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CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
Investigational New Drug Regulations
GFI Pharmacogenomic Data Submissions
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
OMB: 0910-0014
OMB.report
HHS/FDA
OMB 0910-0014
ICR 202303-0910-008
IC 189329
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
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⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0014 can be found here:
2024-03-05 - No material or nonsubstantive change to a currently approved collection
2023-08-09 - Revision of a currently approved collection
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