[Federal Register: May 20, 2004 (Volume 69, Number 98)]
[Notices]
[Page 29139-29140]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my04-52]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: poppy.kendall@fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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