I 

116TH CONGRESS 

2D SESSION H. R. 8644 

To ensure the availability of critical medications in the event of public health 

emergencies, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 20, 2020 

Mr. SMITH of Missouri (for himself and Mr. SCHNEIDER) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To ensure the availability of critical medications in the event 

of public health emergencies, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; SENSE OF CONGRESS. 

4 This Act may be cited as the ‘‘Secure America’s Med5 icine Act of 2020’’. 


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1 SEC. 2. ENSURING THE AVAILABILITY OF CRITICAL MEDI2 CATIONS IN THE EVENT OF PUBLIC HEALTH 

3 EMERGENCIES. 

4 (a) IN GENERAL.—The Public Health Service Act is 

5 amended by inserting after section 319F–4 of such Act 

6 (42 U.S.C. 247d–6e) the following new section: 

7 ‘‘SEC. 319F–5. ENSURING THE AVAILABILITY OF CRITICAL 

8 MEDICATIONS IN THE EVENT OF PUBLIC 

9 HEALTH EMERGENCIES. 

10 ‘‘(a) LIST OF CRITICAL MEDICATIONS.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall main12 tain a list of medications (in this section referred to 

13 as ‘critical medications’) with respect to which it is 

14 critical that the Federal Government ensure avail15 ability in the event of a public health emergency. 

16 ‘‘(2) COLLABORATION.—The Secretary shall 

17 carry out this subsection and subsection (b) in col18 laboration with the Assistant Secretary for Pre19 paredness and Response, the Commissioner of Food 

20 and Drugs, the Director of the Centers for Disease 

21 Control and Prevention, and the Secretary of Home22 land Security. 

23 ‘‘(3) TIMING OF LIST; REPORTING.—The Sec24 retary shall— 

25 ‘‘(A) not later than 180 days after the date 

26 of the enactment of the this section— 


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1 ‘‘(i) establish the initial list required 

2 by paragraph (1); 

3 ‘‘(ii) submit a report, in a manner 

4 that does not compromise national secu5 rity, to the Committee on Appropriations 

6 and the Committee on Energy and Com7 merce of the House of Representatives and 

8 the Committee on Appropriations and the 

9 Committee on Health, Education, Labor, 

10 and Pensions of the Senate, setting 

11 forth— 

12 ‘‘(I) the list in effect under para13 graph (1); 

14 ‘‘(II) the reasons why each crit15 ical medication is included on the list; 

16 ‘‘(III) the reasons why other 

17 medications described in paragraph 

18 (4) were not included; and 

19 ‘‘(IV) which critical medications 

20 are designated critical medications 

21 under subsection (b) and the reasons 

22 for each such designation; and 

23 ‘‘(iii) make publicly available the list 

24 in effect under paragraph (1) and the most 

25 recent report under clause (ii), subject to 


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1 any redactions or edits necessary to re2 move classified information or otherwise 

3 ensure that national security is not com4 promised; and 

5 ‘‘(B) not later than March 15 of each year 

6 following the year in which the first list of crit7 ical medications is required by paragraph (1)— 

8 ‘‘(i) update the list required by para9 graph (1); 

10 ‘‘(ii) submit an updated report under 

11 subparagraph (A)(ii); and 

12 ‘‘(iii) make publicly available such up13 dated list and report in accordance with 

14 subparagraph (A)(iii). 

15 ‘‘(4) REQUIRED INCLUSION ON LIST.—Subject 

16 to paragraph (5), the Secretary shall include on the 

17 list under paragraph (1) the following medications: 

18 ‘‘(A) Commonly-used medications likely to 

19 be needed in order to prevent, mitigate, or treat 

20 the adverse health effects which frequently re21 sult from a public health emergency, including 

22 medications routinely needed to effectively man23 age patients in hospital emergency rooms or in24 tensive care units, and medications needed durVerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644

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1 ing surgical procedures often required during a 

2 public health emergency. 

3 ‘‘(B) Anti-infective medications, including 

4 antibiotic, antifungal, and antiviral medications, 

5 which are either commonly used to treat infec6 tious diseases or have a significant likelihood of 

7 being needed to treat an infectious disease that, 

8 if not so treated, may result in a public health 

9 emergency. 

