[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45624-45629]
[FR Doc No: 2012-18709]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0806]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2013 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User
Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees
for certain animal drug applications and supplements, for certain
animal drug products, for certain establishments where such products
are made, and for certain sponsors of such animal drug applications
and/or investigational animal drug submissions. This notice establishes
the fee rates for FY 2013.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm,
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240-
276-9718. For general questions, you may also email the Center for
Veterinary Medicine (CVM) at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four
different types of user fees: (1) Fees for certain types of animal drug
applications and supplements, (2) annual fees for certain animal drug
products, (3) annual fees for certain establishments where such
products are made, and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions (21
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or
reduce fees (21 U.S.C. 379j-12(d)).
    For FY 2009 through FY 2013, the FD&C Act establishes aggregate
yearly base revenue amounts for each of these fee categories. Base
revenue amounts established for years after FY 2009 are subject to
adjustment for workload. Fees for applications, establishments,
products, and sponsors are to be established each year by FDA so that
the revenue for each fee category will approximate the level
established in the statute, after the level has been adjusted for
workload.
    For FY 2013, the animal drug user fee rates are: $435,200 for an
animal drug application; $217,600 for a supplemental animal drug
application for which safety or effectiveness data is required and for
an animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $8,640 for an annual
product fee; $104,600 for an annual establishment fee; and $87,700 for
an annual sponsor fee. FDA will issue invoices for FY 2013 product,
establishment, and sponsor fees by December 31, 2012, and these
invoices will be due and payable within 30 days of issuance of the
invoice. The application fee rates are effective for applications
submitted on or after October 1, 2012, and will remain in effect
through September 30, 2013. Applications will not be accepted for
review until FDA has received full payment of application fees and any
other animal drug user fees owed.

II. Revenue Amount for FY 2013

A. Statutory Fee Revenue Amounts

    ADUFA II (Pub. L. 110-316 signed by the President on August 14,
2008) specifies that the aggregate revenue amount for FY 2013 for each
of the four animal drug user fee categories is $6,061,000 before any
adjustment for workload is made. (See 21 U.S.C. 379j-12(b)(1) through
(b)(4).)

B. Inflation Adjustment to Fee Revenue Amount

    The amounts established in ADUFA II for each year for FY 2009
through FY 2013 include an inflation adjustment; therefore, no further
inflation adjustment is required.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    For each FY beginning in FY 2010, ADUFA provides that fee revenue
amounts shall be further adjusted to reflect changes in review workload
(21 U.S.C. 379j-12(c)(1)).
    FDA calculated the average number of each of the five types of
applications and submissions specified in the workload adjustment
provision (animal drug applications, supplemental animal drug
applications for which data with respect to safety or efficacy are
required, manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug protocol submissions) received over the 5-year period that
ended on September 30, 2002 (the base years), and the average number of
each of these types of applications and submissions over the most
recent 5-year period that ended June 30, 2012.
    The results of these calculations are presented in the first two
columns 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, reflecting how much of
the total FDA animal drug review workload was accounted for by each
type of application or submission 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 and 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 change in workload
of -32% percent for FY 2013. This is the workload adjuster for FY 2013.

                  Table 1--Workload Adjuster Calculation (Numbers May Not Add Due to Rounding)
----------------------------------------------------------------------------------------------------------------
                                                 Column 1 5-                                           Column 5
                                                  year Avg.     Column 2     Column 3     Column 4     weighted
                Application type                    (base      latest 5-     percent     weighting     percent
                                                    years)     year avg.      change       factor       change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs)...........         28.8         11.4          -60       0.0229           -1
Supplemental NADAs With Safety or Efficacy Data         23.4         11.4          -51       0.0275           -1
Manufacturing Supplements......................        366.6        394.2            8       0.1222            1
Investigational Study Submissions..............        336.6        224.0          -33       0.6435          -22
Investigational Protocol Submissions...........        292.4        148.6          -49       0.1838           -9

    FY 2013 Workload Adjuster..................  ...........  ...........  ...........  ...........          -32
----------------------------------------------------------------------------------------------------------------

    ADUFA specifies that the workload adjuster may not result in fees
that are less than the fee revenue amount in the statute (21 U.S.C.
379j-12(c)(1)(B)). Because applying the FY 2013 workload adjuster would
result in fees less than the statutory amount, the workload adjustment
will not be applied in FY 2013. As a result, the statutory revenue
target amount for each of the four categories of fees remains at
$6,061,000 with the new total revenue target for fees in FY 2013 being
$24,244,000.

