Document ID: FDA-2009-N-0143-1061
Agency: fda
Document Type: Notice
Title: Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period
Posted Date: 2009-10-19T04:00Z

[Federal Register: October 19, 2009 (Volume 74, Number 200)]
[Notices]               
[Page 53509-53510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc09-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0143]

 
Risk Evaluation and Mitigation Strategies for Certain Opioid 
Drugs; Notice of Public Meeting; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
October 19, 2010, the comment period for the notice of public meeting 
published in the Federal Register of April 20, 2009 (74 FR 17967). In 
that notice, FDA announced a public meeting that took place on May 27 
and 28, 2009, to solicit input on developing Risk Evaluation and 
Mitigation Strategies (REMS) for certain opioid drugs. FDA is reopening 
the comment period in light of continued public interest in this topic 
and to provide an opportunity for all interested parties to provide 
information and share views on the matter.

DATES: Submit written or electronic comments by October 19, 2010.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Theresa (Terry) Martin, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993-0002, 301-
796-3448; FAX: 301-847-8752, e-mail: OpioidREMS@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 20, 2009 (74 FR 17967), FDA 
published a notice of a public meeting on developing REMS for certain 
opioid drugs. The affected opioid drugs include long acting and 
extended release brand name and generic products that are formulated 
with the following active ingredients: Fentanyl, hydromorphone, 
methadone, morphine, oxycodone, and oxymorphone. The REMS would be 
intended to ensure that the benefits of these drugs continue to 
outweigh risks associated with: (1) Use of high doses of long acting 
opioid and extended release

[[Page 53510]]

opioid products in non-opioid tolerant and inappropriately selected 
individuals; (2) abuse; (3) misuse; and (4) overdose, both accidental 
and intentional. REMS for these opioids would likely include elements 
to assure safe use to ensure that prescribers, dispensers, and patients 
are aware of and understand the risks and proper use of these products. 
The opioid drugs expected to be subject to REMS are widely prescribed 
by a large number of physicians who practice in a wide variety of 
areas. A REMS that will adequately manage the risks of these products 
without unduly burdening the health care system or reducing patient 
access to these medications must be carefully designed. Recognizing 
this challenge, we identified several specific areas in which FDA 
wishes to obtain information and public comment in our April 2009 
notice of public meeting.
    Interested persons were originally given until June 30, 2009, to 
comment. As a result of continued public interest, FDA is reopening the 
comment period until October 19, 2010 to allow interested persons 
additional time to provide information and share views on this topic.

II. How to Submit Comments

    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 to http://
www.regulations.gov 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.

    Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25022 Filed 10-16-09; 8:45 am]

BILLING CODE 4160-01-S