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Notice: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Dermatologic and Ophthalmic Drugs Advisory Committee, 21144 [E8-8351] Food and Drug Administration
Originaltitel
Notice: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Dermatologic and Ophthalmic Drugs Advisory Committee
Notice: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Dermatologic and Ophthalmic Drugs Advisory Committee, 21144 [E8-8351] Food and Drug Administration
Copyright:
Public Domain
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Notice: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Dermatologic and Ophthalmic Drugs Advisory Committee, 21144 [E8-8351] Food and Drug Administration
Copyright:
Public Domain
Verfügbare Formate
Als PDF, TXT herunterladen oder online auf Scribd lesen
II. Comments DEPARTMENT OF HEALTH AND location of the advisory committee
HUMAN SERVICES meeting, and the background material We are interested in receiving will be posted on FDA’s Web site after comments from sponsors, industry, Food and Drug Administration the meeting. Background material is researchers, investigators, and other available at http://www.fda.gov/ohrms/ interested stakeholders on other types of Dermatologic and Ophthalmic Drugs dockets/ac/acmenu.htm, click on the information and documents that Advisory Committee; Notice of Meeting year 2008 and scroll down to the typically need not be accompanied by a AGENCY: Food and Drug Administration, appropriate advisory committee link. certification. A description of the HHS. Procedure: Interested persons may specific type of information or ACTION: Notice. present data, information, or views, document and an explanation of the orally or in writing, on issues pending rationale for why a certification should This notice announces a forthcoming before the committee. Written not be necessary will assist us in meeting of a public advisory committee submissions may be made to the contact evaluating the need for an of the Food and Drug Administration person on or before May 14, 2008. Oral accompanying certification. (FDA). The meeting will be open to the presentations from the public will be Interested persons may submit to the public. scheduled between approximately 11 Division of Dockets Management (see Name of Committee: Dermatologic and Ophthalmic Drugs Advisory a.m. and 12 noon. Those desiring to ADDRESSES) written or electronic make formal oral presentations should comments regarding this document. Committee. General Function of the Committee: notify the contact person and submit a Submit a single copy of electronic brief statement of the general nature of To provide advice and comments or two paper copies of any the evidence or arguments they wish to recommendations to the agency on mailed comments, except that FDA’s regulatory issues. present, the names and addresses of individuals may submit one paper copy. Date and Time: The meeting will be proposed participants, and an Comments are to be identified with the held on May 29, 2008, from 8 a.m. to 1 indication of the approximate time docket number found in brackets in the p.m. requested to make their presentation on heading of this document. Received Location: Food and Drug or before May 6, 2008. Time allotted for comments may be seen in the Division Administration, Center for Drug each presentation may be limited. If the of Dockets Management between 9 a.m. Evaluation and Research Advisory number of registrants requesting to and 4 p.m., Monday through Friday. Committee Conference Room, Rm. 1066, speak is greater than can be reasonably Please note that on January 15, 2008, 5630 Fishers Lane, Rockville, MD. accommodated during the scheduled the FDA Division of Dockets Contact Person: Yvette Waples, Center open public hearing session, FDA may Management Web site transitioned to for Drug Evaluation and Research (HFD– conduct a lottery to determine the the Federal Dockets Management 21), Food and Drug Administration, speakers for the scheduled open public System (FDMS). FDMS is a 5600 Fishers Lane (for express delivery, hearing session. The contact person will Government-wide, electronic docket 5630 Fishers Lane, Rm. 1093) Rockville, notify interested persons regarding their management system. Electronic MD 20857, 301–827–7001, FAX: 301– request to speak by May 7, 2008. comments or submissions will be 827–6776, e-mail: Persons attending FDA’s advisory Yvette.Waples@fda.hhs.gov, or FDA accepted by FDA through FDMS only. committee meetings are advised that the Advisory Committee Information Line, agency is not responsible for providing III. Paperwork Reduction Act of 1995 1–800–741–8138 (301–443–0572 in the access to electrical outlets. Washington, DC area), code This draft guidance refers to 3014512534. Please call the Information FDA welcomes the attendance of the previously approved collections of Line for up-to-date information on this public at its advisory committee information found in FDA regulations. meeting. A notice in the Federal meetings and will make every effort to These collections of information are Register about last minute modifications accommodate persons with physical subject to review by the Office of that impact a previously announced disabilities or special needs. If you Management and Budget (OMB) under advisory committee meeting cannot require special accommodations due to the Paperwork Reduction Act of 1995 always be published quickly enough to a disability, please contact Yvette (44 U.S.C. 3501–3520). The collections provide timely notice. Therefore, you Waples at least 7 days in advance of the of information have been approved should always check the agency’s Web meeting. under OMB control no. 0910–0616. site and call the appropriate advisory FDA is committed to the orderly committee hot line/phone line to learn IV. Electronic Access conduct of its advisory committee about possible modifications before meetings. Please visit our Web site at Persons with access to the Internet coming to the meeting. http://www.fda.gov/oc/advisory/ Agenda: The committee will discuss may obtain the draft guidance document default.htm for procedures on public new drug application (NDA) 22–212, at either http://www.fda.gov/oc/ conduct during advisory committee difluprednate ophthalmic emulsion, initiatives/advance/fdaaa.html or http:// Sirion Therapeutics, Inc., proposed for meetings. www.regulations.gov. the treatment of inflammation and pain Notice of this meeting is given under Dated: April 14, 2008. following ocular surgery. the Federal Advisory Committee Act (5 Jeffrey Shuren, FDA intends to make background U.S.C. app. 2). material available to the public no later pwalker on PROD1PC71 with NOTICES
Associate Commissioner for Policy and Dated: April 10, 2008.
Planning. than 2 business days before the meeting. Randall W. Lutter, [FR Doc. E8–8349 Filed 4–17–08; 8:45 am] If FDA is unable to post the background material on its Web site prior to the Deputy Commissioner for Policy. BILLING CODE 4160–01–S [FR Doc. E8–8351 Filed 4–17–08; 8:45 am] meeting, the background material will be made publicly available at the BILLING CODE 4160–01–S