Document ID: FDA-2009-N-0664-0076
Agency: fda
Document Type: Notice
Title: Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice
Posted Date: 2009-08-25T04:00Z

[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]               
[Page 42906-42907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au09-85]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Joint Meeting of the Anesthetic and Life Support Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of a meeting of the Anesthetic and Life Support Drugs 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee. This meeting was announced in the Federal

[[Page 42907]]

Register of August 11, 2009 (74 FR 40207). The amendment is being made 
to reflect a change in the Agenda portion of the document. There are no 
other changes.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: 
Kalyani.Bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington DC area), codes 
3014512529 or 3014512535. Please call the Information Line for up-to-
date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 11, 2009, 
FDA announced that a meeting of the Anesthetic and Life Support Drugs 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee would be held on September 23, 2009, from 8 a.m. to 4:30 p.m. 
On page 40207, in the second column, the Agenda portion of the document 
is changed to read as follows:
    Agenda: The committees will discuss new drug application (NDA) 21-
217, EXALGO (hydromorphone HC1), Neuromed Pharmaceuticals, Inc., a 
modified-release hydromorphone drug product indicated for the treatment 
of moderate-to-severe pain in opioid-tolerant patients.
    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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20377 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S