[Federal Register: March 1, 2007 (Volume 72, Number 40)]
[Notices]
[Page 9319-9320]
[DOCID:fr01mr07-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP07-86-000]

CenterPoint Energy Gas Transmission Company; Notice of
Application

February 23, 2007.
    Take notice that on February 20, 2007, CenterPoint Energy Gas
Transmission Company (CEGT), 1111 Louisiana Street, Houston, Texas
77002-5231, filed in Docket No. CP07-86-000, an application pursuant to
section 7(b) of the Natural Gas Act (NGA), to abandon its Line ADT-111
located in Oklahoma by sell to CenterPoint Energy Field Services, Inc.
In conjunction with the abandonment, CEGT seeks a determination that
the line is a gathering facility exempt from the Commission's
jurisdiction under NGA Section 1(b), all as more fully set forth in the
application which is on file with

the Commission and open to public inspection. This filing may also be
viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Lawrence O. Thomas, Director-Rates & Regulatory at CenterPoint Energy
Gas Transmission Co., P.O. Box 21734, Shreveport, Louisiana 71151, or
by calling<PHONE_NUMBER>.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify Federal and State agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments
protests and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1) (iii) and the instructions on the Commission's Web
(http://www.ferc.gov) site under the ``e-Filing'' link.

    Comment Date: March 16, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-3593 Filed 2-28-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35649-35653]
[FR Doc No: 2018-16067]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Generic Drug User Fee Rates for Fiscal Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II),
authorizes the Food and Drug Administration (FDA, Agency, or we) to
assess and collect fees for abbreviated new drug applications (ANDAs),
drug master files (DMFs), generic drug active pharmaceutical ingredient
(API) facilities, finished dosage form (FDF) facilities, contract
manufacturing organization (CMO) facilities, and generic drug applicant
program user fees. In this document, FDA is announcing fiscal year (FY)
2019 rates for GDUFA II fees.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14202J, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42) establish fees associated with human generic drug products. Fees
are assessed on: (1) Certain types of applications for human generic
drug products; (2) certain facilities where APIs and FDFs are produced;
(3) certain DMFs associated with human generic drug products; and (4)
generic drug applicants who have approved ANDAs (the program fee) (see
section 744B(a)(2)-(5) of the FD&C Act).
    GDUFA II stipulates that user fees should total $493,600,000
annually adjusted each year for inflation. For FY 2019, the generic
drug fee rates are: ANDA ($178,799), DMF ($55,013), domestic API
facility ($44,226), foreign API facility ($59,226), domestic FDF
facility ($211,305), foreign FDF facility ($226,305), domestic CMO
facility ($70,435), foreign CMO facility ($85,435), large size
operation generic drug applicant program ($1,862,167), medium size
operation generic drug applicant program ($744,867), and small business
generic drug applicant program ($186,217). These fees are effective on
October 1, 2018, and will remain in effect through September 30, 2019.

II. Fee Revenue Amount for FY 2019

    The base revenue amount for FY 2019 is $493,600,000, as set in the
statute (see section 744B(b)(1) of the FD&C Act). GDUFA II directs FDA
to use the yearly revenue amount as a starting point to set the fee
rates for each fee type. For more information about GDUFA II, please
refer to the FDA website (https://www.fda.gov/gdufa). The ANDA, DMF,
API facility, FDF facility, CMO facility, and generic drug applicant
program fee (GDUFA program fee) calculations for FY 2019 are described
in this document.
    GDUFA II specifies that the $493,600,000 is to be adjusted for
inflation increases for FY 2019 using two separate adjustments--one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see sections 744B(c)(1)(B) and (C) of the FD&C Act).
    The component of the inflation adjustment for PC&B costs shall be
one plus the average annual percent change in the cost of all PC&B paid
per full-time equivalent position (FTE) at FDA for the first 3 of the 4
preceding fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs of human generic drug activities for the first 3 of the
preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act).
    Table 1 summarizes the actual cost and total FTE 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 2019. The 3-year average is 2.4152 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2015               2016               2017          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,232,304,000     $2,414,728,159     $2,581,551,000  .................
Total FTE...........................             15,484             16,381             17,022  .................
PC&B per FTE........................           $144,168           $147,408           $151,660  .................
Percent Change from Previous Year...             2.1136             2.2474             2.8845             2.4152
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.4152 percent should be multiplied
by the proportion of PC&B expended for human generic drug activities
for the first 3 of the preceding 4 fiscal years. Table 2 shows the
amount of PC&B and the total amount obligated for human generic drug
activities from FY 2015 through FY 2017.

Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last
                                                     3 Years
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2015               2016               2017          3-Year average
----------------------------------------------------------------------------------------------------------------
PC&B................................       $201,116,305       $242,963,571       $271,748,229  .................
Non-PC&B............................       $251,589,013       $250,987,599       $262,058,852  .................
Total Costs.........................       $452,705,318       $493,951,170       $533,807,081  .................

PC&B Percent........................            44.4254            49.1878            50.9076            48.1736
Non-PC&B Percent....................            55.5746            50.8122            49.0924            51.8264
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.4152 percent multiplied by 48.1736
percent (or 1.1635 percent).
    The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2019 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;
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 costs of human generic drug activities (see section 744B(c)(1)(C)
of the FD&C Act). Table 3 provides the summary data for the percent
change in the specified CPI. The data are published by the Bureau of
Labor Statistics and can be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.

             Table 3--Annual and 3-Year Average Percent Change in CPI for Baltimore-Washington Area
----------------------------------------------------------------------------------------------------------------
                Year                         2015               2016               2017          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            155.353            157.180            159.202  .................
Annual Percent Change...............             0.3268             1.1760             1.2864             0.9297
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (0.9297 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Because 48.1736 percent was
obligated for PC&B as shown in table 2, 51.8264 percent is the portion
of costs other than PC&B. The non-pay adjustment is 0.9297 percent
times 51.8264 percent, or 0.4818 percent.
    To complete the inflation adjustment for FY 2019, we add the PC&B
component (1.1635 percent) to the non-PC&B component (0.4818 percent)
for a total inflation adjustment of 1.6453 percent (rounded), making
1.016453. We then multiply the base revenue amount for FY 2019
($493,600,000) by 1.016453, yielding an inflation-adjusted amount of
$501,721,000 (rounded to the nearest thousand dollars).

III. ANDA Filing Fee

    Under GDUFA II, the FY 2019 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2018. This fee is
due on the submission date of the ANDA. Section 744B(b)(2)(B) of the
FD&C Act specifies that the ANDA fee will make up 33 percent of the
$501,721,000, which is $165,567,930.
    To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2019. The
submissions are broken down into three categories: New originals
(submissions that have not been received by FDA previously);
submissions that have been refused to receive (RTR) for reasons other
than failure to pay fees; and applications that are resubmitted after
having been RTR for reasons other than failure to pay fees. An ANDA
counts as one FAE; however, 75 percent of the fee paid for an ANDA that
has been RTR shall be refunded according to GDUFA II if (1) the ANDA is
refused for a cause other than failure to pay fees, or (2) the ANDA has
been withdrawn prior to receipt (section 744B(a)(2)(D)(i) of the FD&C
Act). Therefore, an ANDA that is considered not to have been received
by FDA due to reasons other than failure to pay fees or withdrawn prior
to receipt counts as one-fourth of an FAE. After an ANDA has been RTR,
the applicant has the option of resubmitting. For user fee purposes,
these resubmissions are equivalent to new original submissions--ANDA
resubmissions are charged the full amount for an application (one FAE).
    FDA utilized data from ANDAs submitted from October 1, 2013, to
April 30, 2018, to estimate the number of new original ANDAs that will
incur filing fees in FY 2019. For FY 2019, the Agency estimates that
approximately 918 new original ANDAs will be submitted and incur filing
fees. Not all of the new original ANDAs will be received by the Agency
and some of those not received will be resubmitted in the same fiscal
year. Therefore, the Agency expects that the FAE count for ANDAs will
be 926 for FY 2019.
    The FY 2019 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2019 (926) into the fee revenue amount
to be derived from ANDA application fees in FY 2019 ($165,567,930). The
result, rounded to the nearest dollar, is a fee of $178,799 per ANDA.
    The statute provides that those ANDAs that include information
about the production of active pharmaceutical ingredients other than by
reference to a DMF will pay an additional fee that is based on the
number of such active pharmaceutical ingredients and the number of
facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA considers that this additional fee
is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs.

