Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting, 21144 [E8-8351]

Download as PDF 21144 Federal Register / Vol. 73, No. 76 / Friday, April 18, 2008 / Notices II. Comments We are interested in receiving comments from sponsors, industry, researchers, investigators, and other interested stakeholders on other types of information and documents that typically need not be accompanied by a certification. A description of the specific type of information or document and an explanation of the rationale for why a certification should not be necessary will assist us in evaluating the need for an accompanying certification. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information have been approved under OMB control no. 0910–0616. IV. Electronic Access pwalker on PROD1PC71 with NOTICES Persons with access to the Internet may obtain the draft guidance document at either https://www.fda.gov/oc/ initiatives/advance/fdaaa.html or https:// www.regulations.gov. Dated: April 14, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–8349 Filed 4–17–08; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 17:38 Apr 17, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 29, 2008, from 8 a.m. to 1 p.m. Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. Contact Person: Yvette Waples, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: Yvette.Waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512534. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug application (NDA) 22–212, difluprednate ophthalmic emulsion, Sirion Therapeutics, Inc., proposed for the treatment of inflammation and pain following ocular surgery. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 14, 2008. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. Those desiring to make formal oral presentations should notify the contact person 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 requested to make their presentation on or before May 6, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 7, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Yvette Waples at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 10, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–8351 Filed 4–17–08; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 73, Number 76 (Friday, April 18, 2008)]
[Notices]
[Page 21144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8351]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Dermatologic and Ophthalmic Drugs Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 29, 2008, from 8 
a.m. to 1 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers 
Lane, Rockville, MD.
    Contact Person: Yvette Waples, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 
301-827-7001, FAX: 301-827-6776, e-mail: Yvette.Waples@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512534. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 22-
212, difluprednate ophthalmic emulsion, Sirion Therapeutics, Inc., 
proposed for the treatment of inflammation and pain following ocular 
surgery.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
14, 2008. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Those desiring to make formal oral 
presentations should notify the contact person 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 requested to make their presentation 
on or before May 6, 2008. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by May 7, 
2008.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Yvette Waples at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 10, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-8351 Filed 4-17-08; 8:45 am]
BILLING CODE 4160-01-S

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