Written recommendations; content and format of a request, the providing of; refusal to provide
Orphan Products Development; Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation and FDA Orphan Drug Designation Request Form
OMB: 0910-0167
IC ID: 5770
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0167 can be found here: