[Federal Register Volume 60, Number 236 (Friday, December 8, 1995)]
[Notices]
[Pages 63049-63050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29903]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-371W]


Prescription Drug Product Labeling; Public Patient Education 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of a public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
patient education workshop to discuss methods and criteria for 
developing and evaluating prescription drug information for patients. 
The purpose of this workshop is to obtain views and opinions concerning 
the criteria for useful patient information, and is part of FDA's 
ongoing initiative to improve the distribution of adequate and useful 
prescription drug information to patients. FDA encourages health 
professionals, consumer groups, industry, academicians, other experts 
in the field, and interested parties to participate in the workshop. 
FDA also invites the designers of primary information systems, which 
produce either written information or computer programs that generate 
prescription drug patient information, to display their systems for 
educational purposes.

DATES: The public patient education workshop will be held on January 9 
and 10, 1996, from 8:30 a.m. to 5 p.m. Submit registration notices for 
participants by December 26, 1995. Submit registration notices for 
designers of information systems by December 19, 1995. Submit written 
comments by January 31, 1996.

ADDRESSES: The public patient education workshop will be held at the 
National Institutes of Health, Natcher Auditorium, 9000 Rockville Pike, 
Rockville, MD. Pre-registration for workshop participants is 
encouraged, although not required, in order to facilitate logistical 
planning of the 

[[Page 63050]]
breakout discussion groups. There is no registration fee for this 
workshop. Registration forms can be obtained by calling 301-443-5470 or 
writing to the Office of Health Affairs, ATTN: Patient Education 
Workshop, Food and Drug Administration (HFY-40), 5600 Fishers Lane, 
Rockville, MD 20857. Submit written views or comments to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The designers of 
information systems should call the contact person (address below) for 
registration information. A more detailed agenda and written 
presentations will be placed in the docket, identified with the docket 
number found in brackets in the heading of this document, at the 
Dockets Management Branch, and will be available for review between 9 
a.m. and 4 p.m., Monday through Friday. A transcript of the general 
sessions of the workshop will be available for review or purchase (10 
cents per page) at the Dockets Management Branch approximately 5 
business days after the meeting. The breakout sessions will not be 
transcribed.

FOR FURTHER INFORMATION CONTACT: Thomas J. McGinnis, Office of Health 
Affairs (HFY-40), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5470.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 1995 
(60 FR 44182), FDA published a proposed rule which, if finalized, is 
intended to increase the dissemination of useful written prescription 
drug information to patients who receive prescription drugs on an 
outpatient basis. The agency believes that such information must be 
widely distributed and be of sufficient quality to promote the proper 
use of prescription drugs. The agency proposed goals (performance 
standards) that would define acceptable levels of information 
distribution and quality. To meet the performance standard for 
distribution of patient information, the agency proposed that by the 
year 2000, at least 75 percent of people receiving new prescriptions 
receive useful written information. This goal was adapted from the 
Public Health Service's ``Healthy People 2000'' report. In addition, 
the agency proposed that by the year 2006, at least 95 percent of the 
people who receive new prescriptions receive useful written 
information.
    FDA proposed to periodically evaluate and report on the achievement 
of the goals. If the goals are not met in the specified timeframes, FDA 
proposed to either: (1) Implement a mandatory comprehensive medication 
guide program, or (2) seek public comment on whether the comprehensive 
program should be implemented, or whether, and what, other steps should 
be taken to meet the patient information goals.
    In the Federal Register of August 24, 1995, the agency proposed the 
following seven specific components for determining whether patient 
information is useful: Scientific accuracy, consistency with a standard 
format, nonpromotional tone and content, specificity, 
comprehensiveness, understandable language, and legibility. The agency 
defined these components of usefulness, as well as criteria that could 
be used to judge these components, and invited comments on their 
appropriateness. The agency also stated that it would hold a public 
meeting for interested parties to provide recommendations and rationale 
for evaluating usefulness of written information.
    The agency will hold a public patient education workshop to discuss 
the methods and criteria for developing and evaluating the usefulness 
of written information. The patient education workshop will be designed 
to obtain recommendations from the public about the criteria that 
should be applied to help ensure that written information provided to 
patients is ``useful.''
    The patient education workshop will be comprised of both formal 
presentations and open breakout discussion periods. Any interested 
person may attend and participate in the discussions. The workshop will 
include general sessions with presentations from FDA, health 
professional groups, consumer groups, the pharmaceutical industry, 
academicians, and parties with legal and regulatory expertise. The 
agency also intends to hold breakout sessions throughout the 2-day 
workshop to obtain broad participation and input from workshop 
attendees.
    FDA believes that it would be helpful for workshop participants 
(including FDA staff) to learn about the design of current patient 
information systems, in particular, programs that generate drug-
specific patient information. The agency invites the designers of 
primary information systems (not the customizers of systems for retail 
outlets) to display their systems at the workshop for educational 
purposes only. No sales or solicitations may be made by exhibitors at 
the workshop site. Due to space limitations, FDA may be forced to limit 
the number of systems on display. In doing so, FDA would seek to permit 
display of the most representative/comprehensive systems available for 
patient information. However, the agency invites all interested persons 
to submit their views, comments, and descriptions of computer programs 
to the Dockets Management Branch (address above).
    The agency notes that the comment period for the proposed rule that 
published in the Federal Register of August 24, 1995, has recently been 
extended until December 22, 1995 (60 FR 58025, November 24, 1995). 
Because this workshop will occur after the comment period has closed, 
the agency will accept additional comments to the proposed rule on the 
specific issues raised at the workshop. These comments will be 
considered as part of the agency's deliberations regarding further 
action on this rulemaking. For this limited purpose, written comments 
may be submitted to the Dockets Management Branch (address above) until 
January 31, 1996. Comments are to be identified with the docket number 
found in brackets in the heading of this document.
    A summary of the workshop will be included in a subsequent Federal 
Register notice related to this prescription drug labeling initiative.

    Dated: December 1, 1995.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 95-29903 Filed 12-7-95; 8:45 am]
BILLING CODE 4160-01-F