83 FR 63166 - Developing and Labeling In vitro

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 235 (December 7, 2018)

Page Range		63166-63167
FR Document		2018-26554

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.'' This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The draft guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader evidence-based indications will optimally facilitate clinical use.

Federal Register, Volume 83 Issue 235 (Friday, December 7, 2018)

[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63166-63167]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-26554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3380]

Developing and Labeling In vitro Companion Diagnostic Devices for
a Specific Group or Class of Oncology Therapeutic Products; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Developing
and Labeling In vitro Companion Diagnostic Devices for a Specific Group
or Class of Oncology Therapeutic Products.'' This draft guidance
describes considerations for the development and labeling of in vitro
companion diagnostic devices (referred to as companion diagnostics in
this document) to support the indicated uses of multiple drug or
biologic oncology products (referred to as therapeutic products or
oncology therapeutic products in this document), when appropriate. The
draft guidance includes factors for considering when broader labeling
(i.e., labeling that is expanded) of a companion diagnostic would be
appropriate. Oncology companion diagnostics with broader evidence-based
indications will optimally facilitate clinical use.

DATES: Submit either electronic or written comments on the draft
guidance by February 5, 2019 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-3380 for ``Developing and Labeling In vitro Companion
Diagnostic Devices for a Specific Group or Class of Oncology
Therapeutic Products.'' 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 the draft guidance to
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;
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or 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. Send one self-addressed adhesive label to assist that
office in processing your requests. The draft guidance may also be
obtained by mail by calling FDA's Center for Biologics Evaluation and
Research (CBER) at 1-800-835-4709 or 240-402-8010. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: 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; Reena Philip, Center for

[[Page 63167]]

Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5680, Silver Spring, MD 20993-0002,
301-796-6179; or Julie Schneider, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 2208, Silver Spring, MD 20993-0002, 240-402-4658.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Developing and Labeling In vitro Companion Diagnostic
Devices for a Specific Group or Class of Oncology Therapeutic
Products.'' This draft guidance describes considerations for the
development and labeling of companion diagnostics to support the
indicated uses of multiple therapeutic oncology products, when
appropriate. This draft guidance expands on existing policy,
surrounding broader labeling, which notes that in some cases, if
evidence is sufficient to conclude that the companion diagnostic is
appropriate for use with a specific group or class of therapeutic
products (as discussed in the draft guidance), the companion
diagnostic's intended use/indications for use should name the specific
group or class of therapeutic products, rather than specific products.
To describe FDA's thinking on the topic, the draft guidance discusses a
specific example of companion diagnostics for a specific biomarker,
disease, and specimen type (specific epidermal growth factor receptor
mutations in tumors of patients with nonsmall cell lung cancer in
tissue specimens).
Trials designed to support approval of a specific therapeutic
product and a specific companion diagnostic have led to companion
diagnostic labels that reference only a specific therapeutic
product(s). Such specificity in labeling can limit a potentially
broader use of a companion diagnostic that may be scientifically
appropriate. In clinical practice, an oncologist generally considers
the mutation profile of the tumor along with other factors when
determining the treatment for a patient, such as the toxicity profile
of the therapeutic product, the patient's preference, and formulary
options. When a companion diagnostic is labeled for use with a specific
therapeutic product, the clinician may need to order a different
companion diagnostic (i.e., one that includes other therapeutic
products in the labeling), obtain an additional biopsy(ies) from a
patient, or both, to have additional therapy treatment options.
The draft guidance describes considerations for when broader
labeling may be scientifically appropriate and when it may not. FDA
recommends developers of therapeutic oncology products and associated
companion diagnostics collaboratively consider development programs
that may result in broader labeling of companion diagnostics that are
most clinically useful. Developers are encouraged to discuss
development programs that could result in broader labeling with the
CBER, Center for Devices and Radiological Health (CDRH), or Center for
Drug Evaluation and Research, in coordination with the Oncology Center
of Excellence, as appropriate, early to determine if the approach
described in this guidance is appropriate for consideration. Developers
whose approved companion diagnostics may be appropriate for broader
labeling are encouraged to contact CDRH or CBER, as appropriate, to
discuss.
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 current thinking of FDA on ``Developing
and Labeling In vitro Companion Diagnostic Devices for a Specific Group
or Class of Oncology Therapeutic Products.'' 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. Other Issues for Consideration

In addition to providing stakeholders an opportunity to comment on
the draft guidance, the Agency is interested in responses from
stakeholders to the following:
1. Please describe any specific challenges with developing the
evidence needed to identify in labeling a companion diagnostic for use
with a specific group or class of oncology therapeutic products, rather
than a specific therapeutic product. For example, please describe any
challenges resulting from industry or business practices, including
business agreements. What actions can FDA take to address the
challenge(s)?
2. Please describe any specific challenges with submitting a
premarket approval (PMA) supplement to FDA to expand the labeling for
an approved companion diagnostic for use with a specific group or class
of oncology therapeutic products. What actions can FDA take to address
the challenge(s)?
3. Please describe any additional actions FDA can take to
facilitate or encourage broader, evidence-based labeling that supports
the use of a specific group or class of oncology therapeutic products
with a companion diagnostic.
4. The guidance notes that variations in defined cut-points
established for specific biomarkers for companion diagnostics can lead
to challenges in implementing broader labeling for a specific group or
class of oncology therapeutic products. Are there actions that FDA, or
the broader scientific community, can take to facilitate
standardization in this area?

III. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance. 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 parts 801 and 809 have
been approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
814, subparts A through E, have been approved under OMB control number
0910-0231; the collections of information in 21 CFR part 814, subpart
H, have been approved under OMB control number 0910-0332; the
collections of information in the guidance document ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756; and the collections of information
in the guidance ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844.

IV. Electronic Access

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

Dated: December 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26554 Filed 12-6-18; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2018-12-07 01:53:03
Document Modified: 2018-12-07 01:53:03

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		Submit either electronic or written comments on the draft guidance by February 5, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		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; Reena Philip, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5680, Silver Spring, MD 20993-0002, 301-796-6179; or Julie Schneider, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2208, Silver Spring, MD 20993-0002, 240-402-4658.
FR Citation		83 FR 63166

83 FR 63166 - Developing and Labeling In vitro

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 235 (December 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration