80 FR 11998 - Clinical Trial Imaging Endpoint Process Standards; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 43 (March 5, 2015)

Page Range		11998-11999
FR Document		2015-05016

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Trial Imaging Endpoint Process Standards.''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 This draft guidance revises the draft guidance entitled ``Standards for Clinical Trial Imaging Endpoints'' issued on August 19, 2011.

Federal Register, Volume 80 Issue 43 (Thursday, March 5, 2015)

[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11998-11999]
From the Federal Register Online [www.thefederalregister.org]
[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Clinical Trial Imaging Endpoint Process Standards; Draft Guidance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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Clinical Trial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 This draft guidance revises the draft guidance entitled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draft guidance before it begins work on the final version of the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

11998 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices

person with an approved or pending considers your comment on this draft This guidance addresses the
drug product application he will be guidance before it begins work on the background considerations for
subject to civil money penalties. In final version of the guidance, submit determining the role of imaging in a
addition, FDA will not accept or review either electronic or written comments clinical trial as well as the major
any abbreviated new drug applications on the draft guidance by May 4, 2015. considerations in the development of an
submitted by or with the assistance of ADDRESSES: Submit written requests for
imaging charter that describes the trial’s
Dr. Hargrave during his period of single copies of the draft guidance to the imaging methods. The guidance
debarment. Division of Drug Information, Center for specifically addresses the technical
Any application by Dr. Hargrave for Drug Evaluation and Research, Food components of a charter’s description of
termination of debarment under section and Drug Administration, 10001 New the image acquisition, image
306(d) of the FD&C Act should be Hampshire Ave., Hillandale Bldg., 4th interpretation, and image data
identified with Docket No. FDA–2010– development methods.
Floor, Silver Spring, MD 20993–0002, or
N–0299 and sent to the Division of This draft guidance revises the draft
the Office of Communication, Outreach
Dockets Management (see ADDRESSES). guidance entitled ‘‘Standards for
and Development, Center for Biologics Clinical Trial Imaging Endpoints’’
All such submissions are to be filed in Evaluation and Research (CBER), Food
four copies. The public availability of issued on August 19, 2011 (76 FR
and Drug Administration, 10903 New 51993). Comments we received on the
information in these submissions is Hampshire Ave., Bldg. 71, Rm. 3128,
governed by 21 CFR 10.20(j). Publicly draft guidance have been considered
Silver Spring, MD 20993–0002. Send and the guidance has been revised as
available submissions may be seen in one self-addressed adhesive label to
the Division of Dockets Management follows: (1) It has been made clear that
assist that office in processing your the guidance pertains to imaging in
between 9 a.m. and 4 p.m., Monday requests. See the SUPPLEMENTARY
through Friday. Persons with access to clinical trials intended to support
INFORMATION section for electronic approval of drugs and biological
the Internet may obtain documents in access to the draft guidance document.
the Docket at http:// products and focuses upon standards
Submit electronic comments on the that FDA regards as important when
www.regulations.gov/.
draft guidance to http:// imaging is used to assess a trial’s
Dated: February 24, 2015. www.regulations.gov. Submit written primary endpoint; (2) it has been made
Stephen Ostroff, comments to the Division of Dockets clear that the imaging charter can be
Director, Office of the Chief Scientist. Management (HFA–305), Food and Drug either a single document or an ensemble
[FR Doc. 2015–05046 Filed 3–4–15; 8:45 am] Administration, 5630 Fishers Lane, Rm. of documents, depending on multiple
BILLING CODE 4164–01–P 1061, Rockville, MD 20852. factors; (3) it is emphasized that imaging
FOR FURTHER INFORMATION CONTACT: risks are best described in the clinical
Louis Marzella, Center for Drug protocol and should be addressed in
DEPARTMENT OF HEALTH AND Evaluation and Research, Food and consent documents instead of including
HUMAN SERVICES Drug Administration, 10903 New this information in the imaging charter;
Hampshire Ave., Bldg. 22, Rm. 5406, (4) it has been emphasized that this
Food and Drug Administration guidance does not address whether
Silver Spring, MD 20993–0002, 301–
[Docket No. FDA–2011–D–0586] 796–1414; or Stephen Ripley, Center for imaging outcomes are clinically
Biologics Evaluation and Research, meaningful and are acceptable for drug
Clinical Trial Imaging Endpoint Food and Drug Administration, 10903 approval evidence; (5) it has been noted
Process Standards; Draft Guidance for New Hampshire Ave., Bldg. 71, Rm. that image acquisition phantoms may or
Industry; Availability 7301, Silver Spring, MD 20993–0002, may not be necessary, depending on the
240–402–7911. nature of the imaging in a clinical trial;
AGENCY: Food and Drug Administration, (6) it has been modified to emphasize
HHS. SUPPLEMENTARY INFORMATION: the need for the clinical protocol (not
ACTION: Notice. I. Background the charter) to describe how incidental
findings will be handled; (7) it has been
SUMMARY: The Food and Drug FDA is announcing the availability of noted that the charter should identify
Administration (FDA) is announcing the a draft guidance for industry entitled any use of investigational equipment
availability of a draft guidance for ‘‘Clinical Trial Imaging Endpoint (for international trials, the guidance
industry entitled ‘‘Clinical Trial Imaging Process Standards.’’ The purpose of this encourages use of equipment that is
Endpoint Process Standards.’’ This guidance is to assist sponsors in lawfully marketed in the area); and (8)
guidance assists sponsors in optimizing optimizing the quality of imaging data a section has been added that describes
the quality of imaging data obtained in obtained in clinical trials intended to the importance of having the clinical
clinical trials intended to support support approval of drugs and biological trial sponsor ensure the fidelity of all
approval of drugs and biological products. It focuses on imaging charter components with the clinical
products. This guidance focuses on acquisition, display, archiving, and protocol.
imaging acquisition, display, archiving, interpretation standards that FDA This draft guidance is being issued
and interpretation process standards regards as important when imaging is consistent with FDA’s good guidance
that FDA regards as important when used to assess the trial’s primary practices regulation (21 CFR 10.115).
imaging is used to assess a trial’s endpoint or a component of that The draft guidance, when finalized, will
primary endpoint or a component of
mstockstill on DSK4VPTVN1PROD with NOTICES

endpoint. The guidance describes the represent the Agency’s current thinking
that endpoint. This draft guidance minimum standards a sponsor should on the major considerations for
revises the draft guidance entitled use to help ensure that clinical trial standardization of imaging primary
‘‘Standards for Clinical Trial Imaging imaging data are obtained in a manner endpoints in clinical trials of drugs and
Endpoints’’ issued on August 19, 2011. that complies with a trial’s protocol, biological products. It does not create or
DATES: Although you can comment on maintains imaging data quality, and confer any rights for or on any person
any guidance at any time (see 21 CFR provides a verifiable record of the and does not operate to bind FDA or the
10.115(g)(5)), to ensure that the Agency imaging process. public. An alternative approach may be

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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11999

used if such approach satisfies the titled ‘‘The National Adult DEPARTMENT OF HEALTH AND
requirements of the applicable statutes Immunization Plan (NAIP).’’ The HUMAN SERVICES
and regulations. availability of that draft document was
published in the Federal Register on National Institutes of Health
II. The Paperwork Reduction Act of
February 6, 2015, Volume 80, Number
1995 Center for Scientific Review; Notice of
25, pages 6721–6722.
This guidance refers to previously DATES: The comment period is extended
Closed Meetings
approved collections of information that by 14 days and thus will end on March
are subject to review by the Office of Pursuant to section 10(d) of the
23, 2015.
Management and Budget (OMB) under Federal Advisory Committee Act, as
ADDRESSES: (1) The draft NAIP is amended (5 U.S.C. App.), notice is
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections available on the Web at www.hhs.gov/ hereby given of the following meetings.
of information in 21 CFR parts 312 and nvpo/.
(2) Electronic responses are preferred The meetings will be closed to the
314 have been approved under OMB public in accordance with the
control numbers 0910–0014 and 0910– and may be addressed to: Rebecca.Fish@
hhs.gov. provisions set forth in sections
0001, respectively. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
(3) Written responses should be
III. Comments addressed to: National Vaccine Program as amended. The grant applications and
Office, U.S. Department of Health and the discussions could disclose
Interested persons may submit either confidential trade secrets or commercial
electronic comments regarding this Human Services, 200 Independence
Avenue SW., Room 733G, Washington, property such as patentable material,
document to http://www.regulations.gov and personal information concerning
or written comments to the Division of DC 20201.
individuals associated with the grant
Dockets Management (see ADDRESSES). It FOR FURTHER INFORMATION CONTACT:
applications, the disclosure of which
is only necessary to send one set of Rebecca Fish, National Vaccine Program would constitute a clearly unwarranted
comments. Identify comments with the Office, Office of the Assistant Secretary invasion of personal privacy.
docket number found in brackets in the for Health, Department of Health and
heading of this document. Received Human Services; telephone (202) 260– Name of Committee: Center for Scientific
9283; fax (202) 260–1165; email: Review Special Emphasis Panel; Gene
comments may be seen in the Division
Regulation.
of Dockets Management between 9 a.m. Rebecca.Fish@hhs.gov.
Date: February 26, 2015.
and 4 p.m., Monday through Friday, and SUPPLEMENTARY INFORMATION: The notice Time: 1:00 p.m. to 2:00 p.m.
will be posted to the docket at http:// of availability of the draft National Agenda: To review and evaluate grant
www.regulations.gov. Adult Immunization Plan (NAIP) was applications.
IV. Electronic Access published in the Federal Register on Place: National Institutes of Health, 6701
February 6, 2015, Volume 80, Number Rockledge Drive, Bethesda, MD 20892,
Persons with access to the Internet 25, pages 6721–6722, with a deadline (Telephone Conference Call).
may obtain the document at http://www. for comments of March 9, 2015. The Contact Person: Richard A Currie, Ph.D.,
fda.gov/Drugs/GuidanceCompliance NAIP is a national plan that will require Scientific Review Officer, Center for
RegulatoryInformation/Guidances/ engagement from a wide range of Scientific Review, National Institutes of
default.htm, http://www.fda.gov/ Health, 6701 Rockledge Drive, Room 1108,
stakeholders to achieve its full vision.
BiologicsBloodVaccines/Guidance MSC 7890, Bethesda, MD 20892, (301) 435–
The plan emphasizes collaboration and 1219, currieri@csr.nih.gov.
ComplianceRegulatoryInformation/ prioritization of efforts that will have
default.htm, or http:// This notice is being published less than 15
the greatest impact. NVPO is soliciting days prior to the meeting due to the timing
www.regulations.gov. public comment on the draft NAIP from limitations imposed by the review and
Dated: February 27, 2015. a variety of stakeholders, including the funding cycle.
Leslie Kux, general public, for consideration as they Name of Committee: Center for Scientific
Associate Commissioner for Policy. develop their final report to the Review Special Emphasis Panel; Topics in
[FR Doc. 2015–05016 Filed 3–4–15; 8:45 am] Secretary. Since the notice of Biomaterials.
BILLING CODE 4164–01–P
availability and draft guidance Date: March 5–6, 2015.
documents were published, the Time: 8:00 a.m. to 5:00 p.m.
Department has received requests to Agenda: To review and evaluate contract
extend the comment period to allow proposals.
DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701
HUMAN SERVICES sufficient time for a full review of the
Rockledge Drive, Bethesda, MD 20892,
draft NAIP. NVPO is committed to
(Virtual Meeting).
Solicitation of Written Comments on affording the public a meaningful Contact Person: Joseph D Mosca, Ph.D.,
the Draft National Adult Immunization opportunity to comment on the draft Scientific Review Officer, Center for
Plan; Extension of Comment Period NAIP and welcomes comments. Scientific Review, National Institutes of
Persons with access to the Internet Health, 6701 Rockledge Drive, Room 5158,
AGENCY: National Vaccine Program may obtain the draft National Adult MSC 7808, Bethesda, MD 20892, (301) 435–
Office, Office of the Assistant Secretary Immunization Plan on NVPO’s Web site 2344, moscajos@csr.nih.gov.
for Health, Office of the Secretary, at http://www.hhs.gov/nvpo. This notice is being published less than 15
Department of Health and Human days prior to the meeting due to the timing
mstockstill on DSK4VPTVN1PROD with NOTICES

Services (HHS). Dated: February 25, 2015.
limitations imposed by the review and
ACTION: Notice. Bruce Gellin, funding cycle.
Deputy Assistant Secretary for Health, (Catalogue of Federal Domestic Assistance
SUMMARY: The Department of Health and Director, National Vaccine Program Office, Program Nos. 93.306, Comparative Medicine;
Human Services (HHS), through the Executive Secretary, National Vaccine 93.333, Clinical Research, 93.306, 93.333,
National Vaccine Program Office Advisory Committee. 93.337, 93.393–93.396, 93.837–93.844,
(NVPO) is extending the public [FR Doc. 2015–05030 Filed 3–4–15; 8:45 am] 93.846–93.878, 93.892, 93.893, National
comment period for a draft document BILLING CODE 4150–44–P Institutes of Health, HHS)

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Document Created: 2015-12-18 12:09:16
Document Modified: 2015-12-18 12:09:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		80 FR 11998

80 FR 11998 - Clinical Trial Imaging Endpoint Process Standards; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 43 (March 5, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration