Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012, 45814-45818 [2011-19334]
Download as PDF
<![CDATA[
45814
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
TABLE 2—FY 2012 FEE RATES—Continued
Fee rate for
FY 2012
Animal drug user fee category
Animal Drug Establishment Fee 1 ........................................................................................................................................................
Animal Drug Sponsor Fee 2 .................................................................................................................................................................
1 An
2 An
animal drug establishment is subject to only one such fee each fiscal year.
animal drug sponsor is subject to only one such fee each fiscal year.
IX. Procedures for Paying the FY 2012
Fees
A. Application Fees and Payment
Instructions
srobinson on DSK4SPTVN1PROD with NOTICES
93,050
67,200
The appropriate application fee
established in the new fee schedule
must be paid for an animal drug
application or supplement subject to
fees under ADUFA that is submitted
after September 30, 2011. Payment must
be made in U.S. currency by check,
bank draft, or U.S. postal money order
payable to the order of the Food and
Drug Administration, by wire transfer,
or electronically using Pay.gov. (The
Pay.gov payment option is available to
you after you submit a cover sheet. Click
the ‘‘Pay Now’’ button.) On your check,
bank draft, or U.S. postal money order,
please write your application’s unique
Payment Identification Number (PIN),
beginning with the letters AD, from the
upper right-hand corner of your
completed Animal Drug User Fee Cover
Sheet. Also write the FDA post office
box number (P.O. Box 953877) on the
enclosed check, bank draft, or money
order. Your payment and a copy of the
completed Animal Drug User Fee Cover
Sheet can be mailed to: Food and Drug
Administration, P.O. Box 953877, St.
Louis, MO 63195–3877.
If payment is made by wire transfer,
send payment to: U.S. Department of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, FDA Deposit
Account Number: 75060099, U.S.
Department of Treasury routing/transit
number: 021030004, SWIFT Number:
FRNYUS33. You are responsible for any
administrative costs associated with the
processing of a wire transfer. Contact
your bank or financial institution
regarding additional fees.
If you prefer to send a check by a
courier such as Federal Express
(FEDEX) or United Parcel Service (UPS),
the courier may deliver the check and
printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox
953877, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is
for courier delivery only. If you have
any questions concerning courier
delivery contact the U.S. Bank at 314–
418–4821. This telephone number is
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
only for questions about courier
delivery.)
The tax identification number of the
Food and Drug Administration is
530196965. (Note: In no case should the
payment for the fee be submitted to FDA
with the application.)
It is helpful if the fee arrives at the
bank at least a day or two before the
application arrives at FDA’s CVM. FDA
records the official application receipt
date as the later of the following: The
date the application was received by
FDA’s CVM, or the date U.S. Bank
notifies FDA that your payment in the
full amount has been received, or when
the U.S. Treasury notifies FDA of
receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S.
Treasury are required to notify FDA
within one working day, using the PIN
described previously.
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.
B. Application Cover Sheet Procedures
Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Step One—Create a user account and
password. Log on to the ADUFA Web
site at https://www.fda.gov/ForIndustry/
UserFees/AnimalDrugUserFeeAct
ADUFA/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 Fee 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
IX.A of this document.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
C. Product, Establishment, and Sponsor
Fees
By December 31, 2011, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2012 using this Fee
Schedule. Payment will be due and
payable within 30 days of issuance of
the invoice. FDA will issue invoices in
November 2012 for any products,
establishments, and sponsors subject to
fees for FY 2012 that qualify for fees
after the December 2011 billing.
[FR Doc. 2011–19336 Filed 7–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0547]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2012
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2012 generic new animal drug
user fees. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Animal Generic Drug
User Fee Act of 2008 (AGDUFA),
authorizes FDA to collect user fees for
certain abbreviated applications for
generic new animal drugs, on certain
generic new animal drug products, and
on certain sponsors of such abbreviated
applications for generic new animal
drugs and/or investigational
SUMMARY:
E:\FR\FM\01AUN1.SGM
01AUN1
45815
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
submissions for generic new animal
drugs. This notice establishes the fee
rates for FY 2012.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/default.htm
or contact Lisa Kable, Center for
Veterinary Medicine (HFV–10), Food
and Drug Administration, 7529 Standish
Pl., Rockville, MD 20855, 240–276–
9718. For general questions, you may
also email the Center for Veterinary
Medicine (CVM) at:
cvmagdufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21
U.S.C. 379j–21) establishes three
different kinds of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs, (2) annual
fees for certain generic new animal drug
products, and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). When certain conditions are met,
FDA will waive or reduce fees for
generic new animal drugs intended
solely to provide for a minor use or
minor species indication (21 U.S.C.
379j–21(d)).
For FY 2009 through FY 2013, the
FD&C Act establishes aggregate yearly
base revenue amounts for each of these
fee categories. Base revenue amounts
established for years after FY 2009 may
be adjusted for workload. Fees for
applications, products, and sponsors are
to be established each year by FDA so
that the revenue for each fee category
will approximate the level established
in the statute, after the level has been
adjusted for workload.
C. Workload Adjustment to Inflation
Adjusted Fee Revenue Amount
For FY 2012, the generic new animal
drug user fee rates are: $124,900 for
each abbreviated application for a
generic new animal drug; $6,200 for
each generic new animal drug product;
$54,350 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $40,763 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $27,175
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
FY 2012 product and sponsor fees by
December 31, 2011. These fees will be
due and payable within 30 days of the
issuance of the invoices. The
application fee rates are effective for all
abbreviated applications for a generic
new animal drug submitted on or after
October 1, 2011, and will remain in
effect through September 30, 2012.
Applications will not be accepted for
review until FDA has received full
payment of related application fees and
any other fees owed under the Animal
Generic Drug User Fee program.
II. Revenue Amount for FY 2012
A. Statutory Fee Revenue Amounts
AGDUFA (Title II of Pub. L. 110–316
signed by the President on August 14,
2008) specifies that the aggregate
revenue amount for FY 2012 for
abbreviated application fees is
$1,712,000 and each of the other two
generic new animal drug user fee
categories, annual product fees and
annual sponsor fees, is $1,997,000 each,
before any adjustment for workload is
made (see 21 U.S.C. 379j–21(b)).
B. Inflation Adjustment to Fee Revenue
Amount
The amounts established in AGDUFA
for each year for FY 2009 through FY
2013 include an inflation adjustment;
so, no inflation adjustment is required.
For each FY beginning after FY 2009,
AGDUFA provides that statutory fee
revenue amounts shall be further
adjusted to reflect changes in review
workload (21 U.S.C. 379j–21(c)(1)).
FDA calculated the average number of
each of the four types of applications
and submissions specified in the
workload adjustment provision
(abbreviated applications for generic
new animal drugs, manufacturing
supplemental abbreviated applications
for generic new animal drugs,
investigational generic new animal drug
study submissions, and investigational
generic new animal drug protocol
submissions) received over the 5-year
period ended on September 30, 2008
(the base years), and the average number
of each of these types of applications
and submissions over the most recent 5year period that ended on June 30, 2011.
The results of these calculations are
presented in the first two columns of
table 1 of this document. Column 3
reflects the percent change in workload
over the two 5-year periods. Column 4
shows the weighting factor for each type
of application, reflecting how much of
the total FDA generic new animal drug
review workload was accounted for by
each type of application or submission
in the table during the most recent 5
years. Column 5 of table 1 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 1, the sum
of the values in column 5 is calculated,
reflecting a total change in workload of
negative 25.7 percent for FY 2012. This
is the workload adjuster for FY 2012.
TABLE 1—WORKLOAD ADJUSTER CALCULATION
Column 1
5-Year
average
(base years)
Application type
Column 2
Latest
5-year
average
Column 3
Percent
change
Column 4
Weighting
factor
Column 5
Weighted
percent
change
44.2
114.6
17.4
21.6
25.4
118.4
17.0
15.6
¥43
3
¥2
¥28
50%
22%
10%
17%
¥21.3
0.7
¥0.2
¥4.8
FY 2012 AGDUFA Workload Adjuster .............................................
srobinson on DSK4SPTVN1PROD with NOTICES
Abbreviated New Animal Drug Applications (ANADAs) ..........................
Manufacturing Supplements ANADAs .....................................................
Generic Investigational Study Submissions ............................................
Generic Investigational Protocol Submissions ........................................
....................
....................
....................
....................
¥25.7
AGDUFA specifies that the workload
adjuster may not result in fees for a
fiscal year that are less than the
statutory revenue amount (21 U.S.C.
379j–21(c)(1)(B)) for that fiscal year.
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
Because applying the workload adjuster
for FY 2012 would result in fees less
than the statutory amount, the workload
adjustment will not be applied in FY
2012. As a result, the statutory revenue
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
amount for each category of fees for FY
2012 ($1,712,000 for application fees
and $1,997,000 for both product and
sponsor fees) becomes the revenue
target for the fees in FY 2012, for a total
E:\FR\FM\01AUN1.SGM
01AUN1
45816
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
fee revenue target in FY 2012 of
$5,706,000 for fees from all three
categories.
srobinson on DSK4SPTVN1PROD with NOTICES
III. Abbreviated Application Fee
Calculations for FY 2012
The term ‘‘abbreviated application for
a generic new animal drug’’ is defined
in 21 U.S.C. 379j–21(k)(1).
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
The application fee must be paid for
abbreviated applications for a generic
new animal drug that is subject to fees
under AGDUFA and that is submitted
on or after July 1, 2008. The application
fees are to be set so that they will
generate $1,712,000 in fee revenue for
FY 2012. This is the amount set out in
the statute.
To set fees for abbreviated
applications for generic new animal
drugs to realize $1,712,000, FDA must
first make some assumptions about the
number of fee-paying abbreviated
applications it will receive during FY
2012.
