Us Congress 2023-2024 Regular Session

Us Congress House Bill HB447 Compare Versions

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Old	New	Differences
1	1	I
2	2	118THCONGRESS
3	3	1
4	4	STSESSION H. R. 447
5	5	To rescue domestic medical manufacturing activity by providing incentives
6	6	in economically distressed areas of the United States and its possessions.
7	7	IN THE HOUSE OF REPRESENTATIVES
8	8	JANUARY24, 2023
9	9	Mrs. G
10	10	ONZA´LEZ-COLO´N(for herself and Ms. SALAZAR) introduced the fol-
11	11	lowing bill; which was referred to the Committee on Ways and Means,
12	12	and in addition to the Committee on Energy and Commerce, for a period
13	13	to be subsequently determined by the Speaker, in each case for consider-
14	14	ation of such provisions as fall within the jurisdiction of the committee
15	15	concerned
16	16	A BILL
17	17	To rescue domestic medical manufacturing activity by pro-
18	18	viding incentives in economically distressed areas of the
19	19	United States and its possessions.
20	20	Be it enacted by the Senate and House of Representa-1
21	21	tives of the United States of America in Congress assembled, 2
22	22	SECTION 1. SHORT TITLE. 3
23	23	This Act may be cited as the ‘‘Medical Manufac-4
24	24	turing, Economic Development, and Sustainability Act of 5
25	25	2023’’ or the ‘‘MMEDS Act of 2023’’. 6
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29	29	SEC. 2. ECONOMICALLY DISTRESSED ZONES. 1
30	30	(a) I
31	31	NGENERAL.—Chapter 1 of the Internal Rev-2
32	32	enue Code of 1986 is amended by adding at the end the 3
33	33	following new subchapter: 4
34	34	‘‘Subchapter AA—Medical Manufacturing in 5
35	35	Economically Distressed Zones 6
36	36	‘‘SUBCHAPTER AA—MEDICAL MANUFACTURING IN ECONOMICALLY DISTRESSED
37	37	ZONES
38	38	‘‘Sec. 1400AA–1. Medical manufacturing in economically distressed zone credit.
39	39	‘‘Sec. 1400AA–2. Credit for economically distressed zone products and services
40	40	acquired by domestic medical manufacturers.
41	41	‘‘Sec. 1400AA–3. Special rules to secure the national supply chain and for the
42	42	production of population health products.
43	43	‘‘Sec. 1400AA–4. Designation of economically distressed zones.
44	44	‘‘SEC. 1400AA–1. MEDICAL MANUFACTURING IN ECONOMI-
45	45	7
46	46	CALLY DISTRESSED ZONE CREDIT. 8
47	47	‘‘(a) A
48	48	LLOWANCE OF CREDIT.—There shall be al-9
49	49	lowed as a credit against the tax imposed by subtitle A 10
50	50	for the taxable year an amount equal 40 percent of the 11
51	51	sum of— 12
52	52	‘‘(1) the aggregate amount of the taxpayer’s 13
53	53	medical manufacturing economically distressed zone 14
54	54	wages for such taxable year, 15
55	55	‘‘(2) the allocable employee fringe benefit ex-16
56	56	penses of the taxpayer for such taxable year, and 17
57	57	‘‘(3) the depreciation and amortization allow-18
58	58	ances of the taxpayer for the taxable year with re-19
59	59	spect to qualified medical manufacturing facility 20
60	60	property. 21
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64	64	‘‘(b) DENIAL OFDOUBLEBENEFIT.—Any wages or 1
65	65	other expenses taken into account in determining the cred-2
66	66	it under this section may not be taken into account in de-3
67	67	termining the credit under sections 41, and any other pro-4
68	68	vision determined by the Secretary to be substantially 5
69	69	similar. 6
70	70	‘‘(c) D
71	71	EFINITIONS ANDSPECIALRULES.—For pur-7
72	72	poses of this section— 8
73	73	‘‘(1) E
74	74	CONOMICALLY DISTRESSED ZONE 9
75	75	WAGES.— 10
76	76	‘‘(A) I
77	77	N GENERAL.—The term ‘economi-11
78	78	cally distressed zone wages’ means amounts 12
79	79	paid or incurred for wages of an employee by 13
80	80	the taxpayer for the taxable year which are— 14
81	81	‘‘(i) in connection with the active con-15
82	82	duct of a trade or business of the taxpayer, 16
83	83	and 17
84	84	‘‘(ii) paid or incurred for an employee 18
85	85	the principal place of employment of whom 19
86	86	is in a qualified medical manufacturing fa-20
87	87	cility of such taxpayer. 21
88	88	‘‘(B) L
89	89	IMITATION ON AMOUNT OF WAGES 22
90	90	TAKEN INTO ACCOUNT .— 23
91	91	‘‘(i) I
92	92	N GENERAL.—The amount of 24
93	93	wages which may be taken into account 25
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97	97	under subparagraph (A) with respect to 1
98	98	any employee for any taxable year shall 2
99	99	not exceed the contribution and benefit 3
100	100	base determined under section 230 of the 4
101	101	Social Security Act for the calendar year 5
102	102	in which such taxable year begins. 6
103	103	‘‘(ii) T
104	104	REATMENT OF PART -TIME EM-7
105	105	PLOYEES, ETC.—If— 8
106	106	‘‘(I) any employee is not em-9
107	107	ployed by the taxpayer on a substan-10
108	108	tially full-time basis at all times dur-11
109	109	ing the taxable year, or 12
110	110	‘‘(II) the principal place of em-13
111	111	ployment of any employee is not with-14
112	112	in an economically distressed zone at 15
113	113	all times during the taxable year, 16
114	114	the limitation applicable under clause (i) 17
115	115	with respect to such employee shall be the 18
116	116	appropriate portion (as determined by the 19
117	117	Secretary) of the limitation which would 20
118	118	otherwise be in effect under clause (i). 21
119	119	‘‘(C) T
120	120	REATMENT OF CERTAIN EMPLOY -22
121	121	EES.—The term ‘economically distressed zone 23
122	122	wages’ shall not include any wages paid to em-24
123	123	ployees who are assigned by the employer to 25
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127	127	perform services for another person, unless the 1
128	128	principal trade or business of the employer is to 2
129	129	make employees available for temporary periods 3
130	130	to other persons in return for compensation. 4
131	131	‘‘(D) W
132	132	AGES.—For purposes of this para-5
133	133	graph, the term ‘wages’ shall not include any 6
134	134	amounts which are allocable employee fringe 7
135	135	benefit expenses. 8
136	136	‘‘(2) A
137	137	LLOCABLE EMPLOYEE FRINGE BENEFIT 9
138	138	EXPENSES.— 10
139	139	‘‘(A) I
140	140	N GENERAL.—The term ‘allocable 11
141	141	employee fringe benefit expenses’ means the ag-12
142	142	gregate amount allowable as a deduction under 13
143	143	this chapter to the taxpayer for the taxable year 14
144	144	for the following amounts which are allocable to 15
145	145	employment in a qualified medical manufac-16
146	146	turing facility and which are not included as 17
147	147	economically distressed zone wages pursuant to 18
148	148	this subsection: 19
149	149	‘‘(i) Employer contributions under a 20
150	150	stock bonus, pension, profit-sharing, or an-21
151	151	nuity plan. 22
152	152	‘‘(ii) Employer-provided coverage 23
153	153	under any accident or health plan for em-24
154	154	ployees. 25
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158	158	‘‘(iii) The cost of life or disability in-1
159	159	surance provided to employees. 2
160	160	‘‘(B) A
161	161	LLOCATION.—For purposes of sub-3
162	162	paragraph (A), an amount shall be treated as 4
163	163	allocable to a qualified medical manufacturing 5
164	164	facility only if such amount is with respect to 6
165	165	employment of an individual for services pro-7
166	166	vided, and the principal place of employment of 8
167	167	whom is, in such facility. 9
168	168	‘‘(3) Q
169	169	UALIFIED MEDICAL MANUFACTURING FA -10
170	170	CILITY.—The term ‘qualified medical manufacturing 11
171	171	facility’ means any facility that— 12
172	172	‘‘(A) researches and develops or produces 13
173	173	medical products or essential components of 14
174	174	medical products, and 15
175	175	‘‘(B) is located within an economically dis-16
176	176	tressed zone. 17
177	177	‘‘(4) Q
178	178	UALIFIED MEDICAL MANUFACTURING FA -18
179	179	CILITY PROPERTY.—The term ‘qualified medical 19
180	180	manufacturing facility property’ means any property 20
181	181	used in (or consisting of) a qualified medical manu-21
182	182	facturing facility if such property is directly con-22
183	183	nected to the research, development, or production 23
184	184	of a medical product. 24
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188	188	‘‘(5) MEDICAL PRODUCT; ESSENTIAL COMPO-1
189	189	NENT.— 2
190	190	‘‘(A) M
191	191	EDICAL PRODUCT.—The term ‘med-3
192	192	ical product’ means— 4
193	193	‘‘(i) a drug that— 5
194	194	‘‘(I) is a prescription drug sub-6
195	195	ject to regulation under section 505 of 7
196	196	the Federal Food, Drug, and Cos-8
197	197	metic Act (21 U.S.C. 355) or section 9
198	198	351 of the Public Health Service Act 10
199	199	(42 U.S.C. 262), 11
200	200	‘‘(II) is subject to regulation 12
201	201	under section 802 of the Federal 13
202	202	Food, Drug, and Cosmetic Act (21 14
203	203	U.S.C. 382), or 15
204	204	‘‘(III) is described in section 16
205	205	201(jj) of such Act (21 U.S.C. 17
206	206	321(jj)), or 18
207	207	‘‘(ii) a device, as defined in section 19
208	208	201(h) of such Act (21 U.S.C. 321(h)). 20
209	209	‘‘(B) E
210	210	SSENTIAL COMPONENT .—The term 21
211	211	‘essential component’ means, with respect to a 22
212	212	medical product— 23
213	213	‘‘(i) an active pharmaceutical ingre-24
214	214	dient, or 25
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218	218	‘‘(ii) a protein, antibody, enzyme, hor-1
219	219	mone, or other organic material that is an 2
220	220	active ingredient in a biological product. 3
221	221	‘‘(6) A
222	222	GGREGATION RULES.— 4
223	223	‘‘(A) I
224	224	N GENERAL.—For purposes of this 5
225	225	section, members of an affiliated group shall be 6
226	226	treated as a single taxpayer. 7
227	227	‘‘(B) A
228	228	FFILIATED GROUP.—The term ‘af-8
229	229	filiated group’ means an affiliated group (as de-9
230	230	fined in section 1504(a), determined without re-10
231	231	gard to section 1504(b)(3)) one or more mem-11
232	232	bers of which are engaged in the active conduct 12
233	233	of a trade or business within an economically 13
234	234	distressed zone. 14
235	235	‘‘SEC. 1400AA–2. CREDIT FOR ECONOMICALLY DISTRESSED 15
236	236	ZONE PRODUCTS AND SERVICES ACQUIRED 16
237	237	BY DOMESTIC MEDICAL MANUFACTURERS. 17
238	238	‘‘(a) A
239	239	LLOWANCE OFCREDIT.—In the case of an eli-18
240	240	gible medical manufacturer, there shall be allowed as a 19
241	241	credit against the tax imposed by subtitle A for the taxable 20
242	242	year an amount equal to the applicable percentage of the 21
243	243	aggregate amounts paid or incurred by the taxpayer dur-22
244	244	ing such taxable year for qualified economically distressed 23
245	245	zone products or services. 24
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249	249	‘‘(b) APPLICABLEPERCENTAGE.—For purposes of 1
250	250	this section, the term applicable percentage means— 2
251	251	‘‘(1) 30 percent in the case of amounts paid or 3
252	252	incurred to persons not described in paragraph (2) 4
253	253	or (3), 5
254	254	‘‘(2) 40 percent in the case of amounts paid or 6
255	255	incurred to an unrelated minority business, and 7
256	256	‘‘(3) 5 percent in the case of amounts paid or 8
257	257	incurred to a related person. 9
258	258	‘‘(c) E
259	259	LIGIBLEMEDICALMANUFACTURER.—For 10
260	260	purposes of this section, the term ‘eligible medical manu-11
