[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9027-9028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3474]



[[Page 9027]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0057]


Draft Guidance for Industry and Food and Drug Administration 
Staff on Best Practices for Conducting and Reporting 
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data 
Sets; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``Best Practices for Conducting and Reporting Pharmacoepidemiologic 
Safety Studies Using Electronic Healthcare Data Sets.'' The draft 
guidance is intended to describe best practices pertaining to 
conducting and documenting pharmacoepidemiologic safety studies using 
electronic healthcare data sets. The Agency includes recommendations 
for documenting the design, analysis, and results of such studies and 
submitting pharmacoepidemiologic safety study protocols and reports to 
FDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 18, 2011.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. The draft guidance may also be obtained by mail by calling CBER 
at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive 
label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: Regarding human drug products:

Judy Staffa, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4447, Silver 
Spring, MD 20993-0002.

    Regarding human biological products:

Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration (HFM-17), 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Best Practices for Conducting and Reporting 
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data 
Sets.''
    The advent of new technologies and the ability to efficiently 
assemble electronic healthcare data sets for use in drug safety 
research have provided many new opportunities for conducting 
pharmacoepidemiologic studies of product safety issues. These 
technologies provide the possibility to study safety issues quickly 
(relative to alternative approaches) in real world health care 
environments involving large populations of patients. In addition, the 
application of innovative statistical methods to complex drug safety 
questions has allowed investigators to study issues previously 
considered too difficult outside of a clinical trial setting.
    However, these developments have precipitated a great deal of 
discussion over the appropriate use of electronic healthcare data and 
statistical methods in conducting pharmacoepidemiologic safety studies. 
The primary goals of this draft guidance are to provide the following:
    <bullet> Consistent guidance for industry to use when submitting to 
FDA reports and protocols for pharmacoepidemiologic safety studies so 
that study protocols and study reports submitted to FDA contain 
sufficient information to permit thorough review;
    <bullet> A framework for FDA reviewers to use when reviewing and 
interpreting these submissions; and
    <bullet> Consistent guidance for FDA to use when conducting these 
studies.
    This draft guidance does not address real-time active safety 
surveillance studies, as this field is still rapidly evolving, and it 
is not possible at this time to recommend sound best practices. The 
draft guidance is not intended to be prescriptive with regard to choice 
of study design or type of analysis and does not endorse any particular 
type of data resource or methodology. Finally, it does not provide a 
framework for determining the appropriate weight of evidence of studies 
from this data stream in the overall assessment of drug safety, as this 
represents a separate step in the regulatory decisionmaking process and 
is best accomplished in the context of the specific safety issue under 
investigation.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's current thinking on the conduct and reporting 
of pharmacoepidemiologic safety studies using electronic healthcare 
data. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. 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.

III. Paperwork Reduction Act of 1995

    This draft guidance provides best practices for reporting 
pharmacoepidemiologic safety studies using electronic healthcare data 
sets. The reports referenced in the draft guidance would be submitted 
under 21 CFR 314.81, 314.98, and 601.70. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520 and are approved under OMB control numbers 0910-0001 and 0910-
0338).

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm,http://www.fda.gov/BiologicsBloodVaccines/

[[Page 9028]]

GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3474 Filed 2-15-11; 8:45 am]
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