Document ID: FDA-2011-N-0690-0002
Agency: fda
Document Type: Notice
Title: Product Shortage Report; Availability
Posted Date: 2011-11-07T05:00Z

[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Page 68770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28723]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0690]

Product Shortage Report; Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a medical product shortage report entitled ``A Review 
of FDA's Approach to Medical Product Shortages.'' The Agency is making 
the report available by placing it in the docket opened for a previous 
public workshop on drug shortages. The report discusses the Agency's 
approach to product shortages, particularly those products regulated by 
the FDA Center for Drug Evaluation and Research (CDER). FDA requests 
comments, until December 23, 2011, on the report and its 
recommendations, including whether there are additional suggestions for 
recommendations and how we should prioritize work on these 
recommendations.

DATES: Submit either electronic or written comments by December 23, 
2011.

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

FOR FURTHER INFORMATION CONTACT: Peter Lurie, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 4220, Silver Spring, MD 20993-0002, (301) 796-4800.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 29, 2011 (76 FR 60505), FDA 
opened a comment period for a public workshop notice which published in 
the Federal Register of July 28, 2011 (76 FR 45268). This document 
announces the availability of a product shortage report by placing it 
in the docket of the public workshop on drug shortages. This report 
provides background information on product shortages, discusses four 
FDA product centers' various approaches to addressing product 
shortages, particularly those in CDER, and includes recommendations for 
FDA and others. FDA is requesting comment on the report and its 
recommendations, including whether there are additional suggestions for 
recommendations and how we should prioritize work on these 
recommendations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm275051.htm or http://www.regulations.gov.

    Dated: October 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28723 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P