Sec. 1002. DEFINITIONS
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## SEC. 1002 DEFINITIONS ###
(a)Human Drug Application Section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended, in the matter following subparagraph (B), by striking “**an allergenic extract product, or**” and inserting “**does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to**”. ###
(b)Prescription Drug Product Section 735(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended— ####
(1)by redesignating subparagraphs (A), (B), and
(C)as clauses (i), (ii), and (iii), respectively; ####
(2)by striking “**(3) The term**” and inserting “**(3)(A) The term**”; ####
(3)by striking “ Such term does not include whole blood ” and inserting the following: > > ##### “(B) > > Such term does not include whole blood” > ; ####
(4)by striking “**an allergenic extract product,**” and inserting “**an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022,**” ; and ####
(5)by adding at the end the following: > > ##### “(C) > > > ######
(i)> > If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 736(a)(2), the Secretary shall consider such product to have been included in the discontinued section on the later of— > > > ###### “(I) > > the date such request was received; or > > > ###### “(II) > > if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. > > > ###### “(ii) > > For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.” > . ###
(c)Skin-Test Diagnostic Product Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end the following: > > #### “(12) > > The term ‘**skin-test diagnostic product**’— > > > ##### “(A) > > means a product— > > > ###### “(i) > > for prick, scratch, intradermal, or subcutaneous administration; > > > ###### “(ii) > > expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; > > > ###### “(iii) > > not intended to be a preventive or therapeutic intervention; and > > > ###### “(iv) > > intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of— > > > ###### “(I) > > an allergy to an antimicrobial agent; > > > ###### “(II) > > an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or > > > ###### “(III) > > infection with fungal or mycobacterial pathogens; and > > > ##### “(B) > > includes positive and negative controls required to interpret the results of a product described in subparagraph (A).” > .
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