[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37896-37901]
[FR Doc No: 2019-16434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3523]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the fee rates and payment procedures for fiscal year (FY)
2020 animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018
(ADUFA IV), 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 2020.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-
402-6888<EMAIL_ADDRESS>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 2019 through FY 2023, the FD&C Act establishes aggregate
yearly base revenue amounts for each fiscal year (21 U.S.C. 379j-
12(b)(1)). Base revenue amounts are subject to adjustment for inflation
and workload, and for excess collections to reduce workload-based
increases or collection shortfalls after FY 2020 (21 U.S.C. 379j-12(c)
and (g)). Fees for applications, establishments, products, and sponsors
are to be established each year by FDA so that the percentages of the
total revenue that are derived from each type of user fee will be as
follows: Revenue from application fees shall be 20 percent of total fee
revenue; revenue from product fees shall be 27 percent of total fee
revenue; revenue from establishment fees shall be 26 percent of total
fee revenue; and revenue from sponsor fees shall be 27 percent of total
fee revenue (21 U.S.C. 379j-12(b)(2)).
    For FY 2020, the animal drug user fee rates are: $440,446 for an
animal drug application; $220,223 for a supplemental animal drug
application for which safety or effectiveness data are 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)); $11,353 for an annual
product fee; $159,177 for an annual establishment fee; and $144,999 for
an annual sponsor fee. FDA will issue invoices for FY 2020 product,
establishment, and sponsor fees by December 31, 2019, and payment will
be due by January 31, 2020. The application fee rates are effective for
applications submitted on or after October 1, 2019, and will remain in
effect through September 30, 2020. Applications will not be accepted
for review until FDA has received full payment of application fees and
any other animal drug user fees owed under the Animal Drug User Fee Act
program (ADUFA program).

II. Revenue Amount for FY 2020

A. Statutory Fee Revenue Amounts

    ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate fee revenue amount for FY 2020 for all animal drug user fee
categories is $29,931,240 (21 U.S.C. 379j-12(b)(1)(B)).

B. Inflation Adjustment to Fee Revenue Amount

    The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are subject to an inflation adjustment (21
U.S.C. 379j-12(c)(2)).
    ADUFA IV specifies that the annual fee revenue amount is to be
adjusted using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (21 U.S.C. 379j-
12(c)(2)(A)(ii) and (iii)). The component of the inflation adjustment
for payroll costs shall be one plus the average annual percent change
in the cost of all PC&B paid per full-time equivalent (FTE) position at
FDA for the first 3 of the 4 preceding fiscal years, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years. The data on total PC&B paid and numbers
of FTE paid, from which the average cost per FTE can be derived, are
published in FDA's Justification of Estimates for Appropriations
Committees.
    Table 1 summarizes that actual cost and FTE data for the specified
fiscal years and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2020. The 3-year average is 3.1175 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
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             Fiscal year                     2016               2017               2018          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total FTE...........................             16,381             17,022             17,023  .................

PC&B per FTE........................           $147,408           $151,660           $158,061  .................
Percent Change from Previous Year...            2.2474%            2.8845%            4.2206%            3.1175%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 3.1175 percent should be multiplied
by the proportion of PC&B costs to total FDA costs. Table 2 shows the
amount of PC&B and the total amount obligated by FDA for the same 3
years.

                                Table 2--PC&B as a Percent of Total Costs at FDA
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             Fiscal year                     2016               2017               2018          3-Year average
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Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total Costs.........................     $4,666,236,000     $5,104,580,000     $5,370,935,000  .................
PC&B Percent........................           51.7490%           50.5732%           50.0970%           50.8064%
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    The portion of the inflation adjustment relating to payroll costs
is 3.1175 percent multiplied by 50.8064 percent (or 1.5839 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 of the preceding 4
years of available data multiplied by the proportion of all costs other
than PC&B costs to total FDA costs. As a result of a geographical
revision made by the Bureau of Labor and Statistics in January 2018,\1\
the ``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In
order to continue applying a CPI that best reflects the geographic
region in which FDA is headquartered and which provides the most
current data available, the Washington-Arlington-Alexandria less food
and energy index will be used in calculating the relevant adjustment
factors for FY 2020 and subsequent years. Table 3 provides the summary
data for the percent change in the specified CPI for the Washington-
Arlington-Alexandria area. The data from the Bureau of Labor Statistics
is shown in table 3.
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    \1\ https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

   Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
                                                     Energy
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                Year                         2016               2017               2018          3-Year average
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Annual CPI..........................            265.333            266.897            272.414  .................
Annual Percent Change...............            1.5306%            0.5894%            2.0671%            1.3957%
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    To calculate the inflation adjustment for non-payroll costs, we
multiply the 1.3957 percent by the proportion of all costs other than
PC&B to total FDA costs. Since 50.8064 percent was obligated for PC&B
as shown in table 2, 49.1936 percent is the portion of costs other than
PC&B (100 percent - 50.8064 percent = 49.1936 percent). The portion of
the inflation adjustment relating to non-payroll costs is 1.3957
percent times 49.1936 percent, or 0.6866 percent.
    Next, we add the payroll component (1.5839 percent) to the non-
payroll component (0.6866 percent), for a total inflation adjustment of
2.2705 percent, and then add one, making 1.022705. We then multiply the
base revenue amount for FY 2020 ($29,931,240) by 1.022705, yielding an
inflation adjusted amount of $30,611,000 (rounded to the nearest
thousand dollars) for FY 2020.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-12(c)(3)).
    To determine whether a workload adjustment applies, FDA calculates
the weighted average of the change in the total 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, 2018 (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 May 31, 2019.
    The results of these calculations are presented in the first two
columns of table 4. 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 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 0.99 percent for FY
2020. This is the workload adjuster for FY 2020.

                                     Table 4--Workload Adjuster Calculation
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                                    Column 1 5-      Column 2                        Column 4        Column 5
        Application type           Year average    latest 5-Year     Column 3        weighting       weighted
                                   (base years)       average     percent change      factor      percent change
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New Animal Drug Applications                16.4            15.4        -6.0976%          0.0444        -0.2705%
 (NADAs)........................
Supplemental NADAs with Safety              11.6            11.0        -5.1724%          0.0224        -0.1161%
 or Efficacy Data...............
Manufacturing Supplements.......           353.2           355.6         0.6795%          0.1556         0.1057%
Investigational Study                      183.2           177.8        -2.9476%          0.5612        -1.6542%
 Submissions....................
Investigational Protocol                   236.4           268.4        13.5364%          0.2164         2.9297%
 Submissions....................
FY 2020 ADUFA IV Workload         ..............  ..............  ..............  ..............         0.9946%
 Adjuster.......................
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    Under no circumstances will the workload adjustment result in fee
revenues that are less than the base fee revenues for that fiscal year
as adjusted for inflation (21 U.S.C. 379j-12(c)(3)). FDA will not
adjust the FY 2020 fee revenue amount for workload changes because the
workload adjuster was less than 1 percent.\2\
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    \2\ CVM increases the fee revenue amount established for the
fiscal year to reflect changes in workload only if the workload
adjuster is equal to or greater than 1 percent (1%).
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D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections

    Under section 740(c)(3)(B) of the FD&C Act, for fiscal years 2021
through 2023, if application of the workload adjustment increases the
amount of fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections for the second preceding fiscal year, up to the
amount of the fee revenue increase. This provision will not take effect
until FY 2021.

E. Recovery of Collection Shortfalls

    Under section 740(g)(5)(A) of the FD&C Act, for FY 2021, the amount
of fees otherwise authorized to be collected shall be increased by the
amount, if any, by which the amount collected and appropriated for FY
2019 falls below the amount of fees authorized for FY 2019. For FY
2022, the amount of fees otherwise authorized to be collected shall be
increased by the amount, if any, by which the amount collected and
appropriated for FY 2020 falls below the amount of fees authorized for
FY 2020. For FY 2023, the amount of fees otherwise authorized to be
collected shall be increased by the cumulative amount, if any, by which
the amount collected and appropriated for fiscal years 2021 and 2022
(including estimated collections for FY 2022) falls below the
cumulative amount of fees authorized for those 2 fiscal years. Because
the recovery of collection shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2020 fee revenue amount for the
recovery of collection shortfalls.

F. Reduction of Shortfall-Based Fee Increase by Prior Year Excess
Collections

    Under section 740(g)(5)(B) of the FD&C Act, where FDA's
calculations under section 740(g)(5)(A) result in an increase for that
fiscal year to recover a collection shortfall, FDA must reduce the
increase by the amount of any excess collections for preceding fiscal
years (after fiscal year 2018) that have not already been applied for
purposes of reducing workload-based fee increases. Because the recovery
of collection shortfalls does not take effect until FY 2021, FDA will
not adjust the FY 2020 fee revenue amount for the reduction of
shortfall-based fee increases by prior year excess collections.

G. FY 2020 Fee Revenue Amounts

    ADUFA IV specifies that the revenue amount of $30,611,000 (rounded
to the nearest thousand dollars) for FY 2020 is to be divided as
follows: 20 percent, or a total of $6,122,200, is to come from
application fees; 27 percent, or a total of $8,264,970, is to come from
product fees; 26 percent, or a total of $7,958,860, is to come from
establishment fees; and 27 percent, or a total of $8,264,970, is to
come from sponsor fees (21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY2020

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

    Each person who submits an animal drug application or a
supplemental animal drug application shall be subject to an application
fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term
``animal drug application'' means an application for approval of any
new animal drug submitted under section 512(b)(1) of the FD&C Act or an
application for conditional approval of a new animal drug submitted
under section 571 of the FD&C Act (21 U.S.C. 360ccc) (see section
739(1) of the FD&C Act (21 U.S.C. 379j-11(1))). As the expanded
definition of ``animal drug application'' includes applications for
conditional approval submitted under section 571 of the FD&C Act, such
applications are now subject to ADUFA fees, except that fees may be
waived if the drug is intended solely to provide for a minor use or
minor species (MUMS) indication (see 21 U.S.C. 379j-12(d)(1)(D)).
    Prior to ADUFA IV, FDA only had authority to grant conditional
approval for drugs intended for a MUMS indication. Under amendments
made to section 571 of the FD&C Act by ADUFA IV, FDA retains authority
to grant conditional approval for drugs intended for MUMS indications
but also will be able to grant conditional approval for certain drugs
not intended for a MUMS indication provided certain criteria are met.
Beginning with FY 2019, ADUFA IV provides an exception from application
fees for animal drug applications submitted under section 512(b)(1) of
the FD&C Act if the application is submitted by a sponsor who
previously applied for conditional approval under section 571 of the
FD&C Act for the same product and paid an application fee at the time
they applied for conditional approval. The purpose of this exception is
to prevent sponsors of conditionally approved products from having to
pay a second application fee at the time they apply for full approval
of their products under section 512(b)(1) of the FD&C Act, provided the
sponsor's application for full approval is filed consistent with the
timeframes established in section 571(h) of the FD&C Act.

    A ``supplemental animal drug application'' is defined as a request
to the Secretary of Health and Human Services (Secretary) to approve a
change in an animal drug application that has been approved, or a
request to the Secretary to approve a change to an application approved
under section 512(c)(2) of the FD&C Act for which data with respect to
safety or effectiveness are required (21 U.S.C. 379j-11(2)). The
application fees are to be set so that they will generate $6,122,200 in
fee revenue for FY 2020. 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 (21 U.S.C. 379j-12(a)(1)(A)(ii)).
    To set animal drug application fees and supplemental animal drug
application fees to realize $6,122,200, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2020.
    The Agency knows the number of applications that have been
submitted in previous years, which fluctuates annually. In estimating
the fee revenue to be generated by animal drug application fees in FY
2020, FDA is assuming that the number of applications for which fees
will be paid in FY 2020 will equal the average number of submissions
over the 5 most recent completed fiscal years of the ADUFA program (FY
2014 to FY 2018).
    Over the 5 most recent completed fiscal years, the average number
of animal drug applications that would have been subject to the full
fee was 7.6. Over this same period, the average number of supplemental
applications for which safety or effectiveness data are required 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
12.6.

B. Application Fee Rates for FY 2020

    FDA must set the fee rates for FY 2020 so that the estimated 7.6
applications for which the full fee will be paid and the estimated 12.6
supplemental applications for which safety or effectiveness data are
required and applications subject to the criteria set forth in section
512(d)(4) of the FD&C Act for which half of the full fee will be paid
will generate a total of $6,122,200. To generate this amount, the fee
for an animal drug application, rounded to the nearest dollar, will
have to be $440,446, 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 $220,223.