D. Offset for Excess Collections Through FY 2012

    Under the provisions of ADUFA I, which apply to fees collected for
FY 2004 through FY 2008, if the amount of fees collected for a FY
exceeds the amount of fees specified in appropriation acts for that FY,
the excess amount shall be credited to FDA's appropriation account and
shall be subtracted from the amount of fees that would otherwise be
authorized to be collected in a subsequent FY. (See section 740(g)(4)
of the FD&C Act as originally enacted in Public Law 108-130 on November
18, 2003.) In setting ADUFA fees for FY 2008 and FY 2009, offsets
totaling $1,664,000 were made under these provisions ($320,000 when FY
2008 fees were set and another $1,344,000 when fees for FY 2009 were
set), but offsets totaling $394,256 for this period still need to be
made. Table 2 shows the amount of fees specified in FDA's annual
appropriation for each year from 2004 through 2008, the amounts FDA has
collected for each year; the amount of offset previously taken, and the
cumulative difference. FDA will take this difference as an offset
against FY 2013 fee collections.

                        Table 2--Offsets Remaining To Be Taken for ADUFA I, FY 2004-2008
----------------------------------------------------------------------------------------------------------------
                                                                                Excess         Remaining
                                                       Fees       Fees collected    collections       excess
                   Fiscal year                     appropriated     as of 3/31/     offset when   collections to
                                                                       2012        fees were set     be offset
----------------------------------------------------------------------------------------------------------------
2004............................................      $5,000,000      $5,154,700  ..............        $154,700
2005............................................       8,354,000       8,519,101  ..............         165,101
2006............................................      11,318,000      10,901,466  ..............               0
2007............................................      11,604,000      13,342,455  ..............       1,738,455
2008............................................      13,696,000      11,577,312         320,000               0
                                                 ---------------------------------------------------------------
    Totals......................................  ..............  ..............  ..............   \1\ 2,058,256
    Net Excess Appropriations, to be Offset       ..............  ..............  ..............         394,256
     Against 2013 Collections...................
----------------------------------------------------------------------------------------------------------------
\1\ See table 3 of this document for information on additional offset taken in FY 2009.

    In addition, under the provisions of ADUFA, as amended by ADUFA II,
if the cumulative amount of the fees collected for fiscal years 2009
through 2011, and the amount of fees estimated to be collected under
this section for FY 2012, exceeds the cumulative amount appropriated
for fees for fiscal years 2009 through 2012, the excess will be
subtracted from the amount of fees that FDA would otherwise be
authorized to collect for FY 2013 under the FD&C Act (21 U.S.C. 379j-
12(g)(4) as amended by ADUFA II).
    Table 3 shows the amounts appropriated for each year from FY 2009
through FY 2012, and the amounts FDA has collected for fiscal years
2009, 2010, and 2011 as of March 31, 2012, and the amount that FDA
estimated it would collect in FY 2012 when it published the notice of
FY 2012 fees in the Federal Register on August 1, 2011 (76 FR 45811).
The bottom line of Table 3 shows the estimated cumulative amount by
which fees collected fell below amounts appropriated for FY 2009
through FY 2012.

                  Table 3--Offsets To Be Taken for the ADUFA II Period, Fiscal Years 2009-2012
       [for FY 2009-2011, fees collected through March 31, 2012; for FY 2012, estimate as August 1, 2011]
----------------------------------------------------------------------------------------------------------------
                                                                                Excess
                                                       Fees                         collections
                   Fiscal year                     appropriated   Fees collected    offset when     Difference
                                                                                fees were set
----------------------------------------------------------------------------------------------------------------
2009............................................     $15,260,000     $12,893,721      $1,344,000    ($2,366,279)
2010............................................      17,280,000      16,609,805  ..............       (670,195)
2011............................................      19,448,000      18,342,199  ..............     (1,105,801)
2012 estimated..................................      21,768,000      21,768,000  ..............               0
                                                 ---------------------------------------------------------------
    Cumulative Difference Less Than               ..............  ..............  ..............     (4,142,275)
     Appropriations.............................
----------------------------------------------------------------------------------------------------------------

    As can be seen from table 3, no further offset is required for the
period 2009 through 2012 since collections have fallen substantially
below the amounts appropriated each year and in aggregate. The only
offset required at this time is the $394,256 from the ADUFA I period.

