Sec. 111. Reporting
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Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. ), as amended by section 110, is further amended by adding at the end the following: Not later than 1 year after the date of enactment of the Personal Care Products Safety Act , and not later than 60 days prior to the end of each fiscal year for which fees are collected under section 744O, the Food and Drug Administration shall prepare and submit to Congress a report concerning the progress of the Food and Drug Administration in achieving the objectives of the Personal Care Products Safety Act during such fiscal year and the future plans of the Food and Drug Administration for meeting the objectives.
The annual report for a fiscal year shall include— the number of registered facilities and cosmetic ingredient statements on file with the Food and Drug Administration; identification of the cosmetic ingredients and non-functional constituents that have been fully reviewed for safety by the Food and Drug Administration in the prior fiscal year and for which a final administrative order has been released; identification of at least 5 specific cosmetic ingredients and non-functional constituents that will be reviewed by the Food and Drug Administration in the next fiscal year; the number of facilities inspected and mandatory recalls that transpired during that fiscal year; the number of serious adverse event reports received by the Food and Drug Administration during that fiscal year; and any trends identified by the Food and Drug Administration about adverse event reports related to specific cosmetic ingredients or non-functional constituents.
The Food and Drug Administration shall make the reports required under subsection
(a)available to the public on the internet website of the Food and Drug Administration on the date of submission of such reports to Congress. Upon release of the report described in subsection (a), the Food and Drug Administration shall provide the public with an opportunity to provide feedback, at any time during the year, on the identification of ingredients under subsection (a)(3) by— providing an electronic portal, upon release of the report, enabling the public to— comment on the cosmetic ingredients or non-functional constituents under review for the current year; recommend additional cosmetic ingredients and non-functional constituents to be considered for review for safety in future years; and comment on the priorities for the specific cosmetic ingredients and non-functional constituents that the Food and Drug Administration anticipates will be reviewed in the next fiscal year; announcing on the internet website of the Food and Drug Administration, within the first 30 days of the new fiscal year, any amendments to the list of cosmetic ingredients and non-functional constituents submitted pursuant to subsection (a)(3) based on public input, pursuant to paragraph (1); and together with the final announcement of at least 5 specific cosmetic ingredients and non-functional constituents that will be reviewed in the coming year under section 607, providing a comment period for further public input, pursuant to section 607(a)(2). .
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U.S. Code