[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Notices]
[Page 77076]
[FR Doc No: 2012-31460]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9006-8]

Notice of Intent: Designation of an Expanded Ocean Dredged
Material Disposal Site (ODMDS) off Charleston, South Carolina

AGENCY: U.S. Environmental Protection Agency (EPA) Region 4.

ACTION: Notice of Intent to prepare an Environmental Assessment (EA)
for the designation of an expanded ODMDS off Charleston, South
Carolina.

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    Purpose: EPA has the authority to designate ODMDSs under Section
102 of the Marine Protection, Research and Sanctuaries Act of 1972 (33
U.S.C. 1401 et seq.). It is EPA's policy to prepare a National
Environmental Policy Document for all ODMDS designations (63 FR 58045,
October 1998).

For Further Information, to Submit Comments, and To Be Placed On the
Project Mailing List Contact:  Mr. Gary W. Collins, EPA Region 4, 61
Forsyth Street, Atlanta, Georgia 30303, phone<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUMMARY: EPA in cooperation with the U.S. Army Corps of Engineers
Charleston District (USACE) intends to prepare an EA to evaluate the
proposed designation of an expanded ODMDS offshore Charleston, South
Carolina. An EA will provide the environmental information necessary to
evaluate the potential environmental impacts associated with expanding
the ODMDS.
    Need for Action: The USACE has requested that EPA evaluate and
designate an expanded ODMDS. The study area includes an area
approximately 7.18 square miles in size, for the disposal of dredged
material from the proposed harbor deepening dredging at Charleston
Harbor (4.04 square miles are within the current ODMDS and 3.14 square
miles are outside the current ODMDS). The size of an expanded ODMDS
will based on capacity computer modeling results, and will be refined
throughout the study phase.
    Alternatives: The following proposed alternatives have been
tentatively defined.
    1. No action.
    2. Expansion of the existing Charleston ODMDS. Expand the existing
disposal zone and ODMDS to the north, south and east.
    Scoping: EPA is requesting written comments from federal, state,
and local governments, industry, non-governmental organizations, and
the general public on the range of alternatives considered, specific
environmental issues to be evaluated, and the potential impacts of the
alternatives. Scoping comments will be accepted for 60 days, beginning
with the date of this Notice.
    Estimated Date of Draft EA Release: May 2014.
    Responsible Official: Gwendolyn Keyes Fleming, Regional
Administrator, Region 4.

    Dated: December 21, 2012.
Susan E. Bromm,
Director, Office of Federal Activities.
[FR Doc. 2012-31460 Filed 12-28-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 28, 2008 (Volume 73, Number 209)]
[Notices]
[Page 63966-63967]
[DOCID:fr28oc08-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ08-5-001]

United States Department of Energy, Bonneville Power
Administration, Transmission Service Terms and Conditions; Notice of
Filing

October 21, 2008.
    Take notice that on October 15, 2008, Bonneville Power
Administration filed certain attachments to Attachment K to its Open
Access Transmission Tariff in response to the Commission's July 17,
2008 Order and request for declaratory order accepting their proposed
Attachment K as revised and finding that the Commission's standards for
reciprocity, pursuant to 18 CFR 35.28(e) and 18 CFR 385.207.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern Time on November 14, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-25622 Filed 10-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 1, 2008 (Volume 73, Number 149)]
[Notices]
[Page 45017-45022]
[DOCID:fr01au08-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0427]

Prescription Drug User Fee Rates for Fiscal Year 2009

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2009. The Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription
Drug User Fee Amendments of 2007 (PDUFA IV) (Title 1 of the Food and
Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to
collect user fees for certain applications for approval of drug and
biological products, on establishments where the products are made, and
on such products. Base revenue amounts to be generated from PDUFA fees
were established by PDUFA IV, with provisions for certain adjustments.
Fee revenue amounts for applications, establishments, and products are
to be established each year by FDA so that

one-third of the PDUFA fee revenues FDA collects each year will be
generated from each of these categories. This notice establishes fee
rates for FY 2009 for application fees for an application requiring
clinical data ($1,247,200), for an application not requiring clinical
data or a supplement requiring clinical data ($623,600), for
establishment fees ($425,600), and for product fees ($71,520). These
fees are effective on October 1, 2008, and will remain in effect
through September 30, 2009. For applications and supplements that are
submitted on or after October 1, 2008, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2009 will be
issued in August 2008, using the new fee schedule.

FOR FURTHER INFORMATION CONTACT:  David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the act (21 U.S.C. 379g and 379h),
establish three different kinds of user fees. Fees are assessed on the
following: (1) Certain types of applications and supplements for
approval of drug and biological products, (2) certain establishments
where such products are made, and (3) certain products (section 736(a)
of the act). When certain conditions are met, FDA may waive or reduce
fees (section 736(d) of the act).
    For FY 2008 through FY 2012, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA IV. The base
revenue amount for FY 2008 is to be adjusted for workload, and that
adjusted amount becomes the base amount for the remaining 4 fiscal
years. That adjusted base revenue amount is increased for drug safety
enhancements by $10,000,000 in each of the subsequent 4 fiscal years,
and the increased total is further adjusted each year for inflation and
workload. Fees for applications, establishments, and products are to be
established each year by FDA so that revenues from each category will
provide one-third of the total revenue to be collected each year.
    This notice uses the fee base revenue amount for FY 2008 published
on October 12, 2007 (72 FR 58103), adjusts it for the 2009 drug safety
increase (see section 736(b)(4) of the act), for inflation, and for
workload, and then establishes the application, establishment, and
product fees for FY 2009. These fees are effective on October 1, 2008,
and will remain in effect through September 30, 2009.

II. Fee Revenue Amount for FY 2009

    The total fee revenue amount for FY 2009 is $510,665,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation and changes
in workload. The statutory amount and a one-time base adjustment are
described in section II.A and II.B of this document. The adjustment for
inflation is described in section II.C, and the adjustment for changes
in workload in section II.D.

A. FY 2009 Statutory Fee Revenue Amounts Before Adjustments

    PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2009 for all fees is $427,783,000 ($392,783,000 specified in
section 736(b)(1) of the act, plus an additional $35,000,000 for drug
safety in FY 2009 specified in section 736(b)(4) of the act).

