Safely Back to School and Back to Work Act

II 116TH CONGRESS 2D SESSION S. 4322 To help Americans safely get back to school and back to work, and for other purposes. IN THE SENATE OF THE UNITED STATES JULY 27, 2020 Mr. ALEXANDER introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To help Americans safely get back to school and back to work, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Safely Back to School and Back to Work Act’’. 5 (b) TABLE OF CONTENTS.—The table of contents is 6 as follows: 7 Sec. 1. Short title; table of contents. TITLE I—HEALTH PROVISIONS Sec. 101. Improving earlier access to diagnostic tests. Sec. 102. Sustained on-shore manufacturing capacity for public health emer- gencies. VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4322 IS Sec. 103. Improving and sustaining State medical stockpiles. Sec. 104. Strengthening the Strategic National Stockpile. Sec. 105. Guidance for States and Indian Tribes on accessing the Strategic Na- tional Stockpile. Sec. 106. Modernizing infectious disease data collection. Sec. 107. Centers for Public Health Preparedness. Sec. 108. Telehealth plans. Sec. 109. Protection of human genetic information. Sec. 110. Reagan-Udall Foundation and Foundation for the National Institutes of Health. TITLE II—EDUCATION PROVISIONS Sec. 201. Simplifying student loan repayment. Sec. 202. Emergency education freedom grants. Sec. 203. Back to Work Child Care grants. Sec. 204. National emergency educational waivers. Sec. 205. Waivers for career, technical, and adult education. Sec. 206. Additional workforce activities. Sec. 207. Workforce recovery and training services. Sec. 208. Impact Aid provisions. Sec. 209. Amendments to education provisions of CARES. TITLE I—HEALTH PROVISIONS 1 SEC. 101. IMPROVING EARLIER ACCESS TO DIAGNOSTIC 2 TESTS. 3 Section 319D of the Public Health Service Act (42 4 U.S.C. 247d–4) is amended by adding at the end the fol- 5 lowing: 6 ‘‘(k) IMPROVING DIAGNOSTIC TEST, TREATMENT, 7 AND VACCINE RESEARCH AND DEVELOPMENT.— 8 ‘‘(1) VIRUS SAMPLE ACCESS.—Not later than 9 180 days after the date of enactment of this sub- 10 section, the Secretary shall, in coordination with the 11 Director of the Centers for Disease Control and Pre- 12 vention and the Commissioner of Food and Drugs, 13 establish and make publicly available policies and 14 procedures for public and private entities to access 15 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4322 IS samples of specimens containing infectious disease 1 agents, or suitable surrogates or alternatives, as ap- 2 propriate, that may support the development of 3 products, including the development of diagnostic 4 tests, treatments, or vaccines, to address emerging 5 infectious diseases for biomedical research purposes, 6 and for use to otherwise respond to emerging infec- 7 tious diseases, as the Secretary determines appro- 8 priate. 9 ‘‘(2) GUIDANCE.—The Secretary shall issue 10 guidance regarding the procedures for carrying out 11 paragraph (1), including— 12 ‘‘(A) the method for requesting samples of 13 specimens containing infectious disease agents; 14 ‘‘(B) criteria for sample availability and 15 use of suitable surrogates or alternatives, as ap- 16 propriate; and 17 ‘‘(C) information required to be provided 18 in order to receive such samples or suitable sur- 19 rogates or alternatives. 20 ‘‘(3) EARLIER DEVELOPMENT OF DIAGNOSTIC 21 TESTS.—The Secretary, acting through the Director 22 of the Centers for Disease Control and Prevention, 23 may contract with public and private entities, as ap- 24 propriate, to assist in the immediate and rapid de- 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4322 IS velopment, validation, and dissemination of diag- 1 nostic tests, as appropriate, for purposes of bio- 2 surveillance and other immediate public health re- 3 sponse activities to address an emerging infectious 4 disease that has significant potential to cause a pub- 5 lic health emergency. 6 ‘‘(4) CAPACITY PLANNING FOR SUPPLY 7 NEEDS.—The Secretary, in coordination with the 8 Commissioner of Food and Drugs and the Director 9 of the Centers for Disease Control and Prevention, 10 shall, as appropriate, consult with medical product 11 manufacturers, suppliers, and other relevant stake- 12 holders, as appropriate, to— 13 ‘‘(A) identify specific supplies or compo- 14 nents needed, including specimen collection and 15 transport materials, reagents, or other supplies 16 related to the development, validation, or ad- 17 ministration of a diagnostic test to detect an in- 18 fectious disease for which an emergency use au- 19 thorization is in effect under section 564 of the 20 Federal Food, Drug, and Cosmetic Act (21 21 U.S.C. 360bbb–3); 22 ‘‘(B) identify projected demand for and 23 availability of such supplies and communicate 24 such information to medical product manufac- 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4322 IS turers, suppliers, and other relevant stake- 1 holders during a public health emergency; and 2 ‘‘(C) support activities to increase the 3 availability of such supplies or alternative prod- 4 ucts that may be appropriately substituted for 5 such supplies during a public health emer- 6 gency.’’. 7 SEC. 102. SUSTAINED ON-SHORE MANUFACTURING CAPAC- 8 ITY FOR PUBLIC HEALTH EMERGENCIES. 9 (a) IN GENERAL.—Section 319L of the Public 10 Health Service Act (42 U.S.C. 247d–7e) is amended— 11 (1) in subsection (a)(6)(B)— 12 (A) by redesignating clauses (iv) and (v) as 13 clauses (v) and (vi), respectively; 14 (B) by inserting after clause (iii), the fol- 15 lowing: 16 ‘‘(iv) activities to support domestic 17 manufacturing surge capacity of products 18 or platform technologies, including manu- 19 facturing capacity and capabilities to uti- 20 lize platform technologies to provide for 21 flexible manufacturing initiatives;’’; and 22 (C) in clause (vi) (as so redesignated), by 23 inserting ‘‘manufacture,’’ after ‘‘improvement,’’; 24 (2) in subsection (b)— 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4322 IS (A) in the first sentence of paragraph (1), 1 by inserting ‘‘support for domestic manufac- 2 turing surge capacity,’’ after ‘‘initiatives for in- 3 novation,’’; and 4 (B) in paragraph (2)— 5 (i) in subparagraph (B), by striking 6 ‘‘and’’ at the end; 7 (ii) by redesignating subparagraph 8 (C) as subparagraph (D); and 9 (iii) by inserting after subparagraph 10 (B), the following: 11 ‘‘(C) activities to support manufacturing 12 surge capacities and capabilities to increase the 13 availability of existing medical countermeasures 14 and utilize existing novel platforms to manufac- 15 ture new medical countermeasures to meet 16 manufacturing demands to address threats that 17 pose a significant level of risk to national secu- 18 rity; and’’; 19 (3) in subsection (c)— 20 (A) in paragraph (2)— 21 (i) in subparagraph (C), by striking 22 ‘‘and’’ at the end; 23 (ii) in subparagraph (D), by striking 24 the period and inserting ‘‘; and’’; and 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 4322 IS (iii) by adding at the end the fol- 1 lowing: 2 ‘‘(E) promoting domestic manufacturing 3 surge capacity and capabilities for counter- 4 measure advanced research and development, 5 including facilitating contracts to support flexi- 6 ble or surge manufacturing.’’; 7 (B) in paragraph (4)— 8 (i) in subparagraph (B)— 9 (I) in clause (iii), by striking 10 ‘‘and’’ at the end; 11 (II) in clause (iv), by striking the 12 period and inserting ‘‘; and’’; and 13 (III) by adding at the end the 14 following: 15 ‘‘(v) support and maintain domestic 16 manufacturing surge capacity and capabili- 17 ties, including through contracts to sup- 18 port flexible or surge manufacturing, to en- 19 sure that additional production of counter- 20 measures is available in the event that the 21 Secretary determines there is such a need 22 for additional production.’’; 23 (ii) in subparagraph (D)— 24 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 4322 IS (I) in clause (ii), by striking 1 ‘‘and’’ at the end; 2 (II) by redesignating clause (iii) 3 as clause (iv); and 4 (III) by inserting after clause (ii) 5 the following: 6 ‘‘(iii) research to advance manufac- 7 turing capacities and capabilities for med- 8 ical countermeasures and platform tech- 9 nologies that may be utilized for medical 10 countermeasures; and’’; and 11 (iii) in subparagraph (E), by striking 12 clause (ix); and 13 (C) in paragraph (7)(C)(i), by striking ‘‘up 14 to 100 highly qualified individuals, or up to 50 15 percent of the total number of employees, 16 whichever is less,’’ and inserting ‘‘75 percent of 17 the total number of employees’’; 18 (4) in subsection (e)(1)— 19 (A) by redesignating subparagraphs (B) 20 through (D) as subparagraphs (C) through (E), 21 respectively; and 22 (B) by inserting after subparagraph (A), 23 the following: 24 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 4322 IS ‘‘(B) TEMPORARY FLEXIBILITY.