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Food & Drug Administration Drug Shortages Task Force & Strategic Plan Requests Comments

To assist FDA in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages. Comments are due by March 14, 2013.

Food and Drug Administration Drug Shortages Task Force and Strategic Plan Request for Comments
[Docket No. FDA–2013–N–0124]
AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND HUMAN SERVICES
ACTION: Notice; request for comments.
SUMMARY: To assist the Food and Drug Administration (FDA or Agency) in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages.
DATES: Submit either electronic or written comments by March 14, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA–2013–N–0124, by any of the following methods:

Electronic Submissions:
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions:
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper 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 Docket No. FDA–2013–N0124. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document (http://www.gpo.gov/fdsys/pkg/FR-2013-02-12/pdf/2013-03198.pdf?source=govdelivery)

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to
Division of Dockets Management
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

FOR FURTHER INFORMATION CONTACT:
Kalah Auchincloss
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 51, rm. 6208
Silver Spring, MD 20993
301/796–0659



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