Document ID: FDA-2018-D-0944-0001
Agency: fda
Document Type: Notice
Title: Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry
Posted Date: 2018-04-16T04:00Z

[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16366-16367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07812]

[[Page 16366]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0944]

Investigational In Vitro Diagnostics in Oncology Trials: 
Streamlined Submission Process for Study Risk Determination; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined 
Submission Process for Study Risk Determination.'' This guidance, 
developed by the Oncology Center of Excellence, Center for Drug 
Evaluation and Research (CDER), Center for Biologics Evaluation and 
Research (CBER), and Center for Devices and Radiological Health (CDRH) 
at FDA, describes an optional streamlined submission process to 
determine whether an investigational in vitro diagnostic in an oncology 
clinical trial under an investigational new drug application (IND) (an 
oncology co-development program) is significant risk. In the 
streamlined process, all information about the oncology trial 
(including information about the investigational in vitro diagnostic) 
is submitted to the IND. As part of IND review, CBER or CDER works with 
CDRH to determine if the investigational in vitro diagnostic is 
significant risk.

DATES: Submit either electronic or written comments on the draft 
guidance by June 15, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-0944 for ``Investigational In Vitro Diagnostics in Oncology 
Trials: Streamlined Submission Process for Study Risk Determination; 
Draft Guidance for Industry; Availability.'' 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.gpo.gov/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 the draft 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; 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; or 
Office of the Center Director, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002, or via email to [email protected]. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julie Schneider, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2208, Silver Spring, MD 20993, 240-402-
4658; Yun-Fu Hu, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5676, 
Silver Spring, MD 20993-0002, 301-796-6170; 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: 

[[Page 16367]]

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Investigational In Vitro Diagnostics in Oncology Trials: 
Streamlined Submission Process for Study Risk Determination.'' This 
guidance, developed by the Oncology Center of Excellence, CDER, CBER, 
and CDRH at FDA, describes an optional streamlined submission process 
to determine whether an investigational in vitro diagnostic in an 
oncology clinical trial under an IND (an oncology co-development 
program) is significant risk. In the traditional submission process, 
many sponsors submitted a study risk determination Q-submission to CDRH 
and an IND to the appropriate center (CBER or CDER). In the streamlined 
process, all information regarding the oncology co-development program 
(including investigational in vitro diagnostic information) is 
initially submitted to the IND. CBER or CDER works with CDRH to 
determine whether the in vitro diagnostic is significant risk.
    Initially, FDA plans to implement the streamlined submission 
process for oncology-related products, because FDA has received the 
greatest number of co-development submissions in this disease area and 
has the most experience evaluating whether the in vitro diagnostic is 
significant risk. However, FDA is interested in receiving comments on 
whether the streamlined submission process should be extended to other 
disease areas in the future.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance is 
not final nor is it in effect at this time. The draft guidance, when 
finalized, will represent the current thinking of FDA on a streamlined 
submission process for study risk determination for in vitro 
diagnostics in oncology trials. 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 currently approved collections of 
information. 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 part 809 have been approved under OMB control number 0910-0485; the 
collections of information in 21 CFR parts 50 and 56 have been approved 
under OMB control number 0910-0755; the collections of information in 
21 CFR 56.115 have been approved under OMB control number 0910-0130; 
the collections of information in 21 CFR 50.23 have been approved under 
OMB control number 0910-0586; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 312 have been approved under OMB control number 0910-0014; and the 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001. The collections of information in the 
guidance document titled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm311176.pdf) have 
been approved under OMB control number 0910-0756.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07812 Filed 4-13-18; 8:45 am]
 BILLING CODE 4164-01-P