; and (3) small manufacturers (as defined in section 744L of such Act (as added by section 202 of this Act)), beginning 2 years after such date. (c) Enforcement Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 ) is amended by adding at the end the following: (f) If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to current good manufacturing practice, as prescribed by the Secretary. . 104. Adverse event reports Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.), as amended by section 103(a), is further amended by adding at the end the following: 611. Adverse event reporting for cosmetics (a) Submission of serious adverse event reports (1) In general With respect to any cosmetic product distributed in the United States, the responsible person shall submit, not later than 15 days after the receipt by the responsible person, using an electronic system developed under subsection (b), to the Secretary any report of a serious adverse event associated with the use of the cosmetic product, accompanied by a copy of the label on or with the retail packaging of the cosmetic product. (2) New medical information During the 12-month period following the submission of a serious adverse event report under paragraph (1), with respect to any cosmetic product distributed in the United States, the responsible person shall submit, not later than 15 days after the receipt by the responsible person, using an electronic system developed under subsection (b), to the Secretary any new medical information related to such serious adverse event report that is received by the responsible person . (3) Publication The Secretary shall make publicly available on the internet website of the Food and Drug Administration reports submitted under paragraph (1). (4) No duplication In the case of cosmetic product that is also a drug for which a serious adverse event report is filed using Form FDA 3500A (or any successor form