confidential
(restricted-access) and non-confidential (public-access) section 8(e)
information filing, initial evaluation of all submitted section 8(e)
information (including review of TSCA Confidential Business Information
(CBI) substantiations), and the posting of section 8(e)-related
information on the Internet for public access.

	5(b)  	Collection Methodology and Information Management

	EPA uses Document Control Numbers (DCNs) to identify TSCA submissions;
section 8(e) has the following format: 88-YYXXXXXXX.  The assigned
7-digit ascending numbers begin each year with 0000001.  EPA also
identifies section 8(e) submissions by 8EHQ Numbers, which are
chronological from January 1977.  The format is 8EHQ-MMYY-XXXXX.
Initial submissions are assigned as Sequence A; supplemental and
follow-up submissions are assigned Sequence B, C, D, etc.  Internal EPA
tracking of section 8(e) submission information is handled via
non-confidential and confidential computerized data bases.

	In order to assure that the public is kept apprised of new adverse
chemical-related toxicity and exposure information, the Agency provides
public access to and actively disseminates non-confidential section 8(e)
submission information in many ways.  Examples of EPA’s public
access/outreach activities follow.

	Non-confidential section 8(e) initial and follow-up/supplemental
submissions, status reports, submission summaries, and EPA follow-up
letters can be viewed/copied in the TSCA Public Docket located at EPA
Headquarters.  Non-confidential section 8(e)-related documents can also
be obtained by writing to EPA’s Freedom of Information Office.

	Relevant non-confidential information from section 8(e) submissions is
routinely entered into TSCATS (Toxic Substances Control Act Test
Submissions), a publicly available computerized data base that serves as
an on-line index of unpublished health and safety studies submitted to
EPA under TSCA.  The most recent version of the TSCATS data base is
available on the web at   HYPERLINK
"http://yosemite.epa.gov/oppts/epatscat8.nsf/ReportSearch?OpenForm"
http://yosemite.epa.gov/oppts/epatscat8.nsf/ReportSearch?OpenForm .  The
submitted studies themselves are stored and available on microfiche.
Microfiche copies of the studies referenced in the TSCATS database are
available from either CIS or the National Technical Information Service
(NTIS) in Springfield, VA.  EPA has also been creating full electronic
(PDF) copies of all new section 8(e) submissions since June 2001.
Electronic copies of these most recent section 8(e) submissions are
available to the public from the TSCA Public Docket, as well as from the
section 8(e) web site at   HYPERLINK "http://www.epa.gov/oppt/tsca8e"
http://www.epa.gov/oppt/tsca8e .

	Under established Freedom of Information Act (FOIA) procedures, EPA
responds to requests from industry, other stakeholders and the public.
And in cooperation with the Organization for Economic Cooperation and
Development’s (OECD) information-gathering “Switchboard” project,
EPA responds as well to international requests for section 8(e) and
other unpublished health and safety data on chemicals of concern to OECD
members.

	As stated previously, EPA routinely notifies other Federal Agencies on
incoming section 8(e) information via biweekly tabular reports of new
section 8(e) submissions and by targeted referrals.  As the direct
result of these public outreach activities, several of these other
Agencies actively publicize the information even further.  For example,
the National Library of Medicine (NLM) at the National Institutes of
Health makes section 8(e) information available via its publicly
available computerized Hazardous Substances Data Bank (HSDB) and Toxline
data bases.  In addition, the National Institute for Occupational Safety
and Health (NIOSH) cites section 8(e) notices in the printed and on-line
computerized versions of the “Registry of Toxic Effects of Chemical
Substances” (RTECS) data base.

	5(c)  	Small Entity Flexibility

	The statutory obligation to report information under section 8(e) of
TSCA applies to all manufacturers, importers, processors, and/or
distributors of TSCA-covered chemical substances and mixtures.  The
statutory language of section 8(e) itself does not allow for any
reporting exemption or burden minimization based on the size or earnings
of a respondent.  However, nearly all reporting is by large and medium
size companies.  This is mainly because only larger companies have the
financial resources to conduct toxicity testing that comprises most
section 8(e) reporting.  Since there is no routine reporting or
recordkeeping provisions for section 8(e), the true burden on most small
entities is practically nonexistent.

	5(d)  	Collection Schedule

	Considering that section 8(e) submissions are received by the Agency on
an ad hoc basis, there is no standard reporting cycle.  Submitters are
required to comply with section 8(e) immediately when they come into
possession of or know about section 8(e)-reportable information.  If
section 8(e) information were not made available immediately to EPA, the
Agency’s ability to learn about, publicize, effectively assess, and
respond appropriately to newly discovered chemical-related risks would
be severely impeded, if not completely thwarted.

6	ESTIMATING THE BURDEN AND COST OF COLLECTION

	For the current 2008 ICR renewal, EPA utilized data on the number of
section 8(e) submissions for fiscal years FY 2006-2008.  The averaged
annual number of initial 8(e) submissions was 390 (418+379+373=1170/3).
The averaged annual number of supplemental and follow-up 8(e)
submissions was 136 (123+132+154=409/3).

