Document ID: FDA-2013-N-1658-0004
Agency: fda
Document Type: Notice
Title: Characterizing and Communicating Uncertainty in the Assessment of
Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop;
Request for Comments
Posted Date: 2014-04-16T04:00Z

[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Pages 21475-21476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08591]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1658]

Characterizing and Communicating Uncertainty in the Assessment of 
Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; rescheduling of public workshop; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
rescheduling of a February 13, 2014, public workshop convened by the 
Institute of Medicine (IOM) entitled ``Characterizing and Communicating 
Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory 
Decision-Making,'' published in the Federal Register of January 10, 
2014. Due to inclement weather, the Federal Government was closed on 
February 13, 2014. We are rescheduling the public workshop to May 12, 
2014, and extending the comment period for the public docket.

[[Page 21476]]

DATES: The public workshop will be held on May 12, 2014, from 9 a.m. to 
approximately 5 p.m. Registration to attend the workshop must be 
received by May 7, 2014. See the SUPPLEMENTARY INFORMATION section for 
information on how to register for the workshop. Submit either 
electronic or written comments by June 11, 2014.

ADDRESSES: The workshop will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, Sections B and C of 
the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for the 
public workshop participants is through Building 1, where routine 
security check procedures will be performed. For parking and security 
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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. Identify comments with the docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sara Eggers, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave. Bldg. 51, Rm. 1166, Silver Spring, MD 20993-0002, 301-
796-4904, FAX: 301-847-8443, email: sara.eggers@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 10, 2014 
(79 FR 1877), FDA announced a 2-day public workshop on February 12-13, 
2014. Due to the Federal Government closure on February 13, 2014, the 
workshop was postponed. We are rescheduling the public workshop to May 
12, 2014, and extending the comment period to June 11, 2014 (see 
DATES). The purpose of the workshop is twofold: (1) To explore 
potential approaches to addressing and communicating uncertainty and 
(2) to identify key considerations on developing, evaluating, and 
incorporating potential approaches to addressing uncertainty into the 
assessment of benefits and risks in the human drug review process. 
Additional information about the purpose of the workshop, topics for 
discussion, and registration is available on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm378861.htm, 
and is provided in the January 10, 2014, Federal Register notice, which 
is also available on FDA's Web site.

    Dated: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08591 Filed 4-15-14; 8:45 am]
BILLING CODE 4160-01-P