10 ‘‘(C) Commonly-used medications which 

11 are life-supporting, life-sustaining, or intended 

12 for the use in the prevention or treatment of a 

13 debilitating disease or condition, as such terms 

14 are defined in section 506C of the Federal 

15 Food, Drug, and Cosmetics Act and the regula16 tions thereunder. 

17 ‘‘(5) LIMITATIONS ON INCLUSION ON LIST.— 

18 The Secretary— 

19 ‘‘(A) shall not be required to include on 

20 the list under paragraph (1) every medication 

21 meeting the criteria described in paragraph (4); 

22 ‘‘(B) shall prioritize the inclusion on the 

23 list under paragraph (1) of 300 to 400 medica24 tions meeting such criteria— 

25 ‘‘(i) that are most commonly used; or 


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1 ‘‘(ii) for which a shortage would be 

2 most likely to have the greatest potential 

3 adverse health consequences; 

4 ‘‘(C) in applying subparagraph (B), shall 

5 count as a single medication— 

6 ‘‘(i) all strengths, dosage forms, and 

7 package forms of a given medication; 

8 ‘‘(ii) medications that are therapeuti9 cally equivalent (under the Food and Drug 

10 Administration’s most recent publication of 

11 ‘Approved Drug Products with Therapeutic 

12 Equivalence Evaluations’); and 

13 ‘‘(iii) a biological product licensed 

14 under section 351(a) and all biosimilar bio15 logical products that are licensed under 

16 section 351(k) using the biological product 

17 as the reference product; and 

18 ‘‘(D) in applying subparagraph (B), shall 

19 not prioritize the inclusion of any medication 

20 that is a qualified countermeasure (as defined 

21 in section 319F–1(a)(2)), a security counter22 measure (as defined in section 319F– 

23 2(c)(1)(B)), or a qualified pandemic and epi24 demic product (as defined in section 319F– 

25 3(i)). 


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1 ‘‘(6) PUBLIC INPUT AND COMMENT.—In devel2 oping and updating the list under paragraph (1), the 

3 Secretary shall solicit public input, including by— 

4 ‘‘(A) consulting (through public meetings 

5 or other forms of engagement) with relevant 

6 stakeholders, including health care providers, 

7 medical professional societies, public health ex8 perts, State and local public health depart9 ments, patient groups, and drug manufacturers 

10 and distributors; 

11 ‘‘(B) publishing in the Federal Register, 

12 for public review and comment, the Secretary’s 

13 proposed list of critical medications, together 

14 with the Secretary’s reasons why each medica15 tion included on such proposed list was included 

16 and the reasons why other medications were not 

17 included; 

18 ‘‘(C) accepting public comment on such 

19 proposed list and reasons for a period of not 

20 less than 60 days; 

21 ‘‘(D) taking such comments into account 

22 in determining the final list under paragraph 

23 (1); and 

24 ‘‘(E) addressing such comments in report25 ing under paragraph (3). 


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1 ‘‘(7) ADDITIONAL CONSIDERATIONS.—In devel2 oping and updating the list under paragraph (1), the 

3 Secretary shall consider— 

4 ‘‘(A) the most recent annual threat-based 

5 review conducted by the Secretary under section 

6 319F–2(a)(2), the most recent report of the 

7 Comptroller General of the United States under 

8 section 319F–2(a)(5), and the most recent rec9 ommendations of the Public Health Emergency 

10 Countermeasures Enterprise established under 

11 section 2811–1; 

12 ‘‘(B) input from each member of the Pub13 lic Health Emergency Countermeasures Enter14 prise (or a designee thereof); and 

15 ‘‘(C) if available, the report of the National 

16 Academies of Sciences, Engineering, and Medi17 cine prepared pursuant to section 3101 of the 

18 Coronavirus Aid, Relief, and Economic Stability 

19 Act (Public Law 116–136). 

20 ‘‘(b) DESIGNATION OF CRITICAL MEDICATIONS FOR

21 WHICH AVAILABILITY IS AT RISK IN THE EVENT OF A

22 PUBLIC HEALTH EMERGENCY.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall— 

24 ‘‘(A) evaluate each critical medication to 

25 determine whether there is adequate assurance 


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1 that it will be available in sufficient quantities 

2 in the event of a public health emergency, on a 

3 timely basis, within each portion of the United 

4 States where it is needed; and 

5 ‘‘(B) designate each critical medication 

6 with respect to which the Secretary determines 

7 there is not such an adequate assurance. 