E. Final Year Adjustment

    Under the provisions of ADUFA, as amended, the Secretary may, in
addition to the workload adjustment and offset, further increase the
fees and fee revenues if such an adjustment is necessary to provide up
to 3 months of operating reserves of carryover user fees for the
process for the review of animal drug applications for the first 3
months of FY 2014. (See 21 U.S.C. 379j-12(c)(2).) The rationale for the
amount of this increase shall be contained in the annual notice
establishing fee revenues and fees for FY 2013 (See section 740(c)(2)
of the FD&C Act.) Table 4 in this document estimates the amount of
carryover reserve FDA currently estimates to have available at the end
of FY 2013. It begins with the balance available at the end of FY 2011,
rounded to the nearest thousand dollars, adds the net prior year
collections for the 6 months ending March 31, 2012, and subtracts the
amount it will have to use to cover the offset it will make when 2013
fees are set. In addition, FDA is keeping aside a reserve of $1,400,000
for potential refunds, and a net of $379,000 for the last 2 years of
ADUFA II. The amount of carry-over balance FDA expects to have
available for obligation at the end of FY 2013 is $3,694,000, as shown
in the last line of table 4.

    Table 4--Estimated Carryover Balance at the End of FY 2013, After
                               Adjustments
------------------------------------------------------------------------

------------------------------------------------------------------------
Total Carryover Balance End of FY 2011.................       $4,664,000
Net Prior Year Fees Collected After 9/30/2011 (3/31/             445,000
 2012).................................................
Used for Offset in 2013................................        (394,000)
Reserve for Refunds in 2012 and 2013...................      (1,400,000)
Estimated Change to Carryover Balance at the End of FY           636,000
 2012..................................................
Estimated Change to Carryover Balance at the End of FY         (257,000)
 2013..................................................
Estimated 2013 End of FY Carryover Balance.............        3,694,000
------------------------------------------------------------------------

    Table 5 estimates the amount of funds FDA anticipates that it will
need from animal drug user fees in order to operate for the first 3
months of FY 2014.

 Table 5--Estimated Fee Revenue Needed To Sustain FY 2013 Operations for
                      the First 3 Months of FY 2014
------------------------------------------------------------------------

------------------------------------------------------------------------
Estimated Total Spending from Fees in FY 2013...........     $19,652,000
Estimated FY 2014 Inflation Costs at 2.01%..............         395,000
Estimated FY 2014 Funds to Sustain FY 2013 Operations...      20,047,000
Estimated Fees Needed for 3 Months in FY 2014...........       5,012,000
Estimated End-of-FY 2013 Carryover Balance..............       3,694,000
Additional Revenue Needed for 3 Months in FY 2013.......       1,318,000
------------------------------------------------------------------------

    FDA expects to collect and spend a total of $19,652,000 in FY 2013,
rounding to the nearest thousand dollars, after making adjustments for
the offset of $394,256 and for likely revenue shortfalls below the
$24,244,000 amount authorized for collection from ADUFA fee in that
year. To maintain FY 2013 operations in FY 2014, FDA is applying an
anticipated inflation rate of 2.01 percent to the amount of fee
revenues FDA expects to obligate in FY 2013. This 2.01 percent is the
statutory inflation adjustment to be applied to PDUFA and several other
user fee programs in FY 2013, and the only statutory inflation
adjustment for FDA available at this time; its derivation is published
elsewhere in this issue of the Federal Register where the FY 2013 fees
for the PDUFA user fee program is published. FDA expects to obligate a
total of $20,047,000 in FY 2014--or a total of about $5,012,000 during
the first 3 months of FY 2014, rounded to the nearest thousand dollars.
The available carryover balance at the beginning of FY 2013 is
estimated at $3,694,000 (rounded to the nearest thousand dollars). Thus
FDA would need an additional $1,318,000 ($5,012,000 minus $3,694,000
rounded to the nearest thousand dollars) as the final year adjustment
to assure sufficient operating reserves for the first 3 months of FY
2014.
    FDA recognizes that adding $1,318,000 to the fee revenue costs in
FY 2013 poses a substantial burden on the regulated industry at a time
when it is undergoing financial strain. In light of this, and in light
of the fact that the legislative language authorizing the final year
adjustment allows FDA discretion in whether to make this adjustment for
a full 3 months of operating reserves or for a shorter period, FDA has
decided to balance its own risks with the amount of burden the final
year adjustment would place on the industry. In making this decision,
FDA has decided to assume more risk, making the final year adjustment
to allow for only 2 months of operating reserves instead of 3 months.
Accordingly FDA will make the final year adjustment for a lesser
amount, as derived in table 6 of this document.

