Notice2023-13134
Oncology Drug Products Used With Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability
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Published
June 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, clinical laboratories, and FDA staff entitled ``Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program.'' FDA is issuing this guidance to announce and describe FDA's voluntary pilot program for certain oncology drug products regulated by FDA's Center for Drug Evaluation and Research (CDER) used with certain in vitro diagnostic tests. FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers should meet. Through this transparency FDA seeks to support better and more consistent performance of certain laboratory-developed tests (LDTs) used to identify patients for treatment with certain oncology drug products, resulting in better drug selection and improved care for patients with cancer. The guidance has been implemented without prior comment, but remains subject to comment in accordance with the Agency's good guidance practices.
Full Text
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<title>Federal Register, Volume 88 Issue 118 (Wednesday, June 21, 2023)</title>
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[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40273-40275]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13134]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-2275]
Oncology Drug Products Used With Certain In Vitro Diagnostic
Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and
Food and Drug Administration Staff; 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, clinical
laboratories, and FDA staff entitled ``Oncology Drug Products Used with
Certain In Vitro Diagnostic Tests: Pilot Program.'' FDA is issuing this
guidance to announce and describe FDA's voluntary pilot program for
certain oncology drug products regulated by FDA's Center for Drug
Evaluation and Research (CDER) used with certain in vitro diagnostic
tests. FDA intends to pilot a new approach to provide greater
transparency regarding performance characteristics that certain tests
for oncology biomarkers should meet. Through this transparency FDA
seeks to support better and more consistent performance of certain
laboratory-developed tests (LDTs) used to identify patients for
treatment with certain oncology drug products, resulting in better drug
selection and improved care for patients with cancer. The guidance has
been implemented without prior comment, but remains subject to comment
in accