II 

116TH CONGRESS 

2D SESSION S. 3781 

To increase reporting of, help mitigate potential shortages related to, and 

promote, accountability and transparency for pharmaceuticals and medical devices. 

IN THE SENATE OF THE UNITED STATES 

MAY 20, 2020 

Mr. PETERS introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To increase reporting of, help mitigate potential shortages 

related to, and promote, accountability and transparency 

for pharmaceuticals and medical devices. 

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. 

4 This Act may be cited as the ‘‘Pharmaceutical Ac5 countability, Responsibility, and Transparency Act’’ or the 

6 ‘‘PART Act’’. 


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1 SEC. 2. FDA INCREASED DEMAND REPORTING WITH RE2 SPECT TO DRUGS. 

3 Section 506C of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 356c), as amended by the CARES 

5 Act (Public Law 116–136), is further amended— 

6 (1) in subsections (c), (e), (f), (g), and (j), by 

7 inserting ‘‘or (k)’’ after ‘‘subsection (a)’’ each place 

8 such term appears; and 

9 (2) by adding at the end the following: 

10 ‘‘(k) INCREASED DEMAND REPORTING.— 

11 ‘‘(1) IN GENERAL.—The manufacturer of a 

12 drug described in subsection (a) or a biological prod13 uct subject to subsection (i)(3) shall notify the Sec14 retary, in accordance with paragraph (2), of any— 

15 ‘‘(A) increase in demand for the drug that 

16 the manufacturer likely will be unable to meet; 

17 or 

18 ‘‘(B) export restrictions or other limita19 tions imposed, on or after the date of enact20 ment of the PART Act, on manufacturing or 

21 shipment of the drug or any of its active phar22 maceutical ingredients by the country in which 

23 such drug or any such ingredient is manufac24 tured. 

25 ‘‘(2) TIMING.—A notice required under para26 graph (1) shall be submitted to the Secretary as 


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1 soon as practicable but not later than 5 calendar 

2 days after the manufacturer becomes aware of the 

3 issue requiring notification under such paragraph. 

4 ‘‘(3) NOTIFICATION OF RESOLUTION OF

5 ISSUE.—A manufacturer of a drug who submits a 

6 notification to the Secretary under paragraph (1) 

7 shall notify the Secretary after the issue giving rise 

8 to such notification has been resolved or when the 

9 manufacturer is able to meet demand.’’. 

10 SEC. 3. FDA INCREASED DEMAND REPORTING WITH RE11 SPECT TO DEVICES. 

12 Section 506J of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 356c) is amended— 

14 (1) in subsections (c), (e), and (f), by inserting 

15 ‘‘or (j)’’ after ‘‘subsection (a)’’ each place such term 

16 appears; and 

17 (2) by adding at the end the following: 

18 ‘‘(j) INCREASED DEMAND REPORTING.— 

19 ‘‘(1) IN GENERAL.—The manufacturer of a de20 vice described in subsection (a) shall notify the Sec21 retary, in accordance with paragraph (2), of any— 

22 ‘‘(A) increase in demand for the device 

23 that the manufacturer likely will be unable to 

24 meet; or 


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1 ‘‘(B) export restrictions or other limita2 tions imposed, on or after the date of enact3 ment of the PART Act, on manufacturing or 

4 export of the device by the country in which 

5 such device or any component of the device is 

6 manufactured. 

7 ‘‘(2) TIMING.—A notice required under para8 graph (1) shall be submitted to the Secretary as 

9 soon as practicable but not later than 5 calendar 

10 days after the manufacturer becomes aware of the 

11 issue requiring notification under such paragraph. 

12 ‘‘(3) NOTIFICATION OF RESOLUTION OF

13 ISSUE.—A manufacturer of a device who submits a 

14 notification to the Secretary under paragraph (1) 

15 shall notify the Secretary after the issue giving rise 

16 to such notification has been resolved or when the 

17 manufacturer is able to meet demand.’’. 

