# Advisory Committee; Notice of Meeting > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A94-18242 ## Record - **Collection:** Federal Register - **Document type:** Uncategorized Document - **Published:** July 27, 1994 ## 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. MEETING: The following advisory committee meeting is announced: Generic Drugs Advisory Committee With Dermatologic Drugs Advisory Committee Representation Date, time, and place. September 12 and 13, 1994, 8:30 a.m., Parklawn Bldg., conference rms. G, H, I, and J, 5600 Fishers Lane, Rockville, MD. Type of meeting and contact person. Open committee discussion, September 12, 1994, 8:30 a.m. to 1 p.m.; 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.; open committee discussion, September 13, 1994, 8:30 a.m. to 1 p.m.; 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 4 p.m.; Kimberly L. Topper, 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 gives advice on scientific and technical issues concerning the safety and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human diseases and makes appropriate recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, the Commissioner of Food and Drugs, and the Director of the Center for Drug Evaluation and Research. The committee may also review agency sponsored intramural and extramural biomedical research programs in support of FDA's generic drugs regulatory responsibilities. 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 September 1, 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. In April 1992, the Generic Drugs Advisory Committee met to consider methods for documenting the bioequivalence of topical corticosteroids. Subsequently, on July 1, 1992, the Office of Generic Drugs issued a guidance document entitled ``Interim Guidance for Topical Corticosteroids: In Vivo Bioequivalence and In Vitro Release Methods.'' The purpose of the September 1994 meeting is to reexamine the 1992 interim guidance in light of new experimental data and methods of analysis. On September 12, 1994, the committee will discuss the pharmacodynamic (i.e., vasoconstrictor) measurement of bioequivalence. On September 13, 1994, this topic will be further discussed along with other issues related to the documentation of equivalence according to the interim guidance. Discussion will be limited to dermatologic products and will not include ophthalmic or inhaled corticosteroid products. Also, on September 13, 1994, there will be a review of the current status of topics discussed at previous Generic Drugs advisory committee meetings. 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: July 21, 1994. Linda A. Suydam, Interim Deputy Commissioner for Operations. [FR Doc. 94-18242 Filed 7-26-94; 8:45 am] BILLING CODE 4160-01-F --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-18242. Public record. Not legal advice.