83 FR 18571 - Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 82 (April 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 82 (April 27, 2018)
| Page Range | 18571-18573 | |
| FR Document | 2018-08903 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Pages 18571-18573] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08903] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0586] Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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 [[Page 18572]] 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 This guidance finalizes the draft guidance of the same name issued on March 5, 2015. DATES: The announcement of the guidance is published in the Federal Register on April 27, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-D-0586 for ``Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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 guidance document. FOR FURTHER INFORMATION CONTACT: Libero (Louis) Marzella, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5482, 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 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 guidance finalizes the draft guidance issued on March 5, 2015 (80 FR 11998). Changes made to the draft guidance took into consideration written and verbal comments received. In addition to editorial changes primarily for clarification, changes also included the following: clarifying the recommended role of a centralized image interpretation process and the quality control process; streamlining the description of the recommended approach to incidental findings and to discordant image interpretations; and [[Page 18573]] highlighting further the interrelationship between a clinical protocol and an imaging charter. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on clinical trial imaging endpoint process standards. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. 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. Electronic Access Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: April 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-08903 Filed 4-26-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18571
Development, Center for Biologics 520(o)(2) of the FD&C Act describes the III. Electronic Access
Evaluation and Research, Food and regulation and assessment of a software Persons interested in obtaining a copy
Drug Administration, 10903 New product with multiple functions, of the draft guidance may do so by
Hampshire Ave., Bldg. 71, Rm. 3128, including at least one device function downloading an electronic copy from
Silver Spring, MD 20993–0002. Send and at least one software function that the internet. A search capability for all
one self-addressed adhesive label to is not a device. In this draft guidance, Center for Devices and Radiological
assist that office in processing your FDA provides its current thinking on Health guidance documents is available
request. the regulation of products with multiple at https://www.fda.gov/MedicalDevices/
FOR FURTHER INFORMATION CONTACT: functions with at least one device DeviceRegulationandGuidance/
Bakul Patel, Center for Devices and function. Although section 520(o)(2) of GuidanceDocuments/default.htm. This
Radiological Health, Food and Drug the FD&C Act applies to the regulation guidance document is also available at
Administration, 10903 New Hampshire of software products containing at least https://www.fda.gov/Biologics
Ave., Bldg. 66, Rm. 5458, Silver Spring, one device function and at least one BloodVaccines/GuidanceCompliance
MD 20993–0002, 301–796–5528; or non-device function, FDA believes the RegulatoryInformation/default.htm or
Stephen Ripley, Center for Biologics same principles apply to all multiple https://www.regulations.gov. Persons
Evaluation and Research, Food and function products that contain at least unable to download an electronic copy
Drug Administration, 10903 New one device function. of ‘‘Multiple Function Device Products:
Hampshire Ave., Bldg. 71, Rm. 7301, Policy and Considerations’’ may send an
Silver Spring, MD 20993–0002, 240– II. Significance of Guidance email request to CDRH-Guidance@
402–7911. fda.hhs.gov to receive an electronic
This draft guidance is being issued
SUPPLEMENTARY INFORMATION: copy of the document. Please use the
consistent with FDA’s good guidance
document number 17038 to identify the
I. Background practices regulation (21 CFR 10.115). guidance you are requesting.
On December 13, 2016, the Cures Act The draft guidance, when finalized, will
was signed into law. Section 3060(a) of represent the current thinking of FDA IV. Paperwork Reduction Act of 1995
this legislation entitled ‘‘Clarifying on ‘‘Multiple Function Device Products: This guidance refers to previously
Medical Software Regulation’’ amended Policy and Considerations.’’ It does not approved collections of information.
the Federal Food, Drug, and Cosmetic establish any rights for any person and These collections of information are
Act (FD&C Act) to add section 520(o) is not binding on FDA or the public. subject to review by the Office of
(21 U.S.C. 360j(o)), which describes You can use an alternative approach if Management and Budget (OMB) under
software functions that are excluded it satisfies the requirements of the the Paperwork Reduction Act of 1995
from the definition of the term device in applicable statutes and regulations. This (44 U.S.C. 3501–3520). The collections
section 201(h) of the FD&C Act (21 guidance is not subject to Executive of information have been approved by
U.S.C. 321(h)). In addition, section Order 12866. OMB as follows:
Have been approved
The collections of information in this 21 CFR part or guidance document: Regarding this topic: under OMB control No.:
803 ..................................................................................................................... Medical device reporting ..................... 0910–0437
807, subparts A–D ............................................................................................. Registration and listing ........................ 0910–0625
807, subpart E ................................................................................................... Premarket notification .......................... 0910–0120
812 ..................................................................................................................... Investigational device exemption ........ 0910–0078
814, subparts A–E ............................................................................................. Premarket approval applications ......... 0910–0231
814, subpart H ................................................................................................... Humanitarian use devices ................... 0910–0332
820 ..................................................................................................................... Current good manufacturing practice 0910–0073
and the quality system regulation.
601 ..................................................................................................................... Biologics license applications .............. 0910–0338
‘‘User Fees for 513(g) Requests for Information’’ and ‘‘FDA and Industry Pro- 513(g) requests ................................... 0910–0705
cedures for Section 513(g) Requests for Information under the Federal
Food, Drug, and Cosmetic Act’’.
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submis- Q-submissions and presubmissions ... 0910–0756
sion Program and Meetings with Food and Drug Administration Staff’’.
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designa- De Novo requests ............................... 0910–0844
tion)’’.
Dated: April 23, 2018. DEPARTMENT OF HEALTH AND ACTION: Notice of availability.
Leslie Kux, HUMAN SERVICES
Associate Commissioner for Policy.
SUMMARY: The Food and Drug
Food and Drug Administration Administration (FDA or Agency) is
[FR Doc. 2018–08858 Filed 4–26–18; 8:45 am]
announcing the availability of a
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4164–01–P [Docket No. FDA–2011–D–0586] guidance for industry entitled ‘‘Clinical
Clinical Trial Imaging Endpoint Trial Imaging Endpoint Process
Process Standards; Guidance for Standards.’’ This guidance assists
Industry; Availability sponsors in optimizing the quality of
imaging data obtained in clinical trials
AGENCY: Food and Drug Administration, intended to support approval of drugs
HHS. and biological products. This guidance
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![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18573
highlighting further the and Thursday, May 10, 2018, from 9:30 the date that is one year from the
interrelationship between a clinical a.m. to 1:00 p.m. ET. Secretary’s adoption of the condition for
protocol and an imaging charter. ADDRESSES: The public may attend this screening.
This guidance is being issued meeting in person or via Webcast. While Agenda: The meeting agenda will
consistent with FDA’s good guidance this meeting will be open to the public, include: (1) Presentations and
practices regulation (21 CFR 10.115). advance registration is required. Please discussion on risk assessment in
The guidance represents the current register online at http://www.achdnc
thinking of FDA on clinical trial newborn screening; (2) presentation of
meetings.org/ by 12:00 p.m. ET on May educational tools for communicating
imaging endpoint process standards. It 7, 2018.
does not establish any rights for any newborn screening results; (3)
The address for the meeting is 5600
person and is not binding on FDA or the Fishers Lane, Rockville, MD 20857. presentations from states working
public. You can use an alternative Non-U.S. citizens planning to attend in toward timeliness goals in newborn
approach if it satisfies the requirements person will need to provide additional screening; (4) an update on the status of
of the applicable statutes and information to HRSA by Monday, April newborn screening pilot studies for
regulations. This guidance is not subject 30, 2018, 12 p.m. ET. To facilitate access Guanidinoacetate Methyltransferase
to Executive Order 12866. to the building, please contact Ann (GAMT) deficiency; (5) updates from the
Ferrero at the contact information listed Laboratory Standards and Procedures
II. The Paperwork Reduction Act of
below. Individuals who plan to attend workgroup; (6) updates from the Follow-
1995
and need special assistance, such as up and Treatment workgroup; (7)
This guidance refers to previously sign language interpretation or other updates from the Education and
approved collections of information that reasonable accommodations, should Training workgroup; and (8) reviewing
are subject to review by the Office of notify Ms. Ferrero at least 10 days prior the process for assessing the public
Management and Budget (OMB) under to the meeting. health impact of adding conditions to
the Paperwork Reduction Act of 1995 The meeting will also be accessible the RUSP.