261	261	facturer’ means any person in the trade or business of pro-12
262	262	ducing medical products in the United States. 13
263	263	‘‘(d) Q
264	264	UALIFIEDPRODUCT ORSERVICE.—For pur-14
265	265	poses of this section, the term ‘qualified product or service’ 15
266	266	means— 16
267	267	‘‘(1) any product which is produced in an eco-17
268	268	nomically distressed zone and which is integrated 18
269	269	into a medical product produced by the taxpayer, 19
270	270	and 20
271	271	‘‘(2) any service which is provided in an eco-21
272	272	nomically distressed zone and which is necessary to 22
273	273	the production of a medical product by the taxpayer 23
274	274	(including packaging). 24
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278	278	‘‘(e) MINORITYBUSINESS.—For purposes of this sec-1
279	279	tion— 2
280	280	‘‘(1) I
281	281	N GENERAL.—The term ‘minority busi-3
282	282	ness’ means— 4
283	283	‘‘(A) a sole proprietorship carried on by a 5
284	284	qualified individual, or 6
285	285	‘‘(B) a corporation or partnership— 7
286	286	‘‘(i) at least 50 percent of the owner-8
287	287	ship interests in which are held by one or 9
288	288	more qualified individuals, and 10
289	289	‘‘(ii) of which a qualified individual is 11
290	290	the president or chief executive officer (or 12
291	291	a substantially equivalent position). 13
292	292	‘‘(2) Q
293	293	UALIFIED INDIVIDUAL.—The term ‘quali-14
294	294	fied individual’ means any individual who— 15
295	295	‘‘(A) is of Asian-Indian, Asian-Pacific, 16
296	296	Black, Hispanic, or Native American origin or 17
297	297	descent, and 18
298	298	‘‘(B) is a United States citizen or legal 19
299	299	resident of the United States or any of its terri-20
300	300	tories or possessions. 21
301	301	‘‘(f) R
302	302	ELATEDPERSONS.—For purposes of this sec-22
303	303	tion, persons shall be treated as related to each other if 23
304	304	such persons would be treated as a single employer under 24
305	305	the regulations prescribed under section 52(b). 25
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309	309	‘‘(g) OTHERTERMS.—Terms used in this section 1
310	310	which are also used in section 1400AA–1 shall have the 2
311	311	same meaning as when used in such section. 3
312	312	‘‘SEC. 1400AA–3. SPECIAL RULES TO SECURE THE NATIONAL 4
313	313	SUPPLY CHAIN AND FOR THE PRODUCTION 5
314	314	OF POPULATION HEALTH PRODUCTS. 6
315	315	‘‘(a) I
316	316	NGENERAL.—In the case of a qualified repatri-7
317	317	ated medical manufacturing facility or a qualified popu-8
318	318	lation health product manufacturing facility— 9
319	319	‘‘(1) section 1400AA–1(a) shall be applied by 10
320	320	substituting ‘60 percent’ for ‘40 percent’, and 11
321	321	‘‘(2) section 1400AA–2(a) shall be applied— 12
322	322	‘‘(A) by substituting ‘50 percent’ for ‘30 13
323	323	percent’, and 14
324	324	‘‘(B) by substituting ‘60 percent’ for ‘40 15
325	325	percent’. 16
326	326	‘‘(b) E
327	327	LECTIONTOEXPENSE INLIEU OFTAXCRED-17
328	328	IT FORDEPRECIATION.—In the case of a taxpayer which 18
329	329	elects (at such time and in such manner as the Secretary 19
330	330	may provide) the application of this subsection with re-20
331	331	spect to any qualified repatriated medical manufacturing 21
332	332	facility or qualified population health product manufac-22
333	333	turing facility— 23
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337	337	‘‘(1) section 1400AA–1(a)(3) shall not apply 1
338	338	with respect to any qualified medical manufacturing 2
339	339	facility property with respect to such facility, and 3
340	340	‘‘(2) for purposes of section 168(k)— 4
341	341	‘‘(A) such property shall be treated as 5
342	342	qualified property, and 6
343	343	‘‘(B) the applicable percentage with respect 7
344	344	to such property shall be 100 percent. 8
