[Federal Register Volume 59, Number 18 (Thursday, January 27, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-1702] [[Page Unknown]] [Federal Register: January 27, 1994] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Notice of Meetings AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces forthcoming meetings of public advisory committees of the Food and Drug Administration (FDA). This notice also summarizes the procedures for the meetings and methods by which interested persons may participate in open public hearings before FDA's advisory committees. MEETINGS: The following advisory committee meetings are announced: Dermatologic Drugs Advisory Committee Date, time, and place. February 16, 1994, 8 a.m., conference rms. G through J, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD. Type of meeting and contact person. Open public hearing, 8 a.m. to 9 a.m., unless public participation does not last that long; open committee discussion, 9 a.m. to 12 m.; Ermona B. McGoodwin or Valerie M. Mealy, Center for Drug Evaluation and Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443- 5455. General function of the committee. The committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the treatment of dermatologic diseases. Agenda--Open public hearing. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Those desiring to make formal presentations should notify the contact person before February 11, 1994, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments. Open committee discussion. The committee will discuss new drug application NDA 19-821, Soriatane(acitretin), Roche Dermatologics, for treatment of psoriasis. Joint Meeting of the Dermatologic Drugs and Nonprescription Drugs Advisory Committees Date, time, and place. February 16, 1994, 1 p.m., conference rms. G through J, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD. Type of meeting and contact person. Open public hearing, 1 p.m. to 2 p.m., unless public participation does not last that long; open committee discussion, 2 p.m. to 5 p.m.; Ermona B. McGoodwin or Lee L. Zwanziger, Center for Drug Evaluation and Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443- 5455. General function of the committees. The Dermatologic Drugs Advisory Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the treatment of dermatologic diseases. The Nonprescription Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases. Agenda--Open public hearing. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. Those desiring to make formal presentations should notify the contact person before February 11, 1994, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments. Open committee discussion. The committees will discuss new drug application NDA 20-310, ketoconazole 1% shampoo, Johnson and Johnson Consumer Products, for treatment of dandruff. National Mammography Quality Assurance Advisory Committee Date, time, and place. February 17 and 18, 1994, 8:30 a.m., Ballroom, Holiday Inn Metro Center, 775 12th St. NW., Washington, DC. Type of meeting and contact person. Open public hearing, February 17, 1994, 8:30 a.m. to 9:30 a.m., unless public participation does not last that long; open committee discussion, 9:30 a.m. to 5 p.m.; open committee discussion, February 18, 1994, 8:30 a.m. to 5 p.m.; Charles K. Showalter, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1901 Chapman Ave., Rockville, MD 20857, 301-594-3311. General function of the committee. The committee advises on developing appropriate quality standards and regulations for mammography facilities. Agenda--Open public hearing. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Those desiring to make formal presentations should notify the contact person before January 31, 1994, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments. Open committee discussion. The committee will: (1) Discuss the interim final standards for accreditation bodies and for facilities, (2) receive status reports from FDA on activities related to implementation of the Mammography Quality Standards Act of 1992 (Pub. L. 102-539), and (3) discuss priorities for future standards. Board of Tea Experts Date, time, and place. February 24 and 25, 1994, 10 a.m., New York Regional Laboratory, rm. 700, 850 Third Ave., Brooklyn, NY. Type of meeting and contact person. Open public hearing, February 24, 1994, 10 a.m. to 11 a.m., unless public participation does not last that long; open committee discussion, 11 a.m. to 4:30 p.m.; open committee discussion, February 25, 1994, 10 a.m. to 4:30 p.m.; Robert H. Dick, New York Regional Laboratory, Food and Drug Administration, 850 Third Ave., Brooklyn, NY 11232, 718-965-5730. General function of the committee. The committee advises on establishment of uniform standards of purity, quality, and fitness for consumption of all tea imported into the United States under 21 U.S.C. 42. Agenda--Open public hearing. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Open committee discussion. The committee will discuss and select tea standards. FDA public advisory committee meetings may have as many as four separable portions: (1) An open public hearing, (2) an open committee discussion, (3) a closed presentation of data, and (4) a closed committee deliberation. Every advisory committee meeting shall have an open public hearing portion. Whether or not it also includes any of the other three portions will depend upon the specific meeting involved. There are no closed portions for the meetings announced in this notice. The dates and times reserved for the open portions of each committee meeting are listed above. The open public hearing portion of each meeting shall be at least 1 hour long unless public participation does not last that long. It is emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period the committee chairperson determines will facilitate the committee's work. Public hearings are subject to FDA's guideline (subpart C of 21 CFR part 10) concerning the policy and procedures for electronic media coverage of FDA's public administrative proceedings, including hearings before public advisory committees under 21 CFR part 14. Under 21 CFR 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. Meetings of advisory committees shall be conducted, insofar as is practical, in accordance with the agenda published in this Federal Register notice. Changes in the agenda will be announced at the beginning of the open portion of a meeting. Any interested person who wishes to be assured of the right to make an oral presentation at the open public hearing portion of a meeting shall inform the contact person listed above, either orally or in writing, prior to the meeting. Any person attending the hearing who does not in advance of the meeting request an opportunity to speak will be allowed to make an oral presentation at the hearing's conclusion, if time permits, at the chairperson's discretion. The agenda, the questions to be addressed by the committee, and a current list of committee members will be available at the meeting location on the day of the meeting. Transcripts of the open portion of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, approximately 15 working days after the meeting, at a cost of 10 cents per page. The transcript may be viewed at the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, approximately 15 working days after the meeting, between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary minutes of the open portion of the meeting may be requested in writing from the Freedom of Information Office (address above) beginning approximately 90 days after the meeting. This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: January 21, 1994. Jane E. Henney, Deputy Commissioner for Operations. [FR Doc. 94-1702 Filed 1-26-94; 8:45 am] BILLING CODE 4160-01-F