[Federal Register Volume 61, Number 84 (Tuesday, April 30, 1996)] [Notices] [Page 19077] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-10781] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 81N-033P] Background Document for the Dental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs) of the Medical Devices Advisory Committee; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a background document for the meeting of the Dental Drug Products Panel Plaque Subcommittee of the Medical Devices Advisory Committee (the subcommittee). This meeting is announced elsewhere in this issue of the Federal Register, and it is scheduled for June 6 and 7, 1996. This background document is being taken to ensure that all interested parties are aware of the subcommittee's concern regarding the relationship, if any, of alcohol-containing mouthwashes and oral cancer and the development of studies to investigate the relationship. This relationship will be the subject of the subcommittee's discussion on June 6, 1996. DATES: Written comments or data should be submitted by May 10, 1996, in order to be considered for discussion at the June 6, 1996, subcommittee meeting. ADDRESSES: Single copies of the background briefing document may be requested in writing from the Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, at a cost of 10 cents per page. Requests should be identified with the docket number found in brackets in the heading of this document. The background briefing document is available for public examination at the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. Comments and data should be identified with the docket number listed above. Individuals or groups wishing to submit data or comments relevant to alcohol-containing mouthwashes should send them to the Dockets Management Branch (HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Three copies of written comments should be submitted, except that individuals may submit one copy. The comments and data received are available for public examination at the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Jeanne L. Rippere or Stephanie Mason, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 1600 Rockville Pike, Rockville, MD 20857, 301-827-2244. SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal Register, FDA announced that a meeting of the Dental Drug Products Panel Plaque Subcommittee will be held on June 6 and 7, 1996. The purpose of the meeting scheduled for June 6, 1996, is to continue the subcommittee's discussion concerning the alcohol content of oral health care mouthwash drug products begun at its meeting of June 28 and 29, 1994. After evaluating the available data, the subcommittee concluded that it should meet in a workshop environment with representatives of the National Cancer Institute, the National Institute of Dental Research, other professional groups, the agency, and industry to address any new information regarding a causal relationship between alcohol-containing mouthwashes and oral cancer. The subcommittee recommended that this workshop should address the development of sound scientific studies to determine the relationship, if any, between alcohol-containing mouthwash products and cancer of the oral cavity. FDA has established a docket number (81N-033P) as a public record of the comments, views, and other information submitted to the agency from interested persons and organizations regarding alcohol in oral health care mouthwash drug products. After publication of the subcommittee's report, this docket will be the repository of all data and information collected by the agency for the over-the-counter (OTC) antiplaque/antigingivitis drug review, but currently it will contain only those comments and data that are not confidential under the OTC drug review. (See the request for data and information on dental and oral health care drug products for antiplaque use published in the Federal Register of September 19, 1990 (55 FR 38560 at 38562).) Copies of the background briefing documents have been placed in this docket and may be seen in the Dockets Management Branch (address above) or obtained from the agency's Freedom of Information Staff (address above). Copies of the background briefing document will also be available at the committee meeting. Dated: April 23, 1996. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 96-10781 Filed 4-26-96; 2:36 pm] BILLING CODE 4160-01-F