Department of Health and Human Services September 13, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public hearing on direct-to-consumer (DTC) promotion of regulated medical products, including prescription drugs for humans and animals, vaccines, blood products, and medical devices. FDA is particularly interested in hearing the views of individuals and groups most affected by DTC promotion, including consumers, patients, caregivers, health professionals (physicians, physicians' assistants, dentists, nurses, pharmacists, veterinarians, and veterinarian technicians) managed care organizations, and insurers, as well as the regulated industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants in the hearing would like to share. Dates and Times: The public hearing will be held on November 1 and 2, 2005, from 9 a.m. to 5 p.m. Submit written or electronic notices of participation by close of business on October 11, 2005. Written and electronic comments will be accepted until February 28, 2006. Location: The public hearing will be held at the National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594, 202-314-6421; Metro: L'Enfant Plaza station on the green, yellow, blue, and orange lines; see: https://ntsb.gov/events/newlocation.htm. (FDA has verified the Web site address, but FDA is not responsible for any changes to the Web site after this document publishes in the Federal Register.) Addresses: Written or electronic notices of participation should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or on the Internet at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Comments about the meeting or comments after the meeting should be submitted to https://www.fda.gov/dockets/ ecomments. Written or electronic comments can be submitted to https:// www.fda.gov/oc/dockets/ecomments. A consolidated list of all documents and other information related to the public hearing, such as the Federal Register notice, the agenda, public comments, and transcripts will be posted with their links, as the documents are made available, on the Center for Drug Evaluation and Research (CDER) Web site at https://www.fda.gov/cder/ddmac. For further information contact: Rose Cunningham, Center for Drug Evaluation and Research (HFD-006), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852, 301-443-5595, e-mail: cunninghmar@cder.fda.gov. For registration to attend and/or to participate in the meeting: Seating at the hearing is limited. People interested in attending the meeting should register at https://www.accessdata.fda.gov/scripts/oc/ dockets/meetings/meetingdocket.cfm. Registration is free and will be accepted on a first-come, first-served basis. The procedures governing the hearing are found in part 15 (21 CFR part 15). Anyone wishing to make an oral presentation during the hearing must state this intention on the registration form (see Addresses). To participate, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. A written statement also should be submitted at the time of registration for each discussion question to be addressed, with the names and addresses of all individuals who plan to participate, and the approximate time requested for the presentation. The agency requests that interested persons and groups having similar interests consolidate their comments and present them through a single representative. Individuals who have registered to make an oral presentation will be notified of the scheduled time for their presentation prior to the hearing. Depending on the number of presentations, FDA may need to limit the time allotted for each presentation. FDA has identified questions and subject matter of special interest in section III of this document, but presentations do not have to be limited to those questions. Presenters should submit to the agency two copies of each presentation given. All participants are encouraged to attend the entire 2-day meeting. If special accommodations are needed because of a disability, the registration contact person should be informed at the time of registration.