OMB approves the
package for one year. Prior to re-submission for approval, FDA will
solicit comment on, evaluate, and report on the accuracy of their
burden estimates. Furthermore, if FDA receives any comments on this
submission, they are to immediately forward them to OMB.
Inventory as of this Action
The existing rule provides conditions
for the marketing of antheimintic drug products for OTC use. One
provision of the regulation requires the preparation and
distribution of a consumer package insert related to the use of the
drug by discussing pinworm infestation and its symptoms,
identification, detection, and treatment.