Sec. 3101. TECHNICAL CORRECTIONS

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## SEC. 3101 TECHNICAL CORRECTIONS ###

(a)FFDCA ####

(1)References 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.). ####

(2)Amendments #####

(A)Prohibited acts Section 301(r) (21 U.S.C. 331(r)) is amended by inserting “, drug,” after “device” each place the term appears. #####

(B)New Drugs Section 505 (21 U.S.C. 355) is amended— ######

(i)in subsection (d), in the last sentence, by striking “premarket approval” and inserting “marketing approval”; and ######

(ii)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)”. #####

(C)Risk Evaluation and Mitigation Strategies Section 505-1(h)(21 U.S.C. 355-1(h)) is amended— ######

(i)in paragraph (2)(A)(iii)— ######

(I)in the clause heading, by striking “label” and inserting “labeling”; ######

(II)by striking “label” each place the term appears and inserting “labeling”; and ######

(III)by striking “sponsor” and inserting “responsible person”; and ######

(ii)in paragraph (8), by striking “and (7).” and inserting “and (7)”. #####

(D)Pediatric study plans Section 505B (21 U.S.C. 355c) is amended— ######

(i)in subsection (e)— ######

(I)in paragraph (2)— ######

(aa)in subparagraph (A), by inserting “study” after “initial pediatric” each place the term appears; and ######

(bb)in subparagraph (B), in the subparagraph heading, by striking “initial plan” and inserting “initial pediatric study plan”; ######

(II)in paragraph (5), in the paragraph heading, by inserting “agreed initial pediatric study” before “plan”; and ######

(III)in paragraph (6), by striking “agreed initial pediatric plan” and inserting “agreed initial pediatric study plan”; and ######

(ii)in subsection (f)(1), by inserting “and any significant amendments to such plans,” after “agreed initial pediatric study plans,”. #####

(E)Discontinuance or interruption in the production of live-saving drugs Section 506C (21 U.S.C. 356c) is amended— ######

(i)in subsection (c), by striking “discontinuation” and inserting “discontinuance”; and ######

(ii)in subsection (g)(1), by striking “section 505(j) that could help” and inserting “section 505(j), that could help”. #####

(F)Annual reporting on drug shortages Section 506C-1(a) (21 U.S.C. 331(a)) is amended, in the matter before paragraph (1)— ######

(i)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 ######

(ii)by inserting “, with respect to the preceding calendar year,” after “a report”. #####

(G)Drug shortage list Section 506E(b)(3)(E) (21 U.S.C. 356e(b)(3)(E)) is amended by striking “discontinuation” and inserting “discontinuance”. #####

(H)Inspections of establishments Section 510(h) (21 U.S.C. 360(h)) is amended— ######

(i)in paragraph (4), in the matter preceding subparagraph (A), by striking “establishing the risk-based scheduled” and inserting “establishing a risk-based schedule”; and ######

(ii)in paragraph (6)— ######

(I)in subparagraph (A), by striking “fiscal” and inserting “calendar” each place the term appears; and ######

(II)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”. ######

(I)Classification of devices intended for human use Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is amended— ######

(i)in clause (i), by striking “within 30 days”; and ######

(ii)in clause (iv), by striking “low-moderate” and inserting “low to moderate”. #####

(J)Premarket approval 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”. #####

(K)Program to improve the device recall system Section 518A (21 U.S.C. 360h-1) is amended— ######

(i)by striking subsection (c); and ######

(ii)by redesignating subsection

(d)as subsection (c). #####

(L)Unique device identifier Section 519(f) (21 U.S.C. 360i(f)) is amended by striking “and life sustaining” and inserting “or life sustaining”. #####

(M)Priority review to encourage treatments for tropical diseases 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”. #####

(N)Priority review for qualified infectious disease products Section 524A (21 U.S.C. 360n-1) is amended— ######

(i)by striking “ If the Secretary ” and inserting the following: > > ### “(a) In general > > If the Secretary” > ; ######

(ii)by striking “any” and inserting “the first”; and ######

(iii)by adding at the end the following: > > ### “(b) Construction > > 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.” > . #####

(O)Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments 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)”. #####

(P)Optimizing global clinical trials Section 569A(c) (21 U.S.C. 360bbb-8a(c)) is amended by inserting “or under the Public Health Service Act” after “this Act”. #####

(Q)Use of clinical investigation data from outside the united states 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. #####

(R)Medical gases definitions Section 575(1)(H) (21 U.S.C. 360ddd(1)(H)) is amended— ######

(i)by inserting “for a new drug” after “any period of exclusivity”; and ######

(ii)by inserting “or any period of exclusivity for a new animal drug under section 512(c)(2)(F),” after “section 505A,”. #####

(S)Regulation of medical gases Section 576(a) (21 U.S.C. 360ddd-1(a)) is amended— ######

(i)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 ######

(ii)in paragraph (3)— ######

(I)in subparagraph (A)— ######

(aa)in clause (i)(VIII), by inserting “for a new drug” after “any period of exclusivity”; and ######

(bb)in clause (ii), in the matter preceding subclause (I), by inserting “the” before “final use”; and ######

(II)in subparagraph (B)— ######

(aa)in clause (i), by inserting “for a new drug” after “any period of exclusivity”; and ######

(bb)in clause (ii), by inserting a comma after “drug product”. #####

(T)Inapplicability of drug fees to designated medical gases Section 577 (21 U.S.C. 360ddd-2) is amended by inserting “or 740(a)” after “section 736(a)”. #####

(U)Conflicts of interest Section 712(e)(1)(B) (21 U.S.C. 379d-1(e)(1)(B)) is amended by striking “services” and inserting “service”. #####

(V)Authority to assess and use biosimilar biological product fees Section 744H(a) (21 U.S.C. 379j-52(a)) is amended— ######

(i)in paragraph (1)(A)(v), by striking “Biosimilars User Fee Act of 2012” and inserting “Biosimilar User Fee Act of 2012”; and ######

(ii)in paragraph (2)(B), by striking “Biosimilars User Fee Act of 2012” and inserting “Biosimilar User Fee Act of 2012”. #####

(W)Registration of commercial importers ######

(i)Amendment Section 801(s)(2) (21 U.S.C. 381(s)(2)) is amended by adding at the end the following: > > ##### “(D) Effective date > > 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.” > . ######

(ii)Conforming amendment 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). #####

(X)Recognition of foreign government inspections Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by striking “conduction” and inserting “conducting”. ###

(b)FDASIA ####

(1)Findings relating to drug approval 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”. ####

(2)Reporting of inclusion of demographic subgroups Section 907 of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is amended— #####

(A)in the section heading, by striking “biologics” in the heading and inserting “biological products”; and #####

(B)in subsection (a)(2)(B), by striking “applications for new drug applications” and inserting “new drug applications”. ####

(3)Combating prescription drug abuse Section 1122 of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144; 126 Stat. 1112, 1113) is amended— #####

(A)in subsection (a)(2), by striking “dependance” and inserting “dependence”; and #####

(B)in subsection (c), by striking “promulgate” and inserting “issue”.

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