B. Base Adjustment to Statutory Fee Revenue Amount

    The statute also specifies that $354,893,000 of the base amount is
to be further adjusted for workload increases through FY 2007 (see
section 736(b)(1)(B) of the act). The adjustment on this amount is to
be made in accordance with the workload adjustment provisions that were
in effect for FY 2007, except that the adjustment for investigational
new drug (IND) workload is based on the number of INDs with a
submission in the previous 12 months, rather than on the number of new
commercial INDs submitted in the same 12-month period.
    For each fiscal year beginning in FY 2004, the Prescription Drug
User Fee Amendments of 2002 (PDUFA III) provided that fee revenue
amounts, after they had been adjusted for inflation, should be further
adjusted to reflect changes in workload for the process for the review
of human drug applications (see section 736(c)(2) of the act). The
conference report accompanying PDUFA III, House of Representatives
Report number 107-481, provides guidance on how the workload adjustment
provision of PDUFA III is to be implemented. Following that guidance,
FDA calculated the average number of each of the four types of
submissions specified in the workload adjustment provision (human drug
applications, commercial INDs, efficacy supplements, and manufacturing
supplements) received over the 5-year period that ended on June 30,
2002 (base years), and the average number of each of these types of
applications over the most recent 5-year period that ended June 30,
2007. PDUFA IV directs that this same method be used in making the
workload adjustment apply to the 2008 statutory revenue amount, except
that for this calculation the number of commercial INDs with a
submission in the previous 12 months is used for each 12-month period
rather than the number of new commercial INDs submitted (see section
736(b) of the act, as amended by PDUFA IV).
    The results of these calculations are presented in Columns 1 and 2
of Table 1 of this document. Column 3 reflects the percent change in
workload over the two 5-year periods. Column 4 shows the weighting
factor for each type of application, estimating how much of the total
FDA drug review workload was accounted for by each type of application
in the table during the most recent 5 years. Column 5 of Table 1 of
this document is the weighted percent change in each category of
workload. This was derived by multiplying the weighting factor in each
line in Column 4 by the percent change from the base years in Column 3.
At the bottom right of the table the sum of the values in Column 5 is
added, reflecting a total increase in workload of 11.73 percent when
compared to the base years.

                                 Table 1--Summary Workload Adjuster Calculation to be Applied to FY 2009 Statutory Base
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Column 1  5-Year
                 Application Type                     Average Base     Column 2  Latest   Column 3  Percent   Column 4  Weighting   Column 5  Weighted %
                                                         Years         5-Year  Average          Change               Factor                Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New drug applications (NDAs)/biologics license                 119.6              123.8                3.5%                35.2%                 1.24%
 applications (BLAs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active INDs                                                   4751.8             5528.2               16.3%                44.2%                 7.22%
--------------------------------------------------------------------------------------------------------------------------------------------------------

Efficacy supplements                                           159.2              163.4                2.6%                 7.4%                 0.20%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements                                     2100.6             2589.2               23.3%                13.2%                 3.07%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2008 workload adjuster to be applied to the statutory base                                                                                11.73%
--------------------------------------------------------------------------------------------------------------------------------------------------------

Increasing the PDUFA IV statutorily specified amount of $354,893,000 by
the specified workload adjuster (11.73 percent) results in an increase
of $41,629,000, rounded to the nearest thousand dollars. Adding this
amount to the $427,783,000 statutorily specified amount from section
II.A of this document, results in a total adjusted PDUFA IV base
revenue amount of $469,412,000, before further adjustment for inflation
and changes in workload after FY 2007.

C. Inflation Adjustment to FY 2009 Fee Revenue Amount

    PDUFA IV provides that fee revenue amounts for each fiscal year
after 2008 shall be adjusted for inflation. The adjustment must reflect
the greater of: (1) The total percentage change that occurred in the
Consumer Price Index (CPI) (all items; U.S. city average) during the
12-month period ending June 30 preceding the fiscal year for which fees
are being set; (2) the total percentage pay change for the previous
fiscal year for Federal employees stationed in the Washington, DC
metropolitan area; or (3) the average annual change in cost, per full
time equivalent (FTE) FDA position, of all personnel compensation and
benefits paid for the first 5 of the previous 6 fiscal years. PDUFA IV
provides for this annual adjustment to be cumulative and compounded
annually after FY 2008 (see section 736(c)(1) of the act).
    The first factor is the CPI increase for the 12-month period ending
in June 2008. The CPI for June 2008 was 218.815, and the CPI for June
2007 was 208.352. (These CPI figures are available on the Bureau of
Labor statistics Web site, http://data.bls.gov/cgi-bin/surveymost?bls
by checking the first box under ``Price Indexes'' and then clicking
``Retrieve Data'' at the bottom of the page.) The CPI for June 2008 is
5.05 percent higher than the CPI for the previous 12-month period.
    The second factor is the increase in pay for the previous fiscal
year (FY 2008 in this case) for Federal employees stationed in the
Washington, DC metropolitan area. This figure is published by the
Office of Personnel Management, and found on their Web site, http://
www.opm.gov/oca/08tables/html/dcb.asp, above the salary table. For FY
2008 it was 4.49 percent.
    The third factor is the average change in FDA cost for compensation
and benefits per FTE over the previous 5 of the most recent 6 fiscal
years (FY 2002 through FY 2007). The data on total compensation paid
and number of FTEs paid, from which the average cost per FTE can be
derived, are published in FDA's Justification of Estimates for
Appropriations Committees. Table 2 of this document summarizes that
actual cost and FTE use data for the specified fiscal years, and
provides the percent change from the previous fiscal year and the
average percent change over the most 5 recent fiscal years, which is
5.64 percent.

           Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change ($000)
----------------------------------------------------------------------------------------------------------------
                                                                                Annual Average
   Fiscal Year         2003            2004            2005            2006            2007        Increase for
                                                                                Latest 5 Years
----------------------------------------------------------------------------------------------------------------
Total PC&B              $971,255      $1,042,749      $1,077,604      $1,114,704      $1,144,369  ..............
----------------------------------------------------------------------------------------------------------------
Total FTEs                 10257           10141            9910            9698            9569  ..............
----------------------------------------------------------------------------------------------------------------
PC&B per FTE             $94.692        $102.825        $108.739        $114,942        $119.591  ..............
----------------------------------------------------------------------------------------------------------------
% Change from              4.09%           8.59%           5.75%           5.70%           4.05%           5.64%
 Previous Year
----------------------------------------------------------------------------------------------------------------

    Because the average change in pay per FTE (5.64 percent) is the
highest of the three factors, it becomes the inflation adjustment for
total fee revenue for FY 2009. Increasing the FY 2009 fee revenue base
of $469,412,000 by 5.64 percent yields an inflation-adjusted fee
revenue amount for FY 2009 of $495,887,000, rounded to the nearest
thousand dollars, before addition of the FY 2009 workload adjustment.

