[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11998-11999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0586]


Clinical Trial Imaging Endpoint Process Standards; Draft Guidance 
for Industry; 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availability of a draft guidance for industry entitled ``Clinical Trial 
Imaging Endpoint Process Standards.'' This guidance assists sponsors in 
optimizing the quality of imaging data obtained in clinical trials 
intended to support approval of drugs and biological products. This 
guidance focuses on imaging acquisition, display, archiving, and 
interpretation process standards that FDA regards as important when 
imaging is used to assess a trial's primary endpoint or a component of 
that endpoint. This draft guidance revises the draft guidance entitled 
``Standards for Clinical Trial Imaging Endpoints'' issued on August 19, 
2011.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 4, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10001 New 
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-
0002, or the Office of Communication, Outreach and Development, Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that 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INFORMATION section for electronic access to the draft guidance 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Louis Marzella, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5406, Silver Spring, MD 20993-0002, 301-
796-1414; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Clinical Trial Imaging Endpoint Process Standards.'' The 
purpose of this guidance is to assist sponsors in optimizing the 
quality of imaging data obtained in clinical trials intended to support 
approval of drugs and biological products. It focuses on imaging 
acquisition, display, archiving, and interpretation standards that FDA 
regards as important when imaging is used to assess the trial's primary 
endpoint or a component of that endpoint. The guidance describes the 
minimum standards a sponsor should use to help 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.
    This guidance addresses the background considerations for 
determining the role of imaging in a clinical trial as well as the 
major considerations in the development of an imaging charter that 
describes the trial's imaging methods. The guidance specifically 
addresses the technical components of a charter's description of the 
image acquisition, image interpretation, and image data development 
methods.
    This draft guidance revises the draft guidance entitled ``Standards 
for Clinical Trial Imaging Endpoints'' issued on August 19, 2011 (76 FR 
51993). Comments we received on the draft guidance have been considered 
and the guidance has been revised as follows: (1) It has been made 
clear that the guidance pertains to imaging in clinical trials intended 
to support approval of drugs and biological products and focuses upon 
standards that FDA regards as important when imaging is used to assess 
a trial's primary endpoint; (2) it has been made clear that the imaging 
charter can be either a single document or an ensemble of documents, 
depending on multiple factors; (3) it is emphasized that imaging risks 
are best described in the clinical protocol and should be addressed in 
consent documents instead of including this information in the imaging 
charter; (4) it has been emphasized that this guidance does not address 
whether imaging outcomes are clinically meaningful and are acceptable 
for drug approval evidence; (5) it has been noted that image 
acquisition phantoms may or may not be necessary, depending on the 
nature of the imaging in a clinical trial; (6) it has been modified to 
emphasize the need for the clinical protocol (not the charter) to 
describe how incidental findings will be handled; (7) it has been noted 
that the charter should identify any use of investigational equipment 
(for international trials, the guidance encourages use of equipment 
that is lawfully marketed in the area); and (8) a section has been 
added that describes the importance of having the clinical trial 
sponsor ensure the fidelity of all charter components with the clinical 
protocol.
    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 the major 
considerations for standardization of imaging primary endpoints in 
clinical trials of drugs and biological products. 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

[[Page 11999]]

used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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 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.

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.regulations.gov.

    Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05016 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P