Which of the following statements about the initial IND application submission by a sponsor to...

AnInvestigational New Drug (IND) applicationprovides FDA with data to justify human testing.

21 CFR 312.23(a)(3):The IND must contain “a description of the general investigational plan, including the rationale for the drug or the research study.”

The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.

Financial disclosures (D) are reported separately under21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.

Thus, the correct answer isB (Rationale and plan for human testing).