I 
117TH CONGRESS 
2D SESSION 
H. R. 8641 
To mitigate the effects of the COVID–19 pandemic on incentives under 
the Federal Food, Drug, and Cosmetic for the development of orphan 
drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 2, 2022 
Mr. GOTTHEIMER (for himself, Mr. BACON, and Ms. DEAN) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To mitigate the effects of the COVID–19 pandemic on incen-
tives under the Federal Food, Drug, and Cosmetic for 
the development of orphan drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Orphan Drug COVID– 
19 Mitigation Act of 2022’’. 
VerDate Sep 11 2014 
16:02 Aug 17, 2022
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H8641.IH
H8641
pamtmann on DSKBC07HB2PROD with BILLS
SEC. 2. MITIGATION OF EFFECTS OF COVID–19 PANDEMIC 
ON ORPHAN-DRUG DEVELOPMENT INCEN-
TIVES. 
(a) IN GENERAL.—In the case of a covered orphan 
drug, each of the following exclusivity periods is deemed 
to be extended by 180 days, so long as such period is not 
expired: 
(1) The 12-year period referred to in subpara-
graph (A) of section 351(k)(7) of the Public Health 
Service Act (42 U.S.C. 262(k)(7)). 
(2) The 5-year period referred to in subsection 
(c)(3)(E)(ii) and subsection (j)(5)(F)(ii) of section 
505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355). 
(3) The 3-year period referred to in each of 
clauses (iii) and (iv) of subsection (c)(3)(E) and 
clauses (iii) and (iv) of subsection (j)(5)(F) of sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355). 
(4) The 7-year period referred to in section 
527(a) of the Federal, Food, Drug, and Cosmetic 
Act (21 U.S.C. 360cc). 
(5) In the case of a covered orphan drug with 
one or more certifications specified in clauses (ii), 
(iii), and (iv) of section 505(b)(2)(A) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
VerDate Sep 11 2014 
16:02 Aug 17, 2022
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H8641.IH
H8641
pamtmann on DSKBC07HB2PROD with BILLS
355(b)(2)(A)), or in subclauses (II), (III), and (IV) 
of section 505(j)(2)(A) of such Act (21 U.S.C. 
355(j)(2)(A)), each corresponding patent-related ap-
proval-delay period (other than a patent for which 
the information required pursuant to subsection (b) 
or (c) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) has not been filed). 
(b) CONFORMING EXTENSIONS.—In addition to the 
periods extended under subsection (a) for a covered or-
phan drug, the following periods are each deemed to be 
extended by 180 days: 
(1) The 4-year period referred to in subpara-
graph (B) of section 351(k)(7) of the Public Health 
Service Act (42 U.S.C. 262(k)(7)). 
(2) The 4-year, 48-month, and 7 and one-half- 
year periods referred to in subsection (c)(3)(E)(ii) 
and subsection (j)(5)(F)(ii) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355). 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘covered orphan drug’’ means an 
orphan drug for which— 
(A) an application is submitted under sec-
tion 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) during the 
VerDate Sep 11 2014 
16:02 Aug 17, 2022
Jkt 029200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H8641.IH
H8641
pamtmann on DSKBC07HB2PROD with BILLS
COVID–19 emergency period (without regard 
to whether the same applicant has submitted 
such applications for the same drug before De-
cember 1, 2019, for a different rare disease or 
condition); 
(B) an application under section 505(b) of 
the Federal Food, Drug, and Cosmetic Act or 
under section 351(a) of the Public Health Serv-
ice Act (or a supplemental application, as the 
case may be) is approved pursuant to the inves-
tigational new drug application referred to in 
paragraph (1); and 
(C) there is no approved indication that is 
not for a rare disease or condition. 
(2) The term ‘‘corresponding patent-related ap-
proval delay period’’, with respect to a covered or-
phan drug, means the period ending with the last 
applicable date for the approval of an application 
within the meaning of subparagraph (A), (B), or (C) 
of section 505(c)(3) of the Federal, Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(c)(3)), or clause (i), 
(ii), or (iii) of section 505(j)(5)(B) of such Act (21 
U.S.C. 355(j)(5)(B)), whichever applies pursuant to 
the applicable patent certification. 
VerDate Sep 11 2014 
16:02 Aug 17, 2022
Jkt 029200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H8641.IH
H8641
pamtmann on DSKBC07HB2PROD with BILLS