8 ‘‘(2) FACTORS TO BE TAKEN INTO ACCOUNT.— 

9 In carrying out paragraph (1), the Secretary shall 

10 take into account factors including— 

11 ‘‘(A) volume inventories of each critical 

12 medication that are normally available for use 

13 in the United States, in the public and private 

14 sector, in the absence of a public health emer15 gency; 

16 ‘‘(B) current and expected production ca17 pacity, in the United States and in foreign 

18 countries, of each critical medication, including 

19 the domestic and foreign capacity to surge pro20 duction of each critical medication and the time 

21 required to do so, taking into account, among 

22 other things, current marketplace trends and 

23 factors and the economic viability of creating 

24 and maintaining such surge capacity in the ab25 sence of nonemergency commercial demand; 


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1 ‘‘(C) the potential demand and historic de2 mand trends for each critical medication in the 

3 event of a public health emergency, including 

4 demand in the United States and in foreign 

5 countries; and 

6 ‘‘(D) potential constraints on the timely 

7 manufacture and distribution of each critical 

8 medication in sufficient quantities for each por9 tion of the United States where it is needed in 

10 the event of public health emergency, including 

11 constraints due to the unavailability or limited 

12 availability of such critical medication or any 

13 key ingredients thereof (including active phar14 maceutical ingredients) from one or more for15 eign countries. 

16 ‘‘(3) CONDUCT OF EVALUATION.—In carrying 

17 out paragraph (1), the Secretary may consider such 

18 other factors as the Secretary considers relevant to 

19 determining the supply chain vulnerability of each 

20 critical medication and each key ingredient thereof 

21 (including active pharmaceutical ingredients) in the 

22 event of a public health emergency, which may in23 clude— 

24 ‘‘(A) whether and to what extent the exist25 ing sources of such supply for the United 


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1 States are domestic or foreign, the specific for2 eign countries from which any such foreign sup3 ply is obtained and in what quantities, and the 

4 extent of the risk of a disruption in supply from 

5 each such foreign country in the event of a pub6 lic health emergency; 

7 ‘‘(B) the location of each domestic and for8 eign establishment registered under section 510 

9 of the Federal Food, Drug, and Cosmetic Act 

10 and identified in such registration as manufac11 turing, preparing, propagating, or compounding 

12 such critical medication or a key ingredient 

13 thereof, as well as, for each such establishment, 

14 the current and historical production thereof 

15 and the current production capacity thereof; 

16 ‘‘(C) the likelihood of continued or in17 creased production from each domestic and for18 eign establishment referenced in subparagraph 

19 (B), and the timeframe necessary for any in20 crease in production, taking into account regu21 latory, logistical, economic, and other relevant 

22 factors; and 

23 ‘‘(D) any economic, regulatory, or other 

24 impediments to domestic production thereof. 


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1 ‘‘(4) TIMEFRAME FOR DESIGNATION AND RE2 EVALUATION.—The Secretary shall— 

3 ‘‘(A) determine whether to designate a 

4 critical medication under paragraph (1) not 

5 later than 90 days after the earlier of— 

6 ‘‘(i) the date that such medication was 

7 first proposed by the Secretary to be a 

8 critical medication through publication in 

9 the Federal Register in accordance with 

10 subsection (a)(4)(B); or 

11 ‘‘(ii) the date that such medication be12 came a critical medication pursuant to the 

13 final determination of the Secretary in ac14 cordance with subsection (a)(1)(A); or 

15 ‘‘(B) not later than March 15 each year, 

16 reevaluate in accordance with paragraph (1)(A) 

17 each designation in effect under paragraph 

18 (1)(B). 

19 ‘‘(5) PUBLIC INPUT AND FACTORS TO BE CON20 SIDERED.—In carrying out paragraph (1), the Sec21 retary shall— 

22 ‘‘(A) consult with relevant stakeholders, in23 cluding those described in subsection (a)(6)(A); 


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1 ‘‘(B) consider the annual threat-based re2 view and reports referenced in and input re3 ceived under subsection (a)(7); and 

4 ‘‘(C) consult with experts in medication 

5 production, distribution, and demand, including 

6 economists or other analysts with expertise in 

7 the economic factors affecting domestic and for8 eign production and distribution of critical 

9 medications. 