345	345	‘‘(c) Q
346	346	UALIFIEDREPATRIATEDMEDICALMANUFAC-9
347	347	TURINGFACILITY.—For purposes of this section, the term 10
348	348	‘qualified repatriated medical manufacturing facility’ 11
349	349	means any qualified medical manufacturing facility (as de-12
350	350	fined in section 1400AA–1) the production of which was 13
351	351	moved to an economically distressed zone from a foreign 14
352	352	country that the United States Trade Representative has 15
353	353	determined could pose a risk to the national supply chain 16
354	354	because of political or social factors. 17
355	355	‘‘(d) Q
356	356	UALIFIEDPOPULATIONHEALTHPRODUCT 18
357	357	M
358	358	ANUFACTURING FACILITY.—For purposes of this sec-19
359	359	tion, the term ‘qualified population health product manu-20
360	360	facturing facility’ means any qualified medical manufac-21
361	361	turing facility (as defined in section 1400AA–1) that pro-22
362	362	duces a population health product (as defined in section 23
363	363	319L(a)(11) of the Public Health Service Act) which the 24
364	364	Secretary of Health and Human Services has identified 25
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368	368	for support through a strategic initiative under section 1
369	369	319L(c)(4)(F)(ii) of the Public Health Service Act. 2
370	370	‘‘SEC. 1400AA–4. DESIGNATION OF ECONOMICALLY DIS-3
371	371	TRESSED ZONES. 4
372	372	‘‘(a) I
373	373	NGENERAL.—For purposes of this subchapter, 5
374	374	the term ‘economically distressed zone’ means any popu-6
375	375	lation census tract within the United States which— 7
376	376	‘‘(1) has a poverty rate of not less than 35 per-8
377	377	cent for each of the 5 most recent calendar years for 9
378	378	which information is available, or 10
379	379	‘‘(2) satisfies each of the following require-11
380	380	ments: 12
381	381	‘‘(A) has pervasive poverty, unemployment, 13
382	382	low labor force participation, and general dis-14
383	383	tress measured as a prolonged period of eco-15
384	384	nomic decline measured by real gross national 16
385	385	product, 17
386	386	‘‘(B) has a poverty rate of not less than 30 18
387	387	percent for each of the 5 most recent calendar 19
388	388	years for which information is available, and 20
389	389	‘‘(C) has been designated as such by the 21
390	390	Secretary and the Secretary of Commerce pur-22
391	391	suant to an application under subsection (b). 23
392	392	‘‘(b) A
393	393	PPLICATION FORDESIGNATION.— 24
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397	397	‘‘(1) IN GENERAL.—An application for designa-1
398	398	tion as an economically distressed zone may be filed 2
399	399	by a State or local government in which the popu-3
400	400	lation census tract to which the application applies 4
401	401	is located. 5
402	402	‘‘(2) R
403	403	EQUIREMENTS.—Such application shall 6
404	404	include a strategic plan for accomplishing the pur-7
405	405	poses of this subchapter, which— 8
406	406	‘‘(A) describes the coordinated economic, 9
407	407	human, community, and physical development 10
408	408	plan and related activities proposed for the 11
409	409	nominated area, 12
410	410	‘‘(B) describes the process by which the af-13
411	411	fected community is a full partner in the proc-14
412	412	ess of developing and implementing the plan 15
413	413	and the extent to which local institutions and 16
414	414	organizations have contributed to the planning 17
415	415	process, 18
416	416	‘‘(C) identifies the amount of State, local, 19
417	417	and private resources that will be available in 20
418	418	the nominated area and the private/public part-21
419	419	nerships to be used, which may include partici-22
420	420	pation by, and cooperation with, universities, 23
