Page:United States Statutes at Large Volume 121.djvu/868

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[121 STAT. 847]
[121 STAT. 847]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 847



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applicant shall support its claim’’; (iii) by striking ‘‘, partners, and parent firms’’ each place it appears; (iv) by striking the last sentence and inserting ‘‘If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.’’; and (v) by adding at the end the following: ‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.’’. (3) REDUCED FEES.—Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows: ‘‘(C) REDUCED FEES.—Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of— ‘‘(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, or periodic reporting concerning a class III device; and ‘‘(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.’’. (e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET NOTIFICATION SUBMISSIONS.— (1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1)) is amended— (A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and (B) by striking ‘‘(a)(2)(A)(vii)’’ and inserting ‘‘(a)(2)(A)(viii)’’. (2) RULES RELATING TO PREMARKET NOTIFICATION SUBMISSIONS.—

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Certification. Federal Register, publication.



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