REPORT ON REGENERATIVE ADVANCED THERAPIES.

SEC. 3035. [21 U.S.C. 356 note] REPORT ON REGENERATIVE ADVANCED THERAPIES. (a) Report to Congress.—Before March 1 of each calendar year, the Secretary of Health and Human Services shall, with respect to the previous calendar year, submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on— (1) the number and type of applications for approval of regenerative advanced therapies filed, approved or licensed as applicable, withdrawn, or denied; and (2) how many of such applications or therapies, as applicable, were granted accelerated approval or priority review. (b) Regenerative Advanced Therapy.—In this section, the term “regenerative advanced therapy” has the meaning given such term in section 506(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 3033 of this Act.