Editorial Notes
Amendments

2016—Par. (1)(H). Pub. L. 114–255 inserted “for a new drug” after “any period of exclusivity” and “or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title,” after “section 355a of this title,”.

Statutory Notes and Related Subsidiaries
Changes to Regulations

Pub. L. 112–144, title XI, § 1112, July 9, 2012, 126 Stat. 1111, provided that:

“(a)
Report.—
Not later than 18 months after the date of the enactment of this Act [July 9, 2012], the Secretary, after obtaining input from medical gas manufacturers and any other interested members of the public, shall—
“(1)
determine whether any changes to the Federal drug regulations are necessary for medical gases; and
“(2)
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 regarding any such changes.
“(b)
Regulations.—
If the Secretary determines under subsection (a) that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the date of the enactment of this Act [July 9, 2012].
“(c)
Definitions.—
In this section:
“(1)
The term ‘Federal drug regulations’ means regulations in title 21 of the Code of Federal Regulations pertaining to drugs.
“(2)
The term ‘medical gas’ has the meaning given to such term in section 575 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd], as added by section 1111 of this Act.
“(3)
The term ‘Secretary’ means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.”

Rules of Construction

Pub. L. 112–144, title XI, § 1113, July 9, 2012, 126 Stat. 1112, provided that: “Nothing in this subtitle [subtitle B (§§ 1111–1113) of title XI of Pub. L. 112–144, enacting this section and sections 360ddd–1 and 360ddd–2 of this title and provisions set out as notes under this section] and the amendments made by this subtitle applies with respect to—

“(1)
a drug that is approved prior to May 1, 2012, pursuant to an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
“(2)
any gas listed in subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd(1)], as added by section 1111 of this Act, or any combination of any such gases, for an indication that—
“(A)
is not included in, or is different from, those specified in subclauses (I) through (VII) of section 576(a)(3)(A)(i) of such Act [21 U.S.C. 360ddd–1(a)(3)(A)(i)]; and
“(B)
is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 [21 U.S.C. 355, 360b]; or
“(3)
any designated medical gas added pursuant to subparagraph (H) of section 575(1) of such Act [21 U.S.C. 360ddd(1)] for an indication that—
“(A)
is not included in, or is different from, those originally added pursuant to subparagraph (H) of section 575(1) [21 U.S.C. 360ddd(1)(H)] and section 576(a)(3)(A)(i)(VIII) [21 U.S.C. 360ddd–1(a)(3)(A)(i)(VIII)]; and
“(B)
is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 of such Act [21 U.S.C. 355, 360b].”