[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54613-54615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22117]


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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; 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 final 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 at FDA, describes an 
optional streamlined submission process to determine whether use of an 
investigational in vitro diagnostic in an oncology clinical trial is 
considered significant risk, nonsignificant risk, or exempt from 
investigational device exemption requirements. In the streamlined 
process, the sponsor submits all information about the oncology trial 
(including information about the investigational in vitro diagnostic) 
to the investigational new drug application (IND). As part of IND 
review, the Center for Biologics Evaluation and Research (CBER) works 
with the Center for Drug Evaluation and Research (CDER), or CDER or 
CBER works with the Center for Devices and Radiological Health (CDRH), 
as appropriate, to determine if the investigational in vitro diagnostic 
is significant risk, nonsignificant risk, or exempt.

DATES: The announcement of the guidance is published in the Federal 
Register on October 10, 2019.

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

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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.'' 
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 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; the Office of 
Communication and Education, CDRH-Division of Industry and Consumer 
Education, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, 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: Julie Schneider, Oncology Center of 
Excellence, 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: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Investigational In Vitro Diagnostics in Oncology Trials: 
Streamlined Submission Process for Study Risk Determination.'' This 
guidance describes an optional streamlined submission process for 
determining whether use of an investigational in vitro diagnostic in an 
oncology clinical trial under an IND (an oncology codevelopment 
program) is significant risk, nonsignificant risk, or exempt from 
investigational device exemption requirements.
    In the traditional submission process, many sponsors submitted a 
study risk determination Q-submission to the appropriate center (CDRH 
or CBER) and an IND to the appropriate center (CBER or CDER). In the 
streamlined process, all information regarding the oncology 
codevelopment program (including investigational in vitro diagnostic 
information) is initially submitted to the IND. CBER or CDER works with 
CDRH or CDER works with CBER, as appropriate, to determine whether the 
investigational in vitro diagnostic is significant risk, nonsignificant 
risk, or exempt. If the investigational in vitro diagnostic in the 
trial is determined to be significant risk in the streamlined process, 
the sponsor may need to submit an investigational device exemption to 
CDRH in addition to submitting an IND to CDER.
    This guidance finalizes the draft guidance of the same name issued 
on April 16, 2018 (83 FR 16366). All public comments received on the 
draft guidance have been considered, and the guidance has been revised 
as appropriate along with a few editorial changes. Major changes from 
the draft to the final version included adding language to clarify that 
sponsors will receive significant risk determinations within the 30-day 
review period for the IND and to clarify that the streamlined 
submission process only applies to new INDs (not additional protocols 
added to an existing IND, or IND amendments) and adding the definition 
of noninvasive in 21 CFR 812.3(k) to the glossary.
    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 ``Investigational In Vitro Diagnostics in 
Oncology Trials: Streamlined Submission Process for Study Risk 
Determination.'' 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. 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

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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 entitled ``Requests for Feedback and Meetings for 
Medical Device Submissions: The Q-Submission Program'' (available at 
https://www.fda.gov/media/114034/download) have been approved under OMB 
control number 0910-0756.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22117 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P