10 ‘‘(6) INCORPORATION OF FINDINGS AND DE11 TERMINATIONS IN SUBMISSIONS TO CONGRESS.— 

12 With respect to each designated critical medication, 

13 the Assistant Secretary for Preparedness and Re14 sponse shall include in the annual coordinated 5-year 

15 budget plan required to be submitted under section 

16 2811(b)(7) such amounts as are determined to be 

17 necessary or appropriate to fund the procurement or 

18 contracting required under subsection (c) for such 

19 designated critical medications. 

20 ‘‘(c) PROCUREMENT OR CONTRACTING FOR DES21 IGNATED CRITICAL MEDICATIONS TO ENSURE AVAIL22 ABILITY IN THE EVENT OF A PUBLIC HEALTH EMER23 GENCY.—Subject to the availability of appropriations, the 

24 Secretary shall procure for the Strategic National Stock25 pile pursuant to section 319F–2(a)(1)(A)(ii), or otherwise 


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1 enter into contracts under such section, as necessary to 

2 ensure the availability of each designated critical medica3 tion, in the quantities and at the times needed, in the 

4 event of a public health emergency. 

5 ‘‘(d) EVALUATING IMPEDIMENTS TO DOMESTIC PRO6 DUCTION OF CRITICAL MEDICATIONS, AND RELATED

7 RECOMMENDATIONS.— 

8 ‘‘(1) REPORT TO CONGRESS.—Not later than 

9 one year after the date of enactment of this section, 

10 the Secretary shall make available to the Committee 

11 on Appropriations and the Committee on Energy 

12 and Commerce of the House of Representatives and 

13 the Committee on Appropriations and the Com14 mittee on Health, Education, Labor, and Pensions 

15 of the Senate, a report containing— 

16 ‘‘(A) findings on— 

17 ‘‘(i) the domestic and foreign produc18 tion of critical medications and their key 

19 ingredients; and 

20 ‘‘(ii) impediments to the domestic pro21 duction of critical medications and their 

22 key ingredients; and 

23 ‘‘(B) recommendations for measures 

24 (which may include legislative, regulatory, or 

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1 ments or otherwise promote such domestic pro2 duction (which may include measures to ensure 

3 the economic viability of such domestic produc4 tion or to address policies that competitively 

5 disadvantage such domestic production). 

6 ‘‘(2) COORDINATION.—In preparing the report 

7 required by paragraph (1), the Secretary shall take 

8 into account any information provided to, and any 

9 findings and recommendations of, such Commission. 

10 ‘‘(e) DEFINITIONS.—In this section: 

11 ‘‘(1) The term ‘designated critical medication’ 

12 means a critical medication for which a designation 

13 is in effect under subsection (b). 

14 ‘‘(2) The term ‘medication’ means a drug (as 

15 defined in section 201(g)(1) of the Federal Food, 

16 Drug, and Cosmetic Act), a biological product (as 

17 defined in section 351 of this Act), or a combination 

18 product (as described in section 503(g) of the Fed19 eral Food, Drug, and Cosmetic Act) that is ap20 proved, licensed, or cleared, as applicable, under 

21 chapter V of the Federal Food, Drug, and Cosmetic 

22 Act or section 351 of this Act. 

23 ‘‘(3) The term ‘public health emergency’ means 

24 a disease or disorder, including pandemics and other 

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1 rorist attacks, the effects of chemical, biological, ra2 diological, or nuclear agents or toxins, or the effects 

3 of extreme weather, earthquakes, or other natural 

4 disasters, that the Secretary has declared or may de5 clare to be a public health emergency pursuant to 

6 section 319. 

7 ‘‘(4) The term ‘United States’ include the terri8 tories of the United States.’’. 