(44 U.S.C. 3501–3520). The collections via Webcast. Instructions on how to
of information in 21 CFR parts 312 and There are no votes scheduled for this
access the meeting via Webcast will be
314 have been approved under OMB meeting. The final meeting agenda will
provided upon registration.
control numbers 0910–0014 and 0910– be available two (2) days prior to the
FOR FURTHER INFORMATION CONTACT:
0001, respectively. meeting on the Committee’s website at
Anyone requesting information
https://www.hrsa.gov/advisory-
III. Electronic Access regarding the ACHDNC should contact
Ann Ferrero, Maternal and Child Health committees/heritable-disorders/
Persons with access to the internet index.html. Please note that agenda
Bureau (MCHB), HRSA, in one of three
may obtain the guidance at https:// items and meeting times are subject to
ways: (1) Send a request to the following
www.fda.gov/Drugs/ change as priorities dictate.
address: Ann Ferrero, MCHB, HRSA
GuidanceComplianceRegulatory
5600 Fishers Lane, Room 18N100C, Public Participation: Members of the
Information/Guidances/default.htm,
Rockville, MD 20857; (2) call 301–443– public will have the opportunity to
https://www.fda.gov/BiologicsBlood
3999; or (3) send an email to AFerrero@ provide comments, which are part of the
Vaccines/GuidanceCompliance
hrsa.gov. official Committee record. To submit
RegulatoryInformation/default.htm, or
https://www.regulations.gov. SUPPLEMENTARY INFORMATION: written comments or request time for an
Background: The ACHDNC provides oral comment at the meeting, please
Dated: April 24, 2018. advice and recommendations to the register online by 12:00 p.m. ET on May
Leslie Kux, Secretary of HHS on the development of 3, 2018, at http://www.achdnc
Associate Commissioner for Policy. newborn screening activities, meetings.org/. Oral comments will be
[FR Doc. 2018–08903 Filed 4–26–18; 8:45 am] technologies, policies, guidelines, and honored in the order they are requested
BILLING CODE 4164–01–P programs for effectively reducing and may be limited as time allows.
morbidity and mortality in newborns Individuals associated with groups or
and children having, or at risk for, who plan to provide comments on
DEPARTMENT OF HEALTH AND heritable disorders. In addition,
similar topics may be asked to combine
HUMAN SERVICES ACHDNC’s recommendations regarding
their comments and present them
inclusion of additional conditions and
Health Resources and Services through a single representative. No
inherited disorders for screening are
Administration included in the Recommended Uniform audiovisual presentations are permitted.
Screening Panel (RUSP) following Written comments should identify the
Advisory Committee on Heritable individual’s name, address, email,
adoption by the Secretary. Conditions
Disorders in Newborns and Children telephone number, professional or
listed on the RUSP constitute part of the
AGENCY: Health Resources and Services comprehensive preventive health organization affiliation, background or
Administration (HRSA), Department of guidelines supported by HRSA for area of expertise (i.e., parent, family
Health and Human Services (HHS). infants and children under section 2713 member, researcher, clinician, public
ACTION: Notice of Meeting. of the Public Health Service Act (42 health, etc.) and the topic/subject
U.S.C. 300gg–13). Under this provision, matter.
SUMMARY: In accordance with the non-grandfathered health plans and
daltland on DSKBBV9HB2PROD with NOTICES
Federal Advisory Committee Act, this Amy P. McNulty,
health insurance issuers are required to
notice announces that the Advisory provide insurance coverage without Acting Director, Division of the Executive
Committee on Heritable Disorders in Secretariat.
cost-sharing (a co-payment, co-
Newborns and Children (ACHDNC) will insurance, or deductible) for screenings [FR Doc. 2018–08853 Filed 4–26–18; 8:45 am]
hold a public meeting. included in the HRSA-supported BILLING CODE 4165–15–P
DATES: Wednesday, May 9, 2018, from comprehensive guidelines for plan years
9:30 a.m. to 5:00 p.m. Eastern Time (ET) (i.e., policy years) beginning on or after
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Document Created: 2018-04-27 01:45:23
Document Modified: 2018-04-27 01:45:23
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on April 27, 2018. | |
| Contact | Libero (Louis) Marzella, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5482, 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 | 83 FR 18571 |
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