124 STAT. 818 PUBLIC LAW 111–148—MAR. 23, 2010 present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar biological product applications submitted under section 351(k) of the Public Health Service Act (as added by this Act) for the first 5 fiscal years after fiscal year 2012. In developing such recommendations, the Secretary shall consult with— (i) the Committee on Health, Education, Labor, and Pensions of the Senate; (ii) the Committee on Energy and Commerce of the House of Representatives; (iii) scientific and academic experts; (iv) health care professionals; (v) representatives of patient and consumer advocacy groups; and (vi) the regulated industry. (B) PUBLIC REVIEW OF RECOMMENDATIONS.—After nego- tiations with the regulated industry, the Secretary shall— (i) present the recommendations developed under subparagraph (A) to the Congressional committees specified in such subparagraph; (ii) publish such recommendations in the Federal Register; (iii) provide for a period of 30 days for the public to provide written comments on such recommendations; (iv) hold a meeting at which the public may present its views on such recommendations; and (v) after consideration of such public views and comments, revise such recommendations as necessary. (C) TRANSMITTAL OF RECOMMENDATIONS.—Not later than January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under subpara- graph (B), a summary of the views and comments received under such subparagraph, and any changes made to the recommendations in response to such views and comments. (2) ESTABLISHMENT OF USER FEE PROGRAM.—It is the sense of the Senate that, based on the recommendations transmitted to Congress by the Secretary pursuant to paragraph (1)(C), Congress should authorize a program, effective on October 1, 2012, for the collection of user fees relating to the submission of biosimilar biological product applications under section 351(k) of the Public Health Service Act (as added by this Act). (3) TRANSITIONAL PROVISIONS FOR USER FEES FOR BIO- SIMILAR BIOLOGICAL PRODUCTS.— (A) APPLICATION OF THE PRESCRIPTION DRUG USER FEE PROVISIONS.—Section 735(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)(B)) is amended by striking ‘‘section 351’’ and inserting ‘‘subsection (a) or (k) of section 351’’. (B) EVALUATION OF COSTS OF REVIEWING BIOSIMILAR BIOLOGICAL PRODUCT APPLICATIONS.—During the period beginning on the date of enactment of this Act and ending on October 1, 2010, the Secretary shall collect and evaluate data regarding the costs of reviewing applications for biological products submitted under section 351(k) of the Time period. 42 USC 262 note. Effective date. Deadline. Time period. Federal Register, publication. Consultation.
