79–006 

115TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 115–354 

SICKLE CELL DISEASE RESEARCH, SURVEILLANCE, 

PREVENTION, AND TREATMENT ACT OF 2017 

OCTOBER 19, 2017.—Committed to the Committee of the Whole House on the State 

of the Union and ordered to be printed 

Mr. WALDEN, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 2410] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 2410) to amend the Public Health Service Act to reauthorize a sickle cell disease prevention and treatment demonstration program and to provide for sickle cell disease research, 

surveillance, prevention, and treatment, having considered the 

same, report favorably thereon without amendment and recommend that the bill do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Committee Action .................................................................................................... 2 

Committee Votes ...................................................................................................... 3 

Oversight Findings and Recommendations ........................................................... 3 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 3 

Congressional Budget Office Estimate ................................................................... 3 

Federal Mandates Statement ................................................................................. 4 

Statement of General Performance Goals and Objectives .................................... 4 

Duplication of Federal Programs ............................................................................ 4 

Committee Cost Estimate ....................................................................................... 4 

Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................. 4 

Disclosure of Directed Rule Makings ..................................................................... 4 

Advisory Committee Statement .............................................................................. 5 

Applicability to Legislative Branch ........................................................................ 5 

Section-by-Section Analysis of the Legislation ...................................................... 5 

Changes in Existing Law Made by the Bill, as Reported ..................................... 5 

2 

PURPOSE AND SUMMARY

H.R. 2410 was introduced on May 11, 2017, by Rep. Danny K. 

Davis (D–IL). H.R. 2410 reauthorizes the Sickle Cell Disease Treatment Demonstration Program under the Public Health Service Act. 

The bill increases sickle cell disease (SCD) research and surveillance. It also authorizes grants for improving outreach and treatment in populations with a high density of SCD patients, emphasizing collaboration with community-based entities with experience 

in providing services to patients with this disease. 

BACKGROUND AND NEED FOR LEGISLATION

Sickle Cell Disease is a group of inherited blood cell disorders 

that results in misshapen blood cells, creating blockages in small 

blood vessels, leading to various health care complications ranging 

from mild discomfort to death. The exact number of those living 

with SCD in the United States is unknown, but the Centers for 

Disease Control and Prevention estimate that SCD affects approximately 100,000 Americans, occurring in about one out of every 365 

African-American births. 

Treatments for this disease are limited and focus on relieving 

symptoms, reducing pain, and avoiding crises and complications. At 

this time, hematopoietic stem cell transplantation is the only cure. 

Enhancing research and surveillance efforts will improve current 

understanding of this life-long disease and potentially lead to a 

cure. Collaboration with community-based organizations treating 

SCD patients provides an opportunity to reduce costs while enhancing health outcomes. 

COMMITTEE ACTION

During the 114th Congress, on September 8, 2016, the Subcommittee on Health held a hearing on H.R. 1807, which was substantially similar to H.R. 2410. The hearing was entitled ‘‘Examining Legislation to Improve Public Health.’’ The Subcommittee received testimony from: 

• Sonja L. Banks, President and COO, Sickle Cell Disease 

Association of America, Inc.; 

• General Arthur Dean, Chairman and CEO, Community 

Anti-Drug Coalitions of America; 

• Jonathan Leffert, President-Elect, American Association of 

Clinical Endocrinologists; 

• Brad Marino, Chair, Pediatric Congenital Heart Association; and 

• R. Sean Morrison, Director, National Palliative Care Research Center. 

On May 18, 2017, the Subcommittee on Health met in open 

markup session and forwarded H.R. 2410, without amendment, to 

the full Committee by a voice vote. On June 7, 2017, the full Committee on Energy and Commerce met in open markup session and 

ordered H.R. 2410, without amendment, favorably reported to the 

House by a voice vote. 

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COMMITTEE VOTES

Clause 3(b) of rule XIII requires the Committee to list the record 

votes on the motion to report legislation and amendments thereto. 

There were no record votes taken in connection with ordering H.R. 

2410 reported. 

OVERSIGHT FINDINGS AND RECOMMENDATIONS

Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of rule 

XIII, the Committee has not held hearings on this legislation. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Pursuant to clause 3(c)(2) of rule XIII, the Committee finds that 

H.R. 2410 would result in no new or increased budget authority, 

entitlement authority, or tax expenditures or revenues. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII, the following is the cost 

estimate provided by the Congressional Budget Office pursuant to 

section 402 of the Congressional Budget Act of 1974. 

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC. September 22, 2017. 

Hon. GREG WALDEN, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 2410, the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 

2017. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Rebecca Yip. 

Sincerely, 

KEITH HALL, Director. 

Enclosure. 

H.R. 2410—Sickle Cell Disease Research, Surveillance, Prevention, 

and Treatment Act of 2017 

H.R. 2410 would authorize the Secretary of Health and Human 

Services, through the Centers for Disease Control and Prevention 

(CDC), to conduct surveillance and collect data on the prevalence 

of sickle cell disease (SCD). In addition, the bill would authorize 

the Secretary to develop public health initiatives that support community-based organizations in education activities and to support 

regional and state health departments in testing to identify SCD. 

H.R. 2410 would authorize the appropriation of about $4.5 million 

a year for fiscal years 2018 through 2022 to carry out those activities. 

The bill would require CDC to build upon past activities related 

to SCD by conducting surveillance and developing public health initiatives through grants to States. Previous funding from the AmerVerDate Sep 11 2014 03:55 Oct 21, 2017 Jkt 079006 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\HR354.XXX HR354
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ican Jobs Creation Act of 2004 of $10 million a year for SCD expired in 2009. There has been no explicit funding for SCD since 

2009. However, CDC has continued to conduct activities related to 

SCD and other blood disorders. Based on historical spending for 

similar activities, CBO estimates that implementing H.R. 2410 

would cost $18 million over the 2018–2022 period, primarily for additional staff and other administrative costs; the remaining 

amounts would be spent after 2022. Enacting H.R. 2410 would not 

affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. 

CBO estimates that enacting the legislation would not increase 

net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2028. 

H.R. 2410 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would 

impose no costs on state, local, or tribal governments. 

The CBO staff contact for this estimate is Rebecca Yip. The estimate was approved by Holly Harvey, Deputy Assistant Director for 

Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

Pursuant to clause 3(c)(4) of rule XIII, the general performance 

goal or objective of this legislation is to improve SCD research, surveillance and outreach initiatives that enhance the treatment of 

SCD, emphasizing collaboration with community-based entities 

with experience in providing services to patients with this disease. 

DUPLICATION OF FEDERAL PROGRAMS

Pursuant to clause 3(c)(5) of rule XIII, no provision of H.R. 2410 

is known to be duplicative of another Federal program, including 

any program that was included in a report to Congress pursuant 

to section 21 of Public Law 111–139 or the most recent Catalog of 

Federal Domestic Assistance. 

COMMITTEE COST ESTIMATE

Pursuant to clause 3(d)(1) of rule XIII, the Committee adopts as 

its own the cost estimate prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional 

Budget Act of 1974. 

EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, [the Committee finds that H.R. 2410 contains no earmarks, limited tax benefits, or limited tariff benefits. 

DISCLOSURE OF DIRECTED RULE MAKINGS

Pursuant to section 3(i) of H. Res. 5, the Committee finds that 

H.R. 2410 contains no directed rule makings. 

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ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title; table of contents 

Section 1 provides that the Act may be cited as the ‘‘Sickle Cell 

Disease Research, Surveillance, Prevention and Treatment Act of 

2017.’’ 

Section 2. Sickle cell disease research 

Section 2 authorizes the Secretary to conduct and support research to further understand the causes of sickle cell disease and 

to find a cure for sickle cell disease. 

Section 3. Sickle cell disease surveillance 

Section 3 authorizes the Secretary to make grants to States to 

conduct surveillance on the epidemiology of sickle cell disease, implement public health initiatives, and identify and evaluate sickle 

cell disease prevention and treatment strategies. 

Section 4. Sickle cell disease prevention and treatment 

Section 4 reauthorizes the Sickle Cell Disease Treatment Demonstration Program under the Public Health Service Act, providing 

for grants to 25 eligible entities to develop and establish mechanisms to improve prevention and treatment in populations with a 

high density of sickle cell disease patients. 

Section 5. Collaboration with community-based entities 

Section 5 requires eligible grantees to have a collaborative agreement with a community-based organization with at least five years 

of experience in providing services to sickle cell disease patients. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (new matter is printed in italic 

and existing law in which no change is proposed is shown in 

roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

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PART P—ADDITIONAL PROGRAMS 

* * * * * * * 

SEC. 399V–7. NATIONAL SICKLE CELL DISEASE RESEARCH, SURVEILLANCE, PREVENTION, AND TREATMENT PROGRAM. 

(a) RESEARCH.—The Secretary may conduct or support research to 

expand the understanding of the cause of, and to find a cure for, 

sickle cell disease. 

(b) SURVEILLANCE.— 

(1) GRANTS.—The Secretary may, for each fiscal year for 

which appropriations are available to carry out this subsection, 

make grants to not more than 20 States— 

(A) to conduct surveillance and maintain data on the 

prevalence and distribution of sickle cell disease and its associated health outcomes, complications, and treatments; 

(B) to conduct public health initiatives with respect to 

sickle cell disease, including— 

(i) increasing efforts to improve access to, and receipt 

of, high-quality sickle cell disease-related health care, 

including the use of treatments approved under section 

505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; 

(ii) working with partners to improve health outcomes of people with sickle cell disease over the lifespan by promoting guidelines for sickle cell disease 

screening, prevention, and treatment, including management of sickle cell disease complications; 

(iii) providing support to community-based organizations and State and local health departments in conducting sickle cell disease education and training activities for patients, communities, and health care providers; and 

(iv) supporting and training State health departments and regional laboratories in comprehensive testing to identify specific forms of sickle cell disease in 

people of all ages; and 

(C) to identify and evaluate promising strategies for prevention and treatment of sickle cell disease complications, 

including through— 

(i) improving estimates of the national incidence and 

prevalence of sickle cell disease, including estimates 

about the specific types of sickle cell disease; 

(ii) identifying health disparities related to sickle cell 

disease; 

(iii) assessing the utilization of therapies and strategies to prevent complications related to sickle cell disease; and 

(iv) evaluating the impact of genetic, environmental, 

behavioral, and other risk factors that may affect sickle 

cell disease health outcomes. 

(2) POPULATION INCLUDED.—The Secretary shall, to the extent 

practicable, award grants under this subsection to States across 

the United States so as to include data on the majority of the 

United States population with sickle cell disease. 

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(3) APPLICATION.—To seek a grant under this subsection, a 

State shall submit an application to the Secretary at such time, 

in such manner, and containing such information as the Secretary may require. 

(4) DEFINITIONS.—In this subsection: 

(A) The term ‘‘Secretary’’ means the Secretary of Health 

and Human Services, acting through the Director of the 

National Center on Birth Defects and Developmental Disabilities. 

(B) The term ‘‘State’’ includes the 50 States, the District 

of Columbia, the Commonwealth of Puerto Rico, the United 

States Virgin Islands, the Commonwealth of the Northern 

Mariana Islands, American Samoa, Guam, the Federated 

States of Micronesia, the Republic of the Marshall Islands, 

and the Republic of Palau. 

(c) DEMONSTRATION PROGRAM FOR THE DEVELOPMENT AND ESTABLISHMENT OF SYSTEMIC MECHANISMS FOR THE PREVENTION AND

TREATMENT OF SICKLE CELL DISEASE.— (1) AUTHORITY TO CONDUCT DEMONSTRATION PROGRAM.— 

(A) IN GENERAL.—The Administrator, through the Bureau of Primary Health Care and the Maternal and Child 

Health Bureau, shall conduct a demonstration program by 

making grants to up to 25 eligible entities for each fiscal 

year in which the program is conducted under this section 

for the purpose of developing and establishing systemic 

mechanisms to improve the prevention and treatment of 

sickle cell disease in populations with a high density of 

sickle cell disease patients, including through— 

(i) the coordination of service delivery for individuals 

with sickle cell disease; 

(ii) genetic counseling and testing; 

(iii) bundling of technical services related to the prevention and treatment of sickle cell disease; 

(iv) training of health professionals; and 

(v) identifying and establishing other efforts related 

to the expansion and coordination of education, treatment, and continuity of care programs for individuals 

with sickle cell disease. 

(B) GEOGRAPHIC DIVERSITY.—The Administrator shall, to 

the extent practicable, award grants under this section to 

eligible entities located in different regions of the United 

States. 

(2) ADDITIONAL REQUIREMENTS.—An eligible entity awarded 

a grant under this subsection shall use funds made available 

under the grant to carry out, in addition to the activities described in paragraph (1)(A), the following activities: 

(A) To facilitate and coordinate the delivery of education, 

treatment, and continuity of care for individuals with sickle 

cell disease under— 

(i) the entity’s collaborative agreement with a community-based sickle cell disease organization or a nonprofit entity that works with individuals who have 

sickle cell disease; 

(ii) the sickle cell disease newborn screening program 

for the State in which the entity is located; and 

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(iii) the maternal and child health program under 

title V of the Social Security Act (42 U.S.C. 701 et seq.) 

for the State in which the entity is located. 

(B) To train nursing and other health staff who provide 

care for individuals with sickle cell disease. 

(C) To enter into a partnership with adult or pediatric 

hematologists in the region and other regional experts in 

sickle cell disease at tertiary and academic health centers 

and State and county health offices. 

(D) To identify and secure resources for ensuring reimbursement under the medicaid program, State children’s 

health insurance program, and other health programs for 

the prevention and treatment of sickle cell disease. 

(E) To expand, coordinate, and implement transition 

services for adolescents with sickle cell disease making the 

transition to adult health care. 

(3) NATIONAL COORDINATING CENTER. 

(A) ESTABLISHMENT. The Administrator shall enter into 

a contract with an entity to serve as the National Coordinating Center for the demonstration program conducted 

under this subsection. 

(B) ACTIVITIES DESCRIBED. The National Coordinating 

Center shall— 

(i) collect, coordinate, monitor, and distribute data, 

best practices, and findings regarding the activities 

funded under grants made to eligible entities under the 

demonstration program; 

(ii) develop a model protocol for eligible entities with 

respect to the prevention and treatment of sickle cell 

disease; 

(iii) develop educational materials regarding the prevention and treatment of sickle cell disease; and 

(iv) prepare and submit to Congress a final report 

that includes recommendations regarding the effectiveness of the demonstration program conducted under 

this subsection and such direct outcome measures as— 

(I) the number and type of health care resources 

utilized (such as emergency room visits, hospital 

visits, length of stay, and physician visits for individuals with sickle cell disease); and 

(II) the number of individuals that were tested 

and subsequently received genetic counseling for 

the sickle cell trait. 

(4) APPLICATION. An eligible entity desiring a grant under 

this subsection shall submit an application to the Administrator at such time, in such manner, and containing such information as the Administrator may require. 

(5) DEFINITIONS. In this subsection: 

(A) ADMINISTRATOR. The term ‘‘Administrator’’ means the 

Administrator of the Health Resources and Services Administration. 

(B) ELIGIBLE ENTITY. The term ‘‘eligible entity’’ means a 

Federally-qualified health center, a nonprofit hospital or 

clinic, or a university health center that provides primary 

health care, that— 

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(i) has a collaborative agreement with a communitybased sickle cell disease organization or a nonprofit entity with experience in working with individuals who 

have sickle cell disease; and 

(ii) demonstrates to the Administrator that either the 

Federally-qualified health center, the nonprofit hospital 

or clinic, the university health center, the organization 

or entity described in clause (i), or the experts described 

in paragraph (2)(C), has at least 5 years of experience 

in working with individuals who have sickle cell disease. 

(C) FEDERALLY-QUALIFIED HEALTH CENTER. The term 

‘‘Federally-qualified health center’’ has the meaning given 

that term in section 1905(l)(2)(B) of the Social Security Act 

(42 U.S.C. 1396d(l)(2)(B)). 

(6) AUTHORIZATION OF APPROPRIATIONS. There is authorized 

to be appropriated to carry out this subsection, $4,455,000 for 

each of fiscal years 2018 through 2022. 

(d) COLLABORATION WITH COMMUNITY-BASED ENTITIES.—To be 

eligible to receive a grant or other assistance under subsection (b) 

or (c), an entity must have in effect a collaborative agreement with 

a community-based organization with 5 or more years of experience 

in providing services to sickle cell disease patients. 

* * * * * * * 

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