[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Notices]
[Page 8262-8264]
[DOCID:fr24fe09-80]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0209] (formerly Docket No. 2007D-0491)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Dietary Supplement
Labeling Requirements and Recommendations under the Dietary Supplement
and Nonprescription Drug Consumer Protection Act

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. Elsewhere in this issue of the Federal
Register, FDA is announcing that a proposed collection of information
regarding labeling requirements for nonprescription human drugs
marketed without an approved application has been submitted to OMB for
review.

DATES: Fax written comments on the collection of information by March
26, 2009.

ADDRESSES:  To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title, ``Dietary Supplement Labeling Requirements and Recommendations
under the Dietary Supplement and Nonprescription Drug Consumer
Protection Act.'' Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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.

Dietary Supplement Labeling Requirements and Recommendations under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act

    On December 22, 2006, the President signed into law the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA)
(Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food,
Drug, and Cosmetic Act (the act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application. The law also amended the act to add
section 403(y) (21 U.S.C. 343(y)), which requires the label of a
dietary supplement marketed in the United States to include a domestic
address or domestic telephone number through which the product's
manufacturer, packer or distributor may receive a report of a serious
adverse event associated with the dietary supplement.
    In the Federal Register of January 2, 2008 (73 FR 197), FDA
announced the availability of a draft guidance document entitled
``Questions and Answers Regarding the Labeling of Dietary Supplements
as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act. '' In the Federal Register of December 11, 2008 (73 FR
75438), FDA announced the availability of a revised version of the same
draft guidance document . The guidance document contains questions and
answers relating to the labeling requirements in section 403(y) of the
act and provides guidance to industry on the following topics: (1) The
meaning of ``domestic address'' for purposes of the labeling
requirements of section 403(y) of the act; (2) FDA's recommendation for
the use of an introductory statement before the domestic address or
telephone number that is required to appear on the product label under
section 403(y) of the act; and (3) FDA's intent regarding enforcing the
labeling requirements of section 403(y) of the act.
    In the Federal Register of January 2, 2008 (73 FR 197), FDA
published a notice of availability for the original draft guidance that
also gave notice of the proposed collections of information in the
draft guidance, included an analysis and burden estimate for these
proposed collections of information, and provided 60 days for public
comment under the Paperwork Reduction Act of 1995 (PRA). FDA did not
revise the PRA burden analysis and estimate when it issued the revised
draft guidance in December 2008 because the revisions did not affect
them.
    Several comments suggested that FDA underestimated the number of
dietary supplement labels that would have to be revised. Two comments
noted that in the past FDA had estimated the number of distinct dietary
supplement labels at 29,514, and another comment noted that in the past
FDA had estimated the number of distinct dietary supplement labels at
75,000. Several other comments suggested that the number of dietary
supplements sold in the United States was between 50,000 and 60,000
products based on information from the Office of Dietary Supplements at
the National Institutes of Health (NIH). All the aforementioned
comments suggested that the costs associated with re-labeling the
dietary supplements represented a significant burden to the industry.
Based on these comments, FDA has revised its estimate of the number of
labels that would have to be redesigned to include the complete
domestic address or domestic telephone number of the responsible person
for each dietary supplement stockkeeping unit (SKU).
    FDA used A.C. Nielsen Sales Scanner Data from 2004 to improve its
estimate of the number of dietary supplement SKUs. The 2004 A.C.
Nielsen scanner data are more recent and more complete than the data
FDA used to derive the estimate used in the 60-day notice. FDA also
adjusted the Nielsen scanner data estimate to account for methods of
sale not covered by the Nielsen scanner data, such as non-participating
retailers and internet sales. Based on the adjusted Nielsen scanner
data, FDA estimates that the number of dietary supplement SKUs for
which sales of the products are greater than zero is 55,600. This
number of SKUs is similar to the number of dietary supplement products
that was suggested by several comments and the number estimated by the
Office of Dietary Supplements at NIH.
    FDA did not receive any comments regarding the number of firms that
would be responsible for re-labeling the dietary supplement products.
Therefore, we retain our estimate that there are about 1,460 dietary
supplement firms that must comply with the labeling requirements of
section 403(y) of the act. Assuming the 55,600 SKUs are split equally
among the firms, then each firm would be responsible for updating about
38 SKUs. FDA also did not receive any comments regarding how many of
the dietary supplement SKUs would have to undergo a label change to
include the complete domestic address or domestic phone number of the
responsible person as required by the DSNDCPA. Thus, as in the 60-day
notice, FDA is assuming conservatively that all labels will need to be
redesigned.
    Several comments noted that the overall process of changing a label
requires a significant amount of time to implement; however, FDA did
not receive any estimates of the actual time it would take to assess
the current layout of each label and redesign it. FDA also did not
receive any estimates of how many firms would choose to include an
explanatory statement on the reason for the domestic address or
telephone number appearing on the label of the dietary supplement
product, though several comments speculated that all or nearly all
firms would be likely to include an explanatory statement. Because we
did not receive any comments on the burden associated with each of
these tasks, we retain our original estimates. We assume conservatively
that all firms will include an explanatory statement on the label, and
we estimate that the redesign of each label to include the domestic
address or telephone number and the explanatory statement will take a
total of 8 hours (4 hours for each change).
    FDA estimates the burden of this collection of information as
follows:

Hour Burden Estimate

                                Table 1.--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                      No. of       Annual Frequency per     Total annual        Hours Per
                   Respondents           Response            Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Domestic                    1,460               38.0822             55,600                  4            222,400
 address or
 telephone
 number
 labeling
 requirement
 (21 U.S.C.
 343(y))
----------------------------------------------------------------------------------------------------------------
FDA                         1,460               38.0822             55,600                  4            222,400
 recommendatio
 n for label
 statement
 explaining
 purpose of
 domestic
 address or
 telephone
 number
----------------------------------------------------------------------------------------------------------------
Total                                                                                444,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance and operating costs associated with this collection of
  information.