IV. Product Fee Calculations for FY 2020

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

    The animal drug 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 (21 U.S.C. 379j-12(a)(2)). The
term ``animal drug product'' means each specific strength or potency of
a particular active ingredient or ingredients in final dosage form
marketed by a particular manufacturer or distributor, which is uniquely
identified by the labeler code and product code portions of the
national drug code, and for which an animal drug application or a
supplemental animal drug application has been approved (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate
$8,264,970 in fee revenue for FY 2020.
    To set animal drug product fees to realize $8,264,970, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2020. 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
2019, FDA estimates that there are a total of 743 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 743 products will be
subject to this fee in FY 2020.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2020, FDA is assuming that 2 percent of the products
invoiced, or 15, will not pay fees in FY 2020 due to fee waivers and
reductions. FDA has made this estimate at 2 percent this year, based on
historical data over the past 5 completed fiscal years of the ADUFA
program.
    Accordingly, the Agency estimates that a total of 728 (743 minus
15) products will be subject to product fees in FY 2020.

B. Product Fee Rates for FY 2020

    FDA must set the fee rates for FY 2020 so that the estimated 728
products that pay fees will generate a total of $8,264,970. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest dollar, to be $11,353.

V. Establishment Fee Calculations for FY 2020

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

    The animal drug 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. The term ``animal drug establishment'' is defined as a
foreign or domestic place of business at one general physical location,
consisting of one or more buildings, all of which are within 5 miles of
each other, at which one or more animal drug products are manufactured
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $7,958,860 in fee revenue for FY
2020.
    To set animal drug establishment fees to realize $7,958,860, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2020. 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 2019, FDA estimates that there are a total of 55
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 55 establishments
will be subject to this fee in FY 2020.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2020, FDA is assuming that 9 percent of the
establishments invoiced, or 5, will not pay fees in FY 2020 due to fee
waivers and reductions.

FDA has made this estimate at 9 percent this year, based on historical
data over the past 5 completed fiscal years.
    Accordingly, the Agency estimates that a total of 50 establishments
(55 minus 5) will be subject to establishment fees in FY 2020.

B. Establishment Fee Rates for FY 2020

    FDA must set the fee rates for FY 2020 so that the fees paid for
the estimated 50 establishments will generate a total of $7,958,860. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $159,177.

VI. Sponsor Fee Calculations for FY 2020

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

    The animal drug 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 $8,264,970 in
fee revenue for FY 2020.
    To set animal drug sponsor fees to realize $8,264,970, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2020. FDA estimates that a total of 177 sponsors will meet
this definition in FY 2020.
    In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2020, FDA is assuming that 68 percent of the
sponsors invoiced, or 120, will not pay sponsor fees in FY 2020 due to
fee waivers and reductions. FDA has made this estimate at 68 percent
this year, based on historical data over the past 5 completed fiscal
years of the ADUFA program.
    Accordingly, the Agency estimates that a total of 57 sponsors (177
minus 120) will be subject to and pay sponsor fees in FY 2020.

B. Sponsor Fee Rates for FY 2020

    FDA must set the fee rates for FY 2020 so that the estimated 57
sponsors that pay fees will generate a total of $8,264,970. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $144,999.

VII. Fee Schedule for FY 2020

    The fee rates for FY 2020 are summarized in table 5.

                       Table 5--FY 2020 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                   FY 2020
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................        $440,446
    Supplemental Animal Drug Application for Which               220,223
     Safety 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.................................          11,353
Animal Drug Establishment Fee \1\.......................         159,177
Animal Drug Sponsor Fee \2\.............................         144,999
------------------------------------------------------------------------
\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. Fee Waiver or Reduction; Exemption From Fees

A. Barrier to Innovation Waivers

    Under section 740(d)(1)(A) of the FD&C Act, an animal drug
applicant may qualify for a waiver or reduction of one or more ADUFA
fees if the fee would present a significant barrier to innovation
because of limited resources available to the applicant or due to other
circumstances. FDA CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions,'' \3\ states
that for purposes of determining whether to grant a barrier to
innovation waiver or reduction of ADUFA fees on financial grounds, FDA
has determined an applicant with financial resources of less than
$20,000,000 (including the financial resources of the applicant's
affiliates), adjusted annually for inflation, has limited resources
available. Using the CPI for urban consumers (U.S. city average; not
seasonally adjusted; all items; annual index), the inflation-adjusted
level for FY 2020 will be $21,265,320; this level represents the
financial resource ceiling that will be used to determine if there are
limited resources available to an applicant requesting a barrier to
innovation waiver on financial grounds for FY 2020 in addition to the
criteria requiring the product to be innovative.
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    \3\ \.\CVM's GFI #170 is located at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
---------------------------------------------------------------------------

B. Exemptions From Fees

    The types of fee waivers and reductions that applied in ADUFA III
still exist for FY 2020. However, two new exemptions and one new
exception from fees were established by ADUFA IV, as follows:
    If an animal drug application, supplemental animal drug
application, or investigational submission involves the intentional
genomic alteration of an animal that is intended to produce a human
medical product, any person who is the named applicant or sponsor of
that application or submission will not be subject to sponsor, product,
or establishment fees under ADUFA based solely on that application or
submission (21 U.S.C. 379j-12(d)(4)(B)).
    Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental animal drug application relating to
a new animal drug application approved under section 512 of the FD&C
Act, solely to add the application number to the labeling of the drug
in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under ADUFA based only on the submission of the supplemental
application (21 U.S.C. 379j-12(d)(4)(A)).
    There is also an exception from application fees for animal drug
applications submitted under section 512(b)(1) of the FD&C Act if the
application is submitted by a sponsor who previously applied for
conditional

approval under section 571 of the FD&C Act for the same product and
paid an application fee at the time they applied for conditional
approval, provided the sponsor has submitted the application under
section 512(b)(1) of the FD&C Act within the timeframe specified in
section 571(h) of the FD&C Act.