 Table 6--Estimated Fee Revenue Needed To Sustain FY 2013 Operations for
                      the First 2 Months of FY 2014
------------------------------------------------------------------------

------------------------------------------------------------------------
Estimated Total Spending from Fees in FY 2013...........     $19,652,000
Estimated FY 2014 Inflation Costs at 2.01%..............         395,000
Estimated FY 2014 Funds to Sustain FY 2013 Operations...      20,047,000
Estimated Fees Needed for 2 Months in FY 2014...........       3,341,000
Estimated End-of-FY 2013 Carryover Balance..............       3,694,000
Additional Revenue Needed for 2 Months in FY 2013.......               0
------------------------------------------------------------------------

    Accordingly FDA will make no final year adjustment in the ADUFA fee
revenue amount. In making this decision, FDA is assuming that it will
have the revenues to operate in FY 2013 as proposed in the President's
budget request for FDA. Should a significant reduction below that
amount occur, FDA will have to make larger expenditures of user fee
reserves to sustain the animal drug review program in FY 2013, to make
up for appropriation reductions, and will have less carryover balance
at the end of FY 2013 than estimated in this document. If such a
reduction in appropriated funds should occur, FDA is reserving the
right to revise the fees it is setting for FY 2013, due to the need to
assess a final year adjustment in such circumstances. If that fact only
becomes known after the start of FY 2013, FDA may publish a revised fee
schedule with increased FY 2013 fees, and advise any who have paid fees
at the lower rate that they will have to make another payment to make
up the difference between the fees published in this document and the
higher fees necessitated by the need to impose a final year adjustment.

F. FY 2013 Fee Revenue Amounts

    The final estimate of fee revenue for ADUFA fees for FY 2013 is
shown in table 7 in this document. The statutory amount of $6,061,000
for each of the fee components is reduced by a total of $98,564--one
fourth of the total offset amount of $394,256. No final year adjustment
is made. The total is then rounded to the nearest thousand dollars,

for a total of $5,962,000 to come from each fee component.

                            Table 7--Estimate of Total ADUFA Fee Revenue for FY 2013
----------------------------------------------------------------------------------------------------------------
                                    Application    Establishment
         Fee components                fees            fees        Product fees    Sponsor fees        Total
----------------------------------------------------------------------------------------------------------------
Amount in ADUFA II..............      $6,061,000      $6,061,000      $6,061,000      $6,061,000     $24,244,000
Reduction for Offset............        (98,564)        (98,564)        (98,564)        (98,564)       (394,256)
Final Year Adjustment...........               0               0               0               0               0
                                 -------------------------------------------------------------------------------
    Total.......................       5,962,436       5,962,436       5,962,436       5,962,436      23,849,744
                                 -------------------------------------------------------------------------------
    Total Rounded...............       5,962,000       5,962,000       5,962,000       5,962,000      23,848,000
----------------------------------------------------------------------------------------------------------------

III. Application Fee Calculations for FY 2013

    The terms ``animal drug application'' and ``supplemental animal
drug application'' are defined in section 739 of the FD&C Act (21
U.S.C. 379j-11(1) and (2)).