    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3916 Filed 2-23-09; 8:45 am]

BILLING CODE 4160-01-S


* EPA issued a TSCA section 8(d) rule (71 FR 47130) on August 16, 2006 for 243 HPV chemicals that were not sponsored in the voluntary portion of the HPV Challenge Program. EPA later withdrew 33 of these chemicals in a final rule issued on September 29, 2006 (71 FR 57439). In a subsequent direct final rule issued on April 30, 2007, EPA removed two additional chemicals (72 FR 21119), resulting in a total of 208 chemicals subject to Section 8(d) reporting.  (**) The TSCA Interagency Testing Committee added Lead and Lead Compounds to the Priority List as part of its 60[th] ITC Report. Based on this addition, EPA issued a final rule on January 20, 2008 (73 FR 5190) which added 12 Lead and Lead compounds to 40 CFR 716.120.

Moreover, to characterize the reporting implications per chemical addition associated with Section 8(d) reporting, this analysis uses TSCA Inventory Update Rule data from the 1998, 2002, and 2006 reporting cycles, and Chemical Data Reporting Rule data from the 2012 reporting cycle. Table 10 summarizes the models and bases, as applied to the 2022-2025 ICR renewal.
Table 10. Reporting Implications per Chemical Added TSCA Section 8(d)
                                    Metric
                                ICR Model Year
                                Number of firms
                              Number of chemicals
                         Number of reports or studies
                                Reporting basis
                             Reporting basis unit
               Number of firms potentially impacted per chemical
2015-2018 [a]
                                                                            344
                                                                            208
                                      N/A
                                                                            1.7
                                Firms/chemicals

2018-2021 [b]
                                                                            348
                                                                            220

                                                                            1.6

2022-2025 [c]
                                                                            129
                                                                             50

                                                                            2.6

                                Sites per firm
2015-2018 [a]
                                      N/A
                                      N/A
                                      N/A
                                                                            1.5
                                  Sites/firms

2018-2021 [b]

                                                                            1.5

2022-2025 [c]

                                                                            1.5

     Fraction of firms potentially affected who submit reports of studies
2015-2018 [a]
                                                                            344
                                                                            208
                                                                             59
                                                                           0.17
                        Firms submitting reports/firms

2018-2021 [b]
                                                                            348
                                                                            220
                                                                             63
                                                                           0.18

2022-2025 [c]
                                                                            129
                                                                             50
                                                                             63
                                                                           0.49

                     Number of studies per submitting firm
2015-2018 [a]
                                                                             59
                                                                            208
                                                                            527
                                                                              9
                                 Studies/firm

2018-2021 [b]
                                                                             63
                                                                            220
                                                                            542
                                                                              9

2022-2025 [c]
                                                                             63
                                                                             50
                                                                            542
                                                                              9

                        Average length of study, pages
2015-2018 [a]
                                      N/A
                                      N/A
                                      N/A
                                      20
                                     Pages

2018-2021 [b]

2022-2025 [c]

        Percent studies with robust summaries; number of firms affected
2015-2018 [a]
                                      N/A
                                      N/A
                     10% of total studies;
10% of reports
                                       1
                              Robust summary/firm

2018-2021 [b]

2022-2025 [c]

             Percent of affected firms submitting second responses
2015-2018 [a]
                                      N/A
                                      N/A
                                  5% affected
                                       5
                                    Percent

2018-2021 [b]

2022-2025 [c]

Sources:

[a] TSCA IUR data, all manufacturers 1998, 2002, 2006

[b] TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012

[c] TSCA Section 8(d): Economic Impact Analysis for Adding 50 Chemicals from the 74th ITC Report of the TSCA Interagency Testing Committee to the Health and Safety Data Reporting Rule

Estimating Respondent Burden

Firms will undertake a number of actions in response to a TSCA section 8(d) listing and the unit burden associated with each of these tasks is discussed in detail below.

Review the Rule: Firms in the relevant industries that may have unpublished health and safety studies will have to determine whether they manufacture (including import) a listed chemical and may thus be required to report. If so, they will have to review the rule in detail to understand its requirements, such as the types of health and safety studies EPA is asking for, the grade or purity of the test material, and the timeframe of the reporting period.

Note that, unless EPA specifies otherwise, the coverage of section 8(d) rules is limited to chemical manufacturers and petroleum refineries. Most firms in these industries will not manufacture a listed chemical, and many will spend a de minimis amount of time making that determination. Those firms that manufacture a listed chemical must review the rule to understand its specific requirements. This is estimated to take an average of 2 hours of managerial time for each firm manufacturing a listed chemical.

Conduct Corporate Review for Site Identification: Firms that manufacture a listed chemical will need to conduct a corporate review to identify which of the firm's sites must be searched for appropriate health and safety studies. This corporate review is estimated to require an average of 3 managerial hours per firm.

Conduct Site File Search: Firms that manufacture a listed chemical must search the files at appropriate sites to look for studies that are responsive to the TSCA section 8(d) rule. It is estimated that the search will take an average of 3 hours of technical time per site. EPA estimates that each firm will have an average of 1.5 sites manufacturing a listed chemical. This yields an average burden of 4.5 technical hours per firm for site file searching (3 hours per site * 1.5 sites per firm).