	In the previous ICR renewal, it was determined that for initial section
8(e)s,  submission equivalents were also estimated to account for the
need to review data that are not ultimately submitted as TSCA 8(e).  For
initial section 8(e)s, the number of submission equivalents is used
instead of the number of actual submissions.  Estimating that the number
of cases not submitted is 50% of the number of cases submitted, the
number of initial section 8(e) submission equivalents per year for FY
2006-2008 is increased from 390 to 585 (390 x 1.5).

	6(a)  	Estimating Submitter Burden

	The following discussion provides the basis for the Agency’s
upper-bound estimate of approximately 30,515 total hours of annual
reporting burden for submitters in complying with section 8(e).

	EPA believes that it should take approximately 49 hours per submission
to judge and concur on the section 8(e)-applicability of obtained
information plus 2 additional hours to prepare/submit the necessary
information.  The first figure is based on an average of 45 hours per
submission of managerial and technical staff time to review and evaluate
data and an additional 4 hours for staff training on TSCA 8(e)
regulatory requirements.  Using the calculated average of 585 initial
section 8(e) submission equivalents per year, the total number of hours
required for initial section 8(e) reporting is estimated to be 29,835
(585 x 51) hours.  The submission of follow-up/supplemental information
in response to EPA questions on the initial section 8(e) submission, or
as a result of further investigation/evaluation by the company, is
estimated to be 5 hours per notice, assuming 3 hours to assemble the
required information, 1 hour to prepare the submission, and 1 hour for
review.  Using the calculated average of 136 follow-up/supplemental
submissions per year, the total number of hours required for
follow-up/supplemental section 8(e) reporting is estimated to be 680
(136 x 5) hours.  Therefore, the total number of section 8(e) initial
submission equivalents plus follow-up/supplemental submissions is 721
(585 + 136) submissions per year with an estimated respondent reporting
burden of 30,515 (29,835 + 680) hours per year.

INITIAL SUBMISSIONS SUBTOTAL

Burden Item	Hours/Submitter	Submissions/Year	Hours/Year

a1

49

585

28,665

b2

2

585

   1,170

29,835

1  Reflects managerial/technical review, data evaluation,
decision-making and concurrence processes to determine the section
8(e)-reportability and crafting the usually 1-2 page section 8(e)
notification letter.

2  Reflects general clerical work (typing, copying, and sending the
section 8(e) submission).

	Considering that the respondent’s decision-making/concurrence
activities for determining section 8(e)-applicability/reportability has
already taken place for the initial submission, the activities
surrounding the submission of follow-up/supplemental information related
to the initial submission are viewed by the Agency as being less
burdensome as follows:

FOLLOW-UP AND SUPPLEMENTAL SUBMISSIONS SUBTOTAL

Burden Item

Hours/Submitter

Submissions/Year

Hours/Year

a1

4

136

544

b2

1

136

136

680

1  This item involves managerial and technical review, concurrence and
letter writing activities in submitting a follow-up/supplemental section
8(e) submission.

2  This item reflects the typing, copying and transmittal of a
follow-up/supplemental section 8(e) submission.

	Based on the figures presented in the preceding tables, the total
submitter burden (in hours/year) for initial and follow-up/supplemental
section 8(e) submissions to EPA is as follows:

TOTAL HOURLY BURDEN/YEAR

     Initial				Follow-Up/Supplemental			Total

Submissions		+		          Submissions          	=	       Hours/Year

29,835 hours/year	+		       680 hours/year		=		30,515

	6(b)  	Estimating Submitter Costs

	EPA estimates that a respondent incurs costs up to $69.21/hour in
managerial/technical labor costs and $27.59/hour in clerical labor costs
in submitting information to EPA under section 8(e). These hourly costs
take into account the involvement of the respondent’s managerial,
technical and clerical personnel and takes into account standard labor
wage rates (including fringe benefits) using Bureau of Labor Statistics
(BLS) wage rates for the Private Manufacturing industries adjusted for
the year 2007. It should be noted that section 8(e) reporting does not
involve operating/maintenance or capital costs to the respondent.  The
hourly labor wage rates used in the computations appear below.

Hourly Labor Rates *

			Labor Category		2007 Hourly Rate

			Managerial				$ 69.21

			Technical				$ 55.42

			Clerical				$ 27.59

			EPA staff				$ 68.99

*See Appendix A for derivations.

	Based on the total estimated reporting burden of 30,515 hours/year and
the hourly labor rates listed above, the annual cost for submitters to
comply with section 8(e) is estimated to be $2,057,588 as follows.

TOTAL ANNUAL COSTS

Burden Item

Submitter Hours/Year (Initial)

Submitter Hours/Year (Supplemental)

Total Hours/Year	Wage Rate	Total Cost/Year

a1

28,665

544

29,209	$69.21/hr	$2,021,555

b2

1,170

136

1,306	$27.59/hr	$36,033

$2,057,588

1  Reflects managerial/technical review, data evaluation,
decision-making and concurrence processes to determine the section
8(e)-reportability and crafting the usually 1-2 page section 8(e)
notification letter.

2  Reflects general clerical work (typing, copying, and sending the
section 8(e) submission).

	6(c) 	Estimating EPA Burden and Costs

	Based on reasonable costs for reports received by EPA as the result of
general section 8 rule-making activities, EPA estimates the cost per
submission can range from $275 to $900. This assumes that it takes a
GS-13 Step 5 staff member between 4 and 13 hours to process, copy, file,
and initially review and/or answer questions on each section 8(e)
submission (4 * $68.99 and 13 * $68.99). Therefore, EPA estimates its
total annual cost for these activities involving 721 incoming section
8(e) submissions (585 initial plus 136 follow-up/supplemental notices
per year) to range from $198,275 - $648,900 per year as follows:

EPA BURDEN/COSTS

Initial/Follow-Up/Supplemental		 Cost of EPA			   Total

       Submissions per Year        	x      Processing/ Review	=
Cost/Year

       721 submissions/year		x      $275-$900/Submission	=  $198,275 -
$648,900/year

	6(d) 	Bottom Line Burden Hours and Costs

	General note:  A full discussion and description of the rationale used
to derive the following burden estimates can be found in sections 6(a),
6(b) and 6(c) of this Supporting Statement and is summarized below.

(i) 	Submitters’ Annual Burden (Hours and Costs)

		(a) 	Hours

		Initial Section 8(e) Submissions

		51 hours x 585 submissions = 29,835 hours

		Follow-up/Supplemental Section 8(e) Submissions

		5 hours x 136 submissions = 680 hours

		Submitters’ Total Annual Hourly Burden

		29,835 hours + 680 hours = 30,515 hours

		(b) 	Costs

		Submitters’ Total Annual Cost

		29,209 managerial hours x $69.21/hour = $2,021,555

1,306 clerical hours x $27.59/hour = $36,033

$2,021,555 + $36,033 = $2,057,588

	(ii)	 EPA’s Annual Burden/Cost

		Initial Section 8(e) Submissions

		585 submissions x $275-$900/submission = $160,875 - $526,500

		Follow-up/Supplemental Section 8(e) Submissions

		136 submissions x $275-$900/submission = $37,400 - $122,400

		EPA’s Total Annual Estimated Burden/Cost

		721 submissions x $275-$900/submission = $198,275 - $648,900

	6(e)	Reasons for Change in Burden

	There is an increase of 12,380 hours (from 18,135 hours to 30,515
hours) in the total estimated respondent burden compared with that
identified in the information collection request most recently approved
by OMB.  This increase in burden hours is primarily due to an increase
in submissions for a number of reasons. First, there has been increased
awareness and therefore enforcement of the submissions. With the High
Production Volume Challenge Program, the public has the right to know
information on the hazard of certain chemicals. Data from the 8e
submissions are often used for this Program. Companies have also been
submitting information on chemicals to assure that there is no
enforcement action taken upon the companies due to the Chemical
Assessment and Management Program (ChAMP), which reviews chemicals on
the Toxic Release Inventory.

	The estimate in submitter annual costs associated with this ICR is
higher than the previous section 8(e) ICR because of the above
considerations as well as the increased hourly labor rates. The previous
estimate was based on a simpler BLS data series whereas the current ICR
uses an overhead rate of 17% based on assumptions in Wage Rates for
Economic Analyses of the Toxics Release Inventory Program (Rice, 2002)
and the Revised Economic Analysis for the Amended Inventory Update Rule:
Final Report (EPAB, 2002). 2007 is the most recent year for which wage
rates were available not subject to revision by BLS.

	6(f)  	Burden Statement

	The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0046, is estimated to average 51
hours per initial section 8(e) submission and 5 hours per
follow-up/supplemental section 8(e) submission.  According to the
Paperwork Reduction Act, “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.  For this
collection, it includes the time needed to: review instructions;
disclose and provide information; adjust existing procedures to comply
with any previously applicable instructions and requirements; train
personnel to respond to a collection of information; complete and review
the information collection; and transmit or otherwise disclose the
information.  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 number for this
information collection appears above.  In addition, the OMB control
numbers for EPA’s regulations, after initial display in the final
rule, are listed in 40 CFR part 9.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OPPT-2008-0896, which is available for public viewing at the
Pollution Prevention and Toxics Docket in the EPA Docket Center
(EPA/DC), EPA West, Room B102, 1301 Constitution Ave., 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 Pollution Prevention and Toxics Docket is (202)
566-0280.  An electronic version of the public docket is available at
http://www.regulations.gov.  Use regulations.gov to submit or view
public comments, access the index listing of the contents of the public
docket, and to access those documents in the public docket that are
available electronically.  Once in the web site, click the Advanced
Search link at the top of the page and select Docket Search from the
drop-down menu. At the Advanced Search page, select Environmental
Protection Agency in the Agency field; in the Docket ID field key in the
docket ID number identified above; scroll to the bottom of the page to
click on Submit.  At the Docket Search Results page click on the Docket
ID to display all of the documents found within this docket ID number.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA.  Please include
the EPA Docket ID No. EPA-HQ-OPPT-2008-0896 and OMB control number
2070-0046 in any correspondence.