D. Workload Adjustment to the FY 2009 Inflation Adjusted Fee Revenue
Amount

    For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
act). PDUFA IV continues the PDUFA III workload adjustment with
modifications, and provides for a new additional adjustment for changes
in review activity. PDUFA IV also specifies that for FY 2009 the
additional adjustment for changes in review activity may not result in
a total workload adjustment that is more than 2 percentage points
higher than it would have been in the absence of the adjustment for
changes in review workload (see section 736(c)(2)(B) of the act).
    Therefore, FDA will first calculate the FY 2009 workload adjustment
without the PDUFA IV adjustment for changes in review activity. Then
FDA will apply

the adjustment for changes in review activity, to determine if the
total workload adjustment is no more than 2 percentage points higher
than it would have been in the absence of the adjustment for changes in
review activity.
    In calculating the FY 2009 workload adjustment without the PDUFA IV
adjustment for changes in review activity, FDA will follow the guidance
provided in the conference report accompanying the Prescription Drug
User Fee Amendments of 2002, House of Representatives Report number
107-481, using active commercial INDs rather than newly submitted
commercial INDs as the surrogate for IND workload, as specified by
PDUFA IV.
    FDA calculated the average number of each of the four types of
applications specified in the workload adjustment provision: (1) Human
drug applications, (2) active commercial investigational new drug
applications (applications that have at least one submission during the
previous 12 months), (3) efficacy supplements, and (4) manufacturing
supplements received over the 5-year period that ended on June 30, 2007
(base years), and the average number of each of these types of
applications over the most recent 5-year period that ended June 30,
2008.
    The calculations are summarized in Table 3 of this document. The 5-
year averages for each application category are provided in Column 1
(5-Year Average Base Years 2002-2007) and Column 2 (Latest 5-Year
Average 2003-2008). Column 3 reflects the percent change in workload
from Column 1 to Column 2. Column 4 shows the weighting factor for each
type of application, estimating how much of the total FDA drug review
workload was accounted for by each type of application in the table
during the most recent 5 years. Column 5 of Table 1 is the weighted
percent change in each category of workload. This was derived by
multiplying the weighting factor in each line in Column 4 by the
percent change from the base years in Column 3. At the bottom right of
Table 3 of this document is the sum of the values in Column 5 that are
added, reflecting an increase in workload of 2.98 percent for FY 2009
when compared to the base years, but before taking into account the
impact of change in review activity.

                    Table 3--Preliminary Workload Adjuster Calculation for FY 2009 Without Adjustment for Changes in Review Activity
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Column 1  5-Year   Column 2  Latest
                 Application Type                     Average Base     5-Year  Average    Column 3  Percent   Column 4  Weighting   Column 5  Weighted %
                                                    Years 2002-2007       2003- 2008            Change               Factor                Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs                                                      123.8              128.4                3.7%                33.3%                 1.24%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs                                        5755.8             5897.6                2.5%                45.2%                 1.11%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements                                           163.4              173.0                5.9%                 8.3%                 0.49%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements                                     2589.2             2616.2                1.0%                13.2%                 0.14%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2009 workload adjuster without adjustment changes for review activity                                                                         2.98%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to the first two categories (human drug
applications and active commercial INDs). These adjustments, specified
under PDUFA IV, are summarized in the new Columns 2b and 2c in Table 4
of this document. The number in the NDAs/BLAs line of Column 2b of
Table 4 of this document is the percent by which the average workload
for meetings, annual reports, and labeling supplements for NDAs and
BLAs has changed from the 5-year period 2002 through 2007 to the 5-year
period 2003 through 2008. Likewise, the number in the active commercial
INDs line of Column 2b of Table 4 of this document is the percent by
which the workload for meetings and special protocol assessments for
active commercial INDs has changed from the 5-year period 2002 through
2007 to the 5-year period 2003 through 2008. There is no entry in the
last two lines of column 2b because the adjustment for changes in
review workload does not apply to the workload for efficacy supplements
and manufacturing supplements.

                       Table 4--Final Workload Adjuster Calculation for FY 2009 With Adjustment for Changes in Review Activity\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Column 3 %
                                            Column 1  5-    Column 2a       Column 2b      Column 2c  is       Change         Column 4       Column 5
             Application Type               Year Average  Latest 5-Year   Adjustment for     Column 2a      (Column 1 to     Weighting      Weighted %
                                             Base Years   Average 2003-     Changes in      Adjusted by     Column 2c or       Factor         Change
                                             2002-2007         2008      Review Activity     Column 2b           2a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs                                          123.8          128.4          -0.55%           127.7             3.1%          33.3%           1.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs                            5755.8         5897.6          +0.39%          5920.6             2.9%          45.2%           1.31
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements                               163.4          173.0          NA               173.3             5.9%           8.3%           0.49%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements                         2589.2         2516.2          NA              2616.2             1.0%          13.2%           0.14%
--------------------------------------------------------------------------------------------------------------------------------------------------------

FY 2009 workload adjuster with adjustment changes for review activity                                                                             2.98%
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers may not add due to rounding.

    The 2009 workload adjuster with adjustment for changes in review
activity at the bottom of Table 4 of this document is 2.98 percent
exactly the same as the workload adjuster without those changes at the
bottom of Table 3 of this document. Therefore the inflation-adjusted
revenue amount of $495,887,000 from section II.B of this document will
be multiplied by the 2009 workload adjuster of 2.98 percent, resulting
in a total adjusted revenue amount in FY 2009 of $510,665,000, rounded
to the nearest thousand dollars.
    PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the act).
Accordingly, one-third of the total revenue amount, or $ 170,222,000,
rounded to the nearest thousand dollars, is the total amount of fee
revenue that will be derived from each of these fee categories.