IX. Procedures for Paying the FY 2020 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 IV that is submitted on or after October 1, 2019. The
payment must be made in U.S. currency by one of the following methods:
Wire transfer, electronic check, bank draft, or U.S. postal money order
made payable to FDA. The preferred payment method is online using
electronic check (Automated Clearing House (ACH) also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). Secure
electronic payments can be submitted using the User Fees Payment Portal
at https://userfees.fda.gov/pay, or the Pay.gov payment option is
available after you submit a cover sheet. (Note: Only full payments are
accepted. No partial payments can be made online.) Once you search for
and find your invoice, select ``Pay Now'' to be redirected to https://www.pay.gov/. Electronic payment options are based on the balance due.
Payment by credit card is available only for balances that are less
than $25,000. If the balance exceeds this amount, only the ACH option
is available. Payments must be made using U.S. bank accounts as well as
U.S. credit cards.
    When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters AD, on 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 979033) on the enclosed check, bank
draft, or money order. Mail the payment and a copy of the completed
Animal Drug User Fee Cover Sheet to: Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197-9000. When paying by wire transfer, the
invoice number needs to be included. Without the invoice number, the
payment may not be applied. If the payment amount is not applied, the
invoice amount would be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full.
    Use the following account information when sending a payment by
wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, FDA deposit account number: 75060099, U.S.
Department of the Treasury routing/transit number: 021030004, SWIFT
number: FRNYUS33.
    To send a check by a courier such as Federal Express, the courier
must deliver the check and printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery.)
    It is important that the fee arrives at the bank at least a day or
two before the application arrives at CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by 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.
    FDA's tax identification number is 53-0196965. (Note: In no case
should the payment for the fee be submitted to FDA with the
application.)

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log on to the ADUFA
website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet and, under Application Submission
Information, 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 they use this
site. Online instructions will walk you through this process.
    Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with 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 are 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 IX.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, 2019, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2020
using this fee schedule. Payment will be due by January 31, 2020. FDA
will issue invoices in November 2020 for any products, establishments,
and sponsors subject to fees for FY 2020 that qualify for fees after
the December 2019 billing.

    Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16434 Filed 8-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 68 (Tuesday, April 9, 2019)]
[Notices]
[Pages 14120-14121]
[FR Doc No: 2019-06952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0661]

Modifications to Compliance Policy for Certain Deemed Tobacco
Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the draft guidance for industry
entitled ``Modifications to Compliance Policy for Certain Deemed
Tobacco Products'' that appeared in the Federal Register of March 14,
2019. In the draft guidance for industry, FDA requested comments on
changes to the compliance policies for premarket review requirements
for certain deemed tobacco products and how FDA intends to prioritize
its enforcement resources with regard to the marketing of certain
deemed tobacco products that do not have premarket authorization. The
Agency is taking this action in response to requests for an extension
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the draft guidance for
industry published March 14, 2019 (84 FR 9345). Submit either
electronic or written comments by April 30, 2019, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You must submit your comment(s) on or before April 30, 2019,
to ensure that the Agency considers your comment(s) before it begins
work on the final version of the guidance.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0661 for ``Modifications to Compliance Policy for Certain
Deemed Tobacco Products.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 14, 2019,
FDA published a draft guidance for industry with a 30-day comment
period to request comments on changes to the compliance policies for
premarket review requirements and how FDA plans to prioritize its
enforcement resources with regard to certain deemed tobacco products in
the United States that do not have the required FDA premarket
authorization for marketing. Comments on the draft guidance for
industry will inform how FDA intends to finalize the guidance.
    The Agency has received requests for an extension of the comment
period for the draft guidance for industry. The requests conveyed
concern that the current 30-day comment period does not allow
sufficient time to develop a response to the draft guidance for
industry.
    FDA has considered the requests and is extending the comment period
for the draft guidance for industry for 15 days, until April 30, 2019.
The Agency believes that a 15-day extension allows adequate time for
interested persons to submit comments without significantly delaying
the process to finalize this guidance.

    Dated: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06952 Filed 4-8-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37937-37938]
[FR Doc No: 2019-16525]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form SD, SEC File No. 270-647, OMB Control No. 3235-0697

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form SD (17 CFR 249b-400) under Securities Exchange Act of 1934 (15
U.S.C. 78a et seq.) (``Exchange Act'') pursuant to Section 13(p) (15
U.S.C. 78m(p)) of the Exchange Act is filed by issuers to provide
disclosures regarding the source and chain of custody of certain
minerals used in their products. We estimate that Form SD takes
approximately 480.61 hours per response to prepare and is filed by
approximately 864 issuers. We estimate that 75% of the 480.61 hours per
response (360.46 hours) is prepared by the issuer internally for a
total annual burden of 311,437 hours (360.46 hours per response x 864
responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection

of information; (c) ways to enhance the quality, utility, and clarity
of the information collected; and (d) ways to minimize the burden of
the collection of information on respondents, including through the use
of automated collection techniques or other forms of information
technology. Consideration will be given to comments and suggestions
submitted in writing within 60 days of this publication.
    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 control number.
    Please direct your written comment to Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549 or send an
email to<EMAIL_ADDRESS>
    Dated: July 30, 2019.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-16525 Filed 8-1-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Rules and Regulations]
[Pages 45340-45344]
[FR Doc No: 2014-17548]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0268; Directorate Identifier 2011-NM-129-AD;
Amendment 39-17914; AD 2014-15-12]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 737-600, -700, -700C, -800, -900 and -900ER series
airplanes. This AD was prompted by reports of incorrectly installed
bolts common to the rear spar termination fitting on the horizontal
stabilizer. This AD requires inspecting for a serial number that starts
with the letters ``SAIC'' on the left- and right-side horizontal
stabilizer identification plate; inspecting for correct bolt protrusion
and chamfer of the bolts of the rear spar termination fitting of the
horizontal stabilizer, if necessary; inspecting to determine if certain
bolts are installed, if necessary; and doing related investigative and
corrective actions if necessary. We are issuing this AD to prevent loss
of structural integrity of the horizontal stabilizer attachment and
loss of control of the airplane.

DATES: This AD is effective September 9, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September 9,
2014.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2012-
0268; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6440; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a second supplemental notice of proposed rulemaking
(SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to all
The Boeing Company Model 737-600, -700, -700C, -800, -900 and -900ER
series airplanes. The second SNPRM published in the Federal Register on
December 9, 2013 (78 FR 73744). We preceded the second SNPRM with a
first SNPRM that published in the Federal Register on March 7, 2013 (78
FR 14734). We preceded the first SNPRM with a notice of proposed
rulemaking (NPRM) that published in the Federal Register on March 20,
2012 (77 FR 16188).
    The NPRM proposed to require inspecting for a serial number that
starts with the letters ``SAIC'' on the left- and right-side horizontal
stabilizer identification plate; a detailed inspection for correct bolt
protrusion and chamfer of the termination fitting bolts of the
horizontal stabilizer rear spar, if necessary; inspecting to determine
if certain bolts are installed, if necessary, and related investigative
and corrective actions if necessary. The NPRM also proposed to require
repetitive inspections for cracking of the termination fitting at
certain bolt locations, and repair if necessary. The NPRM was prompted
by reports of incorrectly installed bolts common to the rear spar
termination fitting on the horizontal stabilizer. The first SNPRM
revised the NPRM by adding airplanes to the applicability. The second
SNPRM

proposed to revise the applicable thresholds from flight cycles on the
airplane to flight cycles accumulated on the affected horizontal
stabilizer.
    We are issuing this AD to prevent loss of structural integrity of
the horizontal stabilizer attachment and loss of control of the
airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received on the second SNPRM
(78 FR 73744, December 9, 2013).

Request To Provide Instructions To Correct Errors in Service
Information

    Europe Airpost requested that a note be included in the second
SNPRM (78 FR 73744, December 9, 2013) to clarify the instructions for
the re-installation of gap covers of the horizontal stabilizer and for
the re-installation of the lower inboard trailing edge panels and the
lower aft in-spar access doors if removed to perform actions. Europe
Airpost stated that two of the four gap covers removed in Part 1, Steps
f.(1) and f.(2), of Boeing Service Bulletin 737-55-1090, dated March
30, 2011, have different part numbers than the part numbers listed in
the re-installation instructions in Part 9, ``Close Access,'' of Boeing
Service Bulletin 737-55-1090, dated March 30, 2011. Europe Airpost also
stated that Boeing Service Bulletin 737-55-1090, dated March 30, 2011,
does not include instructions for the re-installation of trailing edge
panels and access doors near the horizontal stabilizer.
    We agree with the request for the reason provided. Boeing Service
Bulletin 737-55-1090, dated March 30, 2011, does not specify the
correct gap cover numbers for the re-installation of the gap covers and
does not specify adequate procedures for re-installation of the access
doors and trailing edge panels. We have determined that operators may
use their own maintenance procedures to accomplish the re-installation
of the gap covers, access doors, and trailing edge panels. Therefore,
we have added new paragraph (j)(6) to this final rule regarding the re-
installation of gap covers, access doors, and trailing edge panels.
Paragraph (j)(6) of this final rule indicates that any instructions
specified in Boeing Service Bulletin 737-55-1090, dated March 30, 2011,
regarding the removal and re-installation of gap covers, trailing edge
panels, and access doors are not required by this AD.

Request To Identify Horizontal Stabilizers Using Serial Numbers

    Boeing requested that the second SNPRM (78 FR 73744, December 9,
2013) be revised to allow identification of discrepant horizontal
stabilizers using a list of SAIC serial numbers that Boeing stated it
would provide. Boeing stated that using a list of specific serial
numbers of suspect horizontal stabilizers would provide relief to
operators from having to inspect stabilizers on airplanes prior to line
number (L/N) 1556.
    We do not agree with the request because, although a list of SAIC
serial numbers identifying the suspect horizontal stabilizers may
relieve operators from inspecting all airplanes prior to L/N 1556 to
locate discrepant parts, no such list has been provided to the FAA.
Boeing may submit this information to the FAA for approval as an
alternative method of compliance (AMOC) using the procedures defined in
paragraph (l) of this final rule. We have not changed this final rule
in this regard.

Request To Revise Certain Terminology

    Boeing and Southwest Airlines (Southwest) requested that the use of
the word ``install'' in paragraph (k), ``Parts Installation
Prohibition,'' of the second SNPRM (78 FR 73744, December 9, 2013) be
clarified by noting that the word ``install'' means replace in this
context. Southwest stated that use of the word ``install'' in paragraph
(k) effectively reduces the compliance time to perform the inspections
in paragraphs (g) and (h) of the second SNPRM, if the horizontal
stabilizer is removed for any reason. Without added clarification, this
could be interpreted to mean that any time a stabilizer is removed from
an airplane for reasons not associated with this AD, and then re-
installed on the same airplane, the inspections specified by paragraph
(k) of the second SNPRM must immediately be accomplished.
    We agree to provide clarification. The intent of the ``Parts
Replacement Limitation'' specified in paragraph (k) of this final rule
is that operators replace parts with good parts rather than bad parts.
Although the word ``install'' is generally considered to be broader
than the word ``replace,'' for purposes of this AD, it should be
interpreted as meaning ``replace'' while remaining within the spirit
and intent of the AD. Therefore, simply reinstalling the same part
during maintenance activities is acceptable for compliance with
paragraph (k) of this final rule for that reinstallation.

Request To Clarify Applicability

    Southwest and All Nippon Airways (ANA) requested that paragraphs
(g) and (h) of the second SNPRM (78 FR 73744, December 9, 2013) be
clarified to specify which airplanes are subject to the proposed
requirements. Southwest and ANA requested that paragraph (g)(2) of the
second SNPRM be re-worded to state that any horizontal stabilizer that
can be shown to have been delivered on an airplane having a line number
after L/N 1556, through use of delivery documentation, should not
require inspection, regardless of where that stabilizer is currently
installed. Southwest stated that if it can verify that the horizontal
stabilizer was originally delivered on an airplane having a line number
after L/N 1556, then that stabilizer should not require any inspections
in accordance with paragraph (g) of the second SNPRM. ANA stated that,
on L/N 1556 and subsequent airplanes delivered with a correct
horizontal stabilizer, no inspection is necessary provided the
horizontal stabilizer is not rotated among the fleet. ANA requested
that the inspections in paragraphs (g) and (h) of the second SNPRM be
limited to airplanes delivered prior to the effective date of this AD.
    We agree that the inspection requirements specified by paragraphs
(g) and (h) in this final rule should be limited to airplanes delivered
prior to the effective date of this AD provided the horizontal
stabilizer has not been rotated among the fleet. We revised the
exceptions provided by paragraphs (j)(4) and (j)(5) of this final rule
to limit the applicability of those paragraphs by replacing the phrase
``airplanes, regardless of line number'' with the phrase ``airplanes,
with original airworthiness certificate or original export certificate
of airworthiness dated before the effective date of this AD.''
    We have changed this final rule by adding paragraph (g)(3), which
states:

    If a serial number starting with the letters ``SAIC'' is found
on a horizontal stabilizer identification plate on any airplane, and
the serial number of the horizontal stabilizer is the same as stated
in the delivery documentation of an airplane having a line number
after L/N 1556, no further action is required by paragraph (g) of
this AD for that horizontal stabilizer only.