Provide Study Title Lists: Respondents are required to submit lists containing the titles of any studies being submitted, titles of studies that are initiated or ongoing during the reporting period but that have not yet been completed, titles of any unpublished studies that the respondent knows to exist but does not have in its possession, and titles of studies previously submitted to other federal agencies without confidentiality claims. EPA expects that the major burden of compiling this list was incurred during the file search and would already be available in electronic format; therefore, there is no additional burden associated with this activity.

Prepare Robust Summaries: Respondents may choose to develop and submit robust summaries of the full toxicological study reports. The robust summaries should contain technical information to adequately describe the study and results, and should be written in such a way that the information provided is sufficient to allow a technically qualified person to evaluate study results. Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality description, and references associated with the full study. It is estimated that 8 to 16 hours of technical time are needed to develop and review a robust summary, depending on the type of study conducted. This ICR assumes an average of 12 hours of technical time to prepare a robust summary. Because submission of robust summaries is voluntary, EPA does not expect that many companies will undertake this activity. EPA estimates that each firm will submit an average of 9 studies, with 10% of those studies including a robust summary; therefore, EPA expects to receive an average of 0.9 robust summaries per firm submitting studies, which we round up to 1 robust summary per firm submitting studies. The estimated average burden per robust summary is 12 hours of technical time.

Review Responses for CBI: Firms will need to review responses for possible CBI and delete any material that is considered by the firm to be CBI from one copy of the study. A separate copy of the study must be submitted without deletions of CBI. CBI review is estimated to take an average of 1 hour of managerial time for each study. Since each of the 34 firms is submitting an average of 9 studies, CBI review results in an estimated average of 9 hours of managerial time per firm.

CBI Legal Review and Confidential Business Substantiation: Firms will need to gather and prepare information to substantiate a claim for confidentiality. This will also involve approximately 1.5 hours of managerial and attorney time, split evenly between staff.

Post-Reporting Period Submission (Submit Ongoing or Newly-Initiated Studies): Firms that have an ongoing or newly-initiated study during the reporting period are required to provide EPA with a copy of the study once it is completed. CBI review and submission of ongoing or newly-initiated studies are estimated to require an average of 1 hour of managerial time.
Table 11. Unit Burden for TSCA Section 8(d) Reporting
                              Collection Activity
                        Affected Respondents (Weight)*
                        Average Burden per Firm (Hours)
                                Labor Category
Review of Rule
                                       1
                                       2
                                  Managerial
Site Identification
                                       1
                                       3
                                  Managerial
Site File Search**
                                       1
                                      4.5
                                   Technical
Robust Summaries
                                     0.008
                                      12
                                   Technical
CBI Review
                                     0.168
                                       9
                                  Managerial
CBI Legal Review and CBI Substantiation
                                     0.168
                                     0.75
                                  Managerial

                                     0.168
                                     0.75
                                   Attorney
Post-Reporting Period Submission
                                     0.008
                                       1
                                  Managerial
*Not all respondents perform all activities. This weight reflects that for every firm that has to check for reports:  18% will submit reports, of which 1 firm (about 10%) will provide robust summaries and 5% (about 1 firm) will provide a second response.
** Basis of 1.5 sites per firm

These unit burden estimates are average values. Large multi-divisional, multi-departmental firms may require more than the average time to comply. However, there are smaller firms that are less complicated, and these firms may have a simpler process that requires less time.

Estimating the Respondent Universe

- EPA has added a total of 332 chemicals to the list since 1996 (47 in 1996, 15 in 2004, 208 in 2006, 12 in 2008, and 50 between 2018 and 2021), which is an overall program historical average of approximately 13 chemicals per year. For estimates in this ICR, EPA assumes that the historical average of 13 chemicals per fiscal year will be added to the section 8(d) list. Assuming that each chemical that is added to the list impacts 2.6 firms, then EPA expects 34 chemical manufacturing firms to be affected per year by this ICR.

Based on the reporting bases stated on Table 12, EPA assumes that 18% percent of the potentially affected manufacturers will submit studies each year, yielding 6 firms submitting studies (0.18 * 34 manufacturers) and they will also conduct CBI review. Each submitting firm is expected to submit a total of 9 studies, yielding an estimated total of 54 studies annually (6 firms * 9 studies per firm). A total of 10% of the studies are expected to contain robust summaries, yielding a total of 1 robust summary per firm (9 studies * 0.10, and rounding up to 1); and approximately 1 firm (5% of 4 firms) is estimated to submit a second response (for a newly initiated or ongoing study) after the reporting period ends.

The number of firms estimated to engage in the various reporting activities is summarized in12. Note that not all respondents incur every aspect of reporting burden.

Table 12. Number of Firms Affected per Year, by Activity (13 Chemicals Added Per Year) TSCA Section 8(d)
                              Collection Activity
                                 No. of Firms
Review of Rule
                                      34
Site Identification
                                      34
Site File Search
                                      34
Robust Summaries
                                       6
CBI Review
                                       6
Post-Reporting Period Submission
                                       1

The number of firms or studies described above is combined with the estimated average unit burden hours and wages Table 12 and Table 1, respectively, to estimate the total burden hours and cost per year based on three types of response activities:  searching files, submitting studies during the reporting period, and submitting studies after the reporting period.
Table 13. Annual Respondent Burden Hour and Cost Estimates TSCA Section 8(d) (2021$)
                            Information Collections
                              Response Activities
                          Burden per Response (Hours)
                                Labor Category
                               Cost per Response
                              Number of Responses
                             Total Burden (Hours)
                                  Total Cost
Compliance determination and data search
Rule review
                                       2
                                  Managerial
                                     $835
                                      34
                                      323
                                   $28,390

                                    $94.54

Site Identification
                                       3
                                  Managerial

                                    $94.54

Site File Search
                                      4.5
                                   Technical

