Page:United States Statutes at Large Volume 124.djvu/890

124 STAT. 864 PUBLIC LAW 111–148—MAR. 23, 2010 360c) and is primarily sold to consumers at retail for not more than $100 per unit, or (B) has been classified in class I under such section. (2) UNITED STATES.—For purposes of paragraph (1), the term ‘‘United States’’ means the several States, the District of Columbia, the Commonwealth of Puerto Rico, and the posses- sions of the United States. (3) MEDICAL DEVICE.—For purposes of paragraph (1), the term ‘‘medical device’’ means any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) intended for humans. (e) TAX TREATMENT OF FEES.—The fees imposed by this sec- tion— (1) for purposes of subtitle F of the Internal Revenue Code of 1986, shall be treated as excise taxes with respect to which only civil actions for refund under procedures of such subtitle shall apply, and (2) for purposes of section 275 of such Code, shall be consid- ered to be a tax described in section 275(a)(6). (f) REPORTING REQUIREMENT.— (1) IN GENERAL.—Not later than the date determined by the Secretary following the end of any calendar year, each covered entity shall report to the Secretary, in such manner as the Secretary prescribes, the gross receipts from medical device sales of such covered entity during such calendar year. (2) PENALTY FOR FAILURE TO REPORT.— (A) IN GENERAL.—In the case of any failure to make a report containing the information required by paragraph (1) on the date prescribed therefor (determined with regard to any extension of time for filing), unless it is shown that such failure is due to reasonable cause, there shall be paid by the covered entity failing to file such report, an amount equal to— (i) $10,000, plus (ii) the lesser of— (I) an amount equal to $1,000, multiplied by the number of days during which such failure con- tinues, or (II) the amount of the fee imposed by this section for which such report was required. (B) TREATMENT OF PENALTY.—The penalty imposed under subparagraph (A)— (i) shall be treated as a penalty for purposes of subtitle F of the Internal Revenue Code of 1986, (ii) shall be paid on notice and demand by the Secretary and in the same manner as tax under such Code, and (iii) with respect to which only civil actions for refund under procedures of such subtitle F shall apply. (g) SECRETARY.—For purposes of this section, the term ‘‘Sec- retary’’ means the Secretary of the Treasury or the Secretary’s delegate. (h) GUIDANCE.—The Secretary shall publish guidance necessary to carry out the purposes of this section, including identification of medical devices described in subsection (d)(1)(A) and with respect to the treatment of gross receipts from sales of medical devices Publication. Applicability. Notice.