[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Page 51816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20947]

[[Page 51816]]



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.


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withdrawn nor tentatively approved) at FDA on October 1, 2012.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 [email protected]. 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, 
[email protected].


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.

    \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 
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]