[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Notices]
[Page 51816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20947]
[[Page 51816]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0879]
Notice of Opportunity To Withdraw Abbreviated New Drug
Applications To Avoid Backlog Fee Obligations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice
to provide applicants who are no longer seeking approval of their
pending original abbreviated new drug applications (ANDAs) with an
opportunity to withdraw them as soon as possible to avoid paying a fee.
The fee in question is a one-time backlog fee that was established
through enactment of the Generic Drug User Fee Amendments of 2012
(GDUFA). It will apply to any original ANDA that is pending (neither
withdrawn nor tentatively approved) at FDA on October 1, 2012. This
notice is intended to allow applicants to decide which ANDAs they do
not wish to pursue and by timely notice of withdrawal avoid paying the
new backlog fee on such applications.
DATES: Under GDUFA, to avoid incurring the backlog fee, an ANDA
applicant covered by this notice must submit written notification to
FDA so that it is received by September 28, 2012. However, to expedite
this process, applicants are encouraged to submit their written
notification by September 15, 2012.
ADDRESSES: Applicants should submit written notification of the request
for withdrawal by standard application submission methods. If an
application was submitted by the FDA electronic gateway, a request for
withdrawal should be submitted to the application by the gateway. In
addition, a copy of the electronic notification of withdrawal should be
emailed to OGDGDUFA@fda.hhs.gov. Alternatively, the applicant should
send written notification to the ANDA archival file at the following
address: Office of Generic Drugs, Center for Drug Evaluation and
Research, Food and Drug Administration, Document Control Room, Metro
Park North VII, 7620 Standish Pl., Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT: Thomas Hinchliffe, Center for Drug
Evaluation and Research (HFD-617), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, 240-276-9310,
OGDGDUFA@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Establishment of the Backlog Fee
On July 9, 2012, GDUFA (Pub. L. 112-144, Title III) was signed into
law by the President. Designed to speed delivery of safe and effective
generic drugs to the public and reduce costs to industry, GDUFA
requires that generic drug manufacturers pay user fees to finance
critical and measurable program enhancements. The new law includes a
provision to assess user fees for any original ANDA that is pending on
October 1, 2012, that has not been tentatively approved. Collection of
fees for applications in the backlog will provide the Agency with
necessary funding to reduce the backlog and prepare to meet the ANDA
review performance goals established by GDUFA. Specifically, in the
Commitment Letter that accompanies the law, FDA committed to review and
act on 90 percent of all ANDAs pending on October 1, 2012, by the end
of fiscal year 2017.
II. Backlog Fee Calculations for FY 2013
FDA will set the backlog fee rates for FY 2013 to generate a total
of $50,000,000. Therefore, to determine the fee for a pending original
ANDA, we will divide $50,000,000 by the number of original ANDAs that
are pending on October 1, 2012, and have not been tentatively approved
as of that date.
We have estimated that absent withdrawals there could be 3,000
pending original ANDAs on October 1, 2012. Some currently pending
original ANDAs are old and incomplete, and FDA anticipates that
applicants will withdraw many of them before October 1, 2012, to avoid
incurring the backlog fee. If 2,000 original ANDAs were to remain, the
backlog fee per ANDA would be $25,000. However, this is only an
estimate; the final fee, which will be published along with payment
instructions in a notice in the Federal Register by October 31, 2012,
could be higher or lower.
III. Due Date and Penalty To Pay Backlog Fees
Payment of backlog fees will be due no later than 30 calendar days
after publication in the Federal Register of a notice (to be issued by
October 31, 2012) announcing the amount of the backlog fee. Applicants
with original ANDAs that fail to pay the backlog fee by the due date
will be placed on a publicly available arrears list, and FDA will not
receive new ANDAs or supplements submitted by those applicants, or any
affiliates \1\ of those applicants, within the meaning of 505(j)(5)(A)
of the Federal Food, Drug, and Cosmetic Act, until the outstanding fee
is paid.
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\1\ GDUFA defines the term ``affiliate'' as a business entity
that has a relationship with a second business entity if, directly
or indirectly, one business entity controls, or has the power to
control, the other business entity; or a third party controls, or
has power to control, both of the business entities.
Note: The fee is an obligation to the U.S. Government, and
failure to pay the fee may result in collection activities by the
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Government under applicable laws.
Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20947 Filed 8-22-12; 11:15 am]
BILLING CODE 4160-01-P