Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop, 45268 [2011-19031]
Download as PDF
<![CDATA[
45268
Federal Register / Vol. 76, No. 145 / Thursday, July 28, 2011 / Notices
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.
rmajette on DSK89S0YB1PROD with NOTICES
VerDate Mar<15>2010
15:51 Jul 27, 2011
Jkt 223001
Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
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 https://
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.
[Docket No. FDA–2011–N–0294]
SUPPLEMENTARY INFORMATION:
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: https://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. (https://
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
SUMMARY:
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, firstserved 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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
[FR Doc. 2011–19031 Filed 7–27–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Reprocessing of Reusable Medical
Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is considering
factors affecting the reprocessing of
reusable medical devices, including
reprocessing quality, device design as it
relates to the reprocessing of reusable
medical devices, reprocessing
methodologies, validation
methodologies, and health care facility
best practices. This is part of an ongoing
effort to address patient exposure to
inadequately reprocessed reusable
medical devices. FDA would like to
provide another opportunity for public
comment by establishing a docket to
receive information and comments from
the public on factors affecting the
reprocessing of reusable medical
devices.
SUMMARY:
Submit either electronic or
written comments by September 26,
2011.
DATES:
You may submit comments,
identified with the FDA docket number
found in brackets in the heading of this
document, by any of the following
methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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. (https://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 https://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