                                    $80.50

Submission of health and safety studies during the reporting period and CBI Substantiation
Robust summaries
                                      12
                                   Technical
                                    $1,959
                                       6
                                      135
                                   $11,754

                                    $80.50

CBI Review
                                       9
                                  Managerial

                                    $94.54

CBI Legal Review and CBI Substantiation
                                     0.75
                                  Managerial

                                    $94.54

                                     0.75
                                   Attorney

                                    $94.62

Notification and submission of health and safety studies initiated and/or completed after the reporting period
Post-reporting period submission
                                       1
                                  Managerial
                                     $95
                                       1
                                       1
                                     $95

                                    $94.54

Subtotal
                                      41
                                      459
                                   $40,239
CDX Registration & E-signature

                                     0.93
                                  Managerial
                                     $228
                                       6
                                      16
                                    $1,368

                                    $94.54

                                     1.73
                                   Technical

                                    $80.50

Electronic signature agreements

                                      N/A
                                      N/A
                                    $3.05

                                    $18.30
Subtotal
                                       6
                                      16
                                    $1,386
Total
                                      41
                                      478
                                   $41,607

A typical firm submitting a response is conservatively estimated to engage in review of the rule, site identification, site file search, preparing study title lists, CBI review, CBI substantiation, and possibly submit a robust summary and/or a post-reporting period submission. Assuming 13 chemicals per year are added to the TSCA section 8(d), including the added CBI substantiation, the average annual burden and cost per response is 11 hours and $981, respectively (using the subtotal values in Table 13).

CDX Registration Activities to Enable Electronic Reporting

EPA estimates that respondents will incur a small amount of cost in carrying out the additional paperwork activities that were imposed by the Electronic Reporting under the Substances Control Act (TSCA) Final Rule. This includes the burden associated with activities that facilitate submission of an electronic report: CDX registration and CDX electronic signature. These activities occur only once for each submitter. Some submitters may already have registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with the mandatory electronic reporting requirements of EPA's e-PMN rule and/or IUR/CDR rule. Those submitters will not need to repeat the CDX registration and e-signature process in order to file their health and safety studies. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is using a conservative assumption that all submitters who will file electronically will need to register with CDX and, thus, incur associated burdens. This assumption may overestimate the burdens and costs actually experienced by respondents.

The one-time CDX burden includes the following:
 CDX Registration  -  Based on www.cdx.epa.gov, which is based on the CROMERR Cost Benefit Analysis, EPA assumed that companies would spend 11 minutes per employee to register with CDX. Furthermore, EPA assumed that an average of four technical staff members and one manager would need to register for each company, resulting in 55 minutes of burden per firm.
 CDX electronic signature (labor burden)  -  Based on www.cdx.epa.gov, which is based the CROMERR Cost Benefit Analysis, EPA assumed that firms would spend 15 minutes preparing, submitting, and filing an electronic signature agreement (i.e., authentication of Identity) form to EPA per employee. One manager and four technical staff members per firm would incur this burden, totaling 75 minutes of burden per company. In addition, EPA estimates that a manager would spend an additional 30 minutes accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by firms submitting and then verifying electronic signature agreements would be 105 minutes. It should be noted that the burden associated with CDX Electronic Signatures does not include costs associated with contacting EPA's CDX help desk to notify a change of submitter status, should one occur.
 Non-labor costs include a $0.58- stamp (2021$) and a $0.03 standard business envelope for each of five required electronic signature agreements. The total non-labor cost for electronic signature agreements equals $3.05. This amounts to $18.30 in non-labor costs per year. Note, this non-labor cost is excluded from both the subtotal and total cost estimate in Table 13.
 Conservatively assuming all 6 firms submitting studies will need to register with CDX, the average burden and cost per CDX registration is 2.67 hours and $231, respectively using the values related to CDX registration activities contained in Table 14.
The total estimated burden hours is 475 hours and total estimated costs are $41,607.
Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
 The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
There are no operational or maintenance costs associated with this collection.
Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

Table 14 provides annual agency wage rates for multiple GS and step levels for agency federal staff in the Washington-Baltimore-Northern Virginia-West Virginia locality pay region.
Table 14. Agency Wage Rates (2021$)
                                Labor Category
Data Source for Wage Information (Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area)
                                 Wage ($/hour)
                             Fringes as % wage[b]
                                Fringe Benefit
                              Total Compensation
                      Overhead as % total compensation[c]
                                   Overhead
                              Loaded Wage ($/hr)

                                      (a)
                                      (b)
                                 (c) = (a)*(b)
                                 (d) = (a)+(c)
                                      (e)
                                (f) = (d)*(e)
                                 (g) = (d)+(f)
                                   EPA staff
GS-12 Step 1 pay rates [a]
                                                                        $41.78
                                                                         63.90%
                                                                        $26.70
                                                                        $68.48
                                                                            20%
                                                                        $13.70
                                                                        $82.18

GS-13 Step 1 pay rates [a]
                                                                        $49.68
                                                                         63.90%
                                                                        $31.75
                                                                        $81.43
                                                                            20%
                                                                        $16.29
                                                                        $97.72

GS-13 Step 5 pay rates [a]
                                                                        $56.31
                                                                         63.90%
                                                                        $35.98
                                                                        $92.29
                                                                            20%
                                                                        $18.46
                                                                       $110.75

GS-15 Step 1 pay rates [a]
                                                                        $69.06
                                                                         63.90%
                                                                        $44.13
                                                                       $113.19
                                                                            20%
                                                                        $22.64
                                                                       $135.83
Footnotes:
a Source: U.S. Office of Personnel Management. (2021). Salary Table 2021-DCB. Retrieved February 1, 2022 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/DCB_h.aspx.
b Source: Falk, J. 2012. "Comparing Benefits and Total Compensation in the Federal Government and the Private Sector." Congressional Budget Office Working Paper Series. https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/workingpaper/2012-04fedbenefitswp0.pdf
[c] An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020).

TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
Although, it will be unlikely that the EPA will issue a PAIR rule in this renewal cycle because EPA will most likely use other rulemakings such as the Chemical Data Reporting (CDR) rule to collect similar data, the following describes the EPA's burden if such an event were to occur. The activities routinely conducted by EPA related to the rule development, processing, analysis and storage of the information collected under a PAIR rule (40 CFR part 712) and subpart B of 40 CFR 766 are as follows:
 Chemical nomination, review and selection;
 Rule development;
 Evaluation of the rule (including impact assessments);
 Industry/public assistance;
 Compliance monitoring; and
 Processing of data received for listed chemicals (includes receipt, dissemination, evaluation, etc.).

This analysis assumes that an annual average of 1 report will be submitted over the three-year period of the ICR. Personnel burden and costs associated with industry/public assistance and data processing activities have been adjusted based on that estimate. From the 1989 PAIR ICR update it has been derived that industry/public assistance required approximately 1.5 hours per report or 0.0007 FTE. Similarly, the 1989 PAIR ICR update estimated that about 3.75 hours, or 0.002 FTE, of data processing/system support personnel time would be required per report.

Data processing costs have been updated from 2017 to average 2021 dollars using the GDP implicit price deflator from the Bureau of Economic Analysis (BEA). The BEA GDP price index series with a base of 2012 = 100 has the 2017 index at 107.742 and the 2021 index at 118.477 so the adjustment factor from 2017 to 2021 is 1.0996 (118.477/107.742 = 1.0996). Data processing costs for the 2017 PAIR ICR update were estimated to be approximately $295.01 per report. Adjusting this number to 2021 with the GDP implicit price deflator yields an adjusted data processing cost of $324.39 per report (i.e., $295.01 x 1.0996 = $324.39).).

Table 15 summarizes the government's activities in developing and administrating the PAIR and subpart B of 40 CFR 766. The required FTEs per activity are retained from the 1996 PAIR ICR update and from the previous 8(a) PAIR ICR renewal analyses, for all activities except for the recalculation of the burden associated with industry/public assistance and data processing/system support personnel time. Costs are calculated assuming agency staff at GS 12 Step 1 would perform these activities and the loaded wage rate is in Table 14.
Table 15. Agency Burden Summary for TSCA Section 8(a) PAIR (2021$)
                                   Activity
                                 Annual Burden
                                  Annual Cost
Chemical nomination, review, and selection
                                     0.25
                                   $222,669
Rule development
                                     0.90

Evaluation of rule
                                     0.05

Industry/public assistance
                                    0.0007

Compliance monitoring
                                     0.10

Data processing and system support personnel
                                     0.002

Government data processing cost
                                      N/A
                                     $324
Total
                                      1.3
                                   $222,994

Table 16 presents a summary of the costs to the federal government for TSCA Section 8(a) PAIR information collection. The full time work year is considered 2,080 hours, and there are 2,710 annual burden hours associated with a 1.3 FTE.
Table 16. Government Estimated Annual Burden and Cost Summary for TSCA Section 8(a) PAIR (2021$)
Total FTEs
                                                                            1.3
Annual burden hours
                                                                         2,710
Loaded cost per FTE
                                                                      $170,929
Government labor cost
                                                                      $222,669
Government data processing cost
                                                                          $324
Total annual government cost
                                                                      $222,993

Chemical Specific Rule; TSCA Section 8(a)
For any TSCA section 8(a) chemical-specific rule the Agency would have to perform a number of tasks. They are:
 Industry/Public Assistance (answering questions regarding rule);
 Data Processing and System Support Personnel;
 Review the information submitted;
 Analyze submissions for confidentiality and provide appropriate protection for confidential data;
 Storage and Distribution; and
 Compliance Monitoring.
The Agency has developed the following burden hour estimates for activities related to promulgating a section 8(a) Chemical Specific rule.
Table17. Agency Summary of Burden Hours and Cost Estimates for TSCA Section 8(a) Chemical Specific
                                   Activity
                                 Burden (FTE)
                                 Burden Hours
                                  Annual Cost
Industry/Public Assistance (answering questions regarding the rule)
                                                                            0.1
                                                                            208
                                                                       $17,093
Data processing and systems support personnel
                                                                            0.2
                                                                            416
                                                                       $34,186
Storage and distribution
                                                                            0.1
                                                                            208
                                                                       $17,093
Compliance monitoring
                                                                            0.1
                                                                            208
                                                                       $17,093
Total
                                                                            0.5
                                                                         1,040
                                                                       $85,465

