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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice; reopening of comment period.

# 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                           ( print 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