Request for Non-Material Change and Form Update

UNITED STATES FOOD & DRUG ADMINISTRATION
Applications for FDA Approval to Market a New Drug
OMB Control No. 0910 0001
Request for Non-substantive, non-material change:
I. Burden Adjustments:
Upon review of our ICR inventory, we find that provisions covered by OMB Control No. 09100786, established by rulemaking on October 6, 2016 (81 FR 69580) became effective on
December 5, 2016. The requirements are now incorporated into the applicable regulations at 21
CFR part 314 (21 CFR 314). In our most recent renewal of OMB Control No. 0910-0001,
however (please see agency burden table at pages 3-5, with accompanying notations at the
bottom of page 5), we did not include the burden figures we attribute to these provisions. Rather,
we explained that the burden was accounted for separately under 0910-0786. We are requesting
this change to correct that error, and to ensure that all burden from the applicable regulations are
reflected within the ICR that supports our drug application program. The resultant change is an
additional 2,153 responses and an additional 2,789 burden hours to the collection, reflecting
adjustment within the IC element entitled, “Subpart B – Applications.”
II. Changes to Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for
Human Use
We are also proposing minor changes to Form FDA 2252, draft attached. This form is available
for electronic submission. We believe these revisions allow for a more streamlined approach for
accepting data. These fields currently exist – the wording and layout will be slightly altered
(changes have been italicized for clarification):
Field 7 – This will now be a drop-down field wherein the user can select the options of NDA,
BLA, ANDA, and provide the associated Application Number. Users can ‘Add Row’ or
‘Remove Row.’ Previously, this field was an open text field.
Field 9 (g) – Renaming of the field from ‘STATUS REPORTS OF POSTMARKETING STUDY
COMMITMENTS to STATUS REPORTS OF OPEN PMRS/PMCS (leave blank if no open
PMRs/PMCs to report). This clarifies what is expected in this field.
Field 9 (h) – ‘STATUS OF OTHER POSTMARKETING STUDIES’ to ‘STATUS OF OTHER
OPEN POSTMARKETING STUDIES’. The addition of the word ‘open’ further clarifies what
is expected in the field.
As a result of these changes we have made no adjustment to the cumulative burden for
submission.
Submitted: July 2019