The subject guidance document was
developed to assist drug and biological product application holders
in making safety-related labeling changes as required by statute.
Specifically, section 505(o)(4) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)), added by section
901 of the Food and Drug Administration Amendments Act of 2007
(FDAAA), authorizes FDA to require certain safety-related labeling
changes based on information that becomes available after approval
of the drug or biological product. While these requirements are
codified in agency regulations (21 CFR part 314 – drugs; 21 CFR
part 601 – biologics), the guidance provides background and
procedural information regarding agency implementation.
Based on a review of safety
labeling notifications that were issued during calendar years 2016
and 2017 we have reduced the number of respondents to reflect fewer
submissions. We attribute the adjustment to expected variability
and note that it results in 62 fewer annual responses and 260 fewer
annual burden hours. We have also uploaded costs that were
previously reported, but not reflected at omb.report.