Formatting necessary for an accurate reading of this text may be shown by tags (e.g., <DELETED> or <BOLD>) or may be missing from this TXT display. For complete and accurate display of this text, see the PDF.
[Page S4809]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. DURBIN (for himself, Mr. Cramer, and Ms. Smith):
S. 2103. A bill to improve access to affordable insulin; to the
Committee on Health, Education, Labor, and Pensions.
Mr. DURBIN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2103
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Affordable Insulin Approvals
Now Act''.
SEC. 2. DEEMED APPROVAL UNDER SECTION 351.
Section 7002(e)(4) of the Biologics Price Competition and
Innovation Act of 2009 (Public Law 111-148) is amended--
(1) by striking ``An amended'' and inserting the following:
``(A) In general.--An amended''; and
(2) by adding at the end the following:
``(B) Treatment of certain pending applications.--With
respect to an application for an insulin biological product
submitted under subsection (b)(2) or (j) of section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) with
a filing date that is not later than December 31, 2019, until
the Secretary makes a determination on final approval with
respect to such application, the Secretary shall continue to
review and approve (as appropriate) such application under
such section 505, even if such review and approval process
continues after March 23, 2020. For purposes of completing
the review and approval process for such an application, any
listed drug referenced in the application shall be treated as
a listed drug under section 505(j)(7) of the Federal Food,
Drug, and Cosmetic Act, even if such listed drug is deemed
licensed under section 351 of the Public Health Service Act
during such review and approval process. Effective on the
later of March 23, 2020, or the date of approval under
subsection (c) or (j) of section 505 of the Federal Food,
Drug, and Cosmetic Act of any such application, such approved
application shall be deemed to be a license for the
biological product under section 351 of the Public Health
Service Act.''.
______
By Mr. DURBIN (for himself, Ms. Collins, Mr. Brown, Mr.
Blumenthal, Mr. Markey, Mr. Wyden, Mr. Reed, Mrs. Murray, Mr.
Carper, Mr. Merkley, Ms. Hirono, and Mr. Kaine):
S. 2106. A bill to amend title 38, United States Code, to prohibit
smoking on the premises of any facility of the Veterans Health
Administration, and for other purposes; to the Committee on Veterans'
Affairs.
Mr. DURBIN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2106
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. PROHIBITION ON SMOKING IN FACILITIES OF THE
VETERANS HEALTH ADMINISTRATION.
(a) Prohibition.--
(1) In general.--Section 1715 of title 38, United States
Code, is amended to read as follows:
``Sec. 1715. Prohibition on smoking in facilities of the
Veterans Health Administration
``(a) Prohibition.--No person (including any veteran,
patient, resident, employee of the Department, contractor, or
visitor) may smoke on the premises of any facility of the
Veterans Health Administration.
``(b) Definitions.--In this section:
``(1) The term `facility of the Veterans Health
Administration' means any land or building (including any
medical center, nursing home, domiciliary facility,
outpatient clinic, or center that provides readjustment
counseling) that is--
``(A) under the jurisdiction of the Department of Veterans
Affairs;
``(B) under the control of the Veterans Health
Administration; and
``(C) not under the control of the General Services
Administration.
``(2) The term `smoke' includes--
``(A) the use of cigarettes, cigars, pipes, and any other
combustion or heating of tobacco; and
``(B) the use of any electronic nicotine delivery system,
including electronic or e-cigarettes, vape pens, and e-
cigars.''.
(2) Clerical amendment.--The table of sections at the
beginning of subchapter II of chapter 17 of such title is
amended by striking the item relating to section 1715 and
inserting the following new item:
``1715. Prohibition on smoking in facilities of the Veterans Health
Administration.''.
(b) Conforming Amendment.--Section 526 of the Veterans
Health Care Act of 1992 (Public Law 102-585; 38 U.S.C. 1715
note) is repealed.
(c) Effective Date.--The amendments made by this section
take effect on October 1, 2019.
____________________