    We did not include L/N 1556, as requested by ANA, because L/N 1556
might be affected by the identified unsafe condition and therefore,
must be inspected. We have redesignated paragraph (g)(3) of the second
SNPRM as paragraph (g)(4) of this final rule.

Request To Include Inspection of Additional Part Numbered Bolt

    Southwest and Delta Airlines requested that paragraphs (g)(3) and
(j)(3) of the second SNPRM (78 FR 73744, December 9, 2013) include
inspection of bolts having part number (P/N) BACB30XL so additional
inspections and AMOCs will not be required if these alternative
production bolts are found installed on an airplane. Delta stated that
the AD needs to address the P/N BACB30XL bolts or wait until the
service information is revised.
    We do not agree with the request because Boeing Service Bulletin
737-55-1090, dated March 30, 2011, provides specific inspection
criteria and measurements that are applicable only to bolts having P/N
BACB30US. These criteria cannot be directly applied to bolts having P/N
BACB30XL. The manufacturer plans to revise the service information to
include bolts having P/N BACB30XL. However, to delay this final rule
would be inappropriate because we have determined an unsafe condition
exists and Boeing Service Bulletin 737-55-1090, dated March 30, 2011,
addresses the unsafe condition for bolts having P/N BACB30US. When the
revised service information is available, we will review the service
information and may approve the revised instructions as an AMOC to this
final rule. We have not changed this final rule in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
second SNPRM (78 FR 73744, December 9, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the second SNPRM (78 FR 73744, December 9, 2013).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 1,147 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on
                  Action                              Labor cost            Parts cost    Cost per       U.S.
                                                                                product     operators
----------------------------------------------------------------------------------------------------------------
Inspection................................  1 work-hour x $85 per hour =            $0          $85      $97,495
                                             $85 per inspection cycle.
Replacement of bolts......................  17 work-hours x $85 per hour         1,530        2,975    3,412,325
                                             = $1,445.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
a cost estimate for the on-condition actions specified in this AD.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:
    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-15-12 The Boeing Company: Amendment 39-17914; Docket No. FAA-
2012-0268; Directorate Identifier 2011-NM-129-AD.

(a) Effective Date

    This AD is effective September 9, 2014.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to all The Boeing Company Model 737-600, -
700, -700C, -800, -900, and -900ER series airplanes, certificated in
any category.
    (2) Installation of Supplemental Type Certificate (STC)
ST00830SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/408E012E008616A7862578880060456C?OpenDocument&Highlight=st00830se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which

STC ST00830SE is installed, a ``change in product'' alternative
method of compliance (AMOC) approval request is not necessary to
comply with the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Unsafe Condition

    This AD was prompted by reports of incorrectly installed bolts
common to the rear spar termination fitting on the horizontal
stabilizer. We are issuing this AD to prevent loss of structural
integrity of the horizontal stabilizer attachment and loss of
control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspecting the Horizontal Stabilizer and Corrective Actions

    For Group 1 and Group 2 airplanes identified in Boeing Service
Bulletin 737-55-1090, dated March 30, 2011, except as provided by
paragraphs (j)(4) and (j)(5) of this AD: Except as provided by
paragraphs (i) and (j) of this AD, at the applicable times specified
in paragraph 1.E., ``Compliance,'' of Boeing Service Bulletin 737-
55-1090, dated March 30, 2011, do an inspection for a serial number
that starts with the letters ``SAIC'' on the identification plates
of the left- and right-side horizontal stabilizers, in accordance
with the Accomplishment Instructions of Boeing Service Bulletin 737-
55-1090, dated March 30, 2011. A review of manufacturer delivery and
operator maintenance records is acceptable to make the determination
specified in this paragraph if the serial number can be conclusively
identified from that review.
    (1) If no ``SAIC'' serial number is found, no further action is
required by paragraph (g) of this AD.
    (2) If a serial number starting with the letters ``SAIC'' is
found on a horizontal stabilizer identification plate on an airplane
after line number (L/N) 1556, and the serial number of the
horizontal stabilizer is the same as stated in the delivery
documentation of the airplane, no further action is required by
paragraph (g) of this AD for that horizontal stabilizer only.
    (3) If a serial number starting with the letters ``SAIC'' is
found on a horizontal stabilizer identification plate on any
airplane, and the serial number of the horizontal stabilizer is the
same as stated in the delivery documentation of an airplane having a
line number after L/N 1556, no further action is required by
paragraph (g) of this AD for that horizontal stabilizer only.
    (4) If a serial number starting with the letters ``SAIC'' is
found on a horizontal stabilizer identification plate, except as
specified in paragraphs (g)(2) and (g)(3) of this AD: Except as
provided by paragraphs (i) and (j) of this AD, at the applicable
times specified in paragraph 1.E., ``Compliance,'' of Boeing Service
Bulletin 737-55-1090, dated March 30, 2011, do a detailed inspection
for correct bolt protrusion and correct chamfer of the termination
fitting bolts of the horizontal stabilizer rear spar, in accordance
with the Accomplishment Instructions of Boeing Service Bulletin 737-
55-1090, dated March 30, 2011. Concurrently with the detailed
inspection, inspect to determine if any bolt other than part number
(P/N) BACB30US14K() or BACB30US16K(), as applicable, is installed.
Before further flight, do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 737-55-1090, dated March 30,
2011.

