83-C for changes to 0511 cover sheets due to FDARA

FOOD AND DRUG ADMINISTRATION
Non-Substantive Change Request
OMB Control Nos. 0910-0727; 0910-0297; 0910-0718; and 0910-0511.
Date: August 8, 2017
Purpose:
The Food and Drug Administration (FDA) is requesting non-substantive changes to some of its
user fee cover sheets. Specifically, the changes are listed below, corresponding to the respective
OMB Control Numbers:
Program;
OMB Control No.
GDUFA;
0910-0727

Currently

Proposed

ANDA Fee
PAS Fee

No change
Removed PAS from entire form (no more fees for
PAS))

Facility Fee

Added Contract Manufacturing Organization
(CMO) fee

DMF Fee

No change
Added Program fee tiers
1‐5 approved ANDAs ‐ Small
6‐19 approved ANDAs ‐ Medium
20 or more approved ANDAs ‐ Large
Positron Emission Tomography (PET) No change

Instructions for completing the form

PDUFA;
0910-0297

Added No ANDA fee for drugs manufactured by
State or Federal entities not intended for commercial
use
Made changes related to items noted above, and
other clarifying instructions

Currently
Original Applications
Supplements

Proposed
No change
Removed supplements from entire form (no more
fees for supplements)

Priority Review Voucher (was
previously only Tropical Disease
Voucher)

Added the ability to enter new type of priority
review voucher (Medical Counter Measure) and
voucher number in addition to Tropical Disease
Voucher
Made changes related to items noted above, and
other clarifying instructions

Instructions for completing the form

BsUFA;
0910-0718

MDUFA;
0910-0511

Currently
Initial/Reactivation
351(k) Application
Supplement

Proposed
Edited question regarding previously paid BPD fees
No change
Removed supplements from entire form (no more
fees for supplements)

Small Business question
Instructions for completing the form

Moved the location of this question
Made changes related to items noted above, and
other clarifying instructions

Currently

Proposed
Adding a checkbox for De Novo submissions

Background:
On August 3rd, Congress enacted the Food and Drug Administration User Fee Reauthorization
Act of 2017 (FDARA). The legislation reauthorizes the various user fees that help fund the
agency’s review and oversight of prescription drugs, generic drugs, medical devices, and
biosimilars. FDA’s Office of Financial Management (OFM) is responsible for the administration
of the user fee programs by maintaining an accounts receivable system for user fee invoicing,
collections, reporting, and data maintenance. To facilitate respondent transactions with the
agency, cover sheets are used to submit necessary information to FDA. The cover sheet gathers
the minimum amount of information necessary to determine whether a fee is required, to
determine the amount of the fee, and to allow FDA to track payments. Respondents may use
electronic means to create the cover sheets, however paper submissions may also be submitted as
appropriate.
Accordingly, FDA is requesting approval to its user fee cover sheets as necessitated by the
passage of FDARA and as indicated in the table above.