Form FDA 3792

12/21/2017  
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Withdrawn before filing?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