Clinical Trial Imaging Endpoint Process Standards; Draft Guidance for Industry; Availability, 11998-11999 [2015-05016]

Download as PDF 11998 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices person with an approved or pending drug product application he will be subject to civil money penalties. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Hargrave during his period of debarment. Any application by Dr. Hargrave for termination of debarment under section 306(d) of the FD&C Act should be identified with Docket No. FDA–2010– N–0299 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain documents in the Docket at https:// www.regulations.gov/. Dated: February 24, 2015. Stephen Ostroff, Director, Office of the Chief Scientist. [FR Doc. 2015–05046 Filed 3–4–15; 8:45 am] BILLING CODE 4164–01–P 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SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0586] Clinical Trial Imaging Endpoint Process Standards; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. I. Background The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Clinical Trial Imaging Endpoint Process Standards.’’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 This draft guidance revises the draft guidance entitled ‘‘Standards for Clinical Trial Imaging Endpoints’’ issued on August 19, 2011.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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:28 Mar 04, 2015 considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 4, 2015.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 https:// 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: Jkt 235001 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. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 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 E:\FR\FM\05MRN1.SGM 05MRN1 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 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 https://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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https://www. fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation of Written Comments on the Draft National Adult Immunization Plan; Extension of Comment Period National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services (HHS). ACTION: Notice. mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: The Department of Health and Human Services (HHS), through the National Vaccine Program Office (NVPO) is extending the public comment period for a draft document SUMMARY: VerDate Sep<11>2014 20:45 Mar 04, 2015 Jkt 235001 titled ‘‘The National Adult Immunization Plan (NAIP).’’ The availability of that draft document was published in the Federal Register on February 6, 2015, Volume 80, Number 25, pages 6721–6722. DATES: The comment period is extended by 14 days and thus will end on March 23, 2015. ADDRESSES: (1) The draft NAIP is available on the Web at www.hhs.gov/ nvpo/. (2) Electronic responses are preferred and may be addressed to: Rebecca.Fish@ hhs.gov. (3) Written responses should be addressed to: National Vaccine Program Office, U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 733G, Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Rebecca Fish, National Vaccine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services; telephone (202) 260– 9283; fax (202) 260–1165; email: Rebecca.Fish@hhs.gov. SUPPLEMENTARY INFORMATION: The notice of availability of the draft National Adult Immunization Plan (NAIP) was published in the Federal Register on February 6, 2015, Volume 80, Number 25, pages 6721–6722, with a deadline for comments of March 9, 2015. The NAIP is a national plan that will require engagement from a wide range of stakeholders to achieve its full vision. The plan emphasizes collaboration and prioritization of efforts that will have the greatest impact. NVPO is soliciting public comment on the draft NAIP from a variety of stakeholders, including the general public, for consideration as they develop their final report to the Secretary. Since the notice of availability and draft guidance documents were published, the Department has received requests to extend the comment period to allow sufficient time for a full review of the draft NAIP. NVPO is committed to affording the public a meaningful opportunity to comment on the draft NAIP and welcomes comments. Persons with access to the Internet may obtain the draft National Adult Immunization Plan on NVPO’s Web site at https://www.hhs.gov/nvpo. Dated: February 25, 2015. Bruce Gellin, Deputy Assistant Secretary for Health, Director, National Vaccine Program Office, Executive Secretary, National Vaccine Advisory Committee. [FR Doc. 2015–05030 Filed 3–4–15; 8:45 am] BILLING CODE 4150–44–P PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 11999 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Gene Regulation. Date: February 26, 2015. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Richard A Currie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1108, MSC 7890, Bethesda, MD 20892, (301) 435– 1219, currieri@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Biomaterials. Date: March 5–6, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Joseph D Mosca, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892, (301) 435– 2344, moscajos@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) E:\FR\FM\05MRN1.SGM 05MRN1

Agencies

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


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

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 https://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 https://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 https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://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
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