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate one-third of the total fee
revenue amount, or $170,222,000, rounded to the nearest thousand
dollars, in FY 2009, as calculated in section II.D of this document.

B. Estimate of Number of Fee-Paying Applications and Establishment of
Application Fees

    For FY 2008 through FY 2012, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next fiscal year by averaging the number of fee-paying FAEs
received in the 5 most recent fiscal years. This use of the rolling
average of the 5 most recent fiscal years is the same method that has
applied for the last 6 years.
    In estimating the number of fee-paying FAEs that FDA will receive
in FY 2009, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2004
through FY 2008. For FY 2008, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 6 years.
    Table 5 of this document shows, in Column 1, the total number of
each type of FAE received in the first 9 months of FY 2008, whether
fees were paid or not. Column 2 shows the number of FAEs for which fees
were waived or exempted during this period, and Column 3 shows the
number of fee-paying FAEs received through June 30, 2008. Column 4
estimates the 12-month total fee-paying FAEs for FY 2008 based on the
applications received through June 30, 2008. All of the counts are in
FAEs. A full application requiring clinical data counts as one FAE. An
application not requiring clinical data counts as one-half an FAE, as
does a supplement requiring clinical data. An application that is
withdrawn, or refused for filing, counts as one-fourth of an FAE if the
applicant initially paid a full application fee, or one-eighth of an
FAE if the applicant initially paid one-half of the full application
fee amount.

  Table 5--FY 2008 Full Application Equivalents Received Through June 30, 2008, and Projected Through September
                                                    30, 2008
----------------------------------------------------------------------------------------------------------------
                                                           Column 2  Fee     Column 3  Total
                                       Column 1  Total    Exempt or Waived      Fee Paying       Column 4  12-
        Application or Action          Received Through       Through            Through        Month Fee-Paying
                                      6[sol]30[sol]2008  6[sol]30[sol]2008  6[sol]30[sol]2008      Projection
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data              102.3               40.3               62.0               82.7
----------------------------------------------------------------------------------------------------------------
Applications not requiring clinical                11.1                4.1                7.0                9.3
 data
----------------------------------------------------------------------------------------------------------------
Supplements requiring clinical data                45.0                6.0               39.0               52.0
----------------------------------------------------------------------------------------------------------------
Withdrawn or refused to file                        0.5                0                  0.5                0.7
----------------------------------------------------------------------------------------------------------------
Total                                             158.9               50.4              108.5              144.7
----------------------------------------------------------------------------------------------------------------

    In the first 9 months of FY 2008, FDA received 158.9 FAEs, of which
108.5 were fee-paying. Based on data from the last 9 fiscal years, on
average, 25 percent of the applications submitted each year come in the
final 3 months. Dividing 108.5 by 3 and multiplying by 4 extrapolates
the amount to the full 12 months of the fiscal year and projects the
number of fee-paying FAEs in FY 2008 at 144.7.
    As Table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 5-year period, and including
our estimate for FY 2008, is 136.5 FAEs. FDA will set fees for FY 2009
based on this estimate as the number of FAEs that will pay fees.

                         Table 6--Fee-Paying Full Application Equivalent--5-Year Average
----------------------------------------------------------------------------------------------------------------
                                                                                5-Year
            Fiscal Year                 2004         2005         2006         2007         2008       Average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs                           145.1        121.5        136.7        134.4        144.7        136.5
----------------------------------------------------------------------------------------------------------------

    The FY 2009 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
136.5, into the fee revenue amount to be derived from application fees
in FY 2009, $170,222,000. The result, rounded to the nearest $100, is a
fee of $1,247,200 per full application requiring clinical data, and
$623,600 per application not requiring clinical data or per supplement
requiring clinical data.

IV. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

    At the beginning of FY 2008, the establishment fee was based on an
estimate that 390 establishments would be subject to, and would pay,
fees. By the end of FY 2008, FDA estimates that 435 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. As in previous years, FDA
again estimates that a total of 25 establishment fee waivers or
reductions will be made for FY 2008. In addition, FDA estimates that
another 10 full establishment fees will be exempted this year based on
the orphan drug exemption in the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (see section 736(k) of the act).
Subtracting 35 establishments (25 plus the estimated 10 establishments
under the orphan exemption) from 435 leaves a net of 400 fee-paying
establishments. FDA will use 400 for its FY 2009 estimate of
establishments paying fees, after taking waivers and reductions into
account. The fee per establishment is determined by dividing the
adjusted total fee revenue to be derived from establishments
($170,222,000) by the estimated 400 establishments, for an
establishment fee rate for FY 2009 of $425,600 (rounded to the nearest
$100).

B. Product Fees

    At the beginning of FY 2008, the product fee was based on an
estimate that 2,355 products would be subject to, and would pay,
product fees. By the end of FY 2008, FDA estimates that 2,450 products
will have been billed for product fees, before all decisions on
requests for waivers or reductions are made. FDA assumes that there
will be about 40 waivers and reductions granted, the same amount
estimated last year. In addition, FDA estimates that another 30 product
fees will be exempted this year based on the orphan drug exemption in
FDAAA (see section 736(k) of the act). FDA estimates that 2,380
products will qualify for product fees in FY 2008, after allowing for
waivers and reductions, including the orphan drug products eligible
under the FDAAA exemption, and will use this number for its FY 2009
estimate. Accordingly, the FY 2009 product fee rate is determined by
dividing the adjusted total fee revenue to be derived from product fees
($170,222,000) by the estimated 2,380 products for a FY 2009 product
fee of $71,520 (rounded to the nearest $10).

V. Fee Schedule for FY 2009

    The fee rates for FY 2009 are set out in Table 7 of this document.

