[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2381-2383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4508]


Generic Drug User Fee Amendments II Program Fee: List of 
Abbreviated New Drug Application Sponsors and Application Numbers; 
Request for Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments.

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SUMMARY: The Food and Drug Administration (FDA) is seeking information 
and public comment, in anticipation of the passage of Generic Drug User 
Fee Amendments reauthorization (GDUFA II), relevant to FDA's planned 
approach for administering generic drug program fees under that 
legislation for fiscal year (FY) 2018. This includes requests for 
comment and information regarding FDA's initial inventory of approved 
abbreviated new drug application sponsors and application numbers. The 
information gathered from public comments will assist FDA in accurately 
assessing FY 2018 GDUFA program fees in a timely manner.

DATES: Submit written or electronic comments and information by March 
10, 2017.

ADDRESSES: You may submit comments as follows:

[[Page 2382]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-4508 for ``Generic Drug User Fee Amendments II Program Fee: 
List of Abbreviated New Drug Application Sponsors and Application 
Numbers; Request for Information and Comment.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kristan Callahan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-7900, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In anticipation of the enactment and implementation of GDUFA II, 
FDA has begun taking steps to ensure efficient administration of GDUFA 
for FY 2018. It is projected that the GDUFA II legislation will include 
an annual program fee for which holders of approved abbreviated new 
drug applications (ANDAs) will be responsible.
    Under GDUFA II, it is anticipated that affiliated companies will be 
grouped together and counted as a single entity for purposes of 
assessing the program fee. The proposed legislation defines the term 
``affiliate'' in the same way it was defined in GDUFA. An ``affiliate'' 
is defined 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 the power to control, both of the business 
entities. As set forth in the proposed legislation, the program fee 
will be allocated among three tiers of application holders:
     Large (companies with 20 or more approved ANDAs);
     Medium (companies with between 6 and 19 approved ANDAs); 
and,
     Small (companies with 5 or fewer approved ANDAs).
    To assess program fees in an accurate and timely manner if these 
provisions are enacted, FDA seeks to identify how many approved ANDAs 
belong to each application holder, and which application holders are 
affiliates for purposes of assessing GDUFA II program fees. In 
furtherance of this effort, FDA requests comments and information 
regarding FDA's initial inventory of approved ANDA sponsors and 
application numbers. The current spreadsheet containing this initial 
inventory and instructions on how to use it are available at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm.

II. Request for Information and Comment

    FDA is seeking information and public comment, in anticipation of 
the passage of GDUFA II, relevant to FDA's planned approach for 
administering generic drug program fees under that legislation for FY 
2018. The information gathered from public comments will assist FDA in 
accurately assessing FY 2018 GDUFA Program Fees in a timely manner. 
Interested persons are invited to comment, in general, on any aspect of 
FDA's planned approach for administering these generic drug program 
fees under GDUFA II. FDA is particularly interested in comments and 
information addressing the accuracy and completeness of the information 
in the previously mentioned spreadsheet containing FDA's initial 
inventory of approved ANDA sponsors and application numbers. In 
addition, FDA is interested in any information that could be relevant 
to determining whether two or more companies that are currently listed 
separately in that spreadsheet should be considered to be affiliated 
for purposes of assessing the anticipated program fee. As a general 
matter, FDA does not consider affiliates

[[Page 2383]]

to be confidential commercial information.
    After receiving feedback and comments on the spreadsheet, FDA 
anticipates publishing a Federal Register notice and making available a 
revised spreadsheet that will incorporate information received in the 
comments on this notice. FDA plans to seek comment on the revised 
spreadsheet before compiling the final information regarding affiliated 
entities that will be used as the basis for determining and assessing 
FY 2018 program fees in the event that GDUFA II is enacted.

    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00081 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-P