APPENDIX A

WAGE RATES

WAGE RATES

This appendix describes the derivation of the fully loaded labor rates
used in calculating costs of labor. Costs for this report are for
year-end 2007.

A.1 	Derivation of Loaded Wage Rates

Unit labor costs are calculated by adding fringe benefits and overhead
to the wage or salary to derive a fully loaded labor cost. The basic
method is described in Wage Rates for Economic Analysis of the Toxics
Release Inventory Program (Rice, 2002). The resulting loaded labor rates
are given in   REF _Ref201659447 \h  \* MERGEFORMAT  Table A-1 . Costs
are calculated for several labor categories: Managerial, Professional/
Technical, Clerical, and EPA staff.

A.1.1 Derivation of Labor Rates for Managerial, Professional/Technical,
and Clerical Labor

	Wages and fringe benefits for managerial, professional/technical, and
clerical labor were taken from the Bureau of Labor Statistics (BLS)
Employer Costs for Employee Compensation (ECEC) data, for December, for
manufacturing industries.

	The cost of fringe benefits such as paid leave and insurance, specific
to each labor category, are taken from the same ECEC series. Fringe
benefits as a percent of wages are calculated separately for each labor
category. For example, for December 2007, the average wage rate for
professional/technical labor was $33.14; the average fringe benefit was
$16.65. Fringe benefits as a percent of wages were $16.65/$33.14, or
approximately 50.2 percent.

An additional loading factor of 17 percent is applied to wages to
account for overhead. This approach is used for consistency with Office
of Pollution Prevention and Toxics economic analyses for two major
rulemakings: Wage Rates for Economic Analyses of the Toxics Release
Inventory Program (Rice, 2002) and the Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report (EPAB, 2002). This overhead
loading factor is added to the benefits loading factor, and the total is
then applied to the base wage to derive the fully loaded wage. For
example, the December 2007 fully loaded wage for professional/technical
labor is $33.14 × (1+0.502414 + 0.17) = $55.42.

Fully loaded costs for managerial and clerical labor are calculated in a
similar manner, as shown in   REF _Ref201659447 \h  \* MERGEFORMAT
Table A-1 .

A.1.2 Derivation of Labor Rates for EPA Staff

Agency labor costs are calculated based on annual Federal salaries for
the Washington-Baltimore area published by the Office of Personnel
Management effective January 2007 (OPM, 2007). The average salary for
one Full Time Equivalent (FTE) staff is estimated as the salary for a
GS-13 Step 5 employee.

Multiplying the annual pay by an assumed loading factor of 1.6 to
reflect Federal fringe benefits and overhead, the loaded annual salary
of EPA staff was calculated to be $143,976.

The Agency loading factor is from an EPA guide, Instructions for
Preparing Information Collection Requests (ICRs) (OPPE, 1992, page 30,
footnote 9). The 60 percent assumption was labeled “the benefits
multiplication factor” in the EPA Guide, but has been used in many EPA
Office of Pollution Prevention and Toxics ICRs to reflect both fringe
benefits and overhead for Federal staff. For example, it was used in an
August 2000 document supporting ICR No. 1139.06, with the following
explanation:

“The annual costs per FTE are derived by multiplying the annual pay
rate by 1.6 (the benefits multiplication factor). The multiplication
factor used is recommended in EPA's Office of Policy, Planning, and
Evaluation's Instructions for Preparing Information Collection Requests
(ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie
(OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated
that the 1.6 factor included not only benefits but also overhead.”
(ICR No.1139.06)Table A-  SEQ Table_B- \* ARABIC  1  Derivation of
Loaded Wage Rates

EPAB Labor Category	Data Sources	Date

 	Wage	Fringe Benefit	Fringes as % wage	Over-head % wage1	Fringe +
overhead factor	Loaded Wages

	(a)	(b)	(c) =(b)/(a)	(d)	(e)=(c)+(d)+1	(f)=(a) x (e)

Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business,
and Financial”2	Dec-07	$41.93 	$20.15 	48.06%	17%	1.65	$69.21

Professional/

Technical	BLS ECEC, Private Manufacturing industries, “Professional
and related“2	Dec-07	$33.14 	$16.65 	50.24%	17%	1.67	$55.42

Clerical	BLS ECEC, Private Manufacturing industries, “Office and
Administrative Support” 2	Dec-07	$16.47 	$8.32 	50.52%	17%	1.68	$27.59

EPA staff FTE	Annual Federal staff cost: OPM
Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step
5 pay rates, with 60% overhead. 3	Jan-07	$89,985/year

$43.12/hour	--	[Included in 60% overhead]	60%	1.6	$143,976/year

$68.99/hour

Notes:

1An overhead rate of 17% was used based on assumptions in Wage Rates for
Economic Analyses of the Toxics Release Inventory Program (Rice, 2002),
and the Revised Economic Analysis for the Amended Inventory Update Rule:
Final Report (EPAB, 2002).