                                 Table 7
------------------------------------------------------------------------
                Fee Category                     Fee Rates for FY 2009
------------------------------------------------------------------------
APPLICATIONS
  Requiring clinical data                     $1,247,200
  Not requiring clinical data                 $623,600
------------------------------------------------------------------------
  Supplements requiring clinical data         $623,600
------------------------------------------------------------------------
ESTABLISHMENTS                                $425,600
------------------------------------------------------------------------
PRODUCTS                                      $71,520
------------------------------------------------------------------------

VI. Implementation of Adjusted Fee Schedule

A. Application Fees

    The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2008. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee ID number on your check. Your payment can be
mailed to: Food and Drug Administration, P.O. Box 70963, Charlotte, NC
28272-0963.
    If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: Wachovia Bank, Attn:
Food and Drug Administration Lockbox 70963, 1525 West WT Harris Blvd.,
rm. NC0810, Charlotte, NC 28262. (Note: This Wachovia Bank address is
for courier delivery only.)
    Please make sure that the FDA post office box number (P.O. Box
70963) is written on the check. The tax identification number of the
Food and Drug Administration is 53-0196965.
    Wire transfer payment may also be used. The routing and transit
number is 021030004 and the account number is 75060099.

B. Establishment and Product Fees

    FDA will issue invoices for establishment and product fees for FY
2009 under the new fee schedule in August 2008. Payment will be due on
October 1, 2008. FDA will issue invoices in November 2009 for any
products and establishments subject to fees for FY 2009 that qualify
for fees after the August 2008 billing.

    Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17738 Filed 7-31-08; 8:45 am]

BILLING CODE 4160-01-S


September 3, 2019
SUBJECT: 	Trip report for site visit to U.S. Steel  -  Minntac, Mountain Iron, MN, October 10, 2018
FROM:	Michael Laney, RTI International
TO:		David Putney, U.S. Environmental Protection Agency (EPA)
       BACKGROUND
As part of the risk and technology review (RTR) project for the national emission standards for hazardous air pollutants (NESHAP) for taconite iron ore processing, site visits were conducted to three taconite iron ore processing facilities located along the Mesabi Range in Minnesota. This trip report summarizes the October 10, 2018 visit to the U.S. Steel  -  Minntac mine and processing facility in Mountain Iron, MN.
       PARTICIPANTS
U.S. Steel
Chrissy Bartovich, Director Environmental, Minnesota Ore
Stephani Campbell, Environmental, Minnesota Ore
Jim Chacich, Mine Operations Coordinator, Minnesota Ore
Chris Hardin, Environmental, Headquarters, Pittsburgh
Brett Tunno, Environmental Engineer, Headquarters, Pittsburgh
Tishie Woodwell, Environmental, Headquarters, Pittsburgh
U.S. EPA
David Putney, Office of Air Quality Planning and Standards
RTI International
Michael Laney
       SUMMARY
 Preliminary Discussions
Prior to touring the facility, participants met to discuss the agenda for the day.
David Putney, EPA, provided background information on the RTR project, specific information needs for the RTR project, and responded to questions from U.S. Steel representatives. Topics discussed included the following:
RTR project schedule. The estimated RTR proposal date is April 2019 with promulgation of the final rule in June 2020.
Mercury concentration in raw ore. David Putney explained the process that would be used for setting emission limits for mercury if the EPA decides to propose numerical MACT standards for mercury emissions. He explained that, in addition to emissions data, information on the variability of mercury concentrations in raw ore could be important information for EPA to consider in developing emission standards that accurately reflect variability in mercury emissions. He noted that there is precedence for using information on mercury variability in raw ore to set emission standards. He requested that U.S. Steel provide the EPA with any such mercury data they may have, or can get, to assist EPA in the event they propose mercury emission standards for the industry.
According to U.S. Steel, core samples have not measured mercury concentrations and that may not even be possible.
Minnesota Pollution Control Agency (MPCA) mercury initiative. U.S. Steel representatives stated that they are currently evaluating control options for meeting the 72 percent reduction in mercury emissions that will be required by MPCA. They stated that the inherently low mercury concentrations make the evaluation of control options more difficult. U.S. Steel's proposal for meeting the required reduction is due to the MPCA by December 30, 2018. The MPCA has scheduled implementation of the mercury reductions for January 2025.
Burden reduction. David Putney explained the EPA is interested in industry's experience with any requirements of the current rule that they consider to be burdensome that could be revised to be less burdensome while not comprising environmental protection.
U.S. Steel stated that they did not see a reason for the rule requirement that Method 5 test runs had to be at least 2-hour runs. They stated that with the 2-hour requirement plus the time needed between test runs, a Method 5 test took from 10 to 12 hours to complete and was costly and adds safety concerns. They felt that a 1-hour test run was adequate and would meet the criteria, such as required sample volume, of Method 5.
Technology Review. David Putney explained the technology review aspects of the RTR project and requested information regarding the development of any new controls or processes in the taconite industry that have become available that could reduce emissions.
U.S. Steel stated that they have not developed any new controls or processes in their taconite iron ore processing facilities and were not aware of any such developments in the industry sector.
 Site Tour
Mine Operation. Mine operations are located proximate to the taconite processing facility. At the Minntac site, there are two pits being mined: the West pit and the East pit, which is the smaller of the two pits. The total length of the two pits is about 9 miles with the widest point being 2 miles.
Silica and iron content varies across the mine. Materials from different mine locations are blended to attain the optimum blend.
Mine operations involve blasting, loading large boulders from the blasting into trucks, which deliver the boulders to the primary crusher where they are reduced to about football size. Additional crushing steps further reduce the ore size until it is ready to enter the concentration phase.
The following information was provided on the mine and other related operations:
Blasting is done about three times per week. Meteorological conditions, such as wind direction and cloud ceiling, are evaluated to select blasting times. It takes about 3 weeks to set up a blasting pattern.
Electric and diesel CAT shovels with 40-yard buckets are used to load blasted material into 240-ton trucks. Both diesel and electric drive trucks are used.
Tailings from the mine operation and taconite processing are returned to the mine where they are used for roadways and to backfill and reclaim inactive parts of the mine or sent to the tailings basin for deposition. Reclaimed portions of the mine are vegetated to reduce runoff and erosion.
Water trucks wet mine roads for fugitive dust control.
Processing. Finely crushed ore is conveyed to storage bins at the concentrator building. These bins supply the material for the concentration processes. Wet scrubbers control dust at the transfer of the ore from the ore storage bins to the conveyor into the initial concentrator process. All processing in the concentrating building is wet and any emissions are minimal. The wet ore is fed to rod mills and then ball mills to further reduce the size of the ore. In subsequent steps, the slurry of fine particles goes through magnetic separation steps where the iron containing particles are separated from waste materials. The concentrated iron particles go through additional grinding and separation steps before entering the agglomeration process.
In the agglomeration phase, the iron-containing material is removed from the slurry by a series of vacuum disks filters which pull the particles onto filters. The iron-rich material is dewatered and then released onto a conveyor. Bentonite is added to aid in the agglomeration phase. Other agents, such as limestone and dolomite fluxes are also added at this point. The material is then fed into a balling drum where it is converted into unfired ("green") pellets.
From agglomeration, the green pellets are conveyed to a grate kiln indurating furnace. The pellets travel on a steel grate through gradually hotter temperature zones in order to first dry the pellets before entering the hottest part of the furnace. In the grate kiln furnace, the pellets next enter a rotary kiln and are discharged through a cooler. The heated exhaust from the cooler is recirculated to the furnace. Because of the moisture content of furnace exhaust gases, wet scrubbers are used for the control of PM.
Finished ("fired") pellets are stockpiled and then transported by train to Great Lakes ports for ship transport to steel-making facilities.
Process conditions and control device parameters are monitored from a control room.
 Wrap Up
David Putney described changes to the NESHAP that are being planned beyond any that might be made as a result of the RTR. Among the revisions currently planned are the following:
Once in always in. This refers to a provision of the rule (i.e., 40 CFR 63.9581), and has been EPA policy, whereby if a source was subject to the rule as a result of being a major source for purposes of title III of the CAA (greater than 10 tons of a single HAP or 25 tons of all HAP combined), it would always be subject to the rule, even if they reduce their HAP emissions to less than major source status. As a result of a change in EPA policy, this provision in the NESHAP will be modified.
Startup, shutdown, and malfunction (SSM). As a result of a court ruling, the exemption from the emission standards during periods of SSM will be removed. Sources will be subject to an emissions standard, but it may be a work practice standard if it is not possible to demonstrate compliance with the emission limits.
Electronic Reporting. Compliance test results will be required to be submitted to EPA through EPA's electronic reporting tool (ERT).
Following up on earlier discussions regarding mercury concentrations of taconite ore, parts of the rule that U.S. Steel considered particularly burdensome, and developments in processes, controls, and work practices (as part of the technology review), David Putney requested that any information - or input - that U.S. Steel could provide on these and other topics be provided by the middle of November 2018.