9 (b) ENSURING THE AVAILABILITY OF DESIGNATED

10 CRITICAL MEDICATIONS THROUGH THE STRATEGIC NA11 TIONAL STOCKPILE.—Section 319F–2 of the Public 

12 Health Service Act (42 U.S.C. 247d–6b) is amended— 

13 (1) by amending subsection (a)(1) to read as 

14 follows: 

15 ‘‘(1) IN GENERAL.— 

16 ‘‘(A) MAINTAINING STOCKPILE OR STOCK17 PILES.—The Secretary, in collaboration with 

18 the Assistant Secretary for Preparedness and 

19 Response, the Commissioner of Food and 

20 Drugs, and the Director of the Centers for Dis21 ease Control and Prevention, and in coordina22 tion with the Secretary of Homeland Security 

23 (referred to in this section as the ‘Homeland 

24 Security Secretary’), shall— 


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1 ‘‘(i) maintain a stockpile or stockpiles 

2 of drugs, vaccines, and other biological 

3 products, medical devices, and other sup4 plies (including personal protective equip5 ment, ancillary medical supplies, and other 

6 applicable supplies required for the admin7 istration of drugs, vaccines and other bio8 logical products, medical devices, and diag9 nostic tests in the stockpile) in such num10 bers, types, and amounts as are deter11 mined consistent with section 2811 by the 

12 Secretary to be appropriate and prac13 ticable, taking into account other available 

14 sources, to provide for and optimize the 

15 emergency health security of the United 

16 States, including the emergency health se17 curity of children and other vulnerable 

18 populations, in the event of a bioterrorist 

19 attack or other public health emergency 

20 and, as informed by existing recommenda21 tions of, or consultations with, the Public 

22 Health Emergency Medical Counter23 measure Enterprise established under sec24 tion 2811–1, make necessary additions or 

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1 pile or stockpiles based on the review con2 ducted under paragraph (2); and 

3 ‘‘(ii) enter into multiyear contracts 

4 (each of which shall have a term of no less 

5 than 5 years) with private entities to en6 sure the availability, in the event of a pub7 lic health emergency, of adequate domestic 

8 supplies of each designated critical medica9 tion, as determined by the Secretary under 

10 section 319F–5, in lieu of or as a supple11 ment to procuring and maintaining in such 

12 stockpile or stockpiles a physical accumula13 tion of such designated critical medica14 tions, through measures which may in15 clude— 

16 ‘‘(I) one or more private entities’ 

17 agreement to maintain specified in18 ventory levels, in specified domestic lo19 cations, of one or more such des20 ignated critical medications, or of one 

21 or more key ingredients thereof (in22 cluding active pharmaceutical ingredi23 ents), under specified conditions (in24 cluding maintenance and inventory re25 placement prior to expiration), and to 


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1 make specified quantities of such des2 ignated critical medications or key in3 gredients thereof available when di4 rected by the Secretary, on predeter5 mined terms and conditions; 

6 ‘‘(II) one or more private enti7 ties’ agreement to commence or main8 tain production of one or more such 

9 designated critical medications, in 

10 specified locations, or to build or 

11 maintain specified surge capacity for 

12 such production, and to manufacture 

13 or otherwise make specified quantities 

14 of such designated critical medications 

15 available, when directed, on predeter16 mined terms and conditions; and 

17 ‘‘(III) compensation for mainte18 nance of such inventory, production, 

19 or production capacity and associated 

20 overhead, as necessary or appropriate. 

21 ‘‘(B) FACTORS.—In entering into contracts 

22 under subparagraph (A)(ii), the Secretary shall 

23 take into account as factors more significant 

24 than price— 


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1 ‘‘(i) whether the designated critical 

2 medication would be produced in the 

3 United States; 

4 ‘‘(ii) the track record and dem5 onstrated ability of the given manufacturer 

6 to produce the designated critical medica7 tion in the required quantities when needed 

8 (in domestic or foreign locations, after con9 sideration of whether supply from such for10 eign locations is at significant risk of dis11 ruption in the event of a public health 

12 emergency); and 

13 ‘‘(iii) the United States regulatory 

14 compliance history of the given manufac15 turer. 

16 ‘‘(C) PREFERENCE.—In entering into con17 tracts under subparagraph (A)(ii), the Sec18 retary may give preference to contracting with 

19 manufacturers of medications which are based 

20 in the United States. 

