request access to the datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising the analysis, conclusions, or other findings upon which the Secretary seeks to rely; and

in the event that information described in paragraph (1) is used to support regulatory decision-making, and as otherwise appropriate, to the extent practicable, provide the manufacturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or personally identifiable information.