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