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    The application fee must be paid for any animal drug application or
supplemental animal drug application that is subject to fees under
ADUFA and that is submitted on or after September 1, 2003. The
application fees are to be set so that they will generate $5,962,000 in
fee revenue for FY 2013. This is the amount set out in the statute and
adjusted for the offset with no final year adjustment. The fee for a
supplemental animal drug application for which safety or effectiveness
data are required and for an animal drug application subject to
criteria set forth in section 512(d)(4) of the FD&C Act is to be set at
50 percent of the animal drug application fee. (See 21 U.S.C. 379j-
12(a)(1)(A)(ii), as amended by ADUFA II.)
    To set animal drug application fees and supplemental animal drug
application fees to realize $5,962,000, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2013.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. In estimating the fee revenue to be generated by animal
drug application fees in FY 2013, FDA is assuming that the number of
applications that will pay fees in FY 2013 will equal the average
number of submissions over the 5 most recent completed years (FY 2007-
FY 2011). This may not fully account for possible year to year
fluctuations in numbers of fee-paying applications, but FDA believes
that this is a reasonable approach after 9 years of experience with
this program.
    Over the 5 most recent completed years, the average number of
animal drug applications that would have been subject to the full fee
was 8.2. Over this same period, the average number of supplemental
applications and applications subject to the criteria set forth in
section 512(d)(4) of the FD&C Act that would have been subject to half
of the full fee was 11.0.

B. Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 8.2
applications that pay the full fee and the estimated 11.0 supplemental
applications and applications subject to the criteria set forth in
section 512(d)(4) of the FD&C Act that pay half of the full fee will
generate a total of $5,962,000. To generate this amount, the fee for an
animal drug application, rounded to the nearest hundred dollars, will
have to be $435,200, and the fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act will have to be $217,600.

IV. Product Fee Calculations for FY 2013

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The animal drug product fee (also referred to as the product fee)
must be paid annually by the person named as the applicant in a new
animal drug application or supplemental new animal drug application for
an animal drug product submitted for listing under section 510 of the
FD&C Act (21 U.S.C. 360), and who had an animal drug application or
supplemental animal drug application pending at FDA after September 1,
2003. (See 21 U.S.C. 379j-12(a)(2).) The term ``animal drug product''
is defined in 21 U.S.C. 379j-11(3). The product fees are to be set so
that they will generate $5,962,000 in fee revenue for FY 2013. This is
the amount set out in the statute and adjusted for the offset with no
final year adjustment.
    To set animal drug product fees to realize $5,962,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2013. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or supplement pending after September 1, 2003. As of June
2012, FDA estimates that there are a total of 767 products submitted
for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 767 products will be
subject to this fee in FY 2013.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2013, FDA is again assuming that 10 percent of the
products invoiced, or 77, will not pay fees in FY 2013 due to fee
waivers and reductions. Based on experience with other user fee
programs and the first 9 years of ADUFA, FDA believes that this is a
reasonable basis for estimating the number of fee-paying products in FY
2013.
    Accordingly, the Agency estimates that a total of 690 (767 minus
77) products will be subject to product fees in FY 2013.

B. Product Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 690
products that pay fees will generate a total of $5,962,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest 5 dollars, to be $8,640.

V. Establishment Fee Calculations for FY 2013

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee (also referred to as the
establishment fee) must be paid annually by the person who: (1) Owns or
operates, directly or through an affiliate, an animal drug
establishment; (2) is named as the applicant in an animal drug
application or supplemental animal drug application for an animal drug
product submitted for listing under section 510 of the FD&C Act; (3)
had an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003; and (4) whose establishment
engaged in the manufacture of the animal drug product during the fiscal
year. (See 21 U.S.C. 379j-12(a)(3).) An establishment subject to animal
drug establishment fees is assessed only one such fee per fiscal year.
(See 21 U.S.C. 379j-12(a)(3).) The term ``animal drug establishment''
is defined in 21 U.S.C. 379j-11(4). The establishment fees are to be
set so that they will generate $5,962,000 in fee revenue for FY 2013.
This is the amount set out in the statute and adjusted for the offset
with no final year adjustment.
    To set animal drug establishment fees to realize $5,962,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2013. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplement pending after September 1,
2003. As of June 2012, FDA estimates that there are a total of 63
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 63 establishments
will be subject to this fee in FY 2013.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2013, FDA is assuming that 10 percent of the
establishments invoiced, or 6, will not pay fees in FY 2013 due to fee
waivers and reductions. Based on experience with the first 9 years of
ADUFA, FDA believes that this is a reasonable basis for estimating the
number of fee-paying establishments in FY 2013.
    Accordingly, the Agency estimates that a total of 57 establishments
(63 minus 6) will be subject to establishment fees in FY 2013.

B. Establishment Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 57
establishments that pay fees will generate a total of $5,962,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest 50 dollars, to be $104,600.

