Published in the Federal Register December 18, 2012.
AGENCY: Architectural and Transportation Barriers Compliance Board.
ACTION: Notice of meeting.
SUMMARY: The Food and Drug Administration Safety and Innovation Act authorizes the Access Board to convene a stakeholder working group to develop best practices for making information on prescription drug container labels accessible to people who are blind or visually impaired. The working group will hold its first meeting on January 10 and 11, 2013.
DATES: The Working Group will meet on January 10, 2013, from 9:30 a.m. to 5:00 p.m. and on January 11, 2013, from 9:00 a.m. to 1:00 p.m.
ADDRESSES: The meeting will be held at the Access Board’s Conference Room, 1331 F Street, NW., suite 800, Washington, DC 20004-1111.
FOR FURTHER INFORMATION CONTACT: Susan Crawford, Architectural and Transportation Barriers Compliance Board, 1331 F Street, NW., suite 1000, Washington, DC 20004-1111. Telephone number (202) 272-0029. Electronic mail address: firstname.lastname@example.org.
On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144, 126 Stat. 993). Section 904 of the Act authorizes the Access Board to convene a stakeholder working group to develop best practices for making information on prescription drug container labels accessible to people who are blind or visually impaired. See 29 U.S.C. 792 note. The Act exempts the working group from the Federal Advisory Committee Act. The Board has formed an 18-member working group with equal representation from national organizations representing blind and visually-impaired individuals, the elderly, and industry groups representing retail, mail order, and independent community pharmacies to develop best practices for pharmacies on providing independent access to prescription drug container labels. The working group will explore various alternatives, including braille, large print labels, and various auditory technologies such as "talking bottles" and radio frequency identification tags. The group’s recommendations, which are to be developed within one year, will be advisory only, not mandatory, and will not have the force of guidelines or standards.
The law also calls upon the National Council on Disability to conduct an informational and educational campaign in cooperation with the stakeholder working group to inform the public, including people with disabilities and pharmacists, of the best practices. The Government Accountability Office will undertake a review at a later date to assess the extent to which pharmacies are following the best practices and to what extent barriers to information on prescription drug container labels remain.
The working group will hold its first meeting on January 10 and 11, 2013. The agenda for the meeting includes initial remarks, introduction of working group members, discussion of administrative issues, discussion of prescription label access needs of consumer members, discussion of current practices, discussion and review of evaluation criteria to use to determine best practices, hands-on demonstrations of recommended practices, evaluation of recommended practices, and discussion of next steps. The preliminary meeting agenda, along with information about the working group, is available at http://www.access-board.gov/news/drug-labels-working-group.htm.
Working group meetings are open to the public and interested persons can attend the meetings and communicate their views. Members of the public will have opportunities to address the working group on issues of interest to them during public comment periods scheduled on each day of the meeting.
The meetings will be accessible to persons with disabilities. An assistive listening system, computer assisted real-time transcription (CART), and sign language interpreters will be provided. Persons attending the meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see www.access-board.gov/about/policies/fragrance.htm for more information). Persons wishing to provide handouts or other written information to the working group are requested to provide electronic formats to Susan Crawford via e-mail prior to the meetings so that alternate formats can be distributed to working group members.
David M. Capozzi,