[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]



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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.

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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