Page:United States Statutes at Large Volume 117.djvu/2467

 117 STAT. 2448

Loans.

PUBLIC LAW 108–173—DEC. 8, 2003

‘‘(B) an outreach program for cancer prevention, early diagnosis, and treatment that provides services to multiple Indian tribes; and ‘‘(C)(i) unique research resources (such as population databases); or ‘‘(ii) an affiliation with an entity that has unique research resources. ‘‘(g) FUNDING.— ‘‘(1) IN GENERAL.—There are appropriated, out of amounts in the Treasury not otherwise appropriated, to carry out this section, $200,000,000, to remain available during the period beginning on July 1, 2004, and ending on September 30, 2008. ‘‘(2) ADMINISTRATIVE COSTS.—From funds made available under paragraph (1), the Secretary may use, for the administration of this section, not more than $2,000,000 for each of fiscal years 2004 through 2008. ‘‘(3) AVAILABILITY.—Amounts appropriated under this section shall be available for obligation on July 1, 2004. ‘‘(h) REPORT TO CONGRESS.—Not later than 4 years after the date of the enactment of this section, the Secretary shall submit to Congress a report on the projects for which loans are provided under this section and a recommendation as to whether the Congress should authorize the Secretary to continue loans under this section beyond fiscal year 2008.’’.

TITLE XI—ACCESS TO AFFORDABLE PHARMACEUTICALS Subtitle A—Access to Affordable Pharmaceuticals SEC. 1101. THIRTY-MONTH STAY-OF-EFFECTIVENESS PERIOD.

(a) ABBREVIATED NEW DRUG APPLICATIONS.—Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended— (1) in paragraph (2)— (A) by striking subparagraph (B) and inserting the following: ‘‘(B) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT BE INFRINGED.— ‘‘(i) AGREEMENT TO GIVE NOTICE.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall include in the application a statement that the applicant will give notice as required by this subparagraph. ‘‘(ii) TIMING OF NOTICE.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall give notice as required under this subparagraph— ‘‘(I) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the application has been filed; or ‘‘(II) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect

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