The Agency knows the number of
applications that have been submitted
in previous years. That number
fluctuates significantly from year to
year. FDA is making estimates and
applying different assumptions for two
types of submissions: Original
submissions of abbreviated applications
for generic new animal drugs and
‘‘reactivated’’ submissions of
abbreviated applications for generic new
animal drugs. Any original submissions
of abbreviated applications for generic
new animal drugs that were received by
FDA before July 1, 2008, were not
assessed fees (21 U.S.C. 379j–
21(a)(1)(A)). Some of these non-feepaying submissions were later
resubmitted after July 1 because the
initial submission was not approved by
FDA (i.e., FDA marked the submission
as incomplete and requested additional
nonadministrative information) or
because the original submission was
withdrawn by the sponsor. Because
these abbreviated applications for
generic new animal drugs are
resubmitted after July 1, 2008, they are
assessed fees. In this notice, FDA refers
to these resubmitted applications as
‘‘reactivated’’ applications.
Regarding original submissions of
abbreviated applications for generic new
animal drugs, FDA is assuming that the
number of applications that will pay
fees in FY 2012 will equal 30 percent
less than the average number of
submissions over the 5 most recent
completed years (2006–2010). This 30percent reduction is made because of
the anticipated impact of fees on the
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
number of submissions. The average
number of original submissions of
abbreviated applications for generic new
animal drugs over the 5 most recent
completed years is 14.4. Applying a 30percent reduction to the 14.4 average,
the estimate for original submissions of
abbreviated applications for generic new
animal drugs for FY 2012 is 10.1. (If the
number of original submissions of
abbreviated applications for generic new
animal drugs does not increase over the
next year, a higher percent reduction
will have to be applied next year when
fees are set for FY 2013.)
Regarding reactivated submissions of
abbreviated applications for generic new
animal drugs, FDA is applying a 75percent reduction. This is based on the
fact that there were a limited number of
original submissions of abbreviated
applications for generic new animal
drugs received by FDA before July 1,
2008, which were not assessed fees. For
these original submissions that were not
approved before July 1, 2008,
resubmission to FDA would trigger an
application fee (21 U.S.C. 379j–
21(a)(1)(A)). Once these initial original
submissions of abbreviated applications
for generic new animal drugs received
by FDA before July 1, 2008, have either
been withdrawn or resubmitted,
‘‘reactivation submissions’’ will cease
completely. This reduction is consistent
with estimates made when this user fee
program was in the development
process. The average number of receipts
for reactivated submissions of
abbreviated applications for generic new
animal drugs is 14.5 per year, which is
the average of the 5 most recent
completed years. Applying a 75-percent
reduction to the 14.5 average, the
estimate for reactivated submissions of
abbreviated applications for generic new
animal drugs for FY 2012 is 3.6. These
reductions may not fully account for
possible year to year fluctuations in
numbers of fee-paying applications, but
FDA believes that this is a reasonable
approach after years of experience with
other user fee programs.
Based on the previous assumptions,
FDA is estimating that it will receive a
total of 13.7 fee-paying generic new
animal drug applications in FY 2012
(10.1 original applications and 3.6
reactivations).
B. Fee Rates for FY 2012
FDA must set the fee rates for FY 2012
so that the estimated 13.7 abbreviated
applications that pay the fee will
generate a total of $1,712,000. To
generate this amount, the fee for a
generic new animal drug application,
rounded to the nearest hundred dollars,
will have to be $124,900.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
IV. Generic New Animal Drug Product
Fee Calculations for FY 2012
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The generic new animal drug product
fee (also referred to as the product fee)
must be paid annually by the person
named as the applicant in an
abbreviated new animal drug
application or supplemental abbreviated
application for generic new animal
drugs 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 abbreviated application for
a generic new animal drug or
supplemental abbreviated application
for a generic new animal drug pending
at FDA after September 1, 2008 (see 21
U.S.C. 379j–21(a)(2)). The term ‘‘generic
new 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 abbreviated
application for a generic new animal
drug or supplemental abbreviated
application for a generic new animal
drug has been approved (21 U.S.C. 379j–
21(k)(6)). The product fees are to be set
so that they will generate $1,997,000 in
fee revenue for FY 2012. This is the
amount set out in the statute and no
further adjustments are required for FY
2012.
To set generic new animal drug
product fees to realize $1,997,000, FDA
must make some assumptions about the
number of products for which these fees
will be paid in FY 2012. FDA gathered
data on all generic new 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 FDA estimated would have
an abbreviated new animal drug
application or supplemental abbreviated
application pending after September 1,
2008. FDA estimates a total of 358
products submitted for listing by
persons who had an abbreviated
application for a generic new animal
drug or supplemental abbreviated
application for a generic new animal
drug pending after September 1, 2008.
Based on this, FDA believes that a total
of 358 products will be subject to this
fee in FY 2012.
In estimating the fee revenue to be
generated by generic new animal drug
product fees in FY 2012, FDA is
assuming that approximately 10 percent
of the products invoiced, or 36, will not
pay fees in FY 2012 due to fee waivers
E:\FR\FM\01AUN1.SGM
01AUN1
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
and reductions. Based on experience
with other user fee programs and the
first 3 years of AGDUFA, FDA believes
that this is a reasonable basis for
estimating the number of fee-paying
products in FY 2012.
Accordingly, the Agency estimates
that a total of 322 (358 minus 36)
products will be subject to product fees
in FY 2012.
B. Product Fee Rates for FY 2012
FDA must set the fee rates for FY 2012
so that the estimated 322 products that
pay fees will generate a total of
$1,997,000. To generate this amount
will require the fee for a generic new
animal drug product, rounded to the
nearest 5 dollars, to be $6,200.
V. Generic New Animal Drug Sponsor
Fee Calculations for FY 2012
srobinson on DSK4SPTVN1PROD with NOTICES
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The generic new 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
abbreviated application for a new
generic animal drug, 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 submission for a generic
new animal drug that has not been
terminated or otherwise rendered
inactive; and (2) had an abbreviated
application for a generic new animal
drug, supplemental abbreviated
application for a generic new animal
drug, or investigational submission for a
generic new animal drug pending at
FDA after September 1, 2008 (see 21
U.S.C. 379j–21(k)(7) and 379j–21(a)(3)).
A generic new animal drug sponsor is
subject to only one such fee each fiscal
year (see 21 U.S.C. 379j–21(a)(3)(B)).
Applicants with more than 6 approved
abbreviated applications will pay 100
percent of the sponsor fee, applicants
with 2 to 6 approved abbreviated
applications will pay 75 percent of the
sponsor fee, and applicants with 1 or
fewer approved abbreviated
applications will pay 50 percent of the
sponsor fee (see 21 U.S.C. 379j–
21(a)(3)(B)). The sponsor fees are to be
set so that they will generate $1,997,000
in fee revenue for FY 2012. This is the
amount set out in the statute and no
adjustments are required for FY 2012.
To set generic new animal drug
sponsor fees to realize $1,997,000, FDA
must make some assumptions about the
number of sponsors who will pay these
fees in FY 2012. Based on the number
of firms that meet this definition, FDA
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
estimates that in FY 2012, 12 sponsors
will pay 100 percent fees, 13 sponsors
will pay 75 percent fees, and 38
sponsors will pay 50 percent fees. That
totals the equivalent of 40.75 full
sponsor fees (12 times 100 percent or
12, plus 13 times 75 percent or 9.75,
plus 38 times 50 percent or 19).
FDA estimates that about 10 percent
of all of these sponsors, or 4, may
qualify for a minor use/minor species
waiver.
Accordingly, the Agency estimates
that the equivalent of 36.75 full sponsor
fees (40.75 minus 4) are likely to be paid
in FY 2012.
B. Sponsor Fee Rates for FY 2012
FDA must set the fee rates for FY 2012
so that the estimated equivalent of 36.75
full sponsor fees will generate a total of
$1,997,000. To generate this amount
will require the 100-percent fee for a
generic new animal drug sponsor,
rounded to the nearest $50, to be
$54,350. Accordingly, the fee for those
paying 75 percent of the full sponsor fee
will be $40,763, and the fee for those
paying 50 percent of the full sponsor fee
will be $27,175.
VI. Fee Schedule for FY 2012
The fee rates for FY 2012 are
summarized in table 2 of this document.
TABLE 2—FY 2012 FEE RATES
Generic new animal drug
user fee category
Abbreviated Application Fee
for Generic New Animal
Drug Application ................
Generic New Animal Drug
Product Fee ......................
100 Percent Generic New
Animal Drug Sponsor Fee1
75 Percent Generic New Animal Drug Sponsor Fee1 ....
50 Percent Generic New Animal Drug Sponsor Fee1 ....
Fee rate for
FY 2012
$124,900
6,200
54,350
A. Abbreviated Application Fees and
Payment Instructions
The FY 2012 fee established in the
new fee schedule must be paid for an
abbreviated new animal drug
application subject to fees under
AGDUFA that is submitted on or after
October 1, 2011. Payment must be made
in U.S. currency by check, bank draft, or
U.S. postal money order payable to the
order of the Food and Drug
Administration, by wire transfer, or by
automatic clearing house using Pay.gov.
(The Pay.gov payment option is
Fmt 4703
Sfmt 4703
(Note: This address is for courier delivery
only. If you have any questions concerning
courier delivery, contact the U.S. Bank at
314–418–4821. This telephone number is
only for questions about courier delivery.)
The tax identification number of the
Food and Drug Administration is
27,175
530196965.
VII. Procedures for Paying FY 2012
Generic New Animal Drug User Fees
Frm 00061
available to you after you submit a cover
sheet. Click the ‘‘Pay Now’’ button). On
your check, bank draft, or U.S. postal
money order, please write your
application’s unique Payment
Identification Number (PIN), beginning
with the letters ‘‘AG’’, from the upper
right-hand corner of your completed
Animal Generic Drug User Fee Cover
Sheet. Also write the FDA post office
box number (PO Box 953877) on the
enclosed check, bank draft, or money
order. Your payment and a copy of the
completed Animal Generic Drug User
Fee Cover Sheet can be mailed to: Food
and Drug Administration, P.O. Box
953877, St. Louis, MO 63195–3877.
If payment is made via wire transfer,
send payment to U. S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Name:
Food and Drug Administration, account
number: 75060099, routing number:
021030004, SWIFT number: FRNYUS33.
You are responsible for any
administrative costs associated with the
processing of a wire transfer. Contact
your bank or financial institution
regarding the amount of the fees that
need to be paid in addition to the wire
transfer amount.
If you prefer to send a check by a
courier such as Federal Express
(FEDEX) or United Parcel Service (UPS),
the courier may deliver the check and
printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox
953877, 1005 Convention Plaza, St.
Louis, MO 63101.
40,763
1 An animal drug sponsor is subject to only
one such fee each fiscal year.
PO 00000
45817
(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
abbreviated application arrives at FDA’s
Center for Veterinary Medicine. FDA
records the official abbreviated
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 payment. U.S. Bank and
the U.S. Treasury are required to notify
FDA within 1 working day, using the
PIN described previously.
E:\FR\FM\01AUN1.SGM
01AUN1
45818
Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log onto the AGDUFA Web
site at https://www.fda.gov/ForIndustry/
UserFees/AnimalGenericDrugUserFee
ActAGDUFA/ucm137049.htm and scroll
down the page until you find the link
‘‘Create AGDUFA User Fee Cover
Sheet.’’ Click on that link and follow the
directions. 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 Generic
Drug User Fee 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 Generic
Drug User Fee Cover Sheet. One cover
sheet is needed for each abbreviated
animal drug application. 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
VII.A of this document.
Step Four—Please submit your
application and a copy of the completed
Animal Generic 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 and Sponsor Fees
srobinson on DSK4SPTVN1PROD with NOTICES
By December 31, 2011, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2012
using this fee schedule. Fees will be due
and payable 30 days after the issuance
of the invoices. FDA will issue invoices
in November 2012 for any products and
sponsors subject to fees for FY 2012 that
qualify for fees after the December 2011
billing.
Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19334 Filed 7–29–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:45 Jul 29, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0529]
Burden of Food and Drug
Administration Food Safety
Modernization Act Fee Amounts on
Small Business; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; Request for comments
and information.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to obtain
information that will be used to
formulate a proposed set of guidelines
in consideration of the burden of fee
amounts on small business, as set forth
in the FDA Food Safety Modernization
Act (FSMA). FSMA provides the
Agency with authority under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to assess and collect
user fees, including those for costs
associated with certain domestic and
foreign facility reinspections, failure to
comply with a recall order, and
importer reinspections. The Agency is
seeking public comment on what
burdens these fees impose on small
business, and whether and how the
Agency should alleviate such burdens.
In particular, the Agency is seeking
public comments on whether a
reduction of fees or other consideration
for small business is appropriate, and if
so, what factors the Agency should
consider for each. In addition, the
Agency is seeking public comment on
how small business should be defined
or recognized. FDA is establishing this
docket in order to provide an
opportunity for interested parties to
provide data and share views that will
inform future Agency actions with
respect to these matters.
DATES: Submit either electronic or
written comments by October 17, 2011.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305). Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Alexis Nazario-Negron, Office of
Financial Management, Food and Drug
Administration, 1350 Piccard Dr., rm.
210E,Rockville, MD 20850, 301–796–
7223, Alexis.NazarioNegron@fda.hhs.gov.
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
Each year about 48 million people (1
in 6 Americans) are sickened, 128,000
are hospitalized, and 3,000 die from
food borne diseases, according to recent
data from the Centers for Disease
Control and Prevention (Refs. 1 and 2).
This is a significant public health
burden that is largely preventable.
FSMA (Pub. L. 111–353), signed into
law by President Obama on January 4,
2011, enables FDA to better protect
public health by helping to ensure the
safety and security of the food supply.
It enables FDA to focus more on
preventing food safety problems rather
than reacting to problems after they
occur. The law also provides FDA with
new enforcement authorities to help it
achieve higher rates of compliance with
prevention- and risk-based food safety
standards and to better respond to
problems when they do occur. The law
also gives FDA important new tools to
better ensure the safety of imported
foods and directs FDA to build an
integrated national food safety system in
partnership with State and local
authorities.
Among the new authorities Congress
provided in FSMA, the Secretary of
Health and Human Services (and by
delegation, FDA) is to assess and collect
fees from industry for FDA’s costs
associated with certain activities.
Section 107(a) of FSMA (which amends
the FD&C Act by adding section 743 (21
U.S.C. 379j-31)) mandates that FDA
assess and collect fees for costs
associated with certain domestic and
foreign facility reinspections, failure to
comply with a recall order under
sections 423 and 412(f) of the FD&C Act
(21 U.S.C. 350l and 350a(f)), and certain
importer reinspections (section 743(a)(1)
of the FD&C Act).1
Section 743(b)(2)(A) of the FD&C Act
specifies that the Agency must base
these fees on an estimation of 100
percent of the costs of the various
activities which are described in section
743(a)(1), for the fiscal year. These fees
must be published in the Federal
Register not later than 60 days before
the start of each fiscal year. Elsewhere
in this issue of the Federal Register,
FDA is publishing notice of these fees.
Congress directed FDA to publish,
within 180 days of enactment of FSMA,
a proposed set of guidelines in
consideration of the burden of fee
1 FDA is not soliciting comments, in this Federal
Register notice, on the burdens to small businesses
that participate in the voluntary qualified importer
program (VQIP) under section 743(a)(1)(C) of the
FD&C Act. FDA intends to consider such burdens
at the time the VQIP is established.
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45814-45818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19334]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0547]
Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2012
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) 2012 generic new animal
drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Animal Generic Drug User Fee Act of 2008
(AGDUFA), authorizes FDA to collect user fees for certain abbreviated
applications for generic new animal drugs, on certain generic new
animal drug products, and on certain sponsors of such abbreviated
applications for generic new animal drugs and/or investigational
[[Page 45815]]
submissions for generic new animal drugs. This notice establishes the
fee rates for FY 2012.
FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm or contact Lisa Kable, Center for Veterinary Medicine (HFV-
10), Food and Drug Administration, 7529 Standish Pl., Rockville, MD
20855, 240-276-9718. For general questions, you may also email the
Center for Veterinary Medicine (CVM) at: cvmagdufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different kinds of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs, (2) annual fees for certain
generic new animal drug products, and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
For FY 2009 through FY 2013, the FD&C Act establishes aggregate
yearly base revenue amounts for each of these fee categories. Base
revenue amounts established for years after FY 2009 may be adjusted for
workload. Fees for applications, products, and sponsors are to be
established each year by FDA so that the revenue for each fee category
will approximate the level established in the statute, after the level
has been adjusted for workload.
For FY 2012, the generic new animal drug user fee rates are:
$124,900 for each abbreviated application for a generic new animal
drug; $6,200 for each generic new animal drug product; $54,350 for each
generic new animal drug sponsor paying 100 percent of the sponsor fee;
$40,763 for each generic new animal drug sponsor paying 75 percent of
the sponsor fee; and $27,175 for each generic new animal drug sponsor
paying 50 percent of the sponsor fee. FDA will issue invoices for FY
2012 product and sponsor fees by December 31, 2011. These fees will be
due and payable within 30 days of the issuance of the invoices. The
application fee rates are effective for all abbreviated applications
for a generic new animal drug submitted on or after October 1, 2011,
and will remain in effect through September 30, 2012. Applications will
not be accepted for review until FDA has received full payment of
related application fees and any other fees owed under the Animal
Generic Drug User Fee program.
II. Revenue Amount for FY 2012
A. Statutory Fee Revenue Amounts
AGDUFA (Title II of Pub. L. 110-316 signed by the President on
August 14, 2008) specifies that the aggregate revenue amount for FY
2012 for abbreviated application fees is $1,712,000 and each of the
other two generic new animal drug user fee categories, annual product
fees and annual sponsor fees, is $1,997,000 each, before any adjustment
for workload is made (see 21 U.S.C. 379j-21(b)).
B. Inflation Adjustment to Fee Revenue Amount
The amounts established in AGDUFA for each year for FY 2009 through
FY 2013 include an inflation adjustment; so, no inflation adjustment is
required.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
For each FY beginning after FY 2009, AGDUFA provides that statutory
fee revenue amounts shall be further adjusted to reflect changes in
review workload (21 U.S.C. 379j-21(c)(1)).
FDA calculated the average number of each of the four types of
applications and submissions specified in the workload adjustment
provision (abbreviated applications for generic new animal drugs,
manufacturing supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions) received over the 5-year period ended on September 30,
2008 (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 on June 30, 2011.
The results of these calculations are presented in the first two
columns of table 1 of this document. Column 3 reflects the percent
change in workload over the two 5-year periods. Column 4 shows the
weighting factor for each type of application, reflecting how much of
the total FDA generic new animal drug review workload was accounted for
by each type of application or submission in the table during the most
recent 5 years. Column 5 of table 1 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 1, the sum of the
values in column 5 is calculated, reflecting a total change in workload
of negative 25.7 percent for FY 2012. This is the workload adjuster for
FY 2012.
Table 1--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 5-
Year Column 2 Column 3 Column 4 Column 5
Application type average Latest 5- Percent Weighting Weighted
(base year change factor percent
years) average change
----------------------------------------------------------------------------------------------------------------
Abbreviated New Animal Drug Applications 44.2 25.4 -43 50% -21.3
(ANADAs)......................................
Manufacturing Supplements ANADAs............... 114.6 118.4 3 22% 0.7
Generic Investigational Study Submissions...... 17.4 17.0 -2 10% -0.2
Generic Investigational Protocol Submissions... 21.6 15.6 -28 17% -4.8
----------------------------------------------------------------
FY 2012 AGDUFA Workload Adjuster........... ........... ........... ........... ........... -25.7
----------------------------------------------------------------------------------------------------------------
AGDUFA specifies that the workload adjuster may not result in fees
for a fiscal year that are less than the statutory revenue amount (21
U.S.C. 379j-21(c)(1)(B)) for that fiscal year. Because applying the
workload adjuster for FY 2012 would result in fees less than the
statutory amount, the workload adjustment will not be applied in FY
2012. As a result, the statutory revenue amount for each category of
fees for FY 2012 ($1,712,000 for application fees and $1,997,000 for
both product and sponsor fees) becomes the revenue target for the fees
in FY 2012, for a total
[[Page 45816]]
fee revenue target in FY 2012 of $5,706,000 for fees from all three
categories.
III. Abbreviated Application Fee Calculations for FY 2012
The term ``abbreviated application for a generic new animal drug''
is defined in 21 U.S.C. 379j-21(k)(1).
A. Application Fee Revenues and Numbers of Fee-Paying Applications
The application fee must be paid for abbreviated applications for a
generic new animal drug that is subject to fees under AGDUFA and that
is submitted on or after July 1, 2008. The application fees are to be
set so that they will generate $1,712,000 in fee revenue for FY 2012.
This is the amount set out in the statute.
To set fees for abbreviated applications for generic new animal
drugs to realize $1,712,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2012.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. FDA is making estimates and applying different
assumptions for two types of submissions: Original submissions of
abbreviated applications for generic new animal drugs and
``reactivated'' submissions of abbreviated applications for generic new
animal drugs. Any original submissions of abbreviated applications for
generic new animal drugs that were received by FDA before July 1, 2008,
were not assessed fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these non-
fee-paying submissions were later resubmitted after July 1 because the
initial submission was not approved by FDA (i.e., FDA marked the
submission as incomplete and requested additional nonadministrative
information) or because the original submission was withdrawn by the
sponsor. Because these abbreviated applications for generic new animal
drugs are resubmitted after July 1, 2008, they are assessed fees. In
this notice, FDA refers to these resubmitted applications as
``reactivated'' applications.
Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications that will pay fees in FY 2012 will equal 30 percent less
than the average number of submissions over the 5 most recent completed
years (2006-2010). This 30-percent reduction is made because of the
anticipated impact of fees on the number of submissions. The average
number of original submissions of abbreviated applications for generic
new animal drugs over the 5 most recent completed years is 14.4.
Applying a 30-percent reduction to the 14.4 average, the estimate for
original submissions of abbreviated applications for generic new animal
drugs for FY 2012 is 10.1. (If the number of original submissions of
abbreviated applications for generic new animal drugs does not increase
over the next year, a higher percent reduction will have to be applied
next year when fees are set for FY 2013.)
Regarding reactivated submissions of abbreviated applications for
generic new animal drugs, FDA is applying a 75-percent reduction. This
is based on the fact that there were a limited number of original
submissions of abbreviated applications for generic new animal drugs
received by FDA before July 1, 2008, which were not assessed fees. For
these original submissions that were not approved before July 1, 2008,
resubmission to FDA would trigger an application fee (21 U.S.C. 379j-
21(a)(1)(A)). Once these initial original submissions of abbreviated
applications for generic new animal drugs received by FDA before July
1, 2008, have either been withdrawn or resubmitted, ``reactivation
submissions'' will cease completely. This reduction is consistent with
estimates made when this user fee program was in the development
process. The average number of receipts for reactivated submissions of
abbreviated applications for generic new animal drugs is 14.5 per year,
which is the average of the 5 most recent completed years. Applying a
75-percent reduction to the 14.5 average, the estimate for reactivated
submissions of abbreviated applications for generic new animal drugs
for FY 2012 is 3.6. These reductions may not fully account for possible
year to year fluctuations in numbers of fee-paying applications, but
FDA believes that this is a reasonable approach after years of
experience with other user fee programs.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 13.7 fee-paying generic new animal drug applications
in FY 2012 (10.1 original applications and 3.6 reactivations).
B. Fee Rates for FY 2012
FDA must set the fee rates for FY 2012 so that the estimated 13.7
abbreviated applications that pay the fee will generate a total of
$1,712,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $124,900.
IV. Generic New Animal Drug Product Fee Calculations for FY 2012
A. Product Fee Revenues and Numbers of Fee-Paying Products
The generic new animal drug product fee (also referred to as the
product fee) must be paid annually by the person named as the applicant
in an abbreviated new animal drug application or supplemental
abbreviated application for generic new animal drugs 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 abbreviated application for a generic new
animal drug or supplemental abbreviated application for a generic new
animal drug pending at FDA after September 1, 2008 (see 21 U.S.C. 379j-
21(a)(2)). The term ``generic new 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
abbreviated application for a generic new animal drug or supplemental
abbreviated application for a generic new animal drug has been approved
(21 U.S.C. 379j-21(k)(6)). The product fees are to be set so that they
will generate $1,997,000 in fee revenue for FY 2012. This is the amount
set out in the statute and no further adjustments are required for FY
2012.
To set generic new animal drug product fees to realize $1,997,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2012. FDA gathered data on all generic
new 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 FDA estimated would have an abbreviated new animal drug application
or supplemental abbreviated application pending after September 1,
2008. FDA estimates a total of 358 products submitted for listing by
persons who had an abbreviated application for a generic new animal
drug or supplemental abbreviated application for a generic new animal
drug pending after September 1, 2008. Based on this, FDA believes that
a total of 358 products will be subject to this fee in FY 2012.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2012, FDA is assuming that approximately 10
percent of the products invoiced, or 36, will not pay fees in FY 2012
due to fee waivers
[[Page 45817]]
and reductions. Based on experience with other user fee programs and
the first 3 years of AGDUFA, FDA believes that this is a reasonable
basis for estimating the number of fee-paying products in FY 2012.
