PRIA, Government Policy, Made Personal

Summary

Within 1 year after getting the Advisory Committee’s report, the Secretary of Health, through the CDC, can set up a system to collect information on amyotrophic lateral sclerosis (ALS) and related motor neuron disorders and create a national registry to store that information. The registry’s goals are to better count new and existing ALS cases in the United States, study possible causes like environmental or job exposures, describe key demographics (age, race or ethnicity, gender, family history), look at how ALS is linked to other similar motor neuron diseases, and address other issues the Advisory Committee recommends. Within 180 days after October 8, 2008, the Secretary can create an Advisory Committee with up to 27 members. Two-thirds of members must be government representatives (including NIH with NINDS and NIEHS, the Department of Veterans Affairs, the Agency for Toxic Substances and Disease Registry, and the CDC) and must include at least one clinician, one epidemiologist, one statistician, one ethicist, and one privacy expert. One-third must be public members, such as national voluntary health associations, patients or family members, clinicians, epidemiologists, geneticists, and others interested in the registry. The Committee can advise on what data to collect, how to collect it, how it can be used, and which related disorders to include. Within 270 days of being formed it can send a report to the Secretary. After that report, the Secretary can award grants or contracts to nonprofit groups to collect and study the data. The Secretary can also use and link existing data sources (for example CDC pilot projects, the VA ALS Registry, the NIH DNA and Cell Line Repository, ATSDR studies in Illinois, Missouri, El Paso and San Antonio, Texas, and Massachusetts, state ALS registries, the National Vital Statistics System, and other relevant databases), provide researcher access as recommended, and share epidemiologic information with NIH and VA, all while following privacy laws. A “national voluntary health association” means a national nonprofit with state chapters that has experience serving people with ALS and in ALS research, care, and patient services.

Title 42, §280g–7

The Public Health and Welfare, Source: USLM XML via OLRC

(a)(1)Not later than 1 year after the receipt of the report described in subsection (b)(2)(A), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may, if scientifically advisable—

(A)develop a system to collect data on amyotrophic lateral sclerosis (referred to in this section as “ALS”) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS, including information with respect to the incidence and prevalence of the disease in the United States; and

(B)establish a national registry for the collection and storage of such data to develop a population-based registry of cases in the United States of ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.

(2)It is the purpose of the registry established under paragraph (1)(B) to—

(A)better describe the incidence and prevalence of ALS in the United States;

(B)examine appropriate factors, such as environmental and occupational, that may be associated with the disease;

(C)better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease;

(D)better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS; and

(E)other matters as recommended by the Advisory Committee established under subsection (b).

(b)(1)Not later than 180 days after October 8, 2008, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a committee to be known as the Advisory Committee on the National ALS Registry (referred to in this section as the “Advisory Committee”). The Advisory Committee shall be composed of not more than 27 members to be appointed by the Secretary, acting through the Centers for Disease Control and Prevention, of which—

(A)two-thirds of such members shall represent governmental agencies—

(i)including at least one member representing—

(I)the National Institutes of Health, to include, upon the recommendation of the Director of the National Institutes of Health, representatives from the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences;

(II)the Department of Veterans Affairs;

(III)the Agency for Toxic Substances and Disease Registry; and

(IV)the Centers for Disease Control and Prevention; and

(ii)of which at least one such member shall be a clinician with expertise on ALS and related diseases, an epidemiologist with experience in data registries, a statistician, an ethicist, and a privacy expert (relating to the privacy regulations under the Health Insurance Portability and Accountability Act of 1996); and

(B)one-third of such members shall be public members, including at least one member representing—

(i)national and voluntary health associations; 11 So in original. Probably should be “national voluntary health associations;”.

(ii)patients with ALS or their family members;

(iii)clinicians with expertise on ALS and related diseases;

(iv)epidemiologists with experience in data registries;

(v)geneticists or experts in genetics who have experience with the genetics of ALS or other neurological diseases 22 So in original. Probably should be followed by a semicolon. and

(vi)other individuals with an interest in developing and maintaining the National ALS Registry.

(2)The Advisory Committee may review information and make recommendations to the Secretary concerning—

(A)the development and maintenance of the National ALS Registry;

(B)the type of information to be collected and stored in the Registry;

(C)the manner in which such data is to be collected;

(D)the use and availability of such data including guidelines for such use; and

(E)the collection of information about diseases and disorders that primarily affect motor neurons that are considered essential to furthering the study and cure of ALS.

(3)Not later than 270 days after the date on which the Advisory Committee is established, the Advisory Committee may submit a report to the Secretary concerning the review conducted under paragraph (2) that contains the recommendations of the Advisory Committee with respect to the results of such review.

(c)The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the collection, analysis, and reporting of data on ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS after receiving the report under subsection (b)(3).

(d)(1)In establishing the National ALS Registry under subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may—

(A)identify, build upon, expand, and coordinate among existing data and surveillance systems, surveys, registries, and other Federal public health and environmental infrastructure wherever possible, which may include—

(i)any registry pilot projects previously supported by the Centers for Disease Control and Prevention;

(ii)the Department of Veterans Affairs ALS Registry;

(iii)the DNA and Cell Line Repository of the National Institute of Neurological Disorders and Stroke Human Genetics Resource Center at the National Institutes of Health;

(iv)Agency for Toxic Substances and Disease Registry studies, including studies conducted in Illinois, Missouri, El Paso and San Antonio, Texas, and Massachusetts;

(v)State-based ALS registries;

(vi)the National Vital Statistics System; and

(vii)any other existing or relevant databases that collect or maintain information on those motor neuron diseases recommended by the Advisory Committee established in subsection (b); and

(B)provide for research access to ALS data as recommended by the Advisory Committee established in subsection (b) to the extent permitted by applicable statutes and regulations and in a manner that protects personal privacy consistent with applicable privacy statutes and regulations.

(C)Consistent with applicable privacy statutes and regulations, the Secretary may ensure that epidemiological and other types of information obtained under subsection (a) is made available to the National Institutes of Health and the Department of Veterans Affairs.

(e)For the purposes of this section, the term “national voluntary health association” means a national non-profit organization with chapters or other affiliated organizations in States throughout the United States with experience serving the population of individuals with ALS and have demonstrated experience in ALS research, care, and patient services.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (b)(1)(A)(ii), is Pub. L. 104–191, Aug. 21, 1996, 110 Stat. 1936. For complete classification of this Act to the Code, see

Short Title

of 1996

Amendments

note set out under section 201 of this title and Tables.

§280g–7 Amyotrophic Lateral Sclerosis Registry