2Employer Costs for Employee Compensation Supplementary Tables: December
2007, US Bureau of Labor Statistics, March 12, 2008 (BLS, 2008a).

3The Federal salary is the unloaded Federal GS-13 Step 5 salary for
calendar 2007, from the Office of Personnel Management salary table for
Washington-Baltimore-Northern Virginia (OPM, 2007). The 60%
fringes-and-overhead rate is from an EPA guide, Instructions for
Preparing Information Collection Requests (ICRs) (OPPE, 1992, page 30,
footnote 9).

APPENDIX A REFERENCES

BLS, 2008a.  U.S. Bureau of Labor Statistics. Employer Costs for
Employee Compensation Supplementary

 Tables: December 2007 (March 12, 2008) at
http://www.bls.gov/ncs/ect/sp/ecsuptc5.pdf

EPAB, 2002. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report. Washington, DC. August
2002.

ICR No. 1139.06. [Information Collection Request for] TSCA Existing
Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary
Test Data Submissions: Supporting Statement for Request for OMB Review
under the Paperwork Reduction Act. Attachment 5, Wage Rates Estimation,
August 29, 2000.

OPPE, 1992. U.S. EPA, Office of Policy, Planning, and Evaluation.
Instructions for Preparing Information Collection Requests (ICRs).
Washington, DC, June 1, 1992.

OPM, 2007. Office of Personnel Management, Salary Table 2007-DCB,
Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Accessed from
HYPERLINK "http://www.opm.gov/oca/07tables/html/dcb.asp"
http://www.opm.gov/oca/07tables/html/dcb.asp

Rice, 2002. Cody Rice. Wage Rates for Economic Analysis of the Toxics
Release Inventory Program. Washington, DC: U.S.EPA, Office of Pollution
Prevention and Toxics, Economic and Policy Analysis Branch, June 10,
2002.

ATTACHMENT 1

Toxic Substances Control Action Section 8(e)

15 U.S.C. 2607(e)

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 7, 2003]

TITLE 15--COMMERCE AND TRADE

CHAPTER 53--TOXIC SUBSTANCES CONTROL

SUBCHAPTER I--CONTROL OF TOXIC SUBSTANCES

Sec. 2607. Reporting and retention of information

* * *

(e) Notice to Administrator of substantial risks

    Any person who manufactures, processes, or distributes in commerce
as chemical substance or mixture and who obtains information which
reasonably supports the conclusion that such substance or mixture
presents a substantial risk of injury to health or the environment shall

immediately inform the Administrator of such information unless such
person has actual knowledge that the Administrator has been adequately
informed of such information.

 Employer Costs for Employee Compensation Supplementary Tables for
December 2007 (BLS, 2008a).

 PAGE

 PAGE   - 15 -

  PAGE  - 15 -

	A-  PAGE  1

Economic Analysis of Expedited SNURs, Docket OPPT-2008-251
                  B-  PAGE  4                                       July
2, 2008

A-  PAGE  3

Economic Analysis of Expedited SNURs, Docket OPPT-2008-251	B-  PAGE  2
July 2, 2008

	A-  PAGE  4


[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Notices]
[Page 26355-26357]
[DOCID:fr09my07-63]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-0270; FRL-8125-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Asbestos-Containing Materials in Schools Rule and
Revised Asbestos Model Accreditation Plan Rule; EPA ICR No. 1365.08,
OMB Control No. 2070-0091

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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

SUMMARY:  In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Asbestos-Containing Materials in Schools Rule and Revised
Asbestos Model Accreditation Plan Rule'' and identified by EPA ICR No.
1365.08 and OMB Control No. 2070-0091, is scheduled to expire on
January 31, 2008. Before submitting the ICR to OMB for review and
approval, EPA is soliciting comments on specific aspects of the
proposed information collection.

DATES:  Comments must be received on or before July 9, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID)

number EPA-HQ-OPPT-2007-0270, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID number EPA-HQ-OPPT-2007-0270. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0270. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
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 regulations.gov or e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through 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 the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only

available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Robert Courtnage, National
Program Chemicals Division (7404T), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Information Collection Activity or ICR Does this Action Apply
to?

    Affected entities: Entities potentially affected by this action are
local education agencies (LEAs) (e.g., elementary or secondary public
school districts or a private school or school system); an asbestos
training provider to schools and educational systems; a state

education department or commission; or a state public health department
or commission.
    Title: Asbestos-Containing Materials in Schools Rule and Revised
Asbestos Model Accreditation Plan Rule.
    ICR numbers: EPA ICR No. 1365.08, OMB Control No. 2070-0091.
    ICR status: This ICR is currently scheduled to expire on January
31, 2008. 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, are 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: The Asbestos Hazard Emergency Response Act (AHERA)
requires LEAs to conduct inspections, develop management plans, and
design or conduct response actions with respect to the presence of
asbestos-containing materials in school buildings. AHERA also requires
states to develop model accreditation plans for persons who perform
asbestos inspections, develop management control plans, and design or
conduct response actions. This information collection addresses the
burden associated with recordkeeping requirements imposed on LEAs by
the asbestos in schools rule, and reporting and recordkeeping
requirements imposed on states and training providers related to the
model accreditation plan rule.
    Responses to the collection of information are mandatory (see 40
CFR part 763, subpart E). Respondents may claim all or part of a
document confidential. EPA will disclose information that is covered by
a claim of confidentiality only to the extent permitted by, and in
accordance with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to range between
5.5 hours and 140 hours per response, depending on the category of the
respondent. 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.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 125,691.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 2,530,600 hours.
    Estimated total annual costs: $76,352,159. This includes an
estimated burden cost of $76,352,159 and an estimated cost of $0 for
capital investment or maintenance and operational costs.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a net increase of 45,160 hours in the total estimated
respondent burden compared with that identified in the ICR currently
approved by OMB. This increase reflects EPA's revised estimates of
numbers of LEAs and of training providers. This change is an
adjustment.

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: April 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.

[FR Doc. E7-8943 Filed 5-8-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58257-58258]
[FR Doc No: 2011-24033]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC11-117-000.
    Applicants: Central Vermont Public Service Corporation, Gaz Metro
Limited Partnership, Northern New England Energy Corporation, Green
Mountain Power Corporation.
    Description: Section 203 Application of Central Vermont Public
Service Corporation and Gaz Metro, et al. for Authorization for
Purchase, Disposition and Merger of Jurisdictional Facilities.
    Filed Date: 09/09/2011.
    Accession Number: 20110909-5279.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 8, 2011.

    Docket Numbers: EC11-118-000.
    Applicants: Amsterdam Generating Company, LLC, ESI Energy, LLC,
Blythe Energy, LLC, Calhoun Power Company I, LLC, Doswell Limited
Partnership.
    Description: Amsterdam Generating Company, LLC, et al. joint
application for approval under section 203 of the Federal Power Act,
request for shortened comment period, and request for expedited
treatment.
    Filed Date: 09/09/2011.
    Accession Number: 20110909-5285.
    Comment Date: 5 p.m. Eastern Time on Friday, September 30, 2011.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-3576-003; ER97-3583-007; ER11-3401-004; ER10-
3138-003.
    Applicants: Golden Spread Electric Cooperative, Inc., GS ELECTRIC
GENERATING COOPERATIVE INC, Denver City Energy Associates, L.P., Golden
Spread Panhandle Wind Ranch, LLC.
    Description: Notice of Change in Status of Golden Spread Electric
Cooperative, Inc. et al.
    Filed Date: 09/12/2011.
    Accession Number: 20110912-5118.
    Comment Date: 5 p.m. Eastern Time on Monday, October 3, 2011.

    Docket Numbers: ER11-4498-000.
    Applicants: Smoky Hills Wind Farm, LLC.
    Description: Smoky Hills Wind Farm, LLC submits tariff filing per
35.1: Smoky Hills Wind Farm, LLC MBR Tariff to be effective 10/31/2007.
    Filed Date: 09/12/2011.
    Accession Number: 20110912-5000.
    Comment Date: 5 p.m. Eastern Time on Monday, October 3, 2011.

    Docket Numbers: ER11-4499-000.
    Applicants: Smoky Hills Wind Project II, LLC.
    Description: Smoky Hills Wind Project II, LLC submits tariff filing
per 35.1: Smoky Hills Wind Project II, LLC MBR Tariff to be effective
10/20/2008.
    Filed Date: 09/12/2011.
    Accession Number: 20110912-5001.
    Comment Date: 5 p.m. Eastern Time on Monday, October 3, 2011.

    Docket Numbers: ER11-4500-000.
    Applicants: Enel Stillwater, LLC.
    Description: Enel Stillwater, LLC submits tariff filing per 35.1:
Enel Stillwater, LLC MBR Tariff to be effective 12/5/2008.
    Filed Date: 09/12/2011.
    Accession Number: 20110912-5002.
    Comment Date: 5 p.m. Eastern Time on Monday, October 3, 2011.

    Docket Numbers: ER11-4501-000.
    Applicants: Caney River Wind Project, LLC.
    Description: Caney River Wind Project, LLC submits tariff filing
per 35.12: Caney River Wind Project, LLC MBR Tariff to be effective 10/
1/2011.
    Filed Date: 09/12/2011.
    Accession Number: 20110912-5003.
    Comment Date: 5 p.m. Eastern Time on Monday, October 3, 2011.

    Docket Numbers: ER11-4502-000.
    Applicants: HEEP Fund Inc.
    Description: HEEP Fund Inc submits notice of cancellation to its
FERC Electric Tariff, Original Volume No 1, effective 10/30/11.
    Filed Date: 09/09/2011.
    Accession Number: 20110912-0201.
    Comment Date: 5 p.m. Eastern Time on Friday, September 30, 2011.

    Docket Numbers: ER11-4503-000.

