[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Draft Guidance for Industry and Food and Drug Administration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availability of a draft guidance for industry and FDA staff entitled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 The draft
guidance is intended to describe best practices pertaining to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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 18, 2011.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug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 The draft guidance may also be obtained by mail by calling CBER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Submit electronic comments on the draft guidance to http://www.regulations.gov.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:
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/
[[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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