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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled “Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.” The draft guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies using electronic healthcare data sets.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comment on any guidance at any time (see 21 CFR 10.115(g)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2011.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                        Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800.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                        Submit electronic comments on the draft guidance to                         *http://www.regulations.gov.*                         Submit written comments to the Division of Dockets Management (HFA-305), Food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:
    - 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;
    - A framework for FDA reviewers to use when reviewing and interpreting these submissions; and
    - 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/​      ( print 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]

BILLING CODE 4160-01-P