II 

117TH CONGRESS 

1ST SESSION S. 3427 

To authorize the Secretary of Health and Human Services to establish a 

Neuroscience Center of Excellence. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 16, 2021 

Ms. COLLINS (for herself and Mr. LUJA ́N) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To authorize the Secretary of Health and Human Services 

to establish a Neuroscience Center of Excellence. 

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 ‘‘Neuroscience Center 

5 of Excellence Act of 2021’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) Neuroscience at the Food and Drug Admin9 istration encompasses a broad range of neurological 

10 and psychiatric diseases and disorders, including— 


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1 (A) addiction; 

2 (B) Alzheimer’s disease and other 

3 neurodegenerative conditions that cause demen4 tia; 

5 (C) amyotrophic lateral sclerosis; 

6 (D) autism spectrum disorder, Down syn7 drome, and other neurodevelopmental disorders; 

8 (E) bipolar disorder; 

9 (F) brain aneurysms; 

10 (G) brain tumors; 

11 (H) cerebral palsy; 

12 (I) anxiety and depression; 

13 (J) dyspraxia; 

14 (K) dystonia; 

15 (L) epilepsy and other seizure disorders; 

16 (M) hereditary brain and central nervous 

17 system diseases; 

18 (N) headaches and migraine disease; 

19 (O) Huntington’s disease; 

20 (P) multiple sclerosis; 

21 (Q) pain; 

22 (R) Parkinson’s disease and other move23 ment disorders, including parkinsonisms; 

24 (S) personality disorders; 

25 (T) psychotic disorders; 


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1 (U) traumatic brain injury and chronic 

2 traumatic encephalopathy; and 

3 (V) rare diseases that impact the brain 

4 and central nervous system. 

5 (2) Neurological and psychiatric diseases and 

6 disorders are highly prevalent. According to the Na7 tional Institutes of Health, neurological disorders af8 fect an estimated 50,000,000 people in the United 

9 States each year, and 51,500,000 adults in the 

10 United States live with a mental illness. 

11 (3) The prevalence of neuroscience diseases and 

12 disorders continues to grow. The Centers for Disease 

13 Control and Prevention forecasts that the burden of 

14 dementias in the United States will double by 2060 

15 to 13,900,000 people, which will be 3.3 percent of 

16 the population. 

17 (4) Neurological and psychiatric diseases and 

18 disorders have a significant impact on health care 

19 expenditures and the United States economy as a 

20 whole. The impact of common neurological diseases, 

21 including Alzheimer’s disease and Parkinson’s dis22 ease, on the United States economy is estimated by 

23 the American Neurological Association at over 

24 $789,000,000,000. 


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1 (5) Factors associated with the COVID–19 

2 pandemic, including job loss and social isolation, 

3 have exacerbated the prevalence and impact of psy4 chiatric diseases and disorders. According to the 

5 Centers for Disease Control and Prevention, during 

6 the pandemic, more than one-third of adults in the 

7 United States reported symptoms of anxiety or de8 pression. 

9 (6) The National Institute of Neurological Dis10 orders and Stroke has recognized that the SARS– 

11 CoV–2 virus can lead to serious neurological com12 plications, such as anosmia, headache, impaired con13 sciousness, and stroke, which may affect individuals’ 

14 ability to function or work after the pandemic ends. 

15 (7) Despite the large societal need, medical 

16 products for neurological and psychiatric diseases 

17 and disorders are approved by the Food and Drug 

18 Administration at a much lower rate than products 

19 for other disease areas. According to a 2018 study 

20 conducted by the Tufts Center for the Study of 

21 Drug Development, central nervous system drugs 

22 take 20 percent longer to develop and approve than 

23 non-central nervous system drugs. 


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1 SEC. 3. ESTABLISHMENT OF A NEUROSCIENCE CENTER OF 

2 EXCELLENCE. 

3 (a) ESTABLISHMENT REQUIRED.—The first sentence 

4 of section 1014(a) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 399g(a)) is amended by inserting 

6 ‘‘, at least 1 of which shall be focused on neuroscience 

7 diseases and disorders (as defined in section 1015)’’ before 

8 the period at the end. 

9 (b) TIMING OF ESTABLISHMENT.—Subsection (c) of 

10 section 1014 of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 399g(c)) is amended to read as follows: 

12 ‘‘(c) TIMING.—Not later than 1 year after the date 

13 of enactment of the Neuroscience Center of Excellence Act 

14 of 2021, the Secretary shall establish, in accordance with 

15 this section and section 1015, an Institute under sub16 section (a) focused on neuroscience diseases and disorders, 

17 to be known as the Neuroscience Center of Excellence.’’. 

18 (c) ACTIVITIES.—Chapter X of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend20 ed by adding at the end the following: 

21 ‘‘SEC. 1015. NEUROSCIENCE CENTER OF EXCELLENCE. 

22 ‘‘(a) ACTIVITIES.—The Neuroscience Center of Ex23 cellence established under section 1014(a), shall— 

24 ‘‘(1) carry out the activities described in section 

25 1014(a); 


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1 ‘‘(2) coordinate collaborations among the Cen2 ters (within the meaning of section 1014(a)) and 

3 stakeholders to support the development of medical 

4 products for neuroscience diseases and disorders; 

5 ‘‘(3) establish and carry out the programs de6 scribed in subsection (c); and 

7 ‘‘(4) issue reports to Congress on the activities 

8 of the Neuroscience Center of Excellence, as de9 scribed in subsection (d). 

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

11 ‘‘(1) NEUROSCIENCE DISEASES AND DIS12 ORDERS.—The term ‘neuroscience diseases and dis13 orders’ means— 

14 ‘‘(A) addiction; 

15 ‘‘(B) Alzheimer’s disease and other 

16 neurodegenerative conditions that cause demen17 tia; 

18 ‘‘(C) amyotrophic lateral sclerosis; 

19 ‘‘(D) autism spectrum disorder, Down syn20 drome, and other neurodevelopmental disorders; 

21 ‘‘(E) bipolar disorder; 

22 ‘‘(F) brain aneurysms; 

23 ‘‘(G) brain tumors; 

24 ‘‘(H) cerebral palsy; 

25 ‘‘(I) anxiety and depression; 


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1 ‘‘(J) dyspraxia; 

2 ‘‘(K) dystonia; 

3 ‘‘(L) epilepsy and other seizure disorders; 

4 ‘‘(M) hereditary brain and central nervous 

5 system diseases; 

6 ‘‘(N) headaches and migraine disease; 

7 ‘‘(O) Huntington’s disease; 

8 ‘‘(P) multiple sclerosis; 

9 ‘‘(Q) pain; 

10 ‘‘(R) Parkinson’s disease and other move11 ment disorders, including parkinsonisms; 

12 ‘‘(S) personality disorders; 

13 ‘‘(T) psychotic disorders; 

14 ‘‘(U) traumatic brain injury and chronic 

15 traumatic encephalopathy; and 

16 ‘‘(V) rare diseases that impact the brain 

17 and central nervous system. 

18 ‘‘(2) MEDICAL PRODUCT.—The term ‘medical 

19 product’ means a drug, biological product, or device, 

20 or a combination product described in section 

21 503(g). 

22 ‘‘(3) PATIENT EXPERIENCE DATA.—The term 

23 ‘patient experience data’ has the meaning given such 

24 term in section 569C(c). 


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1 ‘‘(c) PROGRAMS.—The Neuroscience Center of Excel2 lence shall establish and implement the following pro3 grams: 

4 ‘‘(1) NEUROSCIENCE THERAPEUTICS PRO5 GRAM.— 

6 ‘‘(A) PUBLIC ENGAGEMENT.— 

7 ‘‘(i) PUBLIC MEETING.—Not later 

8 than 2 years after the date of enactment 

9 of the Neuroscience Center of Excellence 

10 Act of 2021, and not less than once per 

11 year thereafter, the Secretary shall convene 

12 a public meeting of stakeholders (including 

13 scientists, researchers, patient advocacy or14 ganizations, disease research foundations, 

15 and representatives of the drug and device 

16 industries) to identify and make rec17 ommendations to address current and 

18 emerging regulatory science and public pol19 icy challenges associated with developing 

20 medical products for neuroscience diseases 

21 and disorders. Issues addressed during 

22 such meetings shall include— 

23 ‘‘(I) methods to support the ac24 celerated qualification of appropriate 

25 biomarkers and endpoints, including 


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1 predictive biomarkers and endpoints, 

2 for neuroscience diseases and dis3 orders; and 

4 ‘‘(II) novel drug development 

5 methodologies and study designs to 

6 better support the rapid development 

7 and approval of medical products for 

8 neuroscience diseases and disorders. 

9 ‘‘(ii) REPORT.—Not later than 3 

10 months after the conclusion of each public 

11 meeting under clause (i), the Secretary 

12 shall publish a report identifying the chal13 lenges and opportunities for rapid improve14 ment discussed during such public meet15 ing, and as applicable, any recommenda16 tions to Congress regarding how to address 

17 such challenges and ensure that patients 

18 benefit from optimizing development of 

19 medical products for neurosciences diseases 

20 and disorders. The Secretary shall make 

21 such report public on the website of the 

22 Department of Health and Human Serv23 ices. 

24 ‘‘(B) GUIDANCE.—Not later than 2 years 

25 after the date of enactment of the Neuroscience 


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1 Center of Excellence Act of 2021, the Secretary 

2 shall issue one or more final guidances that ad3 dress— 

4 ‘‘(i) recommendations to sponsors of 

5 medical products for neuroscience diseases 

6 and disorders regarding master protocols 

7 to simultaneously evaluate more than 1 in8 vestigational medical product or more than 

9 1 type of disease or disorder within the 

10 same overall trial structure, as well as 

11 other novel or collaborative study designs 

12 and approaches; and 

13 ‘‘(ii) approaches that may be used to 

14 incorporate clinical outcome assessments, 

15 including patient-reported outcomes, into 

16 endpoints for the development of medical 

17 products for neuroscience diseases and dis18 orders. 

19 ‘‘(2) NEUROSCIENCE PATIENT-FOCUSED DRUG

20 DEVELOPMENT PROGRAM.— 

21 ‘‘(A) IN GENERAL.—The Secretary shall 

22 establish, within the Neuroscience Center of 

23 Excellence, a program to facilitate the collection 

24 of patient experience data, and the systematic 

25 use of such data and related information, in the 


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1 development of medical products for neuro2 science diseases and disorders. 

3 ‘‘(B) PUBLIC ENGAGEMENT.—Not later 

4 than 2 years after the date of enactment of the 

5 Neuroscience Center of Excellence Act of 2021, 

6 and not less than once per year thereafter, the 

7 Secretary shall convene stakeholders (including 

8 patient advocacy groups and disease research 

9 foundations) for a public workshop. Such work10 shop shall— 

11 ‘‘(i) educate stakeholders on current 

12 initiatives and activities at the Neuro13 science Center of Excellence; 

14 ‘‘(ii) solicit feedback from stake15 holders on ongoing initiatives and activities 

16 at the Neuroscience Center of Excellence; 

17 and 

18 ‘‘(iii) provide an opportunity for 

19 stakeholders to discuss their personal expe20 riences, including with respect to symp21 toms, daily impact, and current approaches 

22 to treatment for neuroscience diseases and 

23 disorders. 

24 ‘‘(C) STUDY.—Not later than 2 years after 

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1 ter of Excellence Act of 2021, the Secretary 

2 shall conduct a study on methods to assess the 

3 patient experience in the development of med4 ical products for neuroscience diseases and dis5 orders. The Secretary shall make a report sum6 marizing the results of such study public on the 

7 website of the Department of Health and 

8 Human Services. 

9 ‘‘(D) GUIDANCE.—Not later than 2 years 

10 after the date of enactment of the Neuroscience 

11 Center of Excellence Act of 2021, the Secretary 

12 shall issue final guidance with recommendations 

13 on the collection of patient experience data (as 

14 defined in section 569C of the Federal Food, 

15 Drug, and Cosmetic Act), and the use of such 

16 data and related information, in the develop17 ment of medical products for neuroscience dis18 eases and disorders. 

19 ‘‘(3) NEUROSCIENCE NATURAL HISTORY STUD20 IES PROGRAM.— 

21 ‘‘(A) GUIDANCE.—Not later than 2 years 

22 after the date of enactment of the Neuroscience 

23 Center of Excellence Act of 2021, the Secretary 

24 shall issue final guidance with recommendations 

25 for sponsors on implementing natural history 


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1 studies that can be used to support the develop2 ment of medical products for neuroscience dis3 eases and disorders. 

4 ‘‘(B) DEFINITION.—In this paragraph, the 

5 term ‘natural history study’ means a 

6 preplanned observational study intended to 

7 track the course of the disease. 

8 ‘‘(4) DIGITAL HEALTH TECHNOLOGIES PRO9 GRAM.— 

10 ‘‘(A) GUIDANCE.—Not later than 2 years 

11 after the date of enactment of the Neuroscience 

12 Center of Excellence Act of 2021, the Secretary 

13 shall issue final guidance addressing approaches 

14 to— 

15 ‘‘(i) using digital technologies and dig16 ital endpoints in clinical trials evaluating 

17 medical products for neuroscience diseases 

18 and disorders; and 

19 ‘‘(ii) using digital technologies for the 

20 treatment of such diseases and disorders. 

21 ‘‘(5) COVID–19 IMPACTS PROGRAM.— 

22 ‘‘(A) PUBLIC MEETING.— 

23 ‘‘(i) IN GENERAL.—Not later than 2 

24 years after the date of enactment of the 

25 Neuroscience Center of Excellence Act of 


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1 2021, the Secretary shall convene not 

2 fewer than 2 public meetings for stake3 holders (including scientists, researchers, 

4 health care providers, academics, members 

5 of the regulated industry, patient advocacy 

6 organizations, and disease research foun7 dations) to discuss the impact of COVID– 

8 19 on neuroscience diseases and disorders. 

9 ‘‘(ii) TOPICS.—The topics discussed at 

10 the meeting under clause (i) shall in11 clude— 

12 ‘‘(I) the impact of the SARS– 

13 CoV–2 virus on patients diagnosed 

14 with such diseases and disorders, 

15 without regard to whether such diag16 noses occurred before or after such 

17 patient contracted the SARS–CoV–2 

18 virus; 

19 ‘‘(II) the indirect impact of the 

20 COVID–19 pandemic on such diseases 

21 and disorders, including the effects of 

22 social isolation and heightened levels 

23 of stress and anxiety for those with 

24 neuroscience disease and disorder di25 agnoses; and 


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1 ‘‘(III) strategies for the rapid de2 velopment of medical products to ad3 dress the direct and indirect impacts 

4 of COVID–19 on such diseases and 

5 disorders, including real-world data 

6 collection and real-world evidence de7 velopment. 

8 ‘‘(B) REPORT.—Not later than 1 year 

9 after the date of enactment of the Neuroscience 

10 Center of Excellence Act of 2021, the Secretary 

11 shall publish a report on the direct and indirect 

12 impacts of COVID–19 on neuroscience diseases 

13 and disorders including, as applicable, any rec14 ommendations to Congress on the development 

15 of medical products intended to address the im16 pact of COVID–19 for individuals with such 

17 conditions. The Secretary shall make such re18 port public on the website of the Department of 

19 Health and Human Services. 

20 ‘‘(6) ENSURING EQUITY IN NEUROSCIENCE

21 PROGRAM.— 

22 ‘‘(A) PUBLIC MEETING.—Not later than 2 

23 years after the date of enactment of the Neuro24 science Center of Excellence Act of 2021, the 

25 Secretary shall convene a public meeting of 


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1 stakeholders whose experience directly relates to 

2 patients with neuroscience diseases and dis3 orders (including scientists, health care pro4 viders, academics, members of the regulated in5 dustry, patient advocacy organizations, and dis6 ease research foundations) to discuss how to 

7 promote equity and inclusion of traditionally 

8 underrepresented populations in the research 

9 and development of medical products for neuro10 science diseases and disorders. 

11 ‘‘(B) GUIDANCE.—Not later than 2 years 

12 after the date of enactment of the Neuroscience 

13 Center of Excellence Act of 2021, the Secretary 

14 shall issue guidance for industry on how to en15 sure greater diversity in clinical trials for neu16 roscience diseases and disorders medical prod17 ucts. Such guidance shall consider the feedback 

18 and recommendations from the public meeting 

19 under subparagraph (A) the study under sec20 tion 3(d) of the Neuroscience Center of Excel21 lence Act of 2021. 

22 ‘‘(d) REPORT.—Not later than 1 year after the date 

23 of enactment of the Neuroscience Center of Excellence Act 

24 of 2021, and annually thereafter, the Secretary shall sub25 mit a report to the Committee on Health, Education, 


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1 Labor, and Pensions of the Senate and the Committee on 

2 Energy and Commerce of the House of Representatives 

3 on the activities of the Neuroscience Center of Excellence. 

4 Such report shall include— 

5 ‘‘(1) the number of medical products for neuro6 science diseases and disorders that were approved by 

7 the Food and Drug Administration in the previous 

8 5 calendar years; 

9 ‘‘(2) a summary of challenges to developing 

10 medical products for neuroscience diseases and dis11 orders, and as applicable, recommendations to Con12 gress on how to address such challenges; and 

13 ‘‘(3) the direct and indirect impacts of the 

14 COVID–19 pandemic on neuroscience diseases and 

15 disorders. 

16 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

17 carry out this section, there are authorized to be appro18 priated $25,000,000 for the period of fiscal years 2023 

19 through 2027.’’. 

20 (d) GAO STUDY.—Not later than 2 years after the 

21 date of enactment of this Act, the Comptroller General 

22 of the United States shall— 

23 (1) complete a study that reviews the participa24 tion of traditionally underrepresented populations in 

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1 tion 1015 of the Federal Food, Drug, and Cosmetic 

2 Act, as added by section 3) for the treatment or di3 agnosis of neuroscience diseases and disorders (as 

4 defined in such section 1015); and 

5 (2) submit a report to Congress on the results 

6 of such study, including recommendations on poten7 tial changes in practices and policies to improve par8 ticipation by populations that have been traditionally 

9 underrepresented in such trials. 

Æ 


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