Document ID: FDA-2011-N-0002-0081
Agency: fda
Document Type: Notice
Title: Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop
Posted Date: 2011-07-28T04:00Z

[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Page 45268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19031]

[[Page 45268]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop regarding the approach of the Center for Drug Evaluation and 
Research (CDER) to addressing drug shortages. This public workshop is 
intended to provide information for, and to gain additional insight 
from, professional societies, patient advocates, industry, consumer 
groups, health care professionals, researchers, and other interested 
persons about the causes and impact of drug shortages, and possible 
strategies for preventing or mitigating drug shortages. The input from 
this public workshop will help in developing topics for further 
discussion with industry and professional societies, and other 
stakeholders and may help the Agency to better address drug shortage 
issues.
    Date and Time: The public workshop will be held on September 26, 
2011, from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at 10903 New Hampshire 
Ave., Bldg. 31, rm. 1503 B and C (Great Room), Silver Spring, MD 20993. 
Information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``White Oak Conference Center Parking 
and Transportation Information for FDA Advisory Committee Meetings.'' 
Please note that visitors to the White Oak Campus must enter through 
Building 1. (http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm).
    Contact Persons: 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 or 301-796-1600.
    Registration: To register electronically, e-mail registration 
information (including name, title, firm name, address, telephone, and 
fax number) to dsworkshop@fda.hhs.gov by September 19, 2011. Persons 
without access to the Internet can call Christine Moser at 301-796-1300 
or Lori Benner at 301-796-1300 to register. Registration is free for 
the public workshop. Seating will be available on a first-come, first-
served basis. Persons needing a sign language interpreter or other 
special accommodations should notify Christine Moser or Lori Benner 
(see Contact) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing 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 will focus on providing information and gaining perspective 
from professional societies, patient advocates, industry, consumer 
groups, health care professionals, researchers, and other interested 
persons. The following topics will be 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 discussion will include the public health impact of drug 
shortages and what measures can be taken to prevent the occurrence of a 
drug shortage. The Agency encourages professional societies, patient 
advocates, industry, consumer groups, health care professionals, 
researchers, and other interested persons to attend this public 
workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. 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 (HFI-35), 
Office of Management Programs, Food and Drug Administration, 5600 
Fishers Lane, Rm. 6-30, Rockville, MD 20857.

    Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19031 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P