[Federal Register Volume 74, Number 200 (Monday, October 19, 2009)]
[Notices]
[Pages 53509-53510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25022]
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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: [email protected].
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]
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