Page:United States Statutes at Large Volume 124.djvu/3947

124 STAT. 3921 PUBLIC LAW 111–353—JAN. 4, 2011 the submission of information regarding the article to the Sec- retary under this section, and any contact information for such person or persons that the Secretary has. ‘‘(2) DEFINITIONS.—For purposes of this subsection— ‘‘(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; and ‘‘(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.’’. (b) GUIDANCE.—Not later than 180 days after the date of enact- ment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient. SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST PROCESSING OF RAW OYSTERS. (a) IN GENERAL.—Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Pro- gram’s Model Ordinance, or the issuance of any guidance or regula- tion by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations), where such guidance, regulation or suggested amendment relates to post harvest proc- essing for raw oysters, the Secretary shall prepare and 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 report which shall include— (1) an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner; (2) the projected public health benefits of any proposed post harvest processing; (3) the projected costs of compliance with such post harvest processing measures; (4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters; (5) criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin; (6) an evaluation of alternative measures to prevent, elimi- nate, or reduce to an acceptable level the occurrence of foodborne illness; and (7) the extent to which the Food and Drug Administration has consulted with the States and other regulatory agencies, as appropriate, with regard to post harvest processing meas- ures. (b) LIMITATION.—Subsection (a) shall not apply to the guidance described in section 103(h). Deadline. Reports. 21 USC 342 note. Deadline. Publication. 21 USC 350b note.