421	421	medical centers, and other private and public 24
422	422	entities, 25
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426	426	‘‘(D) identifies the funding requested 1
427	427	under any Federal program in support of the 2
428	428	proposed economic, human, community, and 3
429	429	physical development and related activities, 4
430	430	‘‘(E) identifies baselines, methods, and 5
431	431	benchmarks for measuring the success of car-6
432	432	rying out the strategic plan, including the ex-7
433	433	tent to which poor persons and families will be 8
434	434	empowered to become economically self-suffi-9
435	435	cient, and 10
436	436	‘‘(F) does not include any action to assist 11
437	437	any establishment in relocating from one area 12
438	438	outside the nominated area to the nominated 13
439	439	area, except that assistance for the expansion of 14
440	440	an existing business entity through the estab-15
441	441	lishment of a new branch, affiliate, or sub-16
442	442	sidiary is permitted if— 17
443	443	‘‘(i) the establishment of the new 18
444	444	branch, affiliate, or subsidiary will not re-19
445	445	sult in a decrease in employment in the 20
446	446	area of original location or in any other 21
447	447	area where the existing business entity 22
448	448	conducts business operations, 23
449	449	‘‘(ii) there is no reason to believe that 24
450	450	the new branch, affiliate, or subsidiary is 25
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454	454	being established with the intention of clos-1
455	455	ing down the operations of the existing 2
456	456	business entity in the area of its original 3
457	457	location or in any other area where the ex-4
458	458	isting business entity conducts business op-5
459	459	eration, and 6
460	460	‘‘(iii) includes such other information 7
461	461	as may be required by the Secretary and 8
462	462	the Secretary of Commerce. 9
463	463	‘‘(c) P
464	464	ERIOD FORWHICHDESIGNATIONSARE INEF-10
465	465	FECT.—Designation as an economically distressed zone 11
466	466	may be made at any time during the 10-year period begin-12
467	467	ning on the date of the enactment of this section, and shall 13
468	468	remain in effect with respect to such zone during the 15- 14
469	469	year period beginning on the date of such designation. 15
470	470	Economically distressed zones described in subsection 16
471	471	(a)(1) shall take effect on the date of the enactment of 17
472	472	this Act and shall remain in effect during the 15-year pe-18
473	473	riod beginning on such date. 19
474	474	‘‘(d) T
475	475	ERRITORIES AND POSSESSIONS.—The term 20
476	476	‘United States’ includes the 50 States, the District of Co-21
477	477	lumbia, and the territories and possessions of the United 22
478	478	States. 23
479	479	‘‘(e) R
480	480	EGULATIONS.—The Secretary shall issue such 24
481	481	regulations or other guidance as may be necessary or ap-25
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484	484	•HR 447 IH
485	485	propriate to carry out the purposes of this section, includ-1
486	486	ing— 2
487	487	‘‘(1) not later than 30 days after the date of 3
488	488	the enactment of this section, a list of the population 4
489	489	census tracts described in subsection (a)(1), and 5
490	490	‘‘(2) not later than 60 days after the date of 6
491	491	the enactment of this section, regulations or other 7
492	492	guidance regarding the designation of population 8
493	493	census tracts described in subsection (a)(2).’’. 9
494	494	(b) E
495	495	FFECTIVEDATE.—The amendments made by 10
496	496	this section shall apply to taxable years beginning after 11
497	497	December 31, 2022. 12
498	498	SEC. 3. AUTHORITY TO SUPPORT DEVELOPMENT OF POPU-13
499	499	LATION HEALTH PRODUCTS. 14