The OPPT bases its burden hour and labor cost estimates on prior experience in gathering and processing information associated with other information collections. Because these activities involve a team approach, the Agency has used a composite burden hour estimate containing workers at various GS levels and calculated hourly costs based upon the wage rate for a GS-12 Step 1 employee (Table 17). The full-time work year is considered 2,080 hours, so there are 1,040 burden hours associated with 0.5 FTE at a cost of $85,465.
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
The information collected by employers under 8(c) on employee health effects will involve the following activities:
 Monitoring recordkeeping by employer.
 Initiating requests that employer report employee health effects.
 Reviewing responses of employer to EPA's requests.
 Logging in submissions and reviewing them for confidentiality considerations.
 Making copies of submissions available to offices within OPPT that are assessing the substances of concern.
 Placing non-confidential versions of the submissions in a public docket and making them available for review by other government agencies and the public.
The total annual cost to EPA for TSCA section 8(c) for each of the three years covered by this ICR is estimated to be $90,208.  This figure is based on activities identified in the 1986 and 1989 ICRs.  Costs are estimated based on wages for GS-15 Step 1, GS-13 Step 1, and GS-12 Step 1 employees shown in Table 14.
 Annual costs to EPA associated with the recordkeeping portion of the rule include general administration of the rule, education and outreach activities, and compliance monitoring.  Costs associated with reporting involve preparation of reporting notices, Federal Register printing costs, document control, and document review.  Annual costs to EPA are derived based on an analysis of the cost of performing these various activities.  The various factors that contribute to EPA costs include:
 Each year, general administration of the rule involves approximately one-tenth of a staff specialist's time plus approximately one week's time each for two management personnel at the branch, division and OPPT Office Director's level.
 Education and outreach activities will include ongoing rule support.
 Compliance monitoring costs primarily involve the costs of the TSCA section 8(c) portion of inspection carried out by regional personnel and other administrative costs for headquarters personnel to target and review results of such inspections.
 To date, a total of only 31 reports have been received.  Based on historical data, over the life of the rule an average of only 0.08 notices have been issued per year and an average of only 1.3 reports received. EPA expects that reporting activity under TSCA section 8(c) will remain at low levels during the period covered by this ICR renewal. EPA costs associated with reporting have been adjusted to reflect this large decrease in the level of expected activity.  Labor involved in developing the reporting notices will require decision meetings and either the development of letters, separate Federal Register notices, or the insertion of boilerplate segments in other rule preambles.
 Time will be required to process submissions based upon reporting requirements and to review them for confidentiality considerations.
 The Federal Register notices will be reviewed by the office directly requesting the information as well as by OPPT.
Table 18 presents a summary of Agency annual burden and costs with burden totaling as 1,258 hours with an annual cost of $110,903.
Table 18. Agency Annual Burden and Cost Estimates for TSCA Section 8(c)
                                   Activity
                                   GS-Level
                                 Burden Hours
                                  Annual Cost
Administrative maintenance
                                 GS-13 Step 1
                                                                            208
                                                                       $20,325

                                 GS-15 Step 1
                                                                             80
                                                                       $10,866
Subtotal
                                                                            288
                                                                       $31,191
Education/Outreach
                                 GS-12 Step 1
                                                                            240
                                                                       $19,723
Compliance monitoring
                                 GS-12 Step 1
                                                                            400
                                                                       $32,871
Develop reporting notices
                                 GS-12 Step 1
                                                                            160
                                                                       $13,148
Document control functions
                                 GS-12 Step 1
                                                                             10
                                                                          $822
Notice review, referral, and data entry
                                 GS-12 Step 1
                                                                            160
                                                                       $13,148
Total
                                                                          1,258
                                                                      $110,903

Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies

The activities routinely conducted by EPA related to the rule development, processing, analysis and storage of the information collected under this rule include the following:
 Review and select chemicals;
 Develop and issue an amendment to the TSCA section 8(d) rule to add the      substances or mixtures;
 Answer respondents' questions;
 Process and analyze rule submissions;
 Maintain and distribute the data; and
 Analyze submissions for confidentiality and analyze the information provided to substantiate the confidentiality claim.
The activities routinely conducted by EPA related to processing and storage of the information collected under this rule include processing and analyzing the materials submitted under the rule, including requests for confidentiality; and maintaining and distributing data.
The activities associated with Agency responses to TSCA Section 8(d) listings are assumed to be accomplished by a GS 13 Step 5 federal employee, and the 2021 loaded hourly wage rate for this GS and step level is shown in Table 14.
The estimated annual cost to the federal government for TSCA section 8(d) data collection totals $6,473 for 58.45 hours, as presented in Table 19.
Table19. Agency Annual Burden and Cost Estimates for TSCA section 8(d)
                              Collection Activity
                                     FTEs
                                    Hours
                                  Annual Cost
Data processing and system support
                                                                          0.025
                                                                          41.75
                                                                        $4,624
Storage and distribution
                                                                          0.010
                                                                          16.70
                                                                         $1,850
Total
                                                                          0.035
                                                                          58.45
                                                                         $6,474

Explain the reasons for any program changes or adjustments reported in hour or cost burden.
This information collection combines the burdens from four previously approved ICRs. The total burden hours requested for this ICR is 26,226 and the total estimated cost is $5,109,515. There was an increase in the estimated number of responses for Section 8(d) Health and Safety Studies and Chemical Specific Section 8(a) because of the reinstatement of this ICR, and increased number of potential Section 8(d) submissions. The increase for these two information collections is 50 responses, 7 for Section 8(d) Health and Safety Studies and 43 Chemical Specific Section 8(a) respectively, from the two previously approved ICRs. The total combined cost burden from the Section 8(d) Health and Safety Studies and the Chemical Specific Section 8(a) currently approved ICRs is $23,501 ($23,501 + $0), respectively, and the total cost burden requested for these information collections is ICR is $56,397 ($41,607 + $14,790).
Once this ICR is approved, it will replace the existing ICRs, resulting in an increase in the estimated total cost burden of $297,119 [$5,109,515  -  $4,812,396]. The difference between the current cost burden request and the previously approved requests are due to the consolidation and reinstatement of the individual ICRs when calculating the burden, as well as adjustments in EPA's estimates of the number of respondents and of the burden. In addition to the adjustments listed above, the wage rates and material costs were revised to reflect 2021 dollars for this information collection request.
For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
Not applicable.
If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.
Not applicable.
Explain each exception to the certification statement identified in "Certification for Paperwork Reduction Act Submissions."
EPA does not request an exception to the certification of this information collection.
Supplemental Information
This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-NEW; EPA ICR No. 2701.01). Responses to this collection of information are mandatory for certain persons, as specified at 15 U.S.C. 2607. 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 public reporting and recordkeeping burden for this collection of information is estimated to 50 hours per initial Section 8(a) PAIR submission; 68 hours for Chemical Specific Section 8(a) Rules, 11 hours for Health and Safety Section 8(d); and .97 hours for Section 8(c). Send comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address."
List of Attachments
The attachments listed below can be found in the docket for this ICR or by using the hyperlink that is provided in the list below. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2021-0768.
Ref.
Title
1.
15 U.S.C. 2607
2
8(a) Preliminary Assessment Information Rule (PAIR) 40 CFR 712
3
8(a) PAIR and Dibenzo-para-dioxins/dibenzofurans, 40 CFR 766
4
Dioxin/Furan Report Form EPA Form 7710-51
5
15 U.S.C. 2625
6
Chemical Specific Rules, 40 CFR 704
7
Allegations of Adverse Effects, 40 CFR 717
8
Health and Safety Data Reporting, 40 CFR 716
9
CDX User Guide 8(d) Health and Safety Data
10
CDX Section 8(a) PAIR User Guide
11
Manufacturer's Report Preliminary Assessment Information Form (EPA Form
7710-35) and instructions
12
Good Laboratory Practice Standards  -  40 CFR 792

