
[Federal Register Volume 78, Number 93 (Tuesday, May 14, 2013)]
[Notices]
[Pages 28228-28229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11361]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry and Food and Drug Administration Staff on 
Best Practices for Conducting and Reporting Pharmacoepidemiologic 
Safety Studies Using Electronic Healthcare Data; 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 guidance for industry and FDA staff entitled ``Best 
Practices for Conducting and Reporting Pharmacoepidemiologic Safety 
Studies Using Electronic Healthcare Data.'' The guidance is intended to 
describe best practices pertaining to conducting and documenting 
pharmacoepidemiologic safety studies that use electronic healthcare 
data. The guidance includes recommendations for documenting the design, 
analysis, and results of such studies to optimize FDA's review of 
protocols and final reports that are submitted to the Agency.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 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 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. 274, 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 guidance for industry and 
FDA staff entitled ``Best Practices for Conducting and Reporting 
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare 
Data.'' The primary goals of this guidance are to provide the 
following:
     Consistent guidance for industry and FDA to use when 
designing, conducting, and analyzing pharmacoepidemiologic safety 
studies;
     A framework for industry to use when submitting 
pharmacoepidemiologic safety study protocols and final reports to FDA; 
and
     A framework for FDA reviewers to use when reviewing and 
interpreting pharmacoepidemiologic safety study protocols and final 
reports.
    This 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 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, the guidance does not provide a 
framework for determining the appropriate weight of evidence to be 
given to studies from this data stream in the overall assessment of 
drug safety, as this appraisal represents a separate aspect of the 
regulatory decision-making process and is best accomplished in the 
context of the specific safety issue under investigation.
    In the Federal Register of February 16, 2011 (76 FR 9027), FDA 
issued a draft version of this guidance entitled ``Best Practices for 
Conducting and Reporting Pharmacoepidemiologic Safety Studies Using 
Electronic Healthcare Data Sets.'' The comment period on the draft 
guidance ended on April 18, 2011. Most of the comments sought 
clarification and further illustrations of issues discussed in the 
guidance. FDA has carefully reviewed all comments received on the draft 
guidance (more than 400 comments were submitted to the public docket). 
As a result of the public comments, FDA has clarified the following 
sections of the guidance: Interpretation of findings; study time frame; 
identification and handling of confounding and the use of statistical 
techniques to address confounding; exposure ascertainment; study 
design; outcome definition and validation; prespecified analysis plan; 
and the linkage and pooling of data from different data sources. 
Glossary definitions and references were added to different sections of 
the guidance to clarify terms and cite additional resources.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on best practices for conducting and 
reporting 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance provides best practices for reporting 
pharmacoepidemiologic safety studies using electronic healthcare data. 
The reports referenced in the 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/
GuidanceComplianceRegulatoryInformation/

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

    Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11361 Filed 5-13-13; 8:45 am]
BILLING CODE 4160-01-P