<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN">

<META http-equiv=Content-Type content="text/html; charset=us-ascii">
<META content=Word.Document name=ProgId>
<META content="MSHTML 6.00.2900.2912" name=GENERATOR>
<META content="Microsoft Word 9" name=Originator><LINK
<EMAIL_ADDRESS>rel=File-List>

From: Ram Singhal
[rsinghal@flexpack.org]
Sent: Tuesday, May 23, 2006 11:49
PM
To: Ram Singhal; Reeves, David; Schaffner, Karen S.;
<EMAIL_ADDRESS>hirtz.paula@epa.gov
Subject: Consumer &
Commercial Products 183e: Response to your questions.

Please send this email to Roy as
well.  I do not have his email address on hand.

Paula, Dave S., Dave R., Karen, and Roy
--

FPA members appreciated the opportunity to meet with you
yesterday about the determination that EPA must make on a national rule vs. a
CTG for flexible packaging. This is our best input at this time.  Since our entire membership has not had
the opportunity to review it due to time constraints they may have additional
insights and information to add during the comment period.

As requested, here is some information about 1)capture and
destruction efficiencies at existing presses; 2) alternative compliance limits;
3)some notes on technical feasibility issues at certain facilities with respect
to Permanent Total Enclosures (PTEs) for
capture; and 4) cost data for PTEs on new and existing presses subject to BACT
review, subpart KK or undertaken to limit a plant's emissions to avoid
triggering New Source Review or for NSR . We know of no RACT requirements for
PTEs. The incremental costs of such capture systems (beyond inherent control
achieved by design of the press) would be
exceedingly high in our view.

1. Capture and Destruction Efficiency for
Flexographic and Rotogravure Presses

A.  95%
destruction efficiency is generally achievable from current design
thermal and catalytic oxidizers and solvent recovery systems available
for emissions control on flexographic and rotogravure
presses.

B.  Capture
efficiency appears to generally range from an average 65-70% for
flexographic and rotogravure presses, but there have been no changes in design
of these presses since the 1978 CTG was published.

Companies may be able to purchase new presses that are capable
of achieving higher capture efficiencies (80-85%), but these designs are not feasible to
retrofit existing presses.

2.  Note that
the CTG and State regulations also
provide alternate VOC compliance limits for presses, including a) 25%
VOC by volume of the volatile content in the coating or ink or b) 2.9 pounds VOC/gallon ink
less water.

3.  Technical
Feasibility Issues for PTEs - Certain facilities may be space limited with
regard to the ability to install PTEs because presses are located within close
proximity (e.g., 15 feet). In addition, many presses are located in close
proximity to other equipment such as slitters and finishing processes
machines that prohibit installation of the
PTE.  If PTEs were installed, they
could create material handling and operating problems as well as worker safety
concerns.  Finally, structural
constraints at some facilities may limit the installation of HVACs, additional
oxidizers and other duct work.

4.  Costs and
Other PTE Considerations:
The capital necessary for installation of a PTE generally falls into
five categories: (a) structural (e.g., doors, walls); (b) air handling and
ducting, dependent on number of air room turn-overs (depending in part on OSHA); (c) air cooling
equipment (depending on heat generated by enclosed ovens and OSHA concerns) and
(d) electrical and pressure instrumentation ; (e) increased oxidizer capacity
needed for increased air flow (natural gas is annual operating
expense).

Here are recent costs for PTEs:

#1 For two new flexo presses installed in an existing
facility (new construction in 2006):

Permanent Total Enclosure (For PSD avoidance in ozone attainment
area)

PTE to enclose two presses (walls and doors - rollup and man),
including conditioned makeup air, interface between HVAC and oxidizer,
differential pressure sensor, floor sweeps, increased oxidizer capacity and
ducting

Total cost: $460,000

#2  For 3 flexo
presses of which two are existing and one is new (new construction in
2005):

Permanent Total Enclosure - NSR permit/LAER determination and to
generate emission offsets

PTE to enclose two presses (walls and doors - rollup and
man), including conditioned makeup air, interface between HVAC and oxidizer,
differential pressure sensor, floor sweeps, ducting, positive pressure ovens and
increased oxidizer capacity

Total cost: $575,000

##3-4 Rotogravure PTE Enclosure Installations constructed in
1999 as part of the facility's original 40 CFR 63 Subpart KK compliance
plan.

