[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Page 60505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Center for Drug Evaluation and Research, Approach to Addressing 
Drug Shortage; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is opening a comment 
period for the notice of public workshop published in the Federal 
Register of July 28, 2011 (76 FR 45268). In that notice, FDA announced 
a public workshop regarding the approach of the Center for Drug 
Evaluation and Research to addressing drug shortages. FDA is opening a 
comment period in light of public interest in this topic and in order 
to gain additional insight about the causes and impact of drug 
shortages, and possible strategies for preventing or mitigating drug 
shortages.

DATES: Either electronic or written comments will be accepted after the 
workshop until 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: Christine Moser or Lori Benner, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, Rm. 6202, Silver Spring, MD 20993-0002, 
301-796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA held a public workshop regarding CDER's current approach to 
addressing drug shortages. Given the increasing number of drug 
shortages and the attendant safety concerns for the public's health, it 
is important to discuss the causes of these shortages, as well as 
strategies to address them. This public workshop focused on collecting 
information and gaining perspective from professional societies, 
patient advocates, industry, consumer groups, health care 
professionals, researchers, and other interested persons. The topics 
discussed: How CDER becomes aware of drug shortages, Reasons behind 
drug shortages, Determination of medically necessary products, CGMP 
(current good manufacturing practice) and other compliance issues, 
Actions taken when a drug shortage occurs, and Outcomes of mitigated 
drug shortages. Additional discussions included the public health 
impact of drug shortages and what measures can be taken to prevent the 
occurrence of a drug shortage. The Agency encouraged professional 
societies, patient advocates, industry, consumer groups, health care 
professionals, researchers, and other interested persons to attend this 
public workshop.

II. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov, approximately 45 days 
after the public workshop. It may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD. A transcript will also be available in either 
hardcopy or on CD-ROM, after submission of a Freedom of Information 
request. Written requests are to be sent to the Division of Freedom of 
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn 
Dr., Element Bldg., Rockville, MD 20857.

III. 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.

    Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25116 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P