18 SEC. 4. QUARTERLY MANUFACTURER REPORTING WITH 

19 RESPECT TO DRUGS AND DEVICES. 

20 (a) REGISTRATION OF CERTAIN FOREIGN ESTAB21 LISHMENTS.—Section 510(i) of the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 360(i)) is amended by in23 serting at the end the following new paragraph: 

24 ‘‘(5) The requirements of paragraphs (1) and (2) 

25 shall apply to establishments within a foreign country enVerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3781.IS S3781

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1 gaged in the manufacture, preparation, propagation, com2 pounding, or processing of any drug, including the active 

3 pharmaceutical ingredient, or device that is required to be 

4 listed pursuant to subsection (j). Such requirements shall 

5 apply regardless of whether the drug, active pharma6 ceutical ingredient, or device undergoes further manufac7 ture, preparation, propagation, compounding, or proc8 essing at a separate establishment or establishments out9 side the United States prior to being imported or offered 

10 for import into the United States.’’. 

11 (b) LISTING OF DRUGS.—Section 510(j)(1) of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 360(j)(1)) is amended— 

14 (1) in subparagraph (D), by striking ‘‘and’’ at 

15 the end; 

16 (2) in subparagraph (E), by striking the period 

17 at the end and inserting ‘‘; and’’; and 

18 (3) by adding at the end the following new sub19 paragraph: 

20 ‘‘(F) in the case of a drug contained in the ap21 plicable list, a certification that the registrant has— 

22 ‘‘(i) identified every other establishment 

23 where manufacturing is performed for the drug; 

24 and 


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1 ‘‘(ii) notified each known foreign establish2 ment engaged in the manufacture, preparation, 

3 propagation, compounding, or processing of the 

4 drug, including the active pharmaceutical ingre5 dient, of the inclusion of the drug in the list 

6 and the obligation to register under subsection 

7 (i)(5).’’. 

8 (c) QUARTERLY REPORTING.—Paragraph (3) of sec9 tion 510(j) of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 360(j)), as amended by the CARES Act (Pub11 lic Law 116–136), is amended to read as follows: 

12 ‘‘(3)(A) Subject to subparagraph (C) each person 

13 who registers with the Secretary under this section shall 

14 submit to the Secretary quarterly reports, in such elec15 tronic data format as the Secretary requires, containing 

16 the following information, as applicable, with respect to 

17 all drugs, drug substances, and devices manufactured, pre18 pared, propagated, compounded, or processed at the estab19 lishment, whether for import into the United States or dis20 tribution in another country: 

21 ‘‘(i) With respect to a finished drug product— 

22 ‘‘(I) the number of dosage units manufac23 tured at each establishment since the last re24 port, broken down by— 


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1 ‘‘(aa) the number of dosage units 

2 manufactured at each establishment at 

3 which final manufacturing occurred, and 

4 the unique facility identifier of each such 

5 establishment; 

6 ‘‘(bb) the number of dosage units 

7 from each such establishment that were 

8 distributed (or are intended to be distrib9 uted) for use in the United States and the 

10 number of dosage units that were distrib11 uted (or are intended to be distributed) for 

12 use outside of the United States; and 

13 ‘‘(II) the sources of drug substances used 

14 in the manufacturing of the finished drug prod15 uct, and, for each such source— 

16 ‘‘(aa) the unique facility identifier of 

17 each source of drug substance; and 

18 ‘‘(bb) the number of dosage units of 

19 the finished drug product manufactured 

20 using that drug substance from each 

21 source of drug substance; and 

22 ‘‘(III) the National Drug Code number. 

23 ‘‘(ii) With respect to a drug substance— 

24 ‘‘(I) the amount of drug substance manu25 factured at each establishment since the last reVerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3781.IS S3781

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1 port and the unique facility identifier of each 

2 such establishment; 

3 ‘‘(II) the amount of the drug substance 

4 manufactured at each such establishment that 

5 was distributed (or are intended to be distrib6 uted) for use in the United States and the 

7 amount that was distributed (or are intended to 

8 be distributed) for use outside of the United 

9 States; and 

10 ‘‘(III) the National Drug Code number. 