(h) High Frequency Eddy Current (HFEC) and Ultrasonic Inspections of
Termination Fitting and Repair

    For airplanes identified in paragraph (g)(4) of this AD at any
location where a new bolt having a P/N BACB30US14K() is installed as
corrective action for damage found during any inspection required by
paragraph (g) of this AD: Except as provided by paragraphs (i) and
(j) of this AD, at the times specified in paragraph 1.E.,
``Compliance,'' of Boeing Service Bulletin 737-55-1090, dated March
30, 2011, do HFEC and ultrasonic inspections for cracking of the
forward and aft sides of the termination fitting, in accordance with
the Accomplishment Instructions of Boeing Service Bulletin 737-55-
1090, dated March 30, 2011. If any crack is found in any termination
fitting: Before further flight, repair using a method approved in
accordance with the procedures specified in paragraph (l) of this
AD. Repeat the HFEC and ultrasonic inspections thereafter at
intervals not to exceed 3,500 flight cycles on the horizontal
stabilizer.

(i) Clarification of Compliance Time

    Where the compliance times stated in Boeing Service Bulletin
737-55-1090, dated March 30, 2011, are ``total flight cycles,'' the
compliance time in this AD is total flight cycles accumulated on the
horizontal stabilizer since new.

(j) Exceptions to Service Information Specifications

    (1) Where Boeing Service Bulletin 737-55-1090, dated March 30,
2011, specifies a compliance time ``after the original issue date on
the service bulletin,'' this AD requires compliance within the
specified compliance time after the effective date of this AD.
    (2) Where Figure 1 of Boeing Service Bulletin 737-55-1090, dated
March 30, 2011, points to the location of a part number rather than
the serial number, this AD requires an inspection for an
identification plate with a serial number that starts with the
letters ``SAIC.''
    (3) If, during any inspection required by paragraphs (g) and (h)
of this AD, any bolt other than P/N BACB30US14K() or BACB30US16K(),
as applicable, is found: Before further flight, repair using a
method approved in accordance with the procedures specified in
paragraph (l) of this AD.
    (4) Where Boeing Service Bulletin 737-55-1090, dated March 30,
2011, identifies Group 1 airplanes as 737-600, -700, -800, and -900
airplanes having line numbers 379 through 1556 inclusive, this AD
specifies Group 1 airplanes as 737-600, -700, -800, -900, and -900ER
airplanes ``with original airworthiness certificate or original
export certificate of airworthiness dated before the effective date
of this AD.''
    (5) Where Boeing Service Bulletin 737-55-1090, dated March 30,
2011, identifies Group 2 airplanes as 737-700C airplanes having line
number 496 through 1548 inclusive, this AD specifies Group 2
airplanes as 737-700C airplanes ``with original airworthiness
certificate or original export certificate of airworthiness dated
before the effective date of this AD.''
    (6) Any instructions specified in Boeing Service Bulletin 737-
55-1090, dated March 30, 2011, regarding the removal and re-
installation of gap covers, trailing edge panels, and access doors
are not required by this AD.

(k) Parts Replacement Limitation

    As of the effective date of this AD, no person may install a
horizontal stabilizer on any airplane included in the applicability
of this AD, unless the horizontal stabilizer has been inspected and
any applicable corrective actions have been done in accordance with
paragraphs (g) and (h) of this AD.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (m) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(m) Related Information

    For more information about this AD, contact Nancy Marsh,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin 737-55-1090, dated March 30, 2011.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 17, 2014.
John P. Piccola,
Acting Manager, Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 2014-17548 Filed 8-4-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 20, 2010 (Volume 75, Number 12)]
[Notices]
[Page 3225-3228]
[DOCID:fr20ja10-64]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance at Organization of MISO
States and Midwest ISO Meetings

January 12, 2010.
    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission and Commission staff may attend the following
Midwest Independent Transmission System Operator, Inc.-related and
Organization of MISO States (OMS) meetings:

Regional Expansion and Criteria & Benefits Task Force

January 14, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
January 15, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
January 25, 2010, Monday, Carmel, IN; 2 p.m. to 5 p.m. ET
January 26, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

February 11, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
February 12, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
February 22, 2010, Monday, Carmel, IN; 12 p.m. to 5 p.m. ET
February 23, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

March 11, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
March 12, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
March 22, 2010, Monday, Carmel, IN; 12 p.m. to 5 p.m. ET
March 23, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

April 8, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
April 9, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
April 19, 2010, Monday, Carmel, IN; 12 p.m. to 5 p.m. ET
April 20, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

May 13, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
May 14, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
May 24, 2010, Monday, Carmel, IN; 12 p.m. to 5 p.m. ET
May 25, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

June 10, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
June 11, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
June 21, 2010, Monday, Carmel, IN; 12 p.m. to 5 p.m. ET
June 22, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

July 8, 2010, Thursday, St. Paul, MN; 9 a.m. to 5 p.m. CT
July 9, 2010, Friday, St. Paul, MN; 8 a.m. to 12 p.m. CT
July 19, 2010, Monday, Carmel, IN; 12 p.m. to 5 p.m. ET
July 20, 2010, Tuesday, Carmel, IN; 9 a.m. to 4 p.m. ET

OMS Cost Allocation and Regional Planning

January 12, 2010, Tuesday: Hilton Garden Inn, 411 Minnesota Street, St.
Paul, MN, 8 a.m. to 5 p.m. CT.
January 13, 2010, Wednesday: Hilton Garden Inn, 411 Minnesota Street,
St. Paul, MN, 8 a.m. to 5 p.m. CT.

February 9, 2010, Tuesday, St. Paul, MN; 8 a.m. to 5 p.m. CT
February 10, 2010, Wednesday, St. Paul, MN; 8 a.m. to 5 p.m. CT

March 9, 2010, Tuesday, St. Paul, MN; 8 a.m. to 5 p.m. CT
March 10, 2010, Wednesday, St. Paul, MN; 8 a.m. to 5 p.m. CT

    All meetings scheduled to be held in Carmel will take place at:
Midwest ISO Headquarters, 720 City Center Drive, Carmel, IN 46032.
    Except as otherwise noted above, the meetings scheduled to be held
in St. Paul will take place at:

1125 Energy Park Drive, St. Paul, MN 55108, and
Minnesota Public Utilities Commission, 121 7th Place East, Suite 350,
St. Paul, MN 55101-2147.