500	500	(a) D
501	501	EFINITIONS.— 15
502	502	(1) Q
503	503	UALIFIED COUNTERMEASURE .—Subpara-16
504	504	graph (A) of section 319F–1(a)(2) of the Public 17
505	505	Health Service Act (42 U.S.C. 247d–6a(a)(2)) is 18
506	506	amended to read as follows: 19
507	507	‘‘(A) Q
508	508	UALIFIED COUNTERMEASURE .—The 20
509	509	term ‘qualified countermeasure’ means a drug 21
510	510	(as that term is defined by section 201(g)(1) of 22
511	511	the Federal Food, Drug, and Cosmetic Act (21 23
512	512	U.S.C. 321(g)(1))), biological product (as that 24
513	513	term is defined by section 351(i) of this Act (42 25
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516	516	•HR 447 IH
517	517	U.S.C. 262(i))), or device (as that term is de-1
518	518	fined by section 201(h) of the Federal Food, 2
519	519	Drug, and Cosmetic Act (21 U.S.C. 321(h))), 3
520	520	that the Secretary determines to be a priority 4
521	521	consistent with sections 302(2) and 304(a) of 5
522	522	the Homeland Security Act of 2002— 6
523	523	‘‘(i) to diagnose, mitigate, prevent, or 7
524	524	treat harm from any biological agent (in-8
525	525	cluding organisms that cause an infectious 9
526	526	disease), toxin, chemical, radiological, or 10
527	527	nuclear agent that may cause a public 11
528	528	health emergency affecting national secu-12
529	529	rity; or 13
530	530	‘‘(ii) to diagnose, mitigate, prevent, or 14
531	531	treat harm from an underlying non-com-15
532	532	municable disease which, combined with 16
533	533	pandemic influenza or an emerging infec-17
534	534	tious disease, may result in adverse health 18
535	535	consequences or serious threat to one or 19
536	536	more vulnerable American populations (as 20
537	537	defined in section 319L(a)) in an epidemic 21
538	538	or pandemic.’’. 22
539	539	(2) O
540	540	THER DEFINITIONS.—Subsection (a) of 23
541	541	section 319L of the Public Health Service Act (42 24
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544	544	•HR 447 IH
545	545	U.S.C. 247d–7e) is amended by adding at the end 1
546	546	the following new paragraphs: 2
547	547	‘‘(11) P
548	548	OPULATION HEALTH PRODUCT .—The 3
549	549	term ‘population health product’ means a widely 4
550	550	available drug to diagnose, mitigate, prevent, or 5
551	551	treat harm from an underlying non-communicable 6
552	552	disease which, combined with pandemic influenza or 7
553	553	an emerging infectious disease, may result in ad-8
554	554	verse health consequences or a serious threat to one 9
555	555	or more vulnerable American populations in an epi-10
556	556	demic or pandemic. 11
557	557	‘‘(12) V
558	558	ULNERABLE AMERICAN POPU -12
559	559	LATIONS.—The term ‘vulnerable American popu-13
560	560	lations’ means children, pregnant women, older 14
561	561	adults, minority populations, and other at-risk indi-15
562	562	viduals with relevant characteristics that warrant 16
563	563	consideration during the process of researching and 17
564	564	developing such countermeasures and products.’’. 18
565	565	(b) S
566	566	TRATEGICINITIATIVES.—Clause (ii) of section 19
567	567	319L(c)(4)(F) of the Public Health Service Act (42 20
568	568	U.S.C. 247d–7e(c)(4)(F)) is amended to read as follows: 21
569	569	‘‘(ii) threats that consistently exist or 22
570	570	continually circulate and have a significant 23
571	571	potential to become a pandemic, such as 24
572	572	pandemic influenza and emerging infec-25
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575	575	•HR 447 IH
576	576	tious diseases in combination with under-1
577	577	lying non-communicable diseases, which 2
578	578	may include the advanced research and de-3
579	579	velopment, manufacturing, and appropriate 4
580	580	stockpiling of qualified pandemic or epi-5
