Page:United States Statutes at Large Volume 121.djvu/869

 121 STAT. 848

dkrause on GSDDPC44 with PUBLAW

Certification. Federal Register, publication.

VerDate Aug 31 2005

13:52 Jan 23, 2009

PUBLIC LAW 110–85—SEPT. 27, 2007

(A) DEFINITION.—Section 738(e)(2)(A) (21 U.S.C. 379j(e)(2)(A)) is amended by striking ‘‘, partners, and parent firms’’. (B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) (21 U.S.C. 379j(e)(2)(B)) is amended— (i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following: ‘‘(B) EVIDENCE OF QUALIFICATION.— ‘‘(i) IN GENERAL.—An applicant’’; (ii) by striking ‘‘The applicant shall support its claim’’ and inserting the following: ‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—The 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(e)(2)(C) (21 U.S.C. 379j(e)(2)(C)) is amended to read as follows: ‘‘(C) REDUCED FEES.—For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 50 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).’’. (f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows:

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