IV. DMF Fee

    Under GDUFA II, the DMF fee is owed by each person that owns a type
II active pharmaceutical ingredient DMF that is referenced, on or after
October 1, 2012, in a generic drug submission by an initial letter of
authorization. This is a one-time fee for each DMF. This fee is due on
the earlier of the date on which the first generic drug submission is
submitted that references the associated DMF or the date on which the
drug master file holder requests the initial completeness assessment.
Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has
successfully undergone an initial completeness assessment and the fee
is paid, the DMF will be placed on a publicly available list
documenting DMFs available for reference.
    To calculate the DMF fee, FDA assessed the volume of DMF

submissions over time. The Agency assessed DMFs from October 1, 2016,
to April 30, 2018, and concluded that averaging the number of fee-
paying DMFs provided the most accurate model for predicting fee-paying
DMFs for FY 2019. The monthly average of paid DMF submissions the
Agency received in FY 2017 and FY 2018 is 38. To determine the FY 2019
projected number of fee-paying DMFs, the average of 38 DMF submissions
is multiplied by 12 months, which results in 456 estimated FY 2019 fee-
paying DMFs. FDA is estimating 456 fee-paying DMFs for FY 2019.
    The FY 2019 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2019. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $501,721,000, which is $25,086,050. Dividing the DMF
revenue amount ($25,086,050) by the estimated fee-paying DMFs (456),
and rounding to the nearest dollar, yields a DMF fee of $55,013 for FY
2019.

V. Foreign Facility Fee Differential

    Under GDUFA II, the fee for a facility located outside the United
States and its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United States and
its territories and possessions. The basis for this differential is the
extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.

VI. FDF and CMO Facility Fees

    Under GDUFA II, the annual FDF facility fee is owed by each person
who owns an FDF facility that is identified in at least one approved
generic drug submission owned by that person or his affiliates. The CMO
facility fee is owed by each person who owns an FDF facility that is
identified in at least one approved ANDA but is not identified in an
approved ANDA held by the owner of that facility or its affiliates.
These fees are due no later than the first business day on or after
October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act
specifies that the FDF and CMO facility fee revenue will make up 20
percent of the $501,721,000, which is $100,344,200.
    To calculate the fees, data from FDA's Integrity Services (IS) were
utilized as the primary source of facility information for determining
the denominators of each facility fee type. IS is the master data
steward for all facility information provided in generic drug
submissions received by FDA. A facility's reference status in an
approved generic drug submission is extracted directly from submission
data rather than relying on data from self-identification. This
information provided the number of facilities referenced as FDF
manufacturers in at least one approved generic drug submission. Based
on FDA's IS data, the FDF and CMO facility denominators are 180 FDF
domestic, 216 FDF foreign, 73 CMO domestic, and 97 CMO foreign
facilities for FY 2019.
    GDUFA II specifies that the CMO facility fee is to be equal to one-
third the amount of the FDF facility fee. Therefore, to generate the
target collection revenue amount from FDF and CMO facility fees
($100,344,200), FDA must weight a CMO facility as one-third of an FDF
facility. FDA set fees based on the estimate of 180 FDF domestic, 216
FDF foreign, 24.33 CMO domestic (73 multiplied by one-third), and 32.33
CMO foreign facilities (97 multiplied by one-third), which equals
452.66 total weighted FDF and CMO facilities for FY 2019.
    To calculate the fee for domestic facilities, FDA first determines
the total fee revenue that will result from the foreign facility
differential by subtracting the fee revenue resulting from the foreign
facility fee differential from the target collection revenue amount
($100,344,200) as follows. The foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (216) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (97), totaling $4,695,000. This results in
foreign fee differential revenue of $4,695,000 from the total FDF and
CMO facility fee target collection revenue. Subtracting the foreign
facility differential fee revenue ($4,695,000) from the total FDF and
CMO facility target collection revenue ($100,344,200) results in a
remaining facility fee revenue balance of $95,649,200. To determine the
domestic FDF facility fee, FDA divides the $95,649,200 by the total
weighted number of FDF and CMO facilities (452.66), which results in a
domestic FDF facility fee of $211,305. The foreign FDF facility fee is
$15,000 more than the domestic FDF facility fee, or $226,305.
    According to GDUFA II, the domestic CMO fee is calculated as one-
third the amount of the domestic FDF facility fee. Therefore, the
domestic CMO fee is $70,435, rounded to the nearest dollar. The foreign
CMO fee is calculated as the domestic CMO fee plus the foreign fee
differential of $15,000. Therefore, the foreign CMO fee is $85,435.