List of References
Economic Impact and Small Business Definition Analysis for the Final TSCA Section 8(a) Preliminary Assessment Information Rule, Final Report (EPA, 1981), previous TSCA Section 8(a) PAIR ICRs updates
Economic Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Final Rule (EPA, 2012)
The Economic Analysis of the Premanufacture Notification Electronic Reporting Rule (EPA, 2009) and the electronic submission of TSCA 8(b) Chemical Data Reporting (CDR) submissions in the
Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).
U.S. Bureau of Labor Statistics. 2021. Employer Costs for Employee Compensation (ECEC) Supplementary Tables: December 2006  -  December 2020.
U.S. Bureau of Labor Statistics. 2020. Occupational Employment Statistics (OES) May 2020 National Industry-Specific Occupational Employment and Wage Estimates.
US EPA. 2020. Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other EPA Actions. Accessed on January 25, 2022. https://www.epa.gov/sites/default/files/2020-12/documents/epa_handbook_on_valuing_changes_in_time_use_121520_final_508.pdf
US EPA. 2021. Supporting Statement for EPA Information Collection Request Number 2002.08 "Cross-media Electronic Reporting Rule".


[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Notices]
[Page 1047-1049]
[DOCID:fr09ja07-76]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55019; File No. SR-NYSEArca-2006-35]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change To
Trade the iShares[supreg] S&P Global 100 Index Fund Pursuant to
Unlisted Trading Privileges

December 28, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 18, 2006, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been substantially prepared by the Exchange. The Commission is
publishing this notice and order to solicit comments on the proposal
from interested persons and to approve the proposed rule change on an
accelerated basis.
---------------------------------------------------------------------------

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

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

    The Exchange, through its wholly owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities'') proposes to trade shares
(``Shares'') of the iShares[supreg] S&P Global 100 Index Fund
(``Fund'') (Symbol: IOO) pursuant to unlisted trading privileges
(``UTP'') based on NYSE Arca Equities Rule 5.2(j)(3).
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.nysearca.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 Exchange 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 these statements may be examined at the places specified in
Item III below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects 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 is proposing to trade the Shares pursuant to UTP. The
Fund measures the performance of 100 multinational companies that
comprise the S&P Global 100 Index (``Index'') that are also part of the
S&P Global 1200. Their businesses are global in nature and they derive
a substantial portion of their operating income from multiple
countries. The Fund represents an effort to meet the needs of investors
wishing to track the performance of global companies. With 100 highly
liquid components, the Index is designed to support low-cost, index-
investment products, including exchange-traded funds. The Fund will use
an ``indexing'' investment approach that attempts to replicate, before
expenses, the performance of the Index.
    The Commission previously approved the original listing and trading
of the Fund on the New York Stock Exchange (``NYSE'').\3\ The Exchange
deems the Shares to be equity securities, thus rendering trading in the
Shares subject to the Exchange's existing rules governing the trading
of equity securities. The trading hours for the Shares on the Exchange
would be the same as those set forth in NYSE Arca Equities Rule 7.34,
except that the Shares will not trade during the Opening Session (4
a.m. to 9:30 a.m. Eastern Time) unless the Indicative Optimized
Portfolio Value (``IOPV'') is calculated and disseminated during that
time.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 43658 (December 1,
2000), 65 FR 77408 (December 11, 2000) (SR-NYSE-2000-53).
---------------------------------------------------------------------------

