[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Draft Guidance for Industry on Standards for Clinical Trial 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availability of a draft guidance for industry entitled ``Standards for 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 The purpose of this draft guidance 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 The draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 18, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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