S.Amdt. 926

SA 926. Mr. MARSHALL submitted an amendment intended to be proposed
to amendment SA 891 proposed by Mr. Schumer to the bill H.R. 1319, to
provide for reconciliation pursuant to title II of S. Con. Res. 5;
which was ordered to lie on the table; as follows:
At the end of title II, insert the following:

Subtitle M--Food and Drug Administration

SEC. 2931. USING EMERGENCY USE AUTHORIZATION DATA AND REAL
WORLD EVIDENCE GATHERED DURING AN EMERGENCY TO
SUPPORT DRUG, BIOLOGICAL PRODUCT, AND PREMARKET
DEVICE APPLICATIONS.

(a) In General.--Data generated to support an authorization
under section 564 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-3) with respect to a drug, biological
product, or device, and real world evidence relating to such
drug, biological product, or device used pursuant to such
authorization, may constitute valid scientific evidence, and
shall be considered for purposes of--
(1) reviewing submissions pursuant to section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and
section 351 of the Public Health Service Act (42 U.S.C. 262);
(2) reviewing submissions pursuant to sections 510(k),
513(f), and 515 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 21 U.S.C. 360(k), 360c(f), or 360e); and
(3) otherwise meeting the requirements of such Act and such
section 351 of the Public Health Service Act.
(b) Applicability of Certain Categorizations for Premarket
Device Review.--In the case of a device receiving an
authorization under section 564 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-3) for which the Secretary
has determined, in accordance with subsection (m) of such
section, that a laboratory examination or procedure
associated with such device is deemed to be in the category
of examinations and procedures described in section 353(d)(3)
of the Public Health Service Act (42 U.S.C. 262), such
determination shall apply with regard to a submission
pursuant to section 510(k), 513(f), or 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 21 U.S.C. 360(k),
360c(f), or 360e) for such device, unless the Secretary
(taking into account any applicable conditions specified
pursuant to subsection (m)(2) of section 564 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3)) identifies
new information not included in the request for authorization
that indicates that the criteria under section 353(d)(3) of
the Public Health Service Act (42 U.S.C. 262) are not met.
(c) Rule of Construction.--Nothing in this section shall be
construed as altering the review standards or otherwise
affecting the requirements under section 505, 510(k), 513(f),
or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
21 U.S.C. 355, 360(k), 360c(f), or 360e) or under section 351
of the Public Health Service Act (42 U.S.C. 262) for the
clearance or approval of a device, approval of a drug, or
licensure of a biological product.
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