21 ‘‘(D) REFERENCES.—References in this 

22 paragraph to the United States include any ter23 ritory of the United States.’’; 

24 (2) in subsection (a)(2)(B)— 


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1 (A) in the matter preceding clause (i), by 

2 inserting ‘‘and each new or modified contract 

3 with a private entity under paragraph 

4 (1)(A)(ii)’’ after ‘‘for each new or modified 

5 countermeasure procurement or replenish6 ment’’; 

7 (B) in clause (i)(III), by inserting ‘‘or con8 tracting for procurement’’ after ‘‘procurement’’; 

9 (C) in clause (i)(IV), by inserting ‘‘or con10 tracting for procurement’’ after ‘‘whether such 

11 procurement’’; 

12 (D) in clause (i)(V), by inserting ‘‘(includ13 ing through one or more contracts under para14 graph (1)(A)(ii))’’ after ‘‘stockpile’’; and 

15 (E) in clause (ii), by inserting ‘‘or for 

16 which the Secretary entered into a contract 

17 with a private entity under paragraph 

18 (1)(A)(ii),’’ after ‘‘for each countermeasure pro19 cured or replenished under this subsection,’’; 

20 (3) in subsection (a)(3)(E) by inserting ‘‘the 

21 Commissioner of Food and Drugs,’’ after ‘‘Assistant 

22 Secretary for Preparedness and Response,’’; 

23 (4) in subsection (a)(5)(A)— 

24 (A) in the matter preceding clause (i), by 

25 inserting ‘‘and any contracts entered into under 


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1 paragraph (1)(A)(ii)’’ after ‘‘any changes to the 

2 contents or management of the stockpile’’; 

3 (B) in clause (ii), by striking ‘‘or replenish4 ment’’ and inserting ‘‘replenishment, or con5 tracting’’; 

6 (C) in clause (iv), by striking ‘‘an account7 ing of countermeasures procured, modified, or 

8 replenished under paragraph (1)’’ and inserting 

9 ‘‘an accounting of countermeasures procured, 

10 modified, or replenished under paragraph 

11 (1)(A)(i) or for which contracts with private en12 tities were entered into under paragraph 

13 (1)(A)(ii)’’; 

14 (D) in clause (v)— 

15 (i) by inserting ‘‘and contracts’’ after 

16 ‘‘decisions’’; and 

17 (ii) by striking ‘‘or replenished’’ and 

18 inserting ‘‘replenished or contracted’’; and 

19 (E) in clause (vii), by inserting ‘‘and new 

20 or modified contracts with a private entity’’ 

21 after ‘‘replenishments’’; 

22 (5) in subsection (c)(7)(B)(ii), by adding at the 

23 end the following subclause: 

24 ‘‘(X) NONAPPLICABILITY TO

25 CERTAIN CONTRACTS.—None of the 


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1 requirements set forth in this clause 

2 (ii) shall apply to contracts entered 

3 into under subsection (a)(1)(A)(ii), 

4 other than contracts for procurement 

5 of security countermeasures from the 

6 special reserve fund, except that the 

7 Secretary may, at the Secretary’s dis8 cretion, include any of the terms de9 scribed in this clause, or similar 

10 terms, in any contract entered into 

11 under subsection (a)(1)(A)(ii).’’; and 

12 (6) by amending subsection (e) to read as fol13 lows: 

14 ‘‘(e) DEFINITIONS.—For the purposes of this section: 

15 ‘‘(1) The terms ‘critical medication’, ‘designated 

16 critical medication’, and ‘medication’ have the mean17 ings given to such terms in section 319F–5. 

18 ‘‘(2) The term ‘stockpile’ includes— 

19 ‘‘(A) a physical accumulation (at one or 

20 more locations) of the supplies described in sub21 section (a) (including any maintained in inven22 tory under a contract with a private entity 

23 under subsection (a)(1)(A)(ii) under a contract 

24 with a private entity entered into under sub25 section (a)(1)(A)(ii)); and 


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1 ‘‘(B) any supplies described in subsection 

2 (a)(1)(A)(i) which a vendor or vendors agree to 

3 provide to the Secretary under a contractual 

4 agreement between the Secretary and such ven5 dor or vendors, and any designated critical 

6 medications which a private entity is required 

7 to manufacture or otherwise supply under an 

8 agreement between the Secretary and such pri9 vate entity entered into pursuant to subsection 

10 (a)(1)(A)(ii).’’. 

Æ 


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