[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6062 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 6062
To amend certain provisions in the Federal Food, Drug, and Cosmetic Act
relating to the discontinuance or interruption in the production of
life-saving drugs so as to apply such provisions with respect to life-
saving devices, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 3, 2020
Mr. Schneider (for himself, Mr. Hice of Georgia, and Ms. Schakowsky)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend certain provisions in the Federal Food, Drug, and Cosmetic Act
relating to the discontinuance or interruption in the production of
life-saving drugs so as to apply such provisions with respect to life-
saving devices, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
SAVING DEVICES.
(a) Notification Requirement.--Section 506C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356c) is amended--
(1) in the section heading, by striking ``life-saving
drugs'' and inserting ``life-saving drugs and devices'';
(2) in the matter preceding paragraph (1) in subsection
(a), by striking ``a drug'' and inserting ``a drug or device'';
(3) in subsection (a)(1)(C), by striking ``such drug'' and
inserting ``such drug or device'';
(4) in the matter following paragraph (2) in subsection
(a), by striking ``the drug'' each place it appears and
inserting ``the drug or device'';
(5) in subsection (c), by striking ``the drugs'' and
inserting ``the drugs or devices'';
(6) in the matter before paragraph (1) in subsection (g),
by striking ``a drug shortage of a drug described in subsection
(a)'' and inserting ``a drug or device shortage of a drug or
device described in subsection (a)'';
(7) in subsection (g)(1), by striking ``or a supplement to
such an application submitted under section 505(j), that could
help mitigate or prevent such shortage'' and inserting ``a
supplement to such an application submitted under section
505(j), or a submission for clearance of a device under section
510(k), classification of a device under section 513(f)(2), or
approval of a device under section 515, that could help
mitigate or prevent such shortage'';
(8) in subsection (g)(2), by striking ``such drug
shortage'' and inserting ``such drug or device shortage'';
(9) in subsection (h), by amending paragraph (2) to read as
follows:
``(2) the term `drug or device shortage' or `shortage',
with respect to a drug or device, means a period of time when
the demand or projected demand for the drug or device within
the United States exceeds the supply of the drug or device;
and''; and
(10) in subsection (h)(3)(A), by striking ``a drug'' and
inserting ``a drug or device''.
(b) Annual Reporting on Shortages.--Section 506C-1 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1) is amended--
(1) in the section heading, by striking ``drug shortages''
and inserting ``drug and device shortages'';
(2) in subsections (a) and (b), by striking ``drug
shortages'' each place it appears and inserting ``drug and
device shortages'';
(3) in subsection (a)(2), by striking ``the staff of the
Center for Drug Evaluation and Research's Office of Compliance
and Drug Shortage Program'' and inserting ``the staffs of the
Center for Drug Evaluation and Research's Office of Compliance
and Drug Shortage Program and the Center for Devices and
Radiological Health'';
(4) in subsection (a)(3)(B)(i), by striking ``applications
and supplements'' and inserting ``applications, supplements,
and submissions''; and
(5) in subsections (a)(5) and (c), by striking ``drug
shortage'' and inserting ``drug or device shortage''.
SEC. 2. DEVICE SHORTAGE LIST.
(a) In General.--Section 506E of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356e) is amended--
(1) in the section heading, by striking ``drug shortage
list'' and inserting ``drug and device shortage list''; and
(2) in subsection (a), by striking ``list of drugs'' and
inserting ``list of drugs and devices''.
(b) Contents.--Section 506E(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356e(b)) is amended--
(1) in the matter before paragraph (1), by striking ``each
drug'' and inserting ``each drug and device'';
(2) by striking ``the drug'' each place it appears and
inserting ``the drug or device'';
(3) in paragraph (1), by striking ``the National Drug Code
number for such drug'' and inserting ``the National Drug Code
number for any such drug''; and
(4) in paragraph (2), by striking ``such drug'' and
inserting ``such device''.
(c) Public Availability Public Health Exception.--Section 506E(c)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e(b)) is
amended by striking ``drug products'' and inserting ``drug products or
devices''.
(d) Technical Corrections.--Effective as if included in the
enactment of the 21st Century Cures Act (Public Law 114-255), section
3101(a)(2)(G) of such Act is amended, in the amendments made by such
section to section 506E(b)(3)(E) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356e(b)(3)(E))--
(1) by striking ``discontinuation'' and inserting
``Discontinuation''; and
(2) by striking ``discontinuance'' and inserting
``Discontinuance''.
SEC. 3. IMPORTATION OF DEVICES IN SHORTAGE.
Section 801(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(d)) is amended--
(1) in paragraph (1), by adding at the end the following
subparagraph:
``(C) Except as authorized by the Secretary in the case of a device
that appears on the drug and device shortage list under section 506E,
no device may be imported into the United States for commercial use if
such device is manufactured outside the United States, unless the
manufacturer has authorized the device to be marketed in the United
States and has caused the device to be labeled to be marketed in the
United States.''; and
(2) in paragraph (2), by striking ``drug'' each place it
appears and inserting ``drug or device''.
<all>