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> Dr. Mark McClellan, Administrator
>
> Centers for Medicare and Medicaid Services
>
> Care of Dockets Management Branch (HFA-305)
>
> Food and Drug Administration
>
> 5630 Fishers Lane
>
> Room 1061
>
> Rockville, MD 20852 November 14, 2023
>
> Re: Docket ID 2004S-0170, Medicare Prescription Drug, Improvement and
> Modernization Act of 2003, Section 1003 -- Initial Priority List
>
> Dear Administrator McClellan:
>
> The Alzheimer\'s Association appreciates the opportunity to respond to
> the Request for Comments for the initial priority research list
> pursuant to Section 1003 of the Medicare Prescription Drug,
> Improvement and Modernization Act of 2003. The Alzheimer\'s
> Association is the premier source of information and support for the
> 4.5 million Americans with Alzheimer\'s disease. Through its national
> network of chapters, it offers a broad range of programs and services
> for people with the disease, their families, and caregivers and
> represents their interests on Alzheimer-related issues before federal,
> state, and local government and with health and long term care
> providers. The largest private funder of Alzheimer research, the
> Association has committed more than \$150 million toward research into
> the causes, treatment, prevention, and cure of Alzheimer\'s disease.

##### Medicare and Alzheimer's disease

> Most people diagnosed with Alzheimer's and related dementias are
> Medicare beneficiaries. Medicare expenditures for people with
> Alzheimer's disease are nearly three times higher than the average for
> all beneficiaries. In 2000, Medicare alone spent \$31.9 billion for
> the care of individuals with Alzheimer's disease; this amount is
> projected to increase to \$49.3 billion in 2010.

##### Recommendations

> The Alzheimer's Association respectfully submits a recommendation for
> the priority setting process. According to the Request for Comments,
> the recommendations for research will be reviewed and prioritized by a
> steering committee composed of representatives from various
>
> components of the United States Department of Health and Human
> Services. Absent from the
>
> Dr. Mark McClellan
>
> May 7, 2004
>
> Page 2
>
> list of representatives is the National Institute on Aging (NIA). The
> NIA conducts
>
> and supports research about health issues for older people, and is the
> primary federal agency for Alzheimer\'s disease research. NIA's
> mission is to improve the health and well being of older Americans
> through research, and NIA representatives have the knowledge and
> expertise to make valuable contributions to the work of this important
> steering committee. Therefore, we recommend that the NIA be included
> in the steering committee to review the recommendations for research
> pursuant to Section 1013 of the Medicare Prescription Drug,
> Improvement, and Modernization Act of 2003.
>
> The Alzheimer's Association will not submit specific research
> recommendations within the limited scope of the initial priority list
> identified in the Request for Comments. We will submit recommendations
> for the FY 2006 priority list. Thank you for the opportunity to submit
> our research recommendations in the near future.
>
> Sincerely,
>
> Bonnie Hogue William Thies, Ph.D.
>
> Director of Federal Policy Vice President, Medical-Scientific Affairs