[Congressional Record Volume 167, Number 88 (Thursday, May 20, 2021)]
[Senate]
[Page S3213]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 1742. Ms. SMITH (for herself and Mr. Cassidy) submitted an 
amendment intended to be proposed by her to the bill S. 1260, to 
establish a new Directorate for Technology and Innovation in the 
National Science Foundation, to establish a regional technology hub 
program, to require a strategy and report on economic security, 
science, research, innovation, manufacturing, and job creation, to 
establish a critical supply chain resiliency program, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in title I of division F, insert 
     the following:

     SEC. 61__. ESSENTIAL GENERIC ANTIBIOTIC PROGRAM.

       (a) Grant Program.--
       (1) Establishment.--Not later than 60 days after the date 
     of enactment of this Act, the Secretary shall establish a 
     program to provide grants to manufacturers of essential 
     generic antibiotic drugs, or the active pharmaceutical 
     ingredient or articles used as components of such drug, to 
     support activities described in paragraph (3).
       (2) Eligible entities.--The Secretary shall award grants 
     under this subsection to not more than 3 manufacturers of an 
     essential generic antibiotic drug. Each such recipient shall 
     be a manufacturer that--
       (A) has implemented and maintains an effective quality 
     management system, under parts 210 and 211 of title 21, Code 
     of Federal Regulations (or any successor regulations);
       (B) has a strong record of compliance with the requirements 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.);
       (C) commits to using advanced manufacturing in its domestic 
     manufacturing operations; and
       (D) has existing manufacturing facilities and operations in 
     the United States.
       (3) Use of funds.--A recipient of a grant under this 
     subsection may use such grant funds to--
       (A) with respect to manufacturing an essential generic 
     antibiotic drug--
       (i) expand, upgrade, or recommission an existing 
     manufacturing facility located in the United States; or
       (ii) construct a new manufacturing facility in the United 
     States; and
       (B) manufacture essential generic antibiotic drugs using 
     advanced manufacturing techniques.
       (b) Use of Funds to Purchase Essential Generic Antibiotic 
     Drugs for Stockpiling.--The Secretary may use amounts 
     appropriated under this section to purchase, store, 
     stockpile, or disposition essential generic antibiotic drugs 
     manufactured in the United States.
       (c) Definitions.--For purposes of this section:
       (1) Active pharmaceutical ingredient.--The term ``active 
     pharmaceutical ingredient'' has the meaning given such term 
     in section 744A of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-41).
       (2) Advanced manufacturing.--The term ``advanced 
     manufacturing'' means an approach for the manufacturing of 
     drugs that incorporates novel technology, or uses an 
     established technique or technology in a new or innovative 
     way, that enhances drug product quality or improves the 
     manufacturing process.
       (3) Essential generic antibiotic drug.--The term 
     ``essential generic antibiotic drug'' means an antibacterial 
     or antifungal drug approved by the Food and Drug 
     Administration under section 505(j) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)) that the Secretary 
     determines to be medically necessary to have available at all 
     times in an amount adequate to serve patient needs, including 
     beta-lactams (including penicillin and cephalosporin 
     derivatives) and non-beta lactams (including tetracycline and 
     aminoglycoside derivatives).
       (4) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (5) United states.--The term ``United States'' means the 50 
     States, the District of Columbia, territories, and Tribal 
     lands.
       (d) Funding.--For purposes of carrying out this section 
     (other than subsection (e)), there is appropriated, out of 
     amounts in the Treasury not otherwise appropriated, 
     $500,000,000 for fiscal year 2021, to remain available 
     through September 30, 2023.
       (e) Study and Report.--
       (1) In general.--The Secretary shall enter into a contract 
     with an entity under which such entity carries out a study on 
     the manufacture of essential generic antibiotic drugs and 
     issues a report that includes--
       (A) recommendations about which antibiotics the Secretary 
     should prioritize for purposes of the program under 
     subsection (a), based on factors that include necessity of 
     use, vulnerability to foreign supply chain disruptions, and 
     availability of alternatives; and
       (B) the expected effect of increased domestic manufacturing 
     of drugs on drug costs to consumers.
       (2) Authorization.--To carry out this subsection, there is 
     authorized to be appropriated $2,000,000 for fiscal year 
     2021, to remain available until September 30, 2022.
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