Sec. 3101. Technical corrections

1,261 words·~6 min read·/bill/114/hr/34/enr/section-3101·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Except as otherwise expressly provided, whenever in this subsection an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ). Section 301(r) ( 21 U.S.C. 331(r) ) is amended by inserting , drug, after device each place the term appears. Section 505 ( 21 U.S.C. 355 ) is amended— in subsection (d), in the last sentence, by striking premarket approval and inserting marketing approval ; and in subsection (q)(5)(A), by striking subsection (b)(2) or

(j)of the Act or 351(k) and inserting subsection (b)(2) or

(j)of this section or section 351(k) . Section 505–1(h)( 21 U.S.C. 355–1(h) ) is amended— in paragraph (2)(A)(iii)— in the clause heading, by striking and inserting label ; labeling by striking label each place the term appears and inserting labeling ; and by striking sponsor and inserting responsible person ; and in paragraph (8), by striking and (7). and inserting and

(7). Section 505B ( 21 U.S.C. 355c ) is amended— in subsection (e)— in paragraph (2)— in subparagraph (A), by inserting study after initial pediatric each place the term appears; and in subparagraph (B), in the subparagraph heading, by striking and inserting initial plan ; initial pediatric study plan in paragraph (5), in the paragraph heading, by inserting before agreed initial pediatric study ; and plan in paragraph (6), by striking agreed initial pediatric plan and inserting agreed initial pediatric study plan ; and in subsection (f)(1), by inserting and any significant amendments to such plans, after agreed initial pediatric study plans, . Section 506C ( 21 U.S.C. 356c ) is amended— in subsection (c), by striking discontinuation and inserting discontinuance ; and in subsection (g)(1), by striking section 505(j) that could help and inserting section 505(j), that could help . Section 506C–1(a) ( 21 U.S.C. 331(a) ) is amended, in the matter before paragraph (1)— by striking Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter, and inserting Not later than March 31 of each calendar year, ; and by inserting , with respect to the preceding calendar year, after a report . Section 506E(b)(3)(E) ( 21 U.S.C. 356e(b)(3)(E) ) is amended by striking discontinuation and inserting discontinuance . Section 510(h) ( 21 U.S.C. 360(h) ) is amended— in paragraph (4), in the matter preceding subparagraph (A), by striking establishing the risk-based scheduled and inserting establishing a risk-based schedule ; and in paragraph (6)— in subparagraph (A), by striking fiscal and inserting calendar each place the term appears; and in subparagraph (B), by striking an active ingredient of a drug, a finished drug product, or an excipient of a drug and inserting an active ingredient of a drug or a finished drug product . Section 513(f)(2)(A) ( 21 U.S.C. 360c(f)(2)(A) ) is amended— in clause (i), by striking within 30 days ; and in clause (iv), by striking low-moderate and inserting low to moderate . Section 515(a)(1) ( 21 U.S.C. 360e(a)(1) ) is amended by striking subject to a an order and inserting subject to an order . Section 518A ( 21 U.S.C. 360h–1 ) is amended— by striking subsection (c); and by redesignating subsection

(d)as subsection (c). Section 519(f) ( 21 U.S.C. 360i(f) ) is amended by striking and life sustaining and inserting or life sustaining . Section 524(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(c)(4)(A) ) is amended by striking Services Act and inserting Service Act . Section 524A ( 21 U.S.C. 360n–1 ) is amended— by striking If the Secretary and inserting the following: If the Secretary ; by striking any and inserting the first ; and by adding at the end the following: Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 505(b) that otherwise meets the criteria for the Secretary to grant priority review. . Section 569(a)(2)(A) ( 21 U.S.C. 360bbb–8(a)(2)(A) ) is amended, in the first sentence, by striking subsection

(c)and inserting subsection

(b). Section 569A(c) (21 U.S.C. 360bbb–8a(c)) is amended by inserting or under the Public Health Service Act after this Act . Section 569B ( 21 U.S.C. 360bbb–8b ) is amended by striking drug or device and inserting drug, biological product, or device each place the term appears. Section 575(1)(H) ( 21 U.S.C. 360ddd(1)(H) ) is amended— by inserting for a new drug after any period of exclusivity ; and by inserting or any period of exclusivity for a new animal drug under section 512(c)(2)(F), after section 505A, . Section 576(a) ( 21 U.S.C. 360ddd–1(a) ) is amended— in the matter preceding subparagraph

(A)of paragraph (1), by inserting who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce after any person ; and in paragraph (3)— in subparagraph (A)— in clause (i)(VIII), by inserting for a new drug after any period of exclusivity ; and in clause (ii), in the matter preceding subclause (I), by inserting the before final use ; and in subparagraph (B)— in clause (i), by inserting for a new drug after any period of exclusivity ; and in clause (ii), by inserting a comma after drug product . Section 577 ( 21 U.S.C. 360ddd–2 ) is amended by inserting or 740(a) after section 736(a) . Section 712(e)(1)(B) ( 21 U.S.C. 379d–1(e)(1)(B) ) is amended by striking services and inserting service . Section 744H(a) ( 21 U.S.C. 379j–52(a) ) is amended— in paragraph (1)(A)(v), by striking Biosimilars User Fee Act of 2012 and inserting Biosimilar User Fee Act of 2012 ; and in paragraph (2)(B), by striking Biosimilars User Fee Act of 2012 and inserting Biosimilar User Fee Act of 2012 . Section 801(s)(2) ( 21 U.S.C. 381(s)(2) ) is amended by adding at the end the following: In establishing the effective date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the Secretary of Health and Human Services, provide a reasonable period of time for an importer of a drug to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported product. . Section 714 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 ; 126 Stat. 1074) is amended by striking subsection (d). Section 809(a)(2) ( 21 U.S.C. 384e(a)(2) ) is amended by striking conduction and inserting conducting . Section 901(a)(1)(A) of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 ; 21 U.S.C. 356 note) is amended by striking serious and life-threatening diseases and inserting serious or life-threatening diseases . Section 907 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 ; 126 Stat. 1092, 1093) is amended— in the section heading, by striking in the heading and inserting Biologics ; and Biological Products in subsection (a)(2)(B), by striking applications for new drug applications and inserting new drug applications . Section 1122 of the Food and Drug Administration Safety and Innovation Act ( Public Law 112–144 ; 126 Stat. 1112, 1113) is amended— in subsection (a)(2), by striking dependance and inserting dependence ; and in subsection (c), by striking promulgate and inserting issue .

Connectionstraces to 15

Traces to 15 documents

U.S. Code