Sec. 106. Annual update to Congress on appropriate pediatric indication for certain cough and cold monograph drugs
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Not later than one year after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a letter describing the progress of the Food and Drug Administration— in evaluating the cough and cold monograph described in subsection
(b)with respect to children under age 6; and as appropriate, revising such cough and cold monograph to address such children, through the administrative order process under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 101. The cough and cold monograph described in this subsection consists of the conditions under which nonprescription drug products containing antitussive, expectorant, nasal decongestant, or antihistamine active ingredients (or combinations thereof) are generally recognized as safe and effective, as specified in part 341 of title 21, Code of Federal Regulations (as in effect on the day before the date of enactment of this Act), and included in an administrative order deemed established under such section 505G(b) of the Federal Food, Drug, and Cosmetic Act. Subsection
(a)shall have no force or effect beginning on the date on which the Secretary submits a letter under subsection
(a)in which the Secretary indicates that the Food and Drug Administration has completed its evaluation and revised, in a final administrative order, as applicable, the cough and cold monograph in accordance with this section.