Sec. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT INCENTIVES IN 5 YEARS
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## SEC. 805 REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT INCENTIVES IN 5 YEARS ###
(a)In General Not later than 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall, in consultation with the Food and Drug Administration, the Centers for Disease Control and Prevention, and other appropriate agencies, submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that contains the following: ####
(1)#####
(A)The number of initial designations of drugs as qualified infectious disease products under section 505E of the Federal Food, Drug, and Cosmetic Act. #####
(B)The number of qualified infectious disease products approved under such section 505E. #####
(C)Whether such products address the need for antibacterial and antifungal drugs to treat serious and life-threatening infections. #####
(D)A list of qualified infectious disease products with information on the types of exclusivity granted for each product, consistent with the information published under section 505(j)(7)(A)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii)). #####
(E)The progress made regarding the review and revision of the clinical trial guidance documents required under section 804 and the impact such review and revision has had on the review and approval of qualified infectious disease products. #####
(F)The Federal contribution, if any, to funding of the clinical trials for each qualified infectious disease product for each phase. ####
(2)Recommendations— #####
(A)based on the information under paragraph
(1)and any other relevant data, on any changes that should be made to the list of pathogens that are defined as qualifying pathogens under section 505E(f)(2) of the Federal Food, Drug, and Cosmetic Act, as added by section 801 of this Act; and #####
(B)on whether any additional program (such as the development of public-private collaborations to advance antibacterial drug innovation) or changes to the incentives under this subtitle may be needed to promote the development of antibacterial drugs. ####
(3)An examination of— #####
(A)the adoption of programs to measure the use of antibacterial drugs in health care settings; and #####
(B)the implementation and effectiveness of antimicrobial stewardship protocols across all health care settings. ####
(4)Any recommendations for ways to encourage further development and establishment of stewardship programs. ####
(5)A description of the regulatory challenges and impediments to clinical development, approval, and licensure of qualified infectious disease products, and the steps the Secretary has taken and will take to address such challenges and ensure regulatory certainty and predictability with respect to qualified infectious disease products. ###
(b)Definition For purposes of this section, the term “qualified infectious disease product” has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 801 of this Act.
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Sec. 805
REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE PRODUCT INCENTIVES IN 5 YEARS
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