    Quotations for and last sale information regarding the Shares are
disseminated through the Consolidated Quotation System. The value of
the underlying Index is updated intra-day on a real-time basis as
individual component securities of the underlying Index change in
price. These intra-day values of the underlying Index are disseminated
every 15 seconds throughout the trading day. In addition, a value for
the underlying Index is disseminated once each trading day, based on
closing prices of the Index components in the relevant foreign markets.
The net asset value (``NAV'') of the Fund is calculated and
disseminated each business day, normally at the close of regular
trading of NYSE.
    To provide updated information relating to the Shares for use by
investors, professionals, and persons wishing to create or redeem them,
NYSE disseminates the IOPV for the Fund as calculated by a securities
information provider. The IOPV is disseminated on a per-share basis
every 15 seconds during regular NYSE trading hours of 9:30 a.m. to 4:15
p.m. Eastern Time.
    The IOPV will be calculated utilizing closing prices in the
principal foreign markets for securities in the Fund portfolio,
converted to U.S. dollars. The IOPV is updated during NYSE's trading
hours to reflect changes in currency exchange rates between the U.S.
dollar and the applicable foreign currency and includes the applicable
cash component for the Fund. The Index includes companies trading in
markets with trading hours overlapping NYSE's. During the overlap
period, the IOPV calculator updates the IOPV every 15 seconds to
reflect price changes of the Index components in the principal foreign
markets, and converts such prices into U.S. dollars based on the
currency exchange rate. When the foreign market or markets are closed
but NYSE is open for trading, the IOPV is updated every 15 seconds to
reflect changes in currency exchange rates.
    The IOPV may not reflect the value of all securities included in
the applicable underlying Index. In addition, the IOPV does not
necessarily reflect the precise composition of the current portfolio of
securities held by the Fund at a particular point in time. Therefore,
the IOPV on a per-share basis disseminated during NYSE's regular
trading hours should not be viewed as a real-time update of the NAV of
the Fund, which is calculated only once a day. The IOPV is intended to
closely approximate the value per-share of the portfolio of securities
for the Fund and provide for a close proxy of the NAV at a greater
frequency for investors.
    The Commission has granted the Fund an exemption from certain
prospectus delivery requirements under Section 24(d) of the Investment
Company Act of 1940 (``1940 Act'').\4\ Any product description used in
reliance on the Section 24(d) exemptive order will comply with all
representations made and all conditions

contained in the Fund's application for orders under the 1940 Act.\5\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 80a-24(d).
    \5\ See In the Matter of iShares, Inc., et al., Investment
Company Act Release No. 25623 (June 25, 2002).
---------------------------------------------------------------------------

    In connection with the trading of the Fund, the Exchange would
inform ETP Holders in an Information Circular of the special
characteristics and risks associated with trading the Shares, including
how they are created and redeemed, the prospectus or product
description delivery requirements applicable to the Shares, applicable
Exchange rules, how information about the value of the underlying Index
is disseminated, and trading information. In addition, before an ETP
Holder recommends a transaction in the Shares, the ETP Holder must
determine the Fund is suitable for the customer, as set forth in NYSE
Arca Equities Rule 9.2(a)-(b).
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative products to monitor trading in the
Shares. The Exchange represents that these procedures are adequate to
monitor Exchange trading of the Shares.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \6\ in general and Section 6(b)(5) of the Act \7\ in
particular in that it is designed to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, and to
remove impediments and perfect the mechanisms of a free and open market
and to protect investors and the public interest. In addition, the
Exchange believes that the proposal is consistent withRule 12f-5 under
the Act \8\ because it deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

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.

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

    Written comments on the proposed rule change were neither solicited
nor received.

III. 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 Exchange 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 e-mail to<EMAIL_ADDRESS>Please include File

Number SR-NYSEArca-2006-35 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2006-35. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room. Copies of such
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-2006-35 and should be submitted on or before
January 30, 2007.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\9\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act \10\ which requires that an
exchange have rules designed, among other things, 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. The Commission
believes that this proposal should benefit investors by increasing
competition among markets that trade the Shares.
---------------------------------------------------------------------------

    \9\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Commission finds that the proposal is consistent
with Section 12(f) of the Act,\11\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\12\ The Commission notes that it previously approved the
listing and trading of the Shares on NYSE.\13\ The Commission also
finds that the proposal is consistent with Rule 12f-5 under the
Act,\14\ which provides that an exchange shall not extend UTP to a
security unless the exchange has in effect a rule or rules providing
for transactions in the class or type of security to which the exchange
extends UTP. The Exchange has represented that it meets this
requirement because it deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78l(f).
    \12\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \13\ See supra note 3.
    \14\ 17 CFR 240.12f-5.
---------------------------------------------------------------------------

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\15\ which sets forth
Congress' finding that it is in the

public interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers, and investors of information with respect to
quotations for and transactions in securities. Quotations for and last
sale information regarding the Shares are disseminated through the
Consolidated Quotation System. Furthermore, an IOPV calculator updates
an IOPV for the Fund every 15 seconds to reflect price changes of the
Index components in the principal foreign markets, and converts such
prices into U.S. dollars based on the current currency exchange rate.
When the foreign market or markets are closed but NYSE is open for
trading, the IOPV is updated every 15 seconds to reflect changes in
currency exchange rates. Furthermore, NYSE Arca Equities Rule 7.34
describes the circumstances where the Exchange would halt trading when
the IOPV or the value of the underlying Index is not calculated or
widely available.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Commission notes that, if the Shares should be delisted by
NYSE, the original listing exchange, the Exchange would no longer have
authority to trade the Shares pursuant to this order.
    In support of this proposal, the Exchange has made the following
representations:
    1. The Exchange's surveillance procedures are adequate to monitor
the trading of the Shares.
    2. In connection with the trading of the Shares, the Exchange would
inform ETP Holders in an Information Circular of the special
characteristics and risks associated with trading the Shares.
    3. The Information Circular would inform participants of the
prospectus or product delivery requirements applicable to the Shares.
    This approval order is conditioned on the Exchange's adherence to
these representations.
    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As noted previously, the Commission previously found
that the listing and trading of the Shares on NYSE is consistent with
the Act. The Commission presently is not aware of any regulatory issue
that should cause it to revisit that earlier finding or preclude the
trading of Shares on the Exchange pursuant to UTP. Therefore,
accelerating approval of this proposal should benefit investors by
creating, without undue delay, additional competition in the market for
the Shares.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-NYSEArca-2006-35) is
approved on an accelerated basis.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E7-64 Filed 1-8-07; 8:45 am]

BILLING CODE 8011-01-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="08/07/2008 11:30:38 ">
<TITLE></TITLE>