ALSA Registry Comment

Capital Office

601 Pennsylvania Avenue, N.W.
Suite 900, South Bldg.
Washington, DC 20004

Telephone 202/638-6997
Fax 202/638-6316

July 27, 2009
Via Electronic Mail: [email protected]
Maryam I. Daneshvar
Acting Reports Clearance Officer
Centers for Disease Control and Prevention
1600 Clifton Road
MS–D74
Atlanta, GA 30333
RE: Proposed Data Collections Submitted for Public Comment and
Recommendations [60Day–0923–09BR]
Dear Ms. Daneshvar:
The ALS Association is the only non-profit organization fighting Amyotrophic Lateral
Sclerosis (ALS) or Lou Gehrig’s Disease on every front. By supporting global research,
providing assistance for people with ALS through a nationwide network of chapters,
coordinating multidisciplinary care through certified clinical care centers, and fostering
government partnerships, The Association enhances quality of life while aggressively
searching for new treatments and a cure.
The Association also led the advocacy effort behind the enactment of the ALS Registry Act
(P.L. 110-373), which amended the Public Health Service Act to provide for the
establishment of an ALS Registry at the Centers for Disease Control and Prevention
(CDC). Accordingly, we are pleased to submit the following comments regarding the
Proposed Data Collections Submitted for Public Comment and Recommendations [60Day–0923–09BR]
Federal Register Notice for your consideration.
The Association agrees that the proposed collection of information through a combination
of existing sources of information and a public web site is essential and appropriate to fulfill
the intent of the ALS Registry Act. In particular, we believe that self-identification of ALS
patients through the web site mechanism will be important to capture individuals who are
not otherwise included in the registry data base through other data acquisition strategies. A
robust web portal can be a valuable part of obtaining accurate estimates of ALS, as well as
other benefits of the registry.
In addition, it will be critical to design both the web portal and the entire ALS patient
identification system in a way that optimizes accurate ALS patient identification while
preventing duplication of information or other errors. The ALS Association further agrees
with the agency's proposal to use the web-based registration to enable a survey tool. This
will be a dynamic tool for assessing the community around key issues.
Through these strategies, The Association believes that the ALS Registry should:
Member National Health Council

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promote opportunities to participate in clinical trials;

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provide access to research information; and
facilitate a working partnership between patients and researchers.

Moreover, The Association envisions this system, especially the interactive web site, as a
mechanism to help inform providers and researchers about ALS, as well as to promote an
enhanced relationship between patients/caregivers and clinicians. The web site feature
should:
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address patient questions;
guide patients to clinical care;
inform primary and specialty care providers; and
deliver scientifically sound information and resources.

The Association is in a position to assist the CDC and ATSDR in assuring the quality,
utility, and clarity of the patient information collected for the National ALS Registry. We
believe that the Registry web site should affirmatively link patients, their caregivers, and
other stakeholders to The Association's resources also available on the web, in print format,
or through our points of service across the country. The Association also will undertake
efforts to promote and otherwise encourage the ALS community to participate in the
National ALS Registry through the proposed CDC web portal. The Association anticipates
partnering with the CDC to promote the web portal, including through our more than 40
Chapters and affiliates located across the country, ALS Association Certified Centers of
Excellence and ALS clinics, via communications directly to people with ALS and their
families, and via The Association’s website, which receives an average of more than 48,000
visitors per month.
Beyond the elements discussed above, The Association also encourages the agency to
consider the following elements for the Registry web site:
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relevant research study and clinical trial information (e.g., a link to
clinicaltrials.gov);
capability to authorize an email of current studies and/or clinical trials to
registry participants in which they might be eligible to participate;
capability for participants to elect to authorize study teams to contact the
patient or caregiver directly when matched with a study; and
published research findings on environmental, genetic, and other factors in
ALS.

Thank you for the opportunity to provide comment on the proposed data collection
strategies, including the website. The entire ALS Association looks forward to the timely
completion of the National ALS Registry.
Sincerely,

Steve Gibson
Vice President, Government Relations and Public Affairs