VI. Sponsor Fee Calculations for FY 2013

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The animal drug sponsor fee (also referred to as the sponsor fee)
must be paid annually by each person who: (1) Is named as the applicant
in an animal drug application, except for an approved application for
which all subject products have been removed from listing under section
510 of the FD&C Act, or has submitted an investigational animal drug
submission that has not been terminated or otherwise rendered inactive;
and (2) had an animal drug application, supplemental animal drug
application, or investigational animal drug submission pending at FDA
after September 1, 2003. (See 21 U.S.C. 379j-11(6) and 379j-12(a)(4).)
An animal drug sponsor is subject to only one such fee each fiscal
year. (See 21 U.S.C. 379j-12(a)(4).) The sponsor fees are to be set so
that they will generate $5,962,000 in fee revenue for FY 2013. This is
the amount set out in the statute and adjusted for the offset with no
final year adjustment.
    To set animal drug sponsor fees to realize $5,962,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2013. Based on the number of firms that would have met this
definition in each of the past 9 years, FDA estimates that a total of
171 sponsors will meet this definition in FY 2013.
    Careful review indicates that about one third or 33 percent of all
of these sponsors will qualify for minor use/minor species waiver or
reduction (21 U.S.C. 379j-12(d)(1)(D)). Based on the Agency's
experience to date with sponsor fees, FDA's current best estimate is
that an additional 27 percent will qualify for other waivers or
reductions, for a total of 60 percent of the sponsors invoiced, or 103,
who will not pay fees in FY 2013 due to fee waivers and reductions. FDA
believes that this is a reasonable basis for estimating the number of
fee-paying sponsors in FY 2013.
    Accordingly, the Agency estimates that a total of 68 sponsors (171
minus 103) will be subject to and pay sponsor fees in FY 2013.

B. Sponsor Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 68
sponsors that pay fees will generate a total of $5,962,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest 50 dollars, to be $87,700.

VII. Fee Schedule for FY 2013

    The fee rates for FY 2013 are summarized in table 8 of this
document.

                       Table 8--FY 2013 Fee Rates
------------------------------------------------------------------------
                                                               Fee rate
               Animal drug user fee category                 for FY 2013
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application....................................     $435,200
    Supplemental Animal Drug Application for which Safety        217,600
     or Effectiveness Data are Required or Animal Drug
     Application Subject to the Criteria Set Forth in
     Section 512(d)(4) of the FD&C Act.....................
Animal Drug Product Fee....................................        8,640
Animal Drug Establishment Fee \1\..........................      104,600
Animal Drug Sponsor Fee \2\................................       87,700
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
  fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VIII. Procedures for Paying the FY 2013 Fees

A. Application Fees and Payment Instructions

    The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplement subject to
fees under ADUFA that is submitted after September 30, 2012. 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,
by wire transfer, or electronically using Pay.gov. (The Pay.gov payment
option is available to you after you submit a cover sheet. Click the
``Pay Now'' button.) On your check, bank draft, or U.S. postal money
order, please write your application's unique Payment Identification
Number (PIN), beginning with the letters AD, from the upper right-hand
corner of your completed Animal Drug User Fee Cover Sheet. Also write
the FDA post office box number (P.O. Box 953877) on the enclosed check,
bank draft, or money order. Your payment and a copy of the completed
Animal Drug User Fee Cover Sheet can be mailed to: Food and Drug

Administration, P.O. Box 953877, St. Louis, MO 63195-3877.
    If payment is made by wire transfer, send payment to: U.S.
Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045,
FDA Deposit Account Number: 75060099, U.S. Department of Treasury
routing/transit number: 021030004, SWIFT Number: FRNYUS33. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution
regarding additional fees.
    If you prefer to send a check by a courier such as Federal Express
or United Parcel Service, the courier may deliver the check and printed
copy of the cover sheet to: U.S. Bank, Attn: Government Lockbox 953877,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for
courier delivery only. If you have any questions concerning courier
delivery contact the U.S. Bank at<PHONE_NUMBER>. This telephone number
is only for questions about courier delivery.)
    The tax identification number of the Food and Drug Administration
is 530196965. (Note: In no case should the payment for the fee be
submitted to FDA with the application.)
    It is helpful if the fee arrives at the bank at least a day or two
before the application arrives at FDA's CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by FDA's CVM, or the date U.S. Bank notifies
FDA that your payment in the full amount has been received, or when the
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S. Treasury are required to notify FDA
within 1 working day, using the PIN described previously.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log on to the ADUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources
click ``The Animal Drug User Fee Cover Sheet'' and then click ``Create
ADUFA User Fee Cover Sheet.'' For security reasons, each firm
submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
    Step Two--Create an Animal Drug User Cover Sheet, transmit it to
FDA, and print a copy. After logging into your account with your user
name and password, complete the steps required to create an Animal Drug
User Fee Cover Sheet. One cover sheet is needed for each animal drug
application or supplement. Once you are satisfied that the data on the
cover sheet is accurate and you have finalized the cover sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique PIN.
    Step Three--Send the payment for your application as described in
section VIII.A of this document.
    Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.