11 ‘‘(iii) With respect to a device, the number of 

12 units manufactured at each establishment since the 

13 last report, broken down by— 

14 ‘‘(I) the number of units manufactured at 

15 each establishment at which final manufac16 turing occurred, and the establishment identi17 fication number of each such establishment; 

18 and 

19 ‘‘(II) the number of units from each such 

20 establishment that were distributed (or are in21 tended to be distributed) for use in the United 

22 States and the number of units that were dis23 tributed (or are intended to be distributed) for 

24 use outside of the United States. 


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1 ‘‘(B) By order of the Secretary, certain biological 

2 products or categories of biological products may be ex3 empt from some or all of the reporting requirements under 

4 subparagraph (A), if the Secretary determines, at the Sec5 retary’s sole discretion, that applying such reporting re6 quirements to such biological products or categories is not 

7 necessary to protect the public health. 

8 ‘‘(C) The determination of the appropriate structured 

9 electronic data format by the Secretary under subpara10 graph (A), whether to exempt certain biological products 

11 or categories of biological products under subparagraph 

12 (B), and the date on which reporting begins under this 

13 section shall be exempt from the requirements of section 

14 553 of title 5, United States Code.’’. 

15 (d) EFFECTIVE DATE.—The amendments made by 

16 this section shall take effect on September 23, 2020. 

17 (e) CONFIDENTIALITY.—Nothing in the amendments 

18 made by this section shall be construed as authorizing the 

19 Secretary to disclose any information that is a trade secret 

20 or confidential information subject to section 552(b)(4) of 

21 title 5, United States Code, or section 1905 of title 18, 

22 United States Code. 


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1 SEC. 5. REQUIRING FDA TO SHARE MANUFACTURING IN2 FORMATION WITH ASPR AND THE ASSISTANT 

3 SECRETARY OF DEFENSE FOR HEALTH AF4 FAIRS. 

5 (a) IN GENERAL.—Beginning as soon as practicable, 

6 but not later than 1 year after the date of enactment of 

7 this Act, the Secretary of Health and Human Services, 

8 acting through the Commissioner of Food and Drugs, 

9 shall provide to the Assistant Secretary for Preparedness 

10 and Response and the Assistant Secretary of Defense for 

11 Health Affairs all drug and device manufacturing data de12 scribed in subsection (b), as appropriate and applicable, 

13 for any of the following purposes: 

14 (1) Maintaining the strategic national stockpile 

15 under section 319F–2 of the Public Health Service 

16 Act (42 U.S.C. 247d–6b). 

17 (2) Evaluating health infrastructure under the 

18 Division of Critical Infrastructure Protection of the 

19 Office of the Assistant Secretary for Preparedness 

20 and Response. 

21 (3) Preparing for and responding to public 

22 health emergencies and national security concerns. 

23 (4) Mitigating potential drug shortages. 

24 (b) REPORTING PROVISIONS.—The drug and device 

25 manufacturing data required to be provided as described 

26 in subsection (a) includes— 


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1 (1) information reported by any manufacturer 

2 under subsection (a) or (k) of section 506C(a) of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 356c) or subsection (a) or (j) of section 506J of 

5 such Act (21 U.S.C. 356j); 

6 (2) any risk management plan under section 

7 506C(j) of such Act (21 U.S.C. 356c(j)) that is 

8 made available to the Secretary pursuant to such 

9 section; 

10 (3) records or other information provided under 

11 section 704(a)(4) of such Act (21 U.S.C. 374(a)(4)); 

12 and 

13 (4) to the extent not already provided, the loca14 tions where each drug that is a subject of a report 

15 or plan under paragraph (1), (2), or (3) is manufac16 tured. 

17 (c) MEMORANDA OF UNDERSTANDING.—The Com18 missioner of Food and Drugs and the Assistant Secretary 

19 for Preparedness and Response, and the Commissioner of 

20 Food and Drugs and the Assistant Secretary of Defense 

21 for Health Affairs, shall enter into memoranda of under22 standing to set forth the manner in which data will be 

23 shared under this section and the procedures for pro24 tecting any nonpublic data from further disclosure. 

Æ 


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