VII. API Facility Fee

    Under GDUFA II, the annual API facility fee is owed by each person
who owns a facility that is identified in (1) at least one approved
generic drug submission or (2) in a Type II API DMF referenced in at
least one approved generic drug submission. These fees are due no later
than the first business day on or after October 1 of each such year.
Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee
will make up 7 percent of $501,721,000 in fee revenue, which is
$35,120,470.
    To calculate the API facility fee, data from FDA's IS were utilized
as the primary source of facility information for determining the
denominator. As stated above, IS is the master data steward for all
facility information provided in generic drug submissions received by
FDA. A facility's reference status in an approved generic drug
submission is extracted directly from submission data rather than
relying on data from self-identification. This information provided the
number of facilities referenced as API manufacturers in at least one
approved generic drug submission.
    The total number of API facilities identified was 613; of that
number, 79 were domestic and 534 were foreign facilities. The foreign
facility differential is $15,000. To calculate the fee for domestic
facilities, FDA must first subtract the fee revenue that will result
from the foreign facility fee differential. FDA takes the foreign
facility differential ($15,000) and multiplies it by the number of
foreign facilities (534) to determine the total fee revenue that will
result from the foreign facility differential. As a result of that
calculation, the foreign fee differential revenue will make up
$8,010,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($8,010,000) from the total API
facility target revenue ($35,120,470) results in a remaining balance of
$27,110,470. To determine the domestic API facility fee, we divide the
$27,110,470 by the total number of facilities (613), which gives us a
domestic API facility fee of $44,226. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $59,226.

VIII. Generic Drug Applicant Program Fee

    Under GDUFA II, if a person and its affiliates own at least one but
not more than five approved ANDAs on October 1, 2018, the person and
its affiliates shall owe a small business GDUFA program fee. If a
person and its affiliates own at least 6 but not more than 19

approved ANDAs, the person and its affiliates shall owe a medium size
operation GDUFA program fee. If a person and its affiliates own at
least 20 approved ANDAs, the person and its affiliates shall owe a
large size operation GDUFA program fee. These fees are due no later
than the first business day on or after October 1 of each such year.
Section 744B(b)(2)(E) of the FD&C Act specifies the GDUFA program fee
will make up 35 percent of $501,721,000 in fee revenue, which is
$175,602,350.
    To determine the appropriate number of applicants for each tier,
the Agency has posted lists of approved ANDAs on the FDA website
(https://www.fda.gov/gdufa) and asked applicants on the list to claim
which ANDAs and affiliates belong to the parent company. The original
list of approved ANDAs came from the Agency's Document Archiving,
Reporting, and Regulatory Tracking System (DARRTS), which included all
ANDAs with the status of ``approved'' as of April 30, 2018.
    In determining the appropriate number of approved ANDAs, the Agency
has factored in a number of variables that could affect the collection
of the target revenue: (1) Inactive ANDAs--applicants who have not
submitted an annual report for one or more of their approved
applications within the past 2 years; (2) FY 2018 Program Fee Arrears
List--applicants who failed to satisfy the FY 2018 program fee and were
unresponsive to attempts to collect; and (3) Prediction of Approvals
Due to Goal Dates and Office of Generic Drugs Approval Rate--Due to the
low percentage of additional approved ANDAs for a specified time period
and the difficulties in determining how this population would affect
the program fee tier of each company, this variable was not included in
the determination of the FY 2019 GDUFA program fee. The list of
original approved ANDAs from the DARRTS database as of April 30, 2018,
shows 259 applicants in the small business tier, 62 applicants in the
medium size tier, and 58 applicants in the large size tier. This list
also takes into account all the withdrawals, consolidations, and
transfer of ownerships from industry as of April 30, 2018. Factoring in
all the variables for the second year of GDUFA II, the Agency estimates
there will be 177 applicants in the small business tier, 49 applicants
in the medium size tier, and 57 applicants in the large size tier for
FY 2019.
    To calculate the GDUFA program fee, GDUFA II provides that large
size operation generic drug applicants pay the full fee, medium size
operation applicants pay two-fifths of the full fee, and small business
applicants pay one-tenth of the full fee. To generate the target
collection revenue amount from GDUFA program fees ($175,602,350), we
must weigh medium and small tiered applicants as a subset of a large
size operation generic drug applicant. FDA will set fees based on the
weighted estimate of 17.70 applicants in the small business tier (177
multiplied by 10 percent), 19.60 applicants in the medium size tier (49
multiplied by 40 percent), and 57 applicants in the large size tier,
arriving at 94.30 total weighted applicants for FY 2019.
    To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $175,602,350 by 94.30, which equals
$1,862,167. The medium size operation GDUFA program fee is 40 percent
of the full fee ($744,867), and the small business operation GDUFA
program fee is 10 percent of the full fee ($186,217).

IX. Fee Schedule for FY 2019

    The fee rates for FY 2019 are set out in table 4.

                    Table 4--Fee Schedule for FY 2019
------------------------------------------------------------------------
                                                          Fees rates for
                      Fee category                            FY 2019
------------------------------------------------------------------------
Applications:                                             ..............
    Abbreviated New Drug Application (ANDA).............        $178,799
    Drug Master File (DMF)..............................          55,013
Facilities:                                               ..............
Active Pharmaceutical Ingredient (API) Domestic.........          44,226
    API--Foreign........................................          59,226
    Finished Dosage Form (FDF)--Domestic................         211,305
    FDF--Foreign........................................         226,305
    Contract Manufacturing Organization (CMO)--Domestic.          70,435
    CMO--Foreign........................................          85,435
GDUFA Program:                                            ..............
    Large size operation generic drug applicant.........       1,862,167
    Medium size operation generic drug applicant........         744,867
    Small business operation generic drug applicant.....         186,217
------------------------------------------------------------------------

X. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2018. To pay the ANDA,
DMF, API facility, FDF facility, CMO facility, and GDUFA program fees,
a Generic Drug User Fee Cover Sheet must be completed, available at
https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee identification (ID) number must be
generated. Payment must be made in U.S. currency drawn on a U.S. bank
by electronic check, check, bank draft, U.S. postal money order, credit
card, or wire transfer. 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. (Note: IOnly full payments are
accepted; no partial payments can be made online.) Once an invoice is
located, ``Pay Now'' should be selected to be redirected to https://www.pay.gov/public/home (Pay.gov). 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 made using U.S. bank accounts as
well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the Generic Drug User Fee

Cover Sheet and generating the user fee ID number.
    The user fee ID number must be included on the check, bank draft,
or postal money order and must be made payable to the order of the Food
and Drug Administration. Payments can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. For questions concerning courier
delivery, U.S. Bank can be contacted at<PHONE_NUMBER>. This telephone
number is only for questions about courier delivery.) The FDA post
office box number (P.O. Box 979108) must be written on the check, bank
draft, or postal money order.
    For payments made by wire transfer, the unique user fee ID number
must be referenced. Without the unique user fee ID number, the payment
may not be applied. If the payment amount is not applied, the invoice
amount will be referred to collections. The originating financial
institution may charge a wire transfer fee. Applicable wire transfer
fees must be included with payment to ensure fees are fully paid.
Questions about wire transfer fees should be addressed to the financial
institution. The following account information should be used to send
payments by wire transfer: U.S. Department of Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, account number: 75060099, routing
number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is
53-0196965.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16067 Filed 7-26-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Notices]
[Pages 18743-18744]
[FR Doc No: 2011-7991]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC11-603-000]

Commission Information Collection Activities (FERC-603); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of proposed information collection and request for
comments.

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SUMMARY: In compliance with the requirements of section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A) (2006)
(Pub. L. 104-13), the Federal Energy Regulatory Commission (Commission
or FERC) is soliciting public comment on the proposed information
collection described below.

DATES: Comments in consideration of the collection of information are
due June 3, 2011.

ADDRESSES: Comments may be filed either electronically (eFiled) or in
paper format, and should refer to Docket No. IC11-603-000. Documents
must be prepared in an acceptable filing format and in compliance with
Commission submission guidelines at http://www.ferc.gov/help/submission-guide.asp. eFiling instructions are available at: http://www.ferc.gov/docs-filing/efiling.asp. First time users must follow
eRegister instructions at: http://www.ferc.gov/docs-filing/eregistration.asp, to establish a user name and password before
eFiling. The Commission will send an automatic acknowledgement to the
sender's e-mail address upon receipt of eFiled comments. Commenters
making an

eFiling should not make a paper filing. Commenters that are not able to
file electronically must send an original and two (2) paper copies of
their comments to: Federal Energy Regulatory Commission, Secretary of
the Commission, 888 First Street, NE., Washington, DC 20426.
    Users interested in receiving automatic notification of activity in
this docket may do so through eSubscription at http://www.ferc.gov/docs-filing/esubscription.asp. All comments and FERC issuances may be
viewed, printed or downloaded remotely through FERC's eLibrary at
http://www.ferc.gov/docs-filing/elibrary.asp, by searching on Docket
No. IC11-603. For user assistance, contact FERC Online Support by e-
mail at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.

FOR FURTHER INFORMATION: Ellen Brown may be reached by e-mail at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC-603 ``Critical Energy Infrastructure Information''
(OMB No. 1902-0197) is used by the Commission to implement procedures
for gaining access to critical energy infrastructure information (CEII)
that would not otherwise be available under the Freedom of Information
Act (5 USC 552). On February, 21, 2003, the Commission issued Order No.
630 (66 FR 52917) to address the appropriate treatment of CEII in the
aftermath of the September 11, 2001 terrorist attacks and to restrict
unrestrained general access due to the ongoing terrorism threat. These
steps enable the Commission to keep sensitive infrastructure
information out of the public domain, decreasing the likelihood that
such information could be used to plan or execute terrorist attacks.
The process adopted in Order No. 630 is a more efficient alternative
for handling requests for previously public documents than FOIA The
Commission has defined CEII to include information about ``existing or
proposed critical infrastructure that (i) relates to the production,
generation, transportation, transmission, or distribution of energy;
(ii) could be useful to a person planning an attack on critical
infrastructure; (iii) is exempt from mandatory disclosure under the
Freedom of Information Act, and (iv) does not simply give the location
of the critical infrastructure. Critical infrastructure means existing
and proposed systems and assets, whether physical or virtual, the
incapacity or destruction of which would negatively affect security,
economic security, public health or safety, or any combination of those
matters. A person seeking access to CEII may file a request for that
information by providing information about their identity and reason as
to the need for the information. Through this process, the Commission
is able to review the requester's need for the information against the
sensitivity of the information. The compliance with these requirements
is mandatory.
    Action: The Commission is requesting a three-year extension of the
current expiration date, with changes to the existing collection of
data.
    Burden Statement: Public reporting burden for this collection is
estimated as:

----------------------------------------------------------------------------------------------------------------
                                                 Number of        Number of     Average  burden
               Data collection                  respondents     responses per      hours  per      Total annual
                                                annually \1\      respondent        response       burden hours
                                                         (1)              (2)              (3)      (1)x(2)x(3)
----------------------------------------------------------------------------------------------------------------
FERC-603....................................             200                1              .30               60
----------------------------------------------------------------------------------------------------------------
\1\ The number of respondents corresponds to the number of requests received annually while recognizing that
  some CEII requests are filed by multiple parties.

    The estimated total cost to respondents is $4,080. The cost per
respondent = $20.40. (60 hours @ $68 hourly rate (rounded off)).
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) 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; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including 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.

    Dated: March 17, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-7991 Filed 4-4-11; 8:45 am]
BILLING CODE 6717-01-P