# Advisory Committee; Notice of Meeting > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A96-470 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** January 17, 1996 - **Citation:** 61 FR 1192 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). This notice also summarizes the procedures for the meeting and methods by which interested persons may participate in open public hearings before FDA's advisory committees. FDA has established an Advisory Committee Information Hotline (the hotline) using a voice-mail telephone system. The hotline provides the public with access to the most current information on FDA advisory committee meetings. The advisory committee hotline, which will disseminate current information and information updates, can be accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory committee is assigned a 5-digit number. This 5-digit number will appear in each individual notice of meeting. The hotline will enable the public to obtain information about a particular advisory committee by using the committee's 5-digit number. Information in the hotline is preliminary and may change before a meeting is actually held. The hotline will be updated when such changes are made. MEETING: The following advisory committee meeting is announced: Circulatory System Devices Panel of the Medical Devices Advisory Committee Date, time and place. January 29, 1996, 8:30 a.m., rm. 020B, 9200 Corporate Blvd, Rockville, MD. Attendees with a disability requiring special accommodations should contact Ed Rugenstein, Sociometrics, Inc., 301-608-2151. Type of meeting and contact person. Open public hearing, January 29, 1996, 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 1:30 p.m.; Ramiah Subramanian Center for Devices and Radiological Health (HFZ- 450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320, or FDA Advisory Committee Information Hotline, 1- 800-741-8138 (301-443-0572 in the Washington, D.C. area), Circulatory System Devices Panel, code 12625. General function of the committee. The committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. Agenda--Open public hearing. Interested persons may present data, [[Page 1193]] 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 24, 1996, 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. On January 29, 1996, the committee will discuss clinical data requirements (experimental designs, protocols, quality assurance, etc.) to be incorporated in a draft guidance for Automatic Implantable Pacer Cardioverter Defibrillator (AIPCD) submissions. Single copies of the draft guidance document will be available from the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 800-638-2041 or 301-443-6597. FDA regrets that it was unable to publish this notice 15 days prior to the January 29, 1996, Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting. Because the agency feels that the issue needs to be brought to public discussion urgently and qualified members of the Advisory Panel were available at this time, the agency decided that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice. 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 5, 1996. Michael A. Friedman, Deputy Commissioner for Operations. [FR Doc. 96-470 Filed 1-11-96; 4:33 pm] BILLING CODE 4160-01-F88 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-470. Public record. Not legal advice.