Document ID: FDA-2011-N-0805-0002
Agency: fda
Document Type: Notice
Title: Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment
Posted Date: 2012-02-14T05:00Z

[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Pages 8262-8263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3343]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0805]

Dermatologic and Ophthalmic Drugs Advisory Committee; Amendment 
of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of the meeting of the Dermatologic and Ophthalmic Drugs

[[Page 8263]]

Advisory Committee. This meeting was announced in the Federal Register 
of November 17, 2011 (76 FR 71349). The amendment is being made to 
reflect a change in the Date and Time, Agenda, and Procedure portions 
of the document. We are cancelling (Topic 1), the portion of the 
meeting relating to the appropriate types of clinical evidence for 
developing anti-inflammatory drugs for the treatment of postoperative 
inflammation and reduction of ocular (eye) pain in patients who have 
undergone ocular surgery. The portion of the meeting (Topic 2), 
relating to the appropriateness of marketing a single bottle of anti-
inflammatory ophthalmic products for use in both eyes for post-surgical 
indications as it relates to the potential risk for infection will 
still be held on the same date (February 27, 2012), the time for the 
meeting has been changed to 9 a.m. to 3 p.m.

FOR FURTHER INFORMATION CONTACT: Yvette Waples, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. WO31-2417, Silver Spring, MD 20993-0002, 301-796-9001, 
Fax: 301-847-8533, email: DODAC@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301 443-0572 in the Washington, DC 
area), and follow the prompts to the desired center or product area. 
Please call the Information Line for up-to-date information on this 
meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 
2011, FDA announced that a meeting of the Dermatologic and Ophthalmic 
Drugs Advisory Committee would be held on February 27, 2012. On page 
71349, in the first column, the Date and Time portion of the document 
is changed to read as follows:
    Date and Time: The meeting will be held on February 27, 2012, from 
9 a.m. to 3 p.m.
    On page 71349, in the second column, the Agenda portion of the 
document is changed to read as follows:
    Agenda: The committee will be asked to comment on the 
appropriateness of marketing a single bottle of anti-inflammatory 
ophthalmic products for use in both eyes for post-surgical indications 
as it relates to the potential risk for infection. The FDA's Center for 
Drug Evaluation and Research would like the advisory committee to 
provide advice on the potential risk and approaches to mitigating that 
risk, including limits to fill size where appropriate.
    On page 71349, in the third column, the third sentence in the 
Procedure portion of the document is changed to read as follows:
    Procedure: Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 p.m.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 8, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3343 Filed 2-13-12; 8:45 am]
BILLING CODE 4160-01-P