Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability, 16366-16367 [2018-07812]
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16366
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
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Determination; Draft Guidance for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.
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announcing the availability of a draft
guidance for industry entitled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 codevelopment 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written comments on the draft guidance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draft guidance before it begins work on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:
srobinson on DSK3G9T082PROD with NOTICES
SUMMARY:
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,
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
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
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
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/201523389.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 CDRH-Guidance@fda.hhs.gov.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
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.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16APN1.SGM
16APN1
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
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 codevelopment 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 codevelopment 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.
srobinson on DSK3G9T082PROD with NOTICES
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
19:42 Apr 13, 2018
Jkt 244001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Special
Protocol Assessment.’’ This guidance
provides information about the
procedures and general policies adopted
by the Center for Drug Evaluation and
Research and the Center for Biologics
Evaluation and Research for special
protocol assessment (SPA). This
guidance is intended to improve the
quality of requests for SPAs and
accompanying submission materials,
and the quality of the resulting
interactions between sponsors and FDA.
This guidance finalizes the draft
guidance of the same name issued May
4, 2016, and replaces the guidance of
the same name issued May 17, 2002.
DATES: The announcement of the
guidance is published in the Federal
Register on April 16, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Food and Drug Administration
II. The Paperwork Reduction Act of
1995
VerDate Sep<11>2014
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 PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
(available at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/documents/document/
ucm311176.pdf) have been approved
under OMB control number 0910–0756.
16367
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’’).
[Docket No. FDA–2016–D–1174]
Written/Paper Submissions
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Special Protocol Assessment;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of availability.
Frm 00083
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