—During a 1 public health emergency under section 319, the 2 Secretary shall be provided with an additional 3 60 business days to comply with information re- 4 quests for the disclosure of information under 5 section 552 of title 5, United States Code, re- 6 lated to the activities under this section (unless 7 such activities are otherwise exempt under sub- 8 paragraph (A)).’’; and 9 (5) in subsection (f)— 10 (A) in paragraph (1), by striking ‘‘Not 11 later than 180 days after the date of enactment 12 of this subsection’’ and inserting ‘‘Not later 13 than 180 days after the date of enactment of 14 the Safely Back to School and Back to Work 15 Act’’; and 16 (B) in paragraph (2), by striking ‘‘Not 17 later than 1 year after the date of enactment of 18 this subsection’’ and inserting ‘‘Not later than 19 1 year after the date of enactment of the Safely 20 Back to School and Back to Work Act’’. 21 (b) MEDICAL COUNTERMEASURE INNOVATION PART- 22 NER.—The restrictions under section 202 of division A of 23 the Further Consolidated Appropriations Act, 2020 (Pub- 24 lic Law 116–94), or any other provision of law imposing 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 4322 IS a restriction on salaries of individuals related to a previous 1 appropriation to the Department of Health and Human 2 Services, shall not apply with respect to salaries paid pur- 3 suant to an agreement under the medical countermeasure 4 innovation partner program under section 319L(c)(4)(E) 5 of the Public Health Service Act (42 U.S.C. 247d– 6 7e(c)(4)(E)). 7 SEC. 103. IMPROVING AND SUSTAINING STATE MEDICAL 8 STOCKPILES. 9 Section 319F–2 of the Public Health Service Act (42 10 U.S.C. 247d–6b) is amended by adding at the end the fol- 11 lowing: 12 ‘‘(i) IMPROVING AND MAINTAINING STATE MEDICAL 13 STOCKPILES.— 14 ‘‘(1) IN GENERAL.—The Secretary, acting 15 through the Assistant Secretary for Preparedness 16 and Response, shall award grants, contracts, or co- 17 operative agreements to eligible entities to maintain 18 a stockpile of appropriate drugs, vaccines and other 19 biological products, medical devices, and other med- 20 ical supplies (including personal protective equip- 21 ment, ancillary medical supplies, and other applica- 22 ble supplies required for the administration of drugs, 23 vaccines and other biological products, medical de- 24 vices, and diagnostic tests) to be used during a pub- 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 4322 IS lic health emergency declared by the Governor of a 1 State or by the Secretary under section 319, or a 2 major disaster or emergency declared by the Presi- 3 dent under section 401 or 501, respectively, of the 4 Robert T. Stafford Disaster Relief and Emergency 5 Assistance Act, in order to support the preparedness 6 goals described in paragraphs (2), (3), and (8) of 7 section 2802(b). 8 ‘‘(2) ELIGIBLE ENTITIES.— 9 ‘‘(A) IN GENERAL.—To be eligible to re- 10 ceive an award under paragraph (1), an entity 11 shall— 12 ‘‘(i) be a State or consortium of 13 States that is a recipient of an award 14 under section 319C–1(b); and 15 ‘‘(ii) prepare, in consultation with ap- 16 propriate health care providers and health 17 officials within the State or consortium of 18 States, and submit to the Secretary an ap- 19 plication that contains such information as 20 the Secretary may require, including a 21 plan for the State stockpile and a descrip- 22 tion of the activities such entity will carry 23 out under the agreement, consistent with 24 the requirements of paragraph (3). 25 VerDate Sep 11 2014 02:59 Jul 28, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4322.IS S4322 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 4322 IS ‘‘(B) LIMITATION.—The Secretary may 1 make an award under this subsection to not 2 more than one eligible entity in each State. 3 ‘‘(C) SUPPLEMENT NOT SUPPLANT.— 4 Awards, contracts, or grants awarded under 5 this subsection shall supplement, not supplant, 6 the reserve amounts of medical supplies pro- 7 cured by and for the Strategic National Stock- 8 pile under subsection (a). 9 ‘‘(D) ADMINISTRATIVE EXPENSES.—Not 10 more than 5 percent of amounts received by an 11 entity pursuant to an award under this sub- 12 section may be used for administrative ex- 13 penses. 14 ‘‘(E) CLARIFICATION.—An eligible entity 15 receiving an award under this subsection may 16 assign a lead entity to manage the State stock- 17 pile, which may be a recipient of an award 18 under section 319C–2(b). 19 ‘‘(F) REQUIREMENT OF [Text truncated for display. 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