21 December 2017 Change Request

12/21/2017  

Biosimilar User Fee Cover Sheet - Form FDA 3792
OMB Control No. 0910-0718
JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST
The Food and Drug Administration is submitting this change request (83-C) regarding OMB
Control No. 0910-0718, Biosimilar User Fee Cover Sheet for implementation by April 2018.
The Biosimilar User Fee Act of 2012 (BsUFA) authorized FDA to assess and collect user fees for
certain activities in connection with biosimilar biological product development (BPD) including
certain applications and supplements for approval, certain products, and certain establishments
where biosimilar biological products are manufactured.
The BSUFA program was reauthorized for an additional 5 years in August 2017 (BsUFA II). It
requires FDA to set and publish appropriate biosimilar user fees annually1 and to assess and
collect those user fees for certain BPD meetings concerning biosimilars, for investigational new
drug applications (INDs) intended to support a biosimilar biological product application, and for
biosimilar biological product marketing applications and supplements. BsUFA II has specific
requirements for the amount of fees collected in any given fiscal year. If FDA collects too much
revenue (e.g., fees are set too high or more BsUFA II elements than anticipated are received, then
FDA would potentially have to issue refunds (a significant increase in the cost to administer the
program). If FDA collects too little revenue (e.g., fees are set too low, or number of fees assessed
are fewer than estimated) then the Agency will have to absorb that deficit and FDA loses
available funds for the program. Consequently, as close to actual and accurate information is
required for setting appropriate BsUFA II fees.
Although the BsUFA II program is similar to the agency’s Prescription Drug User Fee program, it
is much smaller in number of participants and much less mature. Available information under
BsUFA does not provide adequate historical data on which to base reasonable estimates of
incoming submissions and BsUFA II participation. Under BsUFA, OMB previously approved an
annual one question e-mail survey of BPD developers of anticipated submissions of biosimilar
applications in the upcoming fiscal year. However, it has been determined that asking
respondents in the BPD program of only their anticipated submission of marketing applications is
insufficient to accurately determine upcoming fiscal year fees for all parts of the BsUFA II
program. FDA believes that amending the survey of BPD sponsors and collecting expanded data
with a few additional questions will resolve FDA’s current difficulty for determining BsUFA II
fees, and will enable FDA to more efficiently administer the BPD program under BsUFA II.
To accomplish this goal for the fiscal year 2019 review cycle and to publish the BsUFA II fees by
August, FDA proposes to administer the attached survey (and clarifying questions if required) via

1 

Some of the BsUFA II fees are due on October 1, the first day of the fiscal year, so FDA publishes the fees by August
prior to the start of the fiscal year. 

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e-mail, on an annual basis in April,2 to all biosimilar product developers (Currently, there are 35
participants). The expanded survey (including what was previously approved) should take no
more than 1 hour to complete.

BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in 
minutes (/60) = burden hours): 

Type/Category of 
No. of Respondents 
Participation 
Total Annual 
Respondent 
Time (minutes) 
Burden 
(hours) 
Fee Determination 
35 
60 
35 hours 
Survey 

2

PRA-0910-0718 expires 12/2018. That collection, including this additional survey information, is currently in the
comment and renewal process for OMB approval.

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ATTACHMENT – BsUFA Survey  
Instructions:  Below is a list of your active pre‐IND/INDs in the Biosimilar Biological Product Development 
(BPD) program.  Please review the list and answer all questions in this survey.  Your responses to these 
questions are vital to assist the Food and Drug Administration in determining the fees for fiscal year 20XX 
(October 1, 20XX to September 30, 20XX). 

Firm Name:   

BPD Program
1. For the active pre‐IND/INDs listed above, do you anticipate
☐No ☐Yes (please list IND
discontinuing participation in the BPD program by August 1 of this year? numbers)

2. Do you anticipate reactivating a pre‐IND/IND that was discontinued from ☐No ☐Yes (please list IND
the BPD program?
numbers)

3. How many new biosimilar biological products do you anticipate will
enter the BPD program in the current fiscal year (October 1, 20XX –
September 30, 20XX)?
4. How many new biosimilar biological products do you anticipate will
enter the BPD program in the next fiscal year (October 1, 20XX –
September 30, 20XX)?

351(k) Submissions
1. Of the active pre‐IND/INDs listed above, do you plan to submit a new
351(k) application in the current fiscal year? If yes, please list the IND
number(s) and the anticipated month and year (MM/YYYY) of submission
in the right‐hand column.
2. Of the active pre‐IND/INDs listed above, do you plan to submit a new
351(k) application in the next fiscal year? If yes, please list the IND
number(s) and the anticipated month and year (MM/YYYY) of submission
in the right‐hand column.
3. Do you plan to resubmit a 351(k) application that was Refuse To File or
Withdrawn before filing? If yes, please list the BLA number(s) and the
anticipated month and year (MM/YYYY) of re‐submission in the right‐hand
column.
4. Do you plan to resubmit a 351(k) application that received a Complete
Response? If yes, please list the BLA number(s) and the anticipated month
and year (MM/YYYY) of re‐submission in the right‐hand column.
5. Do you plan to submit an interchangeability supplement? If yes, please list
the BLA number(s) and the anticipated month and year (MM/YYYY) of re‐
submission in the right column.
6. Do you plan to submit a new strength supplement to an approved
application? If yes, please list the BLA number(s) anticipated month and
year (MM/YYYY), and number of new strengths in the right‐hand column.

☐No ☐Yes

☐No ☐Yes

☐No ☐Yes

☐No ☐Yes

☐No ☐Yes

☐No ☐Yes

Approved Biosimilar Biological Products
1. Are you planning to discontinue marketing of an approved biosimilar
biological product by September 30, 20XX?
2. If yes to the question above, please list the products and the strengths.

☐No ☐Yes ☐N/A