; (2) in subparagraph (E), by striking the semicolon at the end and inserting ; and ; and (3) by adding at the end the following: (F) in vitro clinical tests are analytically and clinically valid; . (r) Office of women’s health Section 1011(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399b(b) ) is amended— (1) in paragraph (1), by inserting in vitro clinical tests, after devices, ; and (2) in paragraph (4), by inserting in vitro clinical test developers, after device manufacturers, . (s) Countermeasure provisions of the public health service act Title III of the Public Health Service Act is amended— (1) in section 319F–1(a)(2)(A) (42 U.S.C. 247d–6a(a)(2)(A))— (A) in the matter preceding clause (i)— (i) by striking or device and inserting device ; and (ii) by inserting or an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )), after Act ( 21 U.S.C. 321(h) )), ; and (B) in each of clauses (ii) and (iii), by striking or device and inserting device, or in vitro clinical test ; (2) in section 319F–2(c)(1)(B) (42 U.S.C. 247d–6b(c)(1)(B))— (A) by striking or device and inserting device ; and (B) by inserting , or an in vitro clinical test (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )) after Act ( 21 U.S.C. 321(h) )), ; and (3) in section 319F–3(i)(7) (42 U.S.C. 247d–6d(i)(7))— (A) in the matter preceding subparagraph (A)— (i) by striking or device and inserting device ; and (ii) by inserting or an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )), after Act ( 21 U.S.C. 321(h) ) ; (B) in subparagraph (A)— (i) by moving the margin of clause (iii) 2 ems to the left; and (ii) in clause (iii), by striking or device and inserting device, or in vitro clinical test