Accordingly, the Agency estimates that a total of 322 (358 minus
36) products will be subject to product fees in FY 2012.
B. Product Fee Rates for FY 2012
FDA must set the fee rates for FY 2012 so that the estimated 322
products that pay fees will generate a total of $1,997,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest 5 dollars, to be $6,200.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2012
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The generic new 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 abbreviated application for a new generic animal
drug, 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 submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive; and
(2) had an abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-
21(a)(3)). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(B)). Applicants
with more than 6 approved abbreviated applications will pay 100 percent
of the sponsor fee, applicants with 2 to 6 approved abbreviated
applications will pay 75 percent of the sponsor fee, and applicants
with 1 or fewer approved abbreviated applications will pay 50 percent
of the sponsor fee (see 21 U.S.C. 379j-21(a)(3)(B)). The sponsor fees
are to be set so that they will generate $1,997,000 in fee revenue for
FY 2012. This is the amount set out in the statute and no adjustments
are required for FY 2012.
To set generic new animal drug sponsor fees to realize $1,997,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2012. Based on the number of firms that meet this
definition, FDA estimates that in FY 2012, 12 sponsors will pay 100
percent fees, 13 sponsors will pay 75 percent fees, and 38 sponsors
will pay 50 percent fees. That totals the equivalent of 40.75 full
sponsor fees (12 times 100 percent or 12, plus 13 times 75 percent or
9.75, plus 38 times 50 percent or 19).
FDA estimates that about 10 percent of all of these sponsors, or 4,
may qualify for a minor use/minor species waiver.
Accordingly, the Agency estimates that the equivalent of 36.75 full
sponsor fees (40.75 minus 4) are likely to be paid in FY 2012.
B. Sponsor Fee Rates for FY 2012
FDA must set the fee rates for FY 2012 so that the estimated
equivalent of 36.75 full sponsor fees will generate a total of
$1,997,000. To generate this amount will require the 100-percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $54,350. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $40,763, and the fee for those paying 50
percent of the full sponsor fee will be $27,175.
VI. Fee Schedule for FY 2012
The fee rates for FY 2012 are summarized in table 2 of this
document.
Table 2--FY 2012 Fee Rates
------------------------------------------------------------------------
Fee rate for
Generic new animal drug user fee category FY 2012
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $124,900
Application............................................
Generic New Animal Drug Product Fee..................... 6,200
100 Percent Generic New Animal Drug Sponsor Fee\1\...... 54,350
75 Percent Generic New Animal Drug Sponsor Fee\1\....... 40,763
50 Percent Generic New Animal Drug Sponsor Fee\1\....... 27,175
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one such fee each fiscal
year.
VII. Procedures for Paying FY 2012 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2012 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA that is submitted on or after October 1, 2011. Payment must be
made in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration, by wire
transfer, or by automatic clearing house using Pay.gov. (The Pay.gov
payment option is available to you after you submit a cover sheet.
Click the ``Pay Now'' button). On your check, bank draft, or U.S.
postal money order, please write your application's unique Payment
Identification Number (PIN), beginning with the letters ``AG'', from
the upper right-hand corner of your completed Animal Generic Drug User
Fee Cover Sheet. Also write the FDA post office box number (PO Box
953877) on the enclosed check, bank draft, or money order. Your payment
and a copy of the completed Animal Generic Drug User Fee Cover Sheet
can be mailed to: Food and Drug Administration, P.O. Box 953877, St.
Louis, MO 63195-3877.
If payment is made via wire transfer, send payment to U. S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Account Name: Food and Drug Administration, account number:
75060099, routing number: 021030004, SWIFT number: FRNYUS33. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution
regarding the amount of the fees that need to be paid in addition to
the wire transfer amount.
If you prefer to send a check by a courier such as Federal Express
(FEDEX) or United Parcel Service (UPS), the courier may deliver the
check and printed copy of the cover sheet to: U.S. Bank, Attn:
Government Lockbox 953877, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. If you have
any questions concerning courier delivery, contact the U.S. Bank at
314-418-4821. This telephone number is only for questions about
courier delivery.)
The tax identification number of the Food and Drug Administration
is 530196965.
(Note: In no case should the payment for the fee be submitted
to FDA with the application.)
It is helpful if the fee arrives at the bank at least a day or two
before the abbreviated application arrives at FDA's Center for
Veterinary Medicine. FDA records the official abbreviated 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 payment. U.S. Bank and the U.S. Treasury are required
to notify FDA within 1 working day, using the PIN described previously.
[[Page 45818]]
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log onto the AGDUFA
Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Click on that link and follow the directions. 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 Generic Drug User Fee 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 Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. 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 VII.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Generic 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 and Sponsor Fees
By December 31, 2011, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2012 using this fee
schedule. Fees will be due and payable 30 days after the issuance of
the invoices. FDA will issue invoices in November 2012 for any products
and sponsors subject to fees for FY 2012 that qualify for fees after
the December 2011 billing.
Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19334 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P
