
[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21248-21249]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Addressing Inadequate Information on Important Health Factors in 
Pharmacoepidemiology Studies Relying on Healthcare Databases; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop, cosponsored by FDA and the University of Maryland Center for 
Excellence in Regulatory Science and Innovation, entitled 
``Methodological Considerations to Address Unmeasured Information About 
Important Health Factors in Pharmacoepidemiology Studies that Rely on 
Electronic Healthcare Databases to Evaluate the Safety of Regulated 
Pharmaceutical Products in the Postapproval Setting.'' The purpose of 
the public workshop is to engage in constructive dialogue among 
regulators, academicians, pharmaceutical industry, clinicians, other 
stakeholders and the general public on potential strategies to improve 
availability of information on important health factors in 
pharmacoepidemiology studies that rely on electronic healthcare 
databases to evaluate the safety of pharmaceutical products in the 
postapproval setting. Electronic healthcare databases are increasingly 
being used in the postapproval assessment of the safety profile of 
pharmaceutical drug products.
    Date and Time: The public workshop will be held on May 4, 2015, 8 
a.m. to 5 p.m.
    Location: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) 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.
    Contact Person: Leslie Wheelock, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4345, 
Silver Spring, MD, 301-796-4580, FAX: 301-847-8106, 
leslie.wheelock@fda.hhs.gov.
    Registration: Submit your online registration information 
(including name, title, firm name, address, telephone and fax numbers) 
by April 30, 2015, at: http://www.pharmacy.umaryland.edu/centers/cersievents/biasinbigdata/. There is no registration fee for University 
of Maryland faculty, students, and staff, University of Maryland Center 
for Excellence in Regulatory Science and Innovation Industrial 
Consortia Members, and Federal Government employees. There is a $50.00 
registration fee for all other participants. Early registration is 
recommended because seating is limited. There will be no onsite 
registration.
    If you need special accommodations due to a disability, please 
contact Leslie Wheelock (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: 
    In many instances, these resources allow for the timely evaluation 
of drug-related adverse events since data on healthcare utilized by a 
large number of individuals are readily available. However, because 
these data are typically collected for administrative purposes, 
information on important health factors necessary to evaluate drug-
outcome relationship may be

[[Page 21249]]

absent or incomplete in these data sources. Examples include tobacco/
smoking use and history, alcohol consumption, weight and height, 
patient and family medical history, or use of over-the-counter 
medications. Incomplete capture or the absence of this information can 
result in biased or uncertain estimates for the drug-outcome 
relationship of interest leading to inadequate evaluation of the safety 
profile of prescription drug products.
    Webcast: Please be advised that as soon as possible after a Webcast 
of the public workshop is available, it will be accessible at: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm429136.htm.

    Dated: April 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08846 Filed 4-16-15; 8:45 am]
 BILLING CODE 4164-01-P