    Further information may be found at http://www.midwestiso.org.
    The above-referenced meetings are open to the public.
    The discussions at each of the meetings described above may address
matters at issue in the following proceedings:
Docket No. AD07-12, Reliability Standard Compliance and Enforcement in
Regions with Independent System Operators and Regional Transmission
Organizations
Docket Nos. EC06-4 and ER06-20, Louisville Gas and Electric Company, et
al.
Docket No. ER02-488, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. ER02-2595, et al., Midwest Independent Transmission System
Operator, Inc.
Docket No. ER04-375, Midwest Independent Transmission System Operator,
Inc., et al.
Docket Nos. ER04-458, et al., Midwest Independent Transmission System
Operator, Inc.
Docket Nos. ER04-691, EL04-104 and ER04-106, et al., Midwest
Independent Transmission System Operator, Inc., et al.

Docket No. ER05-6, et al., Midwest Independent Transmission System
Operator, Inc., et al.
Docket No. ER05-636, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER05-752, Midwest Independent Transmission System Operator,
Inc. and PJM Interconnection, L.L.C.
Docket No. ER05-1047, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER05-1048, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER05-1083, et al., Midwest Independent Transmission System
Operator, Inc., et al.
Docket No. ER05-1085, et al., Midwest Independent Transmission System
Operator, Inc.
Docket No. ER05-1138, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER05-1201, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER05-1230, Midwest Independent Transmission System Operator,
Inc.
Docket No. EL05-103, Northern Indiana Power Service Co. v. Midwest
Independent Transmission System Operator, Inc. and PJM Interconnection,
L.L.C.
Docket No. EL05-128, Quest Energy, L.L.C. v. Midwest Independent
Transmission System Operator, Inc.
Docket Nos. ER06-18, et al., Midwest Independent Transmission System
Operator, Inc.
Docket No. ER06-22, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-27, Midwest Independent Transmission System Operator,
Inc., et al.
Docket No. ER06-56, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-192, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-356, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-360, et al., Midwest Independent Transmission System
Operator, Inc., et al.
Docket No. ER06-532, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-731, Independent Market Monitor for the Midwest
Independent Transmission System Operator, Inc.
Docket No. ER06-866, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-881, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-1420, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-1536, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER06-1552, Midwest Independent Transmission System Operator,
Inc.
Docket No. EL06-31, Midwest Independent Transmission System Operator,
Inc., et al.
Docket No. EL06-49, Midwest Independent Transmission System Operator,
Inc., et al.
Docket No. EL06-80, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-53, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-478, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-532, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-580, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-815, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-940, Midwest Independent Transmission System Operator,
Inc., et al.
Docket No. ER07-1141, International Transmission Co., et al.
Docket No. ER07-1144, American Transmission Co. LLC, et al.
Docket No. ER07-1182, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. ER07-1233 and ER07-1261, Midwest Independent Transmission
System Operator, Inc.
Docket No. ER07-1372, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-1375, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-1388, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER07-1417, Midwest Independent Transmission System Operator,
Inc., et al.
Docket No. EL07-44, Dakota Wind Harvest, LLC v. Midwest Independent
Transmission System Operator, Inc., et al.
Docket No. EL07-79, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. EL07-86, EL07-88, EL07-92, Ameren Services Co., et al. v.
Midwest Independent Transmission System Operator, Inc., et al.
Docket No. EL07-100, E.ON U.S. LLC v. Midwest Independent Transmission
System Operator, Inc.
Docket No. ER08-15, Midwest ISO Transmission Owners
Docket No. ER08-55, Midwest Independent Transmission System Operator,
Inc., et al.
Docket No. ER08-109, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. ER08-185 and ER08-186, Ameren Energy Marketing Company, et
al.
Docket No. ER08-207, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-209, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-269, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-296, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-320, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-370, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-394, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-404, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-637, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-925, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1043, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1074, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1169, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1244, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1252, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1285, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1309, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1370, Midwest Independent Transmission System Operator,
Inc.

Docket No. ER08-1399, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1400, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1401, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1404, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1435, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1485, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1486, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER08-1505, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-59, American Transmission Company, Inc.
Docket No. ER09-66, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-83, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-91, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-108, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-117, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-123, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-160, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-180, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-245, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-266, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-267, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-403, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-499, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-506, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-512, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-573, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-592, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-654, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-660, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-769, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-774, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-783, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-785, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-788, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-807, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-827, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-839, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-861, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-991, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-994, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-998, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-999, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1049, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1074, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1126, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1369, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1396, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1422, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1431, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1432, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1435, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1526, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1543, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1575, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1581, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1619, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1719, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1727, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1769, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER09-1779, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-8, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-27, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-277, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-279, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-224, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-128, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-191, E.ON U.S. LLC
Docket No. OA07-57, Midwest Independent Transmission System Operator,
Inc.
Docket No. OA08-4, Midwest ISO Transmission Owners, et al.
Docket No. OA08-14, Midwest Independent Transmission System Operator,
Inc.
Docket No. OA08-42, Midwest Independent Transmission System Operator,
Inc.

Docket No. OA08-53, Midwest Independent Transmission System Operator,
Inc.
Docket No. OA08-106, Midwest Independent Transmission System Operator,
Inc.
Docket No. OA09-7, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. RR07-2, et al., Delegation Agreement Between the North
American Electric Reliability Corporation and Midwest Reliability
Organization, et al.

    For more information, contact Patrick Clarey, Office of Energy
Markets Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>or Christopher Miller, Office of
Energy Markets Regulation, Federal Energy Regulatory Commission at
(317) 249-5936 or<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-912 Filed 1-19-10; 8:45 a.m.]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Page 11509]
[FR Doc No: 2017-03678]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2016-N-0002]

New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of an abbreviated new animal drug application (ANADA) at the sponsor's
request because the product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 6, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Putney, Inc., One Monument Square, Suite
400, Portland, ME 04101 has requested that FDA withdraw approval of
ANADA 200-524 for Mupirocin Ointment 2% because the product is no
longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of ANADA
200-524, and all supplements and amendments thereto, is hereby
withdrawn, effective March 6, 2017.
    Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of this application.

    Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03678 Filed 2-23-17; 8:45 am]
 BILLING CODE 4164-01-P