    Applicants: PJM Interconnection, L.L.C.
    Description: Notices of Cancellation of PJM Interconnection, L.L.C.
for First Revised Service Agreement No. 2020 and Original Service
Agreement No. 2021.
    Filed Date: 09/09/2011.
    Accession Number: 20110909-5293.
    Comment Date: 5 p.m. Eastern Time on Friday, September 30, 2011.

    Take notice that the Commission received the following land
acquisition reports:

    Docket Numbers: LA11-2-000.
    Applicants: The Detroit Edison Company, DTE Energy Trading, Inc.,
DTE River Rouge No. 1, L.L.C., DTE East China, LLC, DTE Pontiac North,
LLC, DTE Stoneman, LLC, DTE Energy Supply, Inc., Woodland Biomass Power
Ltd.
    Description: Amended Quarterly Report Pursuant to 18 CFR sec.
35.42(d) for the Second Quarter of 2011 of The Detroit Edison Company,
et al.
    Filed Date: 09/09/2011.
    Accession Number: 20110909-5287.
    Comment Date: 5 p.m. Eastern Time on Friday, September 30, 2011.

    Take notice that the Commission received the following electric
reliability filings

    Docket Numbers: RD11-11-000.
    Applicants: Western Electricity Coordinating Council.
    Description: Western Electricity Coordinating Council Compliance
Filing in response to Order Numbers 751 and 752 on Version One Regional
Reliability Standards.
    Filed Date: 06/20/2011.
    Accession Number: 20110620-5190.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 12, 2011.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 12, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-24033 Filed 9-19-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8646-8648]
[FR Doc No: 2013-02626]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68785; File No. SR-NYSEArca-2013-06]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Delaying the
Operative Date of a Rule Change to Exchange Rule 7.12, Which Provides
for Methodology for Determining When To Halt Trading in All Stocks Due
to Extraordinary Market Volatility, From the Date of February 4, 2013,
Until April 8, 2013

January 31, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 23, 2013, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to delay the operative date of a rule change
to Exchange Rule 7.12, which provides for methodology for determining
when to halt trading in all stocks due to extraordinary market
volatility, from the date of February 4, 2013, until April 8, 2013. The
text of the proposed rule change [sic] is available on the Exchange's
Web site at www.nyse.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 7.12, which provides the
methodology for determining when to halt trading in all stocks due to
extraordinary market volatility, to delay the operative date of the
pilot by which such Rule operates from the current scheduled date of
February 4, 2013, until April 8, 2013, to coincide with the initial
date of operations of the Regulation NMS Plan to Address Extraordinary
Market Volatility (``LULD Plan'').\4\ As proposed, the pilot period
will begin and end at the same time [sic] the pilot period for the LULD
Plan. The current Rule 7.12 would remain in effect until April 8, 2013.
If the pilot is not either extended or approved permanently at the end
of the pilot period, the current version of Rule 7.12 would be in
effect.
---------------------------------------------------------------------------

    \4\ The Commission approved the proposed changes to the market-
wide circuit breakers on a pilot basis for a period scheduled to
start on February 4, 2013 that corresponds to the pilot period for
the LULD Plan so that the impact of the two proposals can be
reviewed together. See Securities Exchange Act Release No. 67090
(May 31, 2012), 77 FR 33531 (June 6, 2012) (SR-NYSEArca-2011-68).
The Exchange anticipates that the initial date of LULD Plan
operations will be changed to April 8, 2013. The proposal would
delay the operative date of the market-wide circuit breaker pilot to
April 8, 2013 in order for the implementation date for the market-
wide circuit breaker pilot to remain the same date as for the LULD
Plan.
---------------------------------------------------------------------------

Current Rule 7.12
    In its current form,\5\ the rule provides for Level 1, 2, and 3
declines and specified trading halts following such declines. The
values of Levels 1, 2 and 3 are calculated at the beginning of each
calendar quarter, using 10%, 20% and 30%, respectively, of the average
closing value of the DJIA for the month prior to the beginning of the
quarter. Each percentage calculation is rounded to the nearest fifty
points to create the Levels' trigger points. The Exchange disseminates
the new trigger levels quarterly to the media and via an Information
Memo and [sic] is available on the Exchange's Web site.\6\ The values
then remain in effect until the next quarterly calculation,
notwithstanding whether the DJIA has moved and a Level 1, 2, or 3
decline is no longer equal to an actual 10%, 20%, or 30% decline in the
most recent closing value of the DJIA.
---------------------------------------------------------------------------

    \5\ The rule was last amended in 1998, when declines based on
specified point drops in the DJIA were replaced with the current
methodology of using a percentage decline that is recalculated
quarterly. See Securities Exchange Act Release No. 39846 (April 9,
1998), 63 FR 18477 (April 15, 1998) (SR-NYSE-98-06, SR-Amex-98-09,
SR-BSE-98-06, SR-CHX-98-08, SR-NASD-98-27, and SR-Phlx-98-15).
    \6\ See e.g., NYSE Regulation Information Memos 11-19 (June 30,
2011) and 11-10 (March 31, 2011).
---------------------------------------------------------------------------