C. Product, Establishment, and Sponsor Fees

    By December 31, 2012, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2013
using this Fee Schedule. Payment will be due and payable within 30 days
of issuance of the invoice. FDA will issue invoices in November 2013
for any products, establishments, and sponsors subject to fees for FY
2013 that qualify for fees after the December 2012 billing.

    Dated: July 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18709 Filed 7-31-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 104 (Wednesday, May 31, 2023)]
[Notices]
[Pages 34855-34856]
[FR Doc No: 2023-11443]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0407; FRL--11005-01-OAR]

Agency Information Collection Activities; Proposed Information
Collection Request; Comment Request; EPA's ENERGY STAR Program in the
Commercial and Industrial Sectors (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``EPA's ENERGY STAR
Program in the Commercial and Industrial Sectors'' (EPA ICR Number
1772.09, OMB Control Number 2060-0347) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. Before doing so, EPA is soliciting public comments on
specific aspects of the proposed information collection as described
below. This is a proposed extension of the ICR, which is currently
approved through January 21, 2024. This notice allows for 60 days for
public comments.

DATES: Comments must be submitted on or before July 31, 2023.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2006-0407, to EPA online using www.regulations.gov (our preferred
method), by email to [email protected] or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.

FOR FURTHER INFORMATION CONTACT: Cynthia Veit Maia, Climate Protection
Partnerships Division, (5230A), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-
9494; fax number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through January 31, 2024. 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.
    This notice allows 60 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
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 forms of information technology. 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. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: EPA created ENERGY STAR as a voluntary program to help
businesses and individuals protect the environment through superior
energy efficiency. The program focuses on reducing utility-generated
emissions by reducing the demand for energy. In 1991, EPA launched the
Green Lights Program to encourage corporations, State and local
governments, colleges and universities, and other organizations to
adopt energy-efficient lighting as a profitable means of preventing
pollution and improving lighting quality. Since then, EPA has rolled
Green Lights into ENERGY STAR and expanded ENERGY STAR to encompass
organization-wide energy performance improvement, such as building
technology upgrades, product purchasing initiatives, and employee
training. At the same time, EPA has streamlined the reporting
requirements of ENERGY STAR and focused on providing incentives for
improvements (e.g., ENERGY STAR awards program). EPA also makes tools
and other resources available over the Web to help the public overcome
the barriers to evaluating their energy performance and investing in
profitable improvements.
    To join ENERGY STAR, organizations are asked to complete a
Partnership Application that establishes their commitment to energy
efficiency. Partners agree to undertake efforts such as measuring,
tracking, and benchmarking their organization's energy performance by
using tools such as those offered by ENERGY STAR; developing and
implementing a plan to improve energy performance in their facilities
and operations by adopting a strategy provided by ENERGY STAR; and
educating staff and the public about their Partnership with ENERGY
STAR, and highlighting achievements with the ENERGY STAR, where
available.
    Partners also may be asked to periodically submit information to
EPA as needed to assist in program implementation.
    Partnership in ENERGY STAR is voluntary and can be terminated by
Partners or EPA at any time. EPA does not expect organizations to join
the program unless they expect participation to be cost effective and
otherwise beneficial for them.
    In addition, Partners and other interested parties can seek
recognition and help EPA promote energy-efficient technologies by
evaluating the efficiency of their buildings using EPA's on-line tools
(e.g., Portfolio Manager) and applying for recognition. EPA does

