[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49664-49669]
[FR Doc No: 2016-17848]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2017

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2017 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
the Animal Drug User Fee Amendments of 2013 (ADUFA III), 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 2017.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6888. 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 2014 through FY 2018, 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 established for years after FY 2014 are
subject to adjustment for inflation and workload (21 U.S.C. 379j-
12(c)). 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 2017, the animal drug user fee rates are: $350,700 for an
animal drug application; $175,350 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)); $8,195 for an annual
product fee; $111,900 for an annual establishment fee; and $103,100 for
an annual sponsor fee. FDA will issue invoices for FY 2017 product,
establishment, and sponsor fees by December 31, 2016, and payment will
be due by January 31, 2017. The application fee rates are effective for
applications submitted on or after October 1, 2016, and will remain in
effect through September 30, 2017. 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
program (ADUFA program).

II. Revenue Amount for FY 2017

A. Statutory Fee Revenue Amounts

    ADUFA III, Title I of Public Law 113-14, specifies that the
aggregate fee revenue amount for FY 2017 for all animal drug user fee
categories is $21,600,000 (21 U.S.C. 379j-12(b)(1)(B).).

B. Inflation Adjustment to Fee Revenue Amount

    The fee revenue amount established in ADUFA III for FY 2015 and
subsequent fiscal years are subject to an inflation adjustment (21
U.S.C. 379j-12(c)(2)).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all
personnel compensation and benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the first three of the four
preceding fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs for the first three of the four preceding fiscal years
(see 21 U.S.C. 379j-12(c)(2)(A) and (B)). 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 three of the four
fiscal years preceding FY 2017. The 3-year average is 1.8759 percent.

                                  Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Fiscal year                                     2013                     2014                     2015           3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B...................................................           $1,927,703,000           $2,054,937,000           $2,232,304,000  ..............
Total FTE....................................................                   13,974                   14,555                   15,484  ..............
PC&B per FTE.................................................                  137,949                  141,184                  144,168  ..............
Percent Change from Previous Year............................                  1.1690%                  2.3451%                  2.1136%         1.8759%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.8759 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
FYs.

                                                    Table 2--PC&B as a Percent of Total Costs at FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Fiscal year                                     2013                     2014                     2015           3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B...................................................           $1,927,703,000           $2,054,937,000           $2,232,304,000  ..............
Total Costs..................................................            4,151,343,000            4,298,476,000            4,510,565,000  ..............
PC&B Percent.................................................                 46.4356%                 47.8062%                 49.4906%        47.9108%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8759 percent multiplied by 47.9108
percent (or 0.8988 percent).
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2017 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 (see 21 U.S.C. 379j-12(c)(2)(C)).
Table 3 provides the summary data for the percent change in the
specified CPI for the Baltimore-Washington area. The data from the
Bureau of Labor Statistics is shown in table 3.

                         Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI Less Food and Energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
                             Year                                        2013                     2014                     2015           3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual CPI...................................................                  146.953                  149.581                  152.242  ..............
Annual Percent Change........................................                  1.7588%                  1.7883%                  1.7790%         1.7754%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we
multiply the 1.7754 percent by the proportion of all costs other than
PC&B to total FDA costs. Since 47.9108 percent was obligated for PC&B
as shown in table 2, 52.0892 percent is the portion of costs other than
PC&B (100 percent minus 47.9108 percent equals 52.0892 percent). The
non-payroll adjustment is 1.7754 percent times 52.0892 percent, or
0.9248 percent.
    Next, we add the payroll component (0.8988 percent) to the non-pay
component (0.9248 percent), for a total inflation adjustment of 1.8236
percent for FY 2017.
    ADUFA III provides for the inflation adjustment to be compounded
each fiscal year after FY 2014 (see 21 U.S.C. 379j-12(c)(2)). The
factor for FY 2017 (1.8236 percent) is compounded by adding 1 and then
multiplying by 1 plus the inflation adjustment factor for FY 2016
(2.1121 percent), as published in the Federal Register of August 3,
2015 (80 FR 45993 to 45998), which equals 1.060746 (rounded) (1.018236
times 1.041749) for FY 2017. We then multiply the base revenue amount
for FY 2017 ($21,600,000) by 1.060746, yielding an inflation adjusted
amount of $22,912,114.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    A workload adjustment will be calculated to the inflation adjusted
fee revenue amount established in ADUFA III for FY 2015 and subsequent
fiscal years (21 U.S.C. 379j-12(c)(3)).
    FDA calculated the average number of each of the five types of
applications and submissions specified in the workload adjustment
provision (animal drug applications, supplemental animal drug
applications for which data with respect to safety or efficacy are
required, manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug protocol submissions) received over the 5-year period that
ended on September 30, 2013 (the base years), and the average number of
each of these types of applications and submissions over the most
recent 5-year period that ended June 30, 2016.
    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 five 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 table 4 the sum of the values in column 5 is added, reflecting a
total change in workload of 3.3206 percent for FY 2017. This is the
workload adjuster for FY 2017.

                                     Table 4--Workload Adjuster Calculation
                                      [Numbers may not add due to rounding]
----------------------------------------------------------------------------------------------------------------
                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type          5-year average   Latest 5-year                     Weighting       Weighted
                                   (base years)       average     Percent change      factor      percent change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications              9.8000         13.4000         36.7347          0.0250          0.9168
 (NADAs)........................
Supplemental NADAs with Safety            9.6000         12.4000         29.1667          0.0342          0.9971
 or Efficacy Data...............
Manufacturing Supplements.......        361.0000        324.6000        -10.0831          0.1565         -1.5783
Investigational Study                   216.4000        204.6000         -5.4529          0.6002         -3.2727
 Submissions....................
Investigational Protocol                133.6000        179.0000         33.9820          0.1841          6.2577
 Submissions....................
                                 -------------------------------------------------------------------------------
    FY 2017 Workload Adjuster...  ..............  ..............  ..............  ..............          3.3206
----------------------------------------------------------------------------------------------------------------

    FDA experienced an increase in the number of new animal drug
applications (NADAs) and supplemental NADAs with safety or
effectiveness data. Over the last several years FDA has seen an
increase in the number of animal drug products brought by animal drug
sponsors for review in the drug evaluation process. These new animal
drug products come from both existing animal drug sponsors as well as
sponsors new to the animal drug market. The increase in new animal drug
products have contributed to an increase in the number of protocol
submissions and NADAs submitted for many novel drug classes and novel
indications for both food-producing animals and companion animals. FDA
can expect that the increases in reviewed protocols will lead in the
near future to an increase in the number of Investigational Study
Submissions and NADAs or supplemental NADAs as sponsors work their
products through the regulatory review process. Additionally, FDA has
seen an increase in the number of animal drug sponsors pursuing
multiple changes to their existing NADAs (e.g., new indications, new
species, changes in dosage). For this reason we are seeing an increase
in the number of supplemental NADAs with safety or effectiveness data.
As a result, the statutory revenue amount after the inflation
adjustment ($22,912,114) must now be increased by 3.3206 percent to
reflect the changes in review workload (workload adjustment), for a
total fee revenue target of $23,673,000 (rounded to the nearest
thousand dollars).

D. FY 2017 Fee Revenue Amounts

    ADUFA III specifies that the revenue amount of $23,673,000 for FY
2017 is to be divided as follows: 20 percent, or a total of $4,734,000
(rounded to the nearest thousand dollars), is to come from application
fees; 27 percent, or a total of $6,392,000 (rounded to the nearest
thousand dollars), is to come from product fees; 26 percent, or a total
of $6,155,000 (rounded to the nearest thousand dollars), is to come
from establishment fees; and 27 percent, or a total of $6,392,000
(rounded to the nearest thousand dollars), is to come from sponsor fees
(21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2017

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

    Each person that 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) (21 U.S.C. 379j-
11(1)). A ``supplemental animal drug application'' is defined as a
request to the Secretary to approve a change in an animal drug
application which has been approved, or a request to the Secretary to
approve a change to an application approved under section 512(c)(2) 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 $4,734,000 in fee revenue for FY 2017. 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 $4,734,000 FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2017.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates from year to year.
In estimating the fee revenue to be generated by animal drug
application fees in FY 2017, FDA is assuming that the number of
applications that will pay fees in FY 2017 will equal the average
number of submissions over the five most recent completed years of the
ADUFA program (FY 2011 to FY 2015). FDA believes that this is a
reasonable approach after 12 completed years of experience with this
program.
    Over the five most recent completed years, the average number of
animal drug applications that would have been subject to the full fee
was 7.2. Over this same period, the average number of supplemental
applications and applications subject to the criteria set forth in
section 512(d)(4) of the FD&C Act that would have been subject to half
of the full fee was 12.6.

B. Application Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 7.2
applications that pay the full fee and the estimated 12.6 supplemental
applications and applications subject to the criteria set forth in
section 512(d)(4) of the FD&C Act that pay half of the full fee will
generate a total of $4,734,000. To generate this amount, the fee for an
animal drug application, rounded to the nearest $100, will have to be
$350,700, 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 $175,350.

IV. Product Fee Calculations for FY 2017

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

    The animal drug product fee (also referred to as the product fee)
must be paid annually by the person named as the applicant in a new
animal drug

application or supplemental new animal drug application for an animal
drug product submitted for listing under section 510 of the FD&C Act
(21 U.S.C. 360), and who had an animal drug application or supplemental
animal drug application pending at FDA after September 1, 2003 (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 $6,392,000 in fee revenue for FY 2017.
    To set animal drug product fees to realize $6,392,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2017. 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
2016, FDA estimates that there are a total of 804 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 804 products will be
subject to this fee in FY 2017.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2017, FDA is assuming that 3 percent of the products
invoiced, or 24, will not pay fees in FY 2017 due to fee waivers and
reductions. FDA has kept this estimate at 3 percent this year, based on
historical data over the past 5 completed years of the ADUFA program.
Based on experience over the first 12 completed years of the ADUFA
program, FDA believes that this is a reasonable basis for estimating
the number of fee-paying products in FY 2017.
    Accordingly, the Agency estimates that a total of 780 (804 minus
24) products will be subject to product fees in FY 2017.

B. Product Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 780
products that pay fees will generate a total of $6,392,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest $5, to be $8,195.

V. Establishment Fee Calculations for FY 2017

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

    The animal drug establishment fee (also referred to as the
establishment fee) must be paid annually by the person who: (1) Owns or
operates, directly or through an affiliate, an animal drug
establishment; (2) is named as the applicant in an animal drug
application or supplemental animal drug application for an animal drug
product submitted for listing under section 510 of the FD&C Act; (3)
had an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003; and (4) whose establishment
engaged in the manufacture of the animal drug product during the fiscal
year (see 21 U.S.C. 379j-12(a)(3)). An establishment subject to animal
drug establishment fees is assessed only one such fee per fiscal year.
The term ``animal drug establishment'' is defined as a foreign or
domestic place of business which is 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 $6,155,000 in fee revenue for FY
2017.
    To set animal drug establishment fees to realize $6,155,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2017. 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 2016, FDA estimates that there are a total of 62
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 62 establishments
will be subject to this fee in FY 2017.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2017, FDA is assuming that 11 percent of the
establishments invoiced, or seven, will not pay fees in FY 2017 due to
fee waivers and reductions. FDA has reduced this estimate from 12
percent to 11 percent this year, based on historical data over the past
5 completed years. Based on experience over the past 12 completed years
of the ADUFA program, FDA believes that this is a reasonable basis for
estimating the number of fee-paying establishments in FY 2017.
    Accordingly, the Agency estimates that a total of 55 establishments
(62 minus 7) will be subject to establishment fees in FY 2017.

B. Establishment Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 55
establishments that pay fees will generate a total of $6,155,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest $50, to be $111,900.

VI. Sponsor Fee Calculations for FY 2017

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

    The animal drug sponsor fee (also referred to as the sponsor fee)
must be paid annually by each person who: (1) Is named as the applicant
in an animal drug application, except for an approved application for
which all subject products have been removed from listing under section
510 of the FD&C Act, or has submitted an investigational animal drug
submission that has not been terminated or otherwise rendered inactive
and (2) had an animal drug application, supplemental animal drug
application, or investigational animal drug submission pending at FDA
after September 1, 2003 (see 21 U.S.C. 379j-11(6) and 379j-12(a)(4)).
An animal drug sponsor is subject to only one such fee each fiscal year
(see 21 U.S.C. 379j-12(a)(4)). The sponsor fees are to be set so that
they will generate $6,392,000 in fee revenue for FY 2017.
    To set animal drug sponsor fees to realize $6,392,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2017. Based on the number of firms that would have met this
definition in each of the past 12 completed years of the ADUFA program,
FDA estimates that a total of 189 sponsors will meet this definition in
FY 2017.
    Careful review indicates that 35 percent of these sponsors will
qualify for minor use/minor species waiver or reduction (21 U.S.C.
379j-12(d)(1)(D)). Based on the Agency's experience to date with
sponsor fees, FDA's current best estimate is that an additional 32
percent will qualify for other waivers or reductions, for a total of 67
percent of the sponsors invoiced, or 127, who will not pay fees in FY
2017 due to fee waivers and reductions. FDA has increased this estimate
from 65 percent

to 67 percent this year, based on historical data over the past 5
completed years of the ADUFA program. FDA believes that this is a
reasonable basis for estimating the number of fee-paying sponsors in FY
2017.
    Accordingly, the Agency estimates that a total of 62 sponsors (189
minus 127) will be subject to and pay sponsor fees in FY 2017.

B. Sponsor Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 62
sponsors that pay fees will generate a total of $6,392,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest $50, to be $103,100.

VII. Fee Schedule for FY 2017

    The fee rates for FY 2017 are summarized in Table 5.

                       Table 5--FY 2017 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                 FY 2017 ($)
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................         350,700
    Supplemental Animal Drug Application for Which               175,350
     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.............................           8,195
    Animal Drug Establishment Fee \1\...................         111,900
    Animal Drug Sponsor Fee \2\.........................         103,100
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
  fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VIII. Procedures for Paying the FY 2017 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 III that is submitted on or after October 1, 2016.
Payment must be made in U.S. currency by check, bank draft, U.S. postal
money order payable to the order of the Food and Drug Administration,
wire transfer, or electronically using Pay.gov. 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 to you after you submit a cover
sheet. Once you search for your invoice, click ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
less than $25,000. If the balance exceeds this amount, only the ACH
option is available. Payments must be drawn on U.S bank accounts as
well as U.S. credit cards.
    On your check, bank draft, or U.S. postal money order, please write
your application's unique Payment Identification Number (PIN),
beginning with the letters AD, from the upper right-hand corner of your
completed Animal Drug User Fee Cover Sheet. Also write the FDA post
office box number (P.O. Box 979033) on the enclosed check, bank draft,
or money order. Your payment and a copy of the completed Animal Drug
User Fee Cover Sheet can be mailed to: Food and Drug Administration,
P.O. Box 979033, St. Louis, MO 63197-9000.
    If payment is made by wire transfer, send payment to: U.S.
Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045,
FDA Deposit Account Number: 75060099, U.S. Department of Treasury
routing/transit number: 021030004, SWIFT Number: FRNYUS33, Beneficiary:
FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD 20993-0002. You
are responsible for any administrative costs associated with the
processing of a wire transfer. Contact your bank or financial
institution about the fee and add it to your payment to ensure that
your fee is fully paid.
    If you prefer to send a check by a courier, the courier may 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 the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery.)
    The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
application.)
    It is helpful if the fee arrives at the bank at least a day or two
before the application arrives at FDA's CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by FDA's CVM, or the date U.S. Bank notifies
FDA that your payment in the full amount has been received, or when the
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S. Treasury are required to notify FDA
within 1 working day, using the PIN described previously.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log on to the ADUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources,
click ``The Animal Drug User Fee Cover Sheet'' and then click ``Create
ADUFA User Fee Cover Sheet.'' For security reasons, each firm
submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
    Step Two--Create an Animal Drug User Cover Sheet, transmit it to
FDA, and print a copy. After logging into your account with your user
name and password, complete the steps required to create an Animal Drug
User Fee Cover Sheet. One cover sheet is needed for each animal drug
application or supplement. Once you are satisfied that the data on the
cover sheet is accurate and you have finalized the cover sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique PIN.

    Step Three--Send the payment for your application as described in
section VIII.A.
    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, 2016, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2017
using this fee schedule. Payment will be due by January 31, 2017. FDA
will issue invoices in November 2017 for any products, establishments,
and sponsors subject to fees for FY 2017 that qualify for fees after
the December 2016 billing.

    Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17848 Filed 7-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Rules and Regulations]
[Pages 78967-78969]
[FR Doc No: 2015-31645]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-1139; Airspace Docket No. 15-AWP-4]

Establishment of Class E Airspace; Los Angeles, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E surface area airspace
designated as an extension at Whiteman Airport, Los Angeles, CA. The
FAA found it necessary to establish the airspace area for the safety
and management of Instrument Flight Rules (IFR) operations for arriving
and departing aircraft at the airport.

DATES: Effective 0901 UTC, February 4, 2016. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy and ATC Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 29591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection at
the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.9Z at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E surface area airspace at Whiteman Airport,
Los Angeles, CA.

History

    On October 16, 2015, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class E airspace
designated as an extension at Whiteman Airport, Los Angeles, CA, (80 FR
62509). Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. One anonymous comment was received supporting the proposal.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9Z, dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, Airspace Designations and
Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B,
C, D, and E airspace areas, air traffic service routes, and reporting
points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace designated as an extension to
surface area airspace at Whiteman Airport, Los Angeles, CA. The
airspace extends from the 3-mile radius of Whiteman Airport to 6.6
miles northwest of the airport for the safety and management of IFR
operations.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting Points, dated August 6, 2015, and
effective September 15, 2015, is amended as follows:

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area

* * * * *

AWP CA E4 Los Angeles, CA [New]

Los Angeles, Whiteman Airport, CA
    (Lat. 34[deg]15'34'' N., long. 118[deg]24'48'' W.)

    That airspace extending upward from the surface within 1.1 miles
each side of the 304[deg] bearing from the Whiteman Airport,
extending from the 3-mile radius of Whiteman Airport to 6.6 miles
northwest of the airport. This Class E airspace area is effective
during the specific dates and times established in advance by a
Notice to Airmen. The effective date and time will thereafter be
continuously published in the Airport/Facility Directory.

    Issued in Seattle, Washington, on December 10, 2015.
Tracey Johnson,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-31645 Filed 12-17-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Notices]
[Page 57305-57307]
[DOCID:fr05no09-44]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

October 29, 2009.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC06-129-003.
    Applicants: Capital Research and Management Company.
    Description: Capital Research and Management Company's Request for
Reauthorization and Extension of Blanket Authorization under Section
203 of the Federal Power Act.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-5122.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: EC10-9-000.
    Applicants: Aircraft Services Corporation, Blue Canyon Windpower V
LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Acquisition of Securities by a Holding
Company and Request for Expedited Action of Blue Canyon Windpower V
LLC, et al.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-5125.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

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

    Docket Numbers: ER97-2846-016; ER99-2311-013.
    Applicants: Florida Power Corporation; Carolina Power & Light
Company.
    Description: Carolina Power & Light Co et al. submits notice of
change in status in compliance with requirements set forth in Section
35.42 of the regulations.
    Filed Date: 10/28/2009.
    Accession Number: 20091029-0058.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER98-1643-016.
    Applicants: Portland General Electric Company.
    Description: Portland General Electric Company Notice of Non-
Material Change in status.
    Filed Date: 10/27/2009.
    Accession Number: 20091027-5087.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 17, 2009.

    Docket Numbers: ER01-462-002.
    Applicants: DPL Energy Resources, Inc.
    Description: DPL Energy Resources, Inc submits an application to
modify market based rate tariffs, to request waivers of requirements
for transactions among affiliates and for approvals in conformance with
Order No 697.
    Filed Date: 10/27/2009.
    Accession Number: 20091028-0074.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 17, 2009.

    Docket Numbers: ER08-83-003.
    Applicants: Gilberton Power Company.
    Description: Gilberton Power Company submits First Revised Sheet No
1 et al. to its FERC Electric Tariff, Original Volume No 1 & request
for blanket authority under Section 204 of the FPA and Part 34.
    Filed Date: 10/28/2009.
    Accession Number: 20091029-0059.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER08-1457-004.
    Applicants: PPL Electric Utilities Corporation.
    Description: PJM Interconnection's refund report in compliance with
Order approving settlement.
    Filed Date: 10/28/2009.

    Accession Number: 20091028-5123.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER08-1600-002.
    Applicants: Basin Electric Power Cooperative, Inc.
    Description: Compliance Refund Report of Basin Electric Power
Cooperative.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-5129.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER09-1049-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Informational Filing of Midwest Independent
Transmission System Operator, Inc.
    Filed Date: 10/26/2009.
    Accession Number: 20091026-5095.
    Comment Date: 5 p.m. Eastern Time on Monday, November 09, 2009.

    Docket Numbers: ER09-1051-001.
    Applicants: ISO New England Inc. & New England Power Pool.
    Description: ISO New England Inc et al. submits a filing in
compliance with Order No. 719-A.
    Filed Date: 10/27/2009.
    Accession Number: 20091028-0069.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 10, 2009.

    Docket Numbers: ER09-1650-000; OA09-32-000; TS09-12-000.
    Applicants: BP Wind Energy North America Inc., Fowler Ridge Wind
Farm LLC, Fowler Ridge II Wind Farm LLC, Fowler Ridge III Wind Farm
LLC, Dominion Fowler Ridge Wind II, LLC.
    Description: Response of BP Wind Energy North America Inc., Fowler
Ridge Wind Farm LLC, Fowler Ridge II Wind Farm LLC, Fowler Ridge III
Wind Farm LLC, and Dominion Fowler Ridge Wind II LLC, to Request for
Additional Information.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-5130.
    Comment Date: 5 p.m. Eastern Time on Monday, November 09, 2009.

    Docket Numbers: ER09-1748-001.
    Applicants: Inupiat Energy Marketing, LLC.
    Description: Inupiat Energy Marketing, LLC submits a revised
application for Order Accepting Initial Rate Schedule, Blanket
Authorizations and Certain Waivers etc.
    Filed Date: 10/27/2009.
    Accession Number: 20091028-0072.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 17, 2009.

    Docket Numbers: ER10-90-000.
    Applicants: Lonestar Energy Partners, LLC.
    Description: Lonestar Energy Partners, LLC submits petition for
acceptance of initial rate schedule, FERC Rate Schedule 1, waivers and
blanket authority.
    Filed Date: 10/27/2009.
    Accession Number: 20091029-0147.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 17, 2009.

    Docket Numbers: ER10-98-000.
    Applicants: Southern Company Services, Inc.
    Description: Alabama Power Company et al. submit a transmittal
letter and the amendment to the Open Access transmission Tariff (FERC
Electric Tariff, Fourth Revised Volume 5).
    Filed Date: 10/23/2009.
    Accession Number: 20091026-0278.
    Comment Date: 5 p.m. Eastern Time on Friday, November 13, 2009.

    Docket Numbers: ER10-105-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits revision to
its Transmission Owner Tariff, FERC Electric Tariff Second Revised
Volume 6 etc.
    Filed Date: 10/23/2009.
    Accession Number: 20091028-0010.
    Comment Date: 5 p.m. Eastern Time on Friday, November 13, 2009.

    Docket Numbers: ER10-119-000.
    Applicants: New York Independent System Operator, Inc.
    Description: ISO New England Inc et al. submits a filing in
compliance with Order No. 719-A.
    Filed Date: 10/27/2009.
    Accession Number: 20091028-0070.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 17, 2009.

    Docket Numbers: ER10-120-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits Twenty-
Seventh Quarterly filing of facilities agreements.
    Filed Date: 10/27/2009.
    Accession Number: 20091028-0075.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 17, 2009.

    Docket Numbers: ER10-122-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits a revised
interconnection service agreement.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-0066.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER10-123-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits a Network Integration
Transmission Service Agreement.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-0067.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER10-124-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits a Network Integration
Transmission Service Agreement.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-0068.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER10-125-000.
    Applicants: Xcel Energy Services Inc.
    Description: Xcel Energy on behalf of NSP Companies submits a
notice of cancellation of the Mobile Transformer Agreement.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-0073.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER10-129-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits executed Service
Agreement for Network Integration Transmission Service between SPP as
Transmission Provider and Kansas Electric Power cooperative, Inc as
Network Customer, etc.
    Filed Date: 10/28/2009.
    Accession Number: 20091029-0055.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER10-130-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits 8/6/09 confirmation
between Duke Energy Carolinas and North Carolina Electric Membership
Corporation.
    Filed Date: 10/28/2009.
    Accession Number: 20091029-0056.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.

    Docket Numbers: ER10-131-000.
    Applicants: Mid-Continent Area Power Pool.
    Description: Mid-Continent Area Power Pool submits revisions to
their Restated Agreement, FERC Electric Tariff, First Revised Volume No
2, effective 12/31/09.
    Filed Date: 10/28/2009.
    Accession Number: 20091029-0057.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 18, 2009.
    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES09-54-001.
    Applicants: Midwest Independent Transmission System Operation, Inc.

    Description: Supplement to Section 204 Application of Midwest
Independent Transmission System Operator, Inc.
    Filed Date: 10/28/2009.
    Accession Number: 20091028-5087.
    Comment Date: 5 p.m. Eastern Time on Monday, November 09, 2009.
    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-81-002.
    Applicants: NorthWestern Corporation.
    Description: NorthWestern Corporation submits an errata to its 9/
18/09 filing in compliance with the FERC 9/3/09 Letter Order etc.
    Filed Date: 10/22/2009.
    Accession Number: 20091026-0288.
    Comment Date: 5 p.m. Eastern Time on Thursday, November 12, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-26614 Filed 11-4-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34458-34459]
[FR Doc No: 2012-14088]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2012-0112]

Pipeline Safety: Requests for Special Permit

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice.

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

SUMMARY: Pursuant to the Federal pipeline safety laws, PHMSA is
publishing this notice of special permit requests we have received from
Norgasco, Inc., and BreitBurn Energy Company LP, two natural gas
pipeline operators, seeking relief from compliance with certain
requirements in the Federal pipeline safety regulations. This notice
seeks public comments on the requests, including comments on any safety
or environmental impacts. At the conclusion of the 30-day comment
period, PHMSA will evaluate the requests and determine whether to grant
or deny a special permit.

DATES: Submit any comments regarding these special permit requests by
July 11, 2012.

ADDRESSES: Comments should reference the docket numbers for the
specific special permit request and may be submitted in the following
ways:
     E-Gov Web Site: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: DOT Docket Management System: U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC
20590, between 9:00 a.m. and 5:00 p.m., Monday through Friday, except
Federal holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.

    Note: Comments are posted without changes or edits to http://www.Regulations.gov, including any personal information provided.
There is a privacy statement published on http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:
    General: Kay McIver by telephone at<PHONE_NUMBER>; or, email at
<EMAIL_ADDRESS>    Technical: Jeffery Gilliam by telephone at<PHONE_NUMBER>; or,
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: PHMSA has received requests for special
permits from two natural gas pipeline operators, Norgasco, Inc.,
(``NI''), and BreitBurn Energy Company LP (``BreitBurn'') seeking
relief from compliance with certain pipeline safety regulations.\1\ The
requests include a technical analysis provided by the operators. The
requests are filed in the Federal Docket Management System (FDMS) and
have been assigned docket numbers, (Norgasco--PHMSA-2011-0344 and
BreitBurn--PHMSA-2011-0343) in the FDMS. We invite interested persons
to participate by reviewing these special permit requests at http://www.Regulations.gov, and by submitting written comments, data or other
views. Please include any comments on potential environmental

impacts that may result if these special permits are granted.
---------------------------------------------------------------------------

    \1\ Effective December 31, 2011, BreitBurn Energy Company LP,
changed its name to Pacific Coast Energy Company, LP.
---------------------------------------------------------------------------

    Before acting on these special permit requests, PHMSA will evaluate
all comments received on or before the closing date. Comments will be
evaluated after this date if it is possible to do so without incurring
additional expense or delay. PHMSA will consider each relevant comment
we receive in making our decision to grant or deny the requests.
    PHMSA has received the following special permit requests:

----------------------------------------------------------------------------------------------------------------
                                                            Regulation(s)
            Docket No.                   Requester             affected            Nature of special permit
----------------------------------------------------------------------------------------------------------------
PHMSA-2011-0344..................  Norgasco, Inc.......  49 CFR 192.121.....  The special permit request from
                                                                               Norgasco, Inc. (``NI'') seeks
                                                                               permission to use Fiberspar pipe
                                                                               up to the hydrostatic design
                                                                               basis as listed by ASTM D 2517,
                                                                               to construct and operate a three
                                                                               mile long natural gas pipeline
                                                                               located in the Deadhorse area of
                                                                               Prudhoe Bay, Alaska. The pipeline
                                                                               is intended to transport natural
                                                                               gas from the oil and gas
                                                                               producers on the Alaskan North
                                                                               Slope to the existing Deadhorse
                                                                               natural gas distribution utility,
                                                                               Norgasco, Inc. The main portion
                                                                               is 2.76 miles long. All portions
                                                                               of the pipeline are located
                                                                               within the Alaskan North Slope
                                                                               Prudhoe Bay area. The entire
                                                                               pipeline is in a largely
                                                                               unpopulated area (Class 1) area.
                                                                               The pipeline will be constructed
                                                                               of a thermoset composite pipe
                                                                               that is manufactured by Fiberspar
                                                                               LinePipe, LLC. The pipeline is
                                                                               expected to be constructed during
                                                                               the 2012/2013 Winter construction
                                                                               season.
----------------------------------------------------------------------------------------------------------------
PHMSA-2011-0343..................  BreitBurn Energy      49 CFR 192.53(c),    The special permit request from
                                    Company LP.           192.121, 192.123,    BreitBurn Energy Company LP
                                                          192.619(a).          (``BreitBurn''), seeks permission
                                                                               to use composite, reinforced
                                                                               thermoplastic (``RTP'') for the
                                                                               replacement of a segment of steel
                                                                               pipeline located in the city of
                                                                               Los Angeles, California.
                                                                               BreitBurn plans to insert a 6-
                                                                               inch OD Smart Pipe system into
                                                                               the current 12-inch OD segment of
                                                                               the existing steel gas gathering
                                                                               line. The line is in need of
                                                                               replacement due to the age of the
                                                                               pipeline and the recently
                                                                               discovered presence of internal
                                                                               corrosion. In August 2011, a leak
                                                                               developed from a threaded
                                                                               connection of pipe. On further
                                                                               examination of a cut out section,
                                                                               internal corrosion was found. The
                                                                               normal operating pressure for
                                                                               this line is 220 psig and the
                                                                               MAOP is 245 psig. This line is a
                                                                               Type B line as specified in 49
                                                                               CFR Sec.   192.8. The entire area
                                                                               through which this pipeline
                                                                               travels, and indeed the general
                                                                               area of the City of Los Angeles,
                                                                               is a densely populated and
                                                                               utilized, Class 4 location as
                                                                               defined in 49 CFR Sec.   192.5.
----------------------------------------------------------------------------------------------------------------

    Authority: 49 U.S.C. 60118 (c)(1) and 49 CFR 1.53.

    Issued in Washington, DC on June 7, 2012.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2012-14088 Filed 6-8-12; 8:45 am]
BILLING CODE 4910-60-P


Meeting Summary

EPA/American Chemistry Council Chromated Arsenicals Meeting

August 14, 2008; 11:30 AM to 12:30 PM

Room S-8100, 2777 S. Crystal Drive, Arlington, VA 22202

Participants

American Chemistry Council: Has Shah, Bob Gruber, Seth Goldberg, Kevin
Archer, Chuck Shaw, Teri Muchow, Elizabeth Brown, Russ Morgan, Julie
Ownbey, Jeffrey Driver

EPA: Mark Hartman (AD), Tim Dole (AD), Nader Elkassabany (AD), Jonathan
Chen (AD), Jonathan Becker (BEAD), Tim Kiely (BEAD), Doreen Aviado (AD),
Phil Ross (OGC), Tim McMahon (AD), Najm Shamim (AD), Siroos Mostaghimi
(AD), Lance Wormell (AD)

Summary

On August 14, 2008, EPA reregistration team members met with the
American Chemistry Council’s Arsenical Wood Preservative Task Force
(AWPTF) regarding EPA’s upcoming reregistration eligibility decision
(RED) for wood preservative uses of chromated arsenicals (e.g., CCA).
The meeting was held at the AWPTF’s request to discuss EPA’s
preliminary review of the comments received on the revised risk
assessments during the public comment period ending June 16, 2008.

Based on a preliminary review, EPA intends to make revisions to the
revised risk assessments.  Although revisions are expected throughout
the assessments, EPA’s overall risk conclusions may remain unchanged.
The Agency’s formal review of and response to comments received will
be completed before the reregistration eligibility decision (RED) is
finalized in September 2008 and will be posted to the public docket.


[Federal Register Volume 88, Number 127 (Wednesday, July 5, 2023)]
[Notices]
[Pages 42938-42939]
[FR Doc No: 2023-14165]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0894; FRL-11032-01-OAR]

Proposed Information Collection Request; Comment Request;
Registration of Fuels and Fuel Additives--Requirements for
Manufacturers (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR) ``Registration of Fuels
and Fuel Additives--Requirements for Manufacturers'' (EPA ICR No.
0309.16, OMB Control No. 2060-0150) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA). Before doing so, EPA is soliciting public comments
on specific aspects of the proposed information collection as described
below. This is a proposed extension of the ICR, which is currently
approved through March 31, 2024. An Agency may not conduct or sponsor
and a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before September 5, 2023.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0894, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460. EPA's policy is that all comments
received will be included in the public docket without change including
any personal information provided, unless the comment includes
profanity, threats, information claimed to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance
Division, Office of Transportation and Air Quality, Mail Code 6405A,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: In accordance with the regulations at 40 CFR part 79,
subparts A, B, C, and D, Registration of Fuels and Fuel Additives,
manufacturers (including importers) of motor-vehicle gasoline, motor-
vehicle diesel fuel, and additives to those fuels, are required to have
these products registered by EPA prior to their introduction into
commerce. Registration involves providing a chemical description of the
fuel or additive, and certain technical, marketing, and health-effects
information. Manufacturers are also required to submit annual reports
on production volume and related information. The information is used
to identify products where evaporative or combustion emissions may pose
an unreasonable risk to public health, thus meriting further
investigation and potential regulation. The information is also used to
ensure that fuel additives comply with EPA requirements for protecting
catalytic converters and other automotive emission controls. The data

have been used to construct a comprehensive data base on fuel and
additive composition. The Mine Safety and Health Administration of the
Department of Labor restricts the use of diesel additives in
underground coal mines to those registered by EPA. Most of the
information has been claimed by the manufacturers as CBI.
    Form numbers: EPA Forms 3520-12, for the registration of a new
fuel, and 3520-13, for the registration of a new fuel additive, have
been replaced with on-line registration at: https://www.epa.gov/fuels-registration-reporting-and-compliance-help/register-or-update-fuel-or-fuel-additive-request. EPA Forms for annual reports, 3520-12A, 3520-
12Q, 3520-13A, and 3520-13B, are available at: https://www.epa.gov/fuels-registration-reporting-and-compliance-help/how-report-annually-fuel-and-fuel-additive and may be submitted on-line.
    Respondents/affected entities: Manufacturers and importers of
motor-vehicle gasoline, motor-vehicle diesel fuel, and additives to
those fuels.
    Respondents obligation to respond: Mandatory per 40 CFR part 79.
    Estimated number of respondents: 1,975.
    Frequency of response: On occasion, annually.
    Total estimated burden: 20,990 hours per year. Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $2.3 million per year, includes $53,500
annualized capital or operation & maintenance costs.
    Changes in estimates: There is a decrease of 1,260 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to a slight decrease in new
registration activity and reduction in reporting frequency from the
conversion of quarterly reports for fuel manufacturers to an annual
report. The change from quarterly to annual reports is found in 40 CFR
79.5(a).

Byron Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality.
[FR Doc. 2023-14165 Filed 7-3-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Notices]
[Page 57390]
[DOCID:fr05no09-109]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Gunnison-Crested Butte Regional Airport, Gunnison, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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

SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the Gunnison-Crested Butte Regional Airport under
the provisions of Section 47125(a) of Title 49 United States Code
(U.S.C.).

DATES: Comments must be received on or before December 7, 2009.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Craig A. Sparks, Manager, Federal
Aviation Administration, Northwest Mountain Region, Airports Division,
Denver Airports District Office, 26805 E. 68th Ave., Suite 224, Denver,
Colorado, 80249.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Mr. John DeVore, Airport Manager, 519 West Rio
Grande, Gunnison, Colorado 81230.

FOR FURTHER INFORMATION CONTACT: Mr. Chris Schaffer, Project Manager,
Federal Aviation Administration, Northwest Mountain Region, Airports
Division, Denver Airports District Office, 26805 E. 68th Ave., Suite
224, Denver, Colorado 80249.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Gunnison-Crested Butte Regional
Airport under the provisions of Section 47 125(a) of Title 49 United
States Code (U.S.C.). On October 16, 2009, the FAA determined that the
request to release property at the Gunnison-Crested Butte Regional
Airport submitted by the County of Gunnison, Colorado met the
procedural requirements of the Federal Aviation Regulations, Part 155.
The FAA may approve the request, in whole or inpart, no later than
December 7, 2009.
    The following is a brief overview of the request:
    The County of Gunnison, Colorado requests the release of 160 acres
of non-aeronautical airport property, otherwise known as Parcel 41 of
the Gunnison-Crested Butte Regional Airport. The purpose of this
release is to allow non-aviation related development of the parcel. The
sale of this parcel will provide funds for airport improvements.
    Any person may inspect the request by appointment at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, inspect the application, notice and
other documents germane to the application in person at the Gurmison-
Crested Butte Regional Airport, 519 West Rio Grande, Gunnison,
Colorado, 81230.

    Issued in Denver, Colorado, on October 16, 2009.
Craig A. Sparks,
Manager, Denver Airports District Office.
[FR Doc. E9-26481 Filed 11-4-09; 8:45 am]

BILLING CODE 4910-13-M