#3  One 1960-65
Rotogravure Vintage Press - 8 application stations enclosed; 1 application water based (not
enclosed).:

PTE Cost:  Safety
Design, Enclosure Construction, Enclosure HVAC, Ductwork, Electrical
(lighting/controls)

Total cost $170,000 (The costs do not
include additional Thermal Oxidizer/Catalytic
Oxidizer capacity that may need to
be added.)

#4 Two 1990-95 Vintage Press- 10 application stations (Cost
below is for each press)

PTE Cost: Safety Design ,
Enclosure Construction, Enclosure HVAC, Ductwork Install/Modification
,Electrical (lighting/controls).

Total cost
 $219,000 ($438,000 total
for both presses).  Cost data
not available regarding addition of
oxidizer capacity.

<![if !supportEmptyParas]><![endif]><o:p></o:p>

Ram K.
Singhal<o:p></o:p>

Director,
Regulatory & Government Relations<o:p></o:p>

Flexible
Packaging Association<o:p></o:p>

971 Corporate
Blvd., Suite 403<o:p></o:p>

Linthicum, MD
21090-2211<o:p></o:p>

(410) 694-0823
[phone]<o:p></o:p>

(410) 694-0900
[fax]<o:p></o:p>

mailto:
<EMAIL_ADDRESS>size=2><o:p></o:p>

<![if !supportEmptyParas]><![endif]> <o:p></o:p>


[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Notices]
[Page 45515-45516]
[DOCID:fr02se09-102]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Advisory Circular 33-8, Guidance for Parts Manufacturer Approval
of Turbine Engine and Auxiliary Power Unit Parts Under Test and
Computation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of issuance of advisory circular.

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

SUMMARY: This notice announces the issuance of Advisory Circular (AC)
33-8, Guidance for Parts Manufacturer Approval of Turbine Engine and
Auxiliary Power Unit Parts under Test and Computation. This AC provides
guidance for developing substantiation data to support the design
approval of critical and complex turbine engine and auxiliary power
unit (APU) parts produced under parts manufacturer approval. This
guidance is for the comparative test and analysis method used to show
compliance to the airworthiness requirements under test and
computation, per S21.303 of Title 14 of the Code of Federal Regulations
(14 CFR). This method supports showing the engine or APU still complies
with 14 CFR part 33 and Technical Standard Order (TSO) C77.

DATES: The Engine and Propeller Directorate issued AC 33-8 on August
19, 2009.

FOR FURTHER INFORMATION CONTACT: The Federal Aviation Administration,
Attn: Karen M. Grant, Engine and Propeller Standards Staff, ANE-111, 12
New England Executive Park, Burlington, MA 01803-5299; telephone: (781)
238-7119; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    We have filed in the docket all substantive comments received, and
a report summarizing them. If you wish to review the docket in person,
you may go to the above address between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. If you wish to contact the
above individual directly, you can use the above telephone number or e-
mail address provided.
    How to Obtain Copies: A paper copy of AC 33-8 may be obtained by
writing to the U.S. Department of

Transportation, Subsequent Distribution Office, DOT Warehouse, SVC
121.23, Ardmore East Business Center, 3341Q 75th Ave., Landover, MD
20785, telephone<PHONE_NUMBER>, or by faxing your request to the
warehouse at<PHONE_NUMBER>. The AC will also be available on the
Internet at http://www.faa.gov. regulations--policies (then click on
``Advisory Circulars'').

    Authority:  49 U.S.C. 106(g), 40113, 44701-44702, 44704.

    Issued in Burlington, Massachusetts, on August 19, 2009.
Peter A. White,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-21066 Filed 9-1-09; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: March 15, 2006 (Volume 71, Number 50)]
[Notices]
[Page 13384-13386]
[DOCID:fr15mr06-105]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2006-0037, FRL-8045-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exchange Network Grants Progress Report; EPA ICR No.
2207.02, OMB Control No. 2025-0006

AGENCY: Environmental Protection Agency.

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 for a new Information Collection Request (ICR) to the
Office of Management and Budget (OMB). Before submitting the ICR to OMB
for review

and approval, EPA is soliciting comments on specific aspects of the
proposed information collection as described below.

DATES: Comments must be submitted on or before May 15, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OEI-2006-0037, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Exchange Network Grants Progress Report,
Environmental Protection Agency, Mailcode: 2823-T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
     Hand Delivery: Exchange Network Grants Progress Report,
EPA West Building, 1301 Constitution Ave., NW., Rm. B102,
Washington, DC 20004. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OEI-
2006-0037. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.
    Do not submit information that you consider to be CBI or otherwise
protected through http://www.regulations.gov or e-mail. The

http://www.regulations.gov Web site is an ``anonymous access'' system, which

means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.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 Home page at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Jeffrey Wells, OEI/OIC/IESD, Mailcode
2823T, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-1684; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OEI-2006-0037, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the OEI Docket in the EPA

Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 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 OEI Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft collection of

information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

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:
    (i) 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;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) 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.

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. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. 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.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are
Environmental Information Exchange Network grant recipients. These
recipients include state, territorial, and tribal governments.
    Title: Exchange Network Grants Progress Report Renewal.
    ICR numbers: EPA ICR No. 2207.02, OMB Control No. 2025-0006.
    ICR status: This ICR is for a renewal of information collection
activity. 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 are listed in Title 40 of the Code of Federal Regulations
(CFR), after OMB approval. The OMB control numbers are displayed in 40
CFR part 9, or may be displayed by other appropriate means, such as on
the collection forms.
    Abstract: This notice announces the proposed collection of
information related to the U.S. EPA Environmental Information Exchange
Network (EIEN) Grant Program. The EPA Office of Environmental
Information provides funding to EPA's Exchange Network partners:
States; territories; and Federally recognized Indian tribes to support
the development of the EIEN. The EIEN is an Internet-and-standards-
based, secure information system that