581	581	demic products, and products, technologies, 6
582	582	or processes to support the advanced re-7
583	583	search and development of such counter-8
584	584	measures (including multiuse platform 9
585	585	technologies for diagnostics, vaccines, and 10
586	586	therapeutics; virus seeds; clinical trial lots; 11
587	587	novel virus strains; and antigen and adju-12
588	588	vant material); and’’. 13
589	589	(c) A
590	590	T-RISKINDIVIDUALS.—Paragraph (6) of section 14
591	591	319L(c) of the Public Health Service Act (42 U.S.C. 15
592	592	247d–7e(c)) is amended to read as follows: 16
593	593	‘‘(6) A
594	594	T-RISK INDIVIDUALS.—In carrying out 17
595	595	the functions under this section, the Secretary may 18
596	596	give a priority to advanced research and develop-19
597	597	ment of— 20
598	598	‘‘(A) qualified countermeasures and quali-21
599	599	fied pandemic or epidemic products likely to be 22
600	600	safe and effective with respect to vulnerable 23
601	601	American populations; and 24
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605	605	‘‘(B) population health products likely to 1
606	606	protect vulnerable American populations with 2
607	607	underlying non-communicable diseases from dis-3
608	608	proportionate harm in epidemics and 4
609	609	pandemics.’’. 5
610	610	(d) O
611	611	THERAUTHORITIES.—Section 319L(c) of the 6
612	612	Public Health Service Act (42 U.S.C. 247d–7e(c)) is 7
613	613	amended by adding at the end the following: 8
614	614	‘‘(8) T
615	615	IMELY DELIVERY OF POPULATION 9
616	616	HEALTH PRODUCTS TO AT -RISK INDIVIDUALS.—The 10
617	617	Secretary shall collaborate with the Administrator of 11
618	618	the Centers for Medicare & Medicaid Services, the 12
619	619	Secretary of Defense, the Secretary of Veterans Af-13
620	620	fairs, the Commissioner of Food and Drugs, and the 14
621	621	heads of other Federal agencies involved with ap-15
622	622	proval and distribution of health products to assure 16
623	623	that such Federal agencies distribute approved pop-17
624	624	ulation health products as promptly and effectively 18
625	625	as possible, and as continuously as possible, to pro-19
626	626	tect vulnerable American populations from harm in 20
627	627	epidemics and pandemics. 21
628	628	‘‘(9) R
629	629	EPORT ON NEED FOR INCENTIVIZING DE -22
630	630	VELOPMENT OF POPULATION HEALTH PRODUCTS .— 23
631	631	Not later than 90 days after the date of enactment 24
632	632	of the Medical Manufacturing, Economic Develop-25
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636	636	ment, and Sustainability Act of 2023, the Secretary 1
637	637	shall examine and report to the Congress on— 2
638	638	‘‘(A) the extent to which the health of 3
639	639	aging Americans, African Americans, His-4
640	640	panics, Native Americans, veterans, or other 5
641	641	vulnerable American populations has been dis-6
642	642	proportionately harmed by the COVID–19 pan-7
643	643	demic and prior epidemics and pandemics; 8
644	644	‘‘(B) the population health products cur-9
645	645	rently available and whether there is a need for 10
646	646	additional innovation and development to 11
647	647	produce population health products to reduce 12
648	648	the exposure of vulnerable American popu-13
649	649	lations to risk of disproportionate harm in 14
650	650	epidemics and pandemics; and 15
651	651	‘‘(C) whether the Secretary recommends 16
652	652	providing the same incentives for the develop-17
653	653	ment and marketing of population health prod-18
654	654	ucts as is given with respect to covered infec-19
655	655	tious disease products under the Federal Food, 20
656	656	Drug, and Cosmetic Act, including under sec-21
657	657	tion 505E of such Act.’’. 22
658	658	Æ
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