[Federal Register Volume 69, Number 98 (Thursday, May 20, 2004)]
[Notices]
[Pages 29139-29140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0221]


Medicare Prescription Drug, Improvement, and Modernization Act of 
2003; Study on Making Prescription Pharmaceutical Information 
Accessible for Blind and Visually-Impaired Individuals; Establishment 
of Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is establishing a docket to receive information and comments on certain 
issues related to the accessibility of pharmaceutical information to 
blind and visually-impaired individuals. This action is intended to 
ensure that there is a venue for information and comments to be 
communicated to the agency for consideration in a study on making 
prescription drug information accessible for blind and visually-
impaired individuals, which was mandated by the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Medicare 
Modernization Act).

DATES: The agency encourages interested parties to submit information 
and comments by June 21, 2004.

ADDRESSES: Submit written comments and information to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm.1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Poppy Kendall, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 8, 2003, President Bush signed the Medicare 
Modernization Act (Public Law 108-173). Section 107(f) of this 
legislation requires that the Secretary of Health and Human Services 
undertake a study on how to make prescription pharmaceutical 
information, including drug labels and usage instructions, accessible 
to blind and visually-impaired individuals. The legislation requires 
that the study ``include a review of existing and emerging 
technologies, including assistive technology, that makes essential 
information on the content and prescribed use of pharmaceutical 
medicines available in a usable format for blind and visually-impaired 
individuals.''

II. Request for Comments

    To assist in this effort, we are asking for public comment on the 
following issues:
    A. Information About the Population of Interest:
    1. What is known about the population of people who are blind and 
visually-impaired in the United States (e.g., information on age of 
onset; cause of impairment (e.g., congenital defect versus disease-
related versus injury); extent and type of impairment; association 
between visual impairment and age, hearing loss, comorbidities, health 
outcomes, socioeconomic status, health literacy, and adaptive learning 
capabilities)?
    2. Is there an appropriate way to divide this population into 
subpopulations to better evaluate needs and beneficial technologies?
    B. Information About the Use of Prescription Medication Information 
By People Who Are Blind or Visually-Impaired:
    1. How do people who are blind and visually-impaired currently get 
their prescription drug information?
    2. What aspects of visual impairment are important to addressing 
the issue of access to prescription drug information? What other 
factors (see examples listed in Question A1) might be 
important to addressing this issue?
    3. How can essential drug information be effectively communicated 
to people who are blind or visually impaired?
    4. Are there data associating medication errors with blindness? 
With visual impairment? What types of medication errors are most common 
among people who are blind or visually impaired?
    C. Information About Existing and Emerging Technologies (Including 
Internet-based Information Sources):
    1. What assistive technologies are currently used by people who are 
blind or visually-impaired? In what setting?
    2. What proportion of people who are blind and visually-impaired 
currently use these technologies? Are there specific characteristics 
(see examples listed in Question A1) of this ``user'' 
population that distinguish them from blind and visually-impaired 
individuals who do not use these technologies?
    3. Are there data on the effectiveness of these technologies?
    4. Do these technologies contribute to an increase or decrease in 
medication errors reported amongst people who are blind or visually 
impaired?
    5. What is the cost of these technologies?
    6. Who are the primary purchasers of these technologies? Is use of 
these technologies currently subsidized by any government or private 
program?
    7. What are barriers to use of these assistive technologies?
    8. What is the practicability of these assistive technologies?
    9. How do people who are blind or visually-impaired learn of these 
technologies?
    9a. What are the most effective resources for conveying information 
about these assistive technologies to blind and visually impaired 
individuals.
    10. Are there emerging technologies that show promise? If so, what 
is the

[[Page 29140]]

anticipated cost and timeline for market entry?

III. Submission of Comments

    All comments submitted to the public docket are public information 
and may be posted to FDA's Web site at: http://www.fda.gov for public 
viewing. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Comments received may be 
reviewed in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11365 Filed 5-19-04; 8:45 am]
BILLING CODE 4160-01-S