[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 51993-51994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0586]
Draft Guidance for Industry on Standards for Clinical Trial
Imaging Endpoints; 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availability of a draft guidance for industry entitled ``Standards for
Clinical Trial Imaging Endpoints.'' The purpose of this draft guidance
is to assist sponsors in the use of imaging endpoints in clinical
trials of therapeutic drugs and biological products. The draft guidance
describes standards sponsors can use to ensure that clinical trial
imaging data are obtained in a manner that complies with a trial's
protocol, maintains imaging data quality, and provides a verifiable
record of the imaging process.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 18, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Rafel Dwaine Rieves, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 2354, Silver Spring, MD 20993 -0002, 301-
796-2050; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Standards for Clinical Trial Imaging Endpoints.'' This draft
guidance is intended to assist sponsors in the standardization of
imaging procedures when an important imaging endpoint is used in a
clinical trial of a therapeutic drug or biological product, especially
for an efficacy endpoint. As part of the reauthorization of the
Prescription Drug User Fee Act (PDUFA 4), FDA committed to certain
performance goals (see letters from the Secretary of Health and Human
Services to the Chairman of
[[Page 51994]]
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record).\1\ This
draft guidance addresses one of these goals with the creation of a
guidance document that addresses the ``imaging standards for use as an
endpoint in clinical trials.'' This draft guidance also follows the
April 13, 2010, public workshop ``Standards for Imaging Endpoints in
Clinical Trials'' cosponsored by FDA, the Society of Nuclear Medicine,
and the Radiological Society of North America.\2\
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\1\ See ``Section A: PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2008 Through 2012'' (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm).
\2\ See http://www.rsna.org/snm/index.html.
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This draft guidance outlines the major considerations for
standardization of image acquisition, image interpretation methods, and
other procedures to help ensure imaging data quality. The draft
guidance describes two categories of image acquisition and
interpretation standardization, a medical practice standard and a
clinical trial standard, and provides guidance on the role of each
standard in a clinical trial. With a medical practice standard, the
image acquisition and interpretation methods in the trial do not exceed
those used in medical practice. In contrast, a clinical trial standard
involves imaging methods that exceed those used in medical practice.
The draft guidance focuses on the methods important for image
acquisition and interpretation and provides a detailed outline of other
procedures important for optimizing clinical trial imaging data
quality.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on standards
for clinical trial imaging endpoints. 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. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. 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). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. 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.
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/default.htm, or http://www.egulations.gov.
Dated: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21244 Filed 8-18-11; 8:45 am]
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