    Once a Rule 7.12 circuit breaker is in effect, trading in all
stocks halt for the time periods specified below:
Level 1 Halt
    Anytime before 2:00 p.m.--one hour;
    At or after 2:00 p.m. but before 2:30 p.m.--30 minutes;
    At or after 2:30 p.m.--trading shall continue, unless there is a
Level 2 Halt.
Level 2 Halt
    Anytime before 1:00 p.m.--two hours;
    At or after 1:00 p.m. but before 2:00 p.m.--one hour;
    At or after 2:00 p.m.--trading shall halt and not resume for the
rest of the day.
Level 3 Halt
    At any time--trading shall halt and not resume for the rest of the
day.
    Unless stocks are halted for the remainder of the trading day,
price indications are disseminated during a Rule 7.12 trading halt for
stocks that comprise the DJIA.
Amended Rule 7.12
    The Exchange amended Rule 7.12 to revise the current methodology
for determining when to halt trading in all stocks due to extraordinary
market volatility (``market-wide circuit

breakers'').\7\ The Exchange, other equities, options, and futures
markets, and FINRA amended the market-wide circuit breakers to take
into consideration the recommendations of the Joint CFTC-SEC Advisory
Committee on Emerging Regulatory Issues, and to provide for more
meaningful measures in today's markets of when to halt trading in all
stocks. Accordingly, the Exchange amended Rule 7.12 as follows: (i)
Replaced the DJIA with the S&P 500; (ii) replaced the quarterly
calendar recalculation of Rule 7.12 triggers with daily recalculations;
(iii) replaced the 10%, 20%, and 30% market decline percentages with
7%, 13%, and 20% market decline percentages; (iv) modified the length
of the trading halts associated with each market decline level; and (v)
modified the times when a trading halt may be triggered. The Exchange
believes that these amendments update the rule to reflect today's high-
speed, highly electronic trading market while still meeting the
original purpose of Rule 7.12: to ensure that market participants have
an opportunity to become aware of and respond to significant price
movements.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-NYSEArca-2011-68).
---------------------------------------------------------------------------

    The Exchange adopted the proposed changes to the market-wide
circuit breakers on a pilot basis for a period that corresponds to the
pilot period for the LULD Plan so that the impact of the two proposals
can be reviewed together.\8\ In addition, in order for the markets and
the single plan processors responsible for the consolidation of
information pursuant to Rule 603(b) of Regulation NMS under the
Securities Exchange Act of 1934 to make the necessary technological
changes to implement both the changes to the market-wide circuit
breakers and the proposed LULD Plan, the Exchange established that the
implementation date for the proposed rule changes should be the same
date that the LULD Plan is implemented. The Exchange anticipates that
the initial date of LULD Plan operations will be changed to April 8,
2013. For the same reasons as stated above, the Exchange proposes to
delay the operative date of the market-wide circuit breaker pilot to
April 8, 2013 in order for the implementation date for the market-wide
circuit breaker pilot to remain the same date as for the LULD Plan.
---------------------------------------------------------------------------

    \8\ See id.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Securities Exchange Act of 1934 (the ``Act''),\9\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\10\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, this rule proposal supports the objectives of
perfecting the mechanism of a free and open market and the national
market system because it promotes uniformity across markets concerning
when and how to halt trading in all stocks as a result of extraordinary
market volatility. Additionally, delaying the operative date of the
market-wide circuit breakers pilot until the initial date of operations
of the LULD Plan would allow the pilot to begin and end at the same
time of the LULD Plan so that the Exchange and the Commission could
further assess the impact of the two pilots on the marketplace or
whether other initiatives should be adopted in lieu of the pilots,
which contributes to the protection of investors and the public
interest.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed changes are
being made to delay the operation of the market-wide circuit breakers
pilot until April 8, 2013 to allow the pilot period to begin and end at
the same time as the LULD Plan, which contributes to the protection of
investors and the public interest. Other competing equity exchanges are
subject to the same methodology for determining when to halt trading in
all stocks due to extraordinary market volatility and the same
requirements specified in the LULD Plan. Thus, the proposed changes
will not impose any burden on competition while providing that the
market-wide circuit breakers pilot period corresponds to the pilot
period for the LULD Plan so that the impact of the two proposals can be
reviewed together.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6)\13\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\14\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. Doing so will delay
the operative date of the market-wide circuit breakers pilot until the
initial date of operations of the LULD Plan, thereby allowing the pilot
to run simultaneously with the LULD Plan, providing an opportunity to
properly assess the impact of the two pilots on the marketplace and
evaluate the pilots' effectiveness. Therefore, the Commission hereby
waives the 30-day operative delay and designates the proposal operative
upon filing.\15\
---------------------------------------------------------------------------

    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may

temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings under Section 19(b)(2)(B) \16\
of the Act to determine whether the proposed rule change should be
approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2013-06 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2013-06. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2013-06 and should
be submitted on or before February 27, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02626 Filed 2-5-13; 8:45 am]
BILLING CODE 8011-01-P