supports the electronic collection, exchange, and integration of data
among its partners. The goal of the EIEN is to improve information
quality, timeliness, accessibility and the ability to integrate data,
while offering business process improvements. Funding for the Grant
Program has been provided through annual congressional appropriations
for the EPA.
    To enhance the quality and overall public benefit of the Network,
EPA proposes to collect information from the EIEN grantees about how
they intend to ensure quality in their projects and the environmental
outcomes and outputs from their projects. The proposed Quality
Assurance Reporting Form is intended to provide a simple means for
grant recipients to present how quality will be addressed throughout
their projects. The Quality Assurance Reporting Form is derived from
guidelines provided in the EIEN's fiscal year 2006 grant solicitation
notice. As a stipulation of their award, grant recipients are to submit
the form within ninety days of grant award.
    Grantees are also currently required to submit semiannual progress
reports as a stipulation of their award. In these reports, grantees
outline project goals, the activities required to meet these goals, and
the outputs and outcomes of the activities to date. At the request of
numerous grantees, we are proposing to offer the Performance Progress
Reporting Form as a vehicle for collecting this information. This form
is easier to complete than an unstructured narrative, and the
information returned will be of higher quality.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.5
hours per Performance Progress Reporting Form and 1 hour per Quality
Assurance Reporting Form response. Burden means the total time, effort,
or financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal agency.
This includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information; process and maintain
information; disclose and provide 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 the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 225.
    Frequency of response: Semi-Annual for Performance Progress
Reporting Form; once for Quality Assurance Reporting Form.
    Estimated total annual number of responses for each respondent: 3.
    Estimated total annual burden hours: 900 hours.
    Estimated total annual costs: $0. This includes an estimated burden
cost of $0 and an estimated cost of $0 for capital investment or
maintenance and operational costs.

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. At that time, 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.

    Dated: March 7, 2006.
Doreen Sterling,
Acting Director, Information Exchange and Services Division.
[FR Doc. E6-3730 Filed 3-14-06; 8:45 am]

BILLING CODE 6560-50-P


TABLE 1 Annual Respondent Burden and Cost NSPS for Portland Cement Plants ( 40 CFR Part 60, Subpart F)

REPORTING/ RECORDKEEPING REQUIREMENT Hours/ Occurence ( A) Occurences/

Plant/ Year ( B) Total Hours/

Year ( C) Plants/

Year ( D) Technical Hours/ Yr ( E) Mgt. Hours/ Yr ( F)

( E x .05) Clerical Hours/ Yr ( G)

( E x .1) Total Hours ( H) Total Cost / Year ( I)

1. APPLICATIONS 2. SURVEY AND STUDIES 3. REPORTING REQUIREMENTS a. Read Instructions 1 1 1 2 2 0.10 0.20 2.30 $ 147 b. Required Activities Initial Performance Tests 24 1 24 2 48 2.40 4.80 55.20 $ 3,522 Reference Method 9 Tests 4 1 4 2 8 0.40 0.80 9.20 $ 587 Repeat of Performance Tests 24 0.2 4.8 2 9.6 0.48 0.96 11.04 $ 704 c. Create Information d. Gather Existing Information e. Write Report Notification of Construction/ Reconstruction 2 1 2 2 4 0.20 0.40 4.60 $ 294 Notification of Actual Startup 2 1 2 2 4 0.20 0.40 4.60 $ 294 Notification of Physical or Operational change 2 1 2 2 4 0.20 0.40 4.60 $ 294 Notification of Demonstration of CMS 2 1 2 2 4 0.20 0.40 4.60 $ 294 Notification of Initial Performance Test 2 1 2 2 4 0.20 0.40 4.60 $ 294 Report of Performance Test  Included in 3b

Report of Semi annual Reports 24 2 48 118 5664 283.20 566.40 6,513.60 $ 415,596 SUBTOTAL 4. RECORDKEEPING REQUIREMENTS a. Read Instructions  Included in 3a

b. Plan Activities  Included in 4c

c. Implement Activities  Included in 3b

d. Develop Record System N/ A N/ A N/ A N/ A N/ A N/ A N/ A N/ A N/ A e. Time to Enter Information Daily Production and Kiln Feed Rates 0.125 300 37.5 118 4,425 221.25 442.50 5,088.75 324,684 Data Collection 0.1 300 30.0 118 3,540 177.00 354.00 4,071.00 259,748 Records of Startups, Shutdowns,

Malfunctions, etc. 1.5 1 1.5 118 177 8.85 17.70 203.55 12,987 f. Train Personnel 16 2 32 0 0 0 0 0 0 g. Audits 16 1 16 0 0 0 0 0 0 TOTAL ANNUAL BURDEN 15,978 $ 1,019,445 ( Rounded) ( Rounded)


[Federal Register Volume 80, Number 110 (Tuesday, June 9, 2015)]
[Notices]
[Pages 32556-32557]
[FR Doc No: 2015-14015]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER15-1837-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): 2015-
06-02_SA 2782 ATXI-AIC Construction Agreement to be effective 6/2/2015.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5108.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER15-1838-000.
    Applicants: New England Power Company, Massachusetts Electric
Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Amended Service Agmt with Paxton Municipal Light Dept. & Notice Waiver
Request to be effective 4/1/2015.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5150.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER15-1839-000.
    Applicants: Interstate Power and Light Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): IPL
Change in Depreciation Rates for Wholeasle Production Service to be
effective 7/1/2015.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5158.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER15-1840-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): CDWR
WPA Regarding Wind Gap Pre-Energization Testing to be effective 6/1/
2015 under ER15-1840 Filing Type: 10.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5159.
    Comments Due: 5 p.m. ET 6/23/15.

    Docket Numbers: ER15-1841-000.
    Applicants: Panda Liberty LLC.
    Description: Initial rate filing per 35.12 FERC Electric Tariff,
Volume No. 1 (MBR Application) to be effective 7/17/2015 under ER15-
1841 Filing Type: 400.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5161.
    Comments Due: 5 p.m. ET 6/23/15.

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

    Docket Numbers: RR15-11-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Request of the North American Electric Reliability
Corporation for Approval of the Amended Compliance and Certification
Committee Charter.
    Filed Date: 6/2/15.
    Accession Number: 20150602-5107.
    Comments Due: 5 p.m. ET 6/23/15.

    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 5:00
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: June 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-14015 Filed 6-8-15; 8:45 am]
 BILLING CODE 6717-01-P