Request for Non-Material Change

UNITED STATES FOOD & DRUG ADMINISTRATION
Applications for FDA Approval to Market a New Drug
OMB Control No. 0910 0014
Request for Non-substantive, non-material change:
Upon review of our ICR inventory, we find that provisions covered by OMB Control No. 09100672, established by rulemaking on September 29, 2010 (75 FR 59935), became effective on
March 28, 2011. The requirements are now incorporated into the applicable regulations at 21
CFR part 312 (21 CFR 312 – Investigational New Drugs), and we therefore intend to discontinue
the collection 0910-0672. We invite OMB to review our supporting statement for 0910-0672 at
Question 1, where we discuss our plans to consolidate the collections accordingly; as well as our
supporting statement for 0910-0014 at Question 12, where we have included those provisions
that were amended and account for the associated burden. We have, therefore, made no
adjustment in burden to collection 0910-0014, but will discontinue OMB Control No. 09100672.
Submitted: July 2019