not expect any information collected under ENERGY STAR to be
Confidential Business Information (CBI).
    Form Numbers: 5900-19, 5900-195, 5900-197, 5900-198, 5900-22, 5900-
262, 5900-263, 5900-264, 5900-265, 5900-382, 5900-383, 5900-387, 5900-
436, 5900-437, 5900-441, 5900-441a, 5900-442, 5900-443, 5900-444, 5900-
445, 5900-89.
    Respondents/affected entities: Participants in EPA's ENERGY STAR
Program in the commercial and industrial sectors.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 37,021 (total).
    Frequency of response: One-time, annually, or on occasion.
    Total estimated burden: 210,306 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $14,859,991 (per year), which includes
$5,034,450 annualized capital or operation & maintenance costs.
    Changes in the Estimates: The burden estimates presented in this
notice are from the last approval. EPA is currently evaluating and
updating these estimates as part of the ICR renewal process. EPA will
discuss its updated estimates, as well as changes from the last
approval, in the next Federal Register notice to be issued for this
renewal.

Jean Lupinacci,
Director, Climate Protection Partnerships Division.
[FR Doc. 2023-11443 Filed 5-30-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Page 58121]
[FR Doc No: 2012-23045]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC12-134-000.
    Applicants: NRG Energy, Inc, GenOn Energy, Inc.
    Description: NRG Energy, Inc et al. submits additional information
in support of the application pursuant to Section 203(a)(1) et al.
    Filed Date: 9/10/12.
    Accession Number: 20120911-0249.
    Comments Due: 5 p.m. ET 10/9/12.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG12-108-000.
    Applicants: Prairie Rose Wind, LLC.
    Description: Notice of Self-certification of Exempt Wholesale
Generator Status of Prairie Rose Wind, LLC.
    Filed Date: 9/11/12.
    Accession Number: 20120911-5102.
    Comments Due: 5 p.m. ET 10/2/12.

    Docket Numbers: EG12-109-000.
    Applicants: Prairie Rose Transmission, LLC.
    Description: Notice of Self-certification of Exempt Wholesale
Generator Status of Prairie Rose Transmission, LLC.
    Filed Date: 9/11/12.
    Accession Number: 20120911-5103.
    Comments Due: 5 p.m. ET 10/2/12.

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

    Docket Numbers: ER12-2606-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance Filing per 7/11/2012 Order in EL12-50-000
(sections eff 10/1/2012) to be effective 10/1/2012.
    Filed Date: 9/10/12.
    Accession Number: 20120910-5160.
    Comments Due: 5 p.m. ET 10/1/12.

    Docket Numbers: ER12-2611-000.
    Applicants: NorthWestern Corporation.
    Description: SA 646--SGIA with NPS re Mammoth Project to be
effective 9/12/2012.
    Filed Date: 9/11/12.
    Accession Number: 20120911-5080.
    Comments Due: 5 p.m. ET 10/2/12.

    Docket Numbers: ER12-2612-000.
    Applicants: Nevada Power Company.
    Description: Rate Schedule No. 130 Concurrence in TEP RS No. 321
SRSG Participation Agreement to be effective 12/28/2011.
    Filed Date: 9/11/12.
    Accession Number: 20120911-5088.
    Comments Due: 5 p.m. ET 10/2/12.

    Docket Numbers: ER12-2613-000.
    Applicants: Southern California Edison Company.
    Description: Amended SGIA and DSA to 570 E. Mill St San Bernardino
Roof Top Solar Project to be effective 9/13/2012.
    Filed Date: 9/12/12.
    Accession Number: 20120912-5001.
    Comments Due: 5 p.m. ET 10/3/12.

    Docket Numbers: ER12-2614-000.
    Applicants: Dynamo Power LLC.
    Description: Market-Based Rates Tariff to be effective 9/12/2012.
    Filed Date: 9/12/12.
    Accession Number: 20120912-5002.
    Comments Due: 5 p.m. ET 10/3/12.

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

    Docket Numbers: ES12-55-000.
    Applicants: Kansas City Power & Light Company.
    Description: Kansas City Power & Light Company Application for
Authorization of Issuance of Short-Term Debt Securities Under Section
204 of the Federal Power Act.
    Filed Date: 9/12/12.
    Accession Number: 20120912-5012.
    Comments Due: 5 p.m. ET 10/3/12.

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

    Dated: September 12, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-23045 Filed 9-18-12; 8:45 am]
BILLING CODE 6717-01-P