; (4) clinicians with expertise in rare diseases or conditions; (5) research scientists with expertise in rare diseases or conditions, or experience conducting translational research or utilizing surveillance systems for scientific research purposes; and (6) patients, and caregivers of patients, with rare diseases or conditions. (c) Report Not later than 3 months after completing the study required by subsection (a), the Director shall submit a report to the Congress on the results of the study. (d) Definition In this section, the terms rare diseases and conditions and rare diseases or conditions refer to human diseases and conditions that are— (1) a rare disease or condition, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ); or (2) determined by the Director to be rare and lacking in treatment options, so as to warrant consideration in the study required by subsection (a).