Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments, 60505 [2011-25116]

Download as PDF Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in § 330.14 have been approved under OMB control number 0910–0688. The collections of information in 21 CFR part 25 and the guidance for industry entitled ‘‘Environmental Assessment of Human Drug and Biologics Applications,’’ which are referenced in the guidance announced in this document, are approved under OMB control number 0910–0322. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: September 26, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–25118 Filed 9–28–11; 8:45 am] BILLING CODE 4160–01–P 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. 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 tkelley on DSKG8SOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:29 Sep 28, 2011 Jkt 223001 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 https:// 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 https:// 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 60505 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Food Defense Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Office (SWRO), in cosponsorship with Oklahoma State University, Robert M. Kerr Food & Agricultural Products Center (FAPC), is announcing a public workshop entitled ‘‘Food Defense Workshop.’’ This public workshop is intended to provide information about food defense as it relates to food facilities such as farms, manufacturers, processors, distributors, retailers, and restaurants. Date and Time: This public workshop will be held on November 2, 2011, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Robert M. Kerr Food & Agricultural Products Center, Oklahoma State University, 148 FAPC, Stillwater, OK 74078–6055. Contact: David Arvelo, Office of Regulatory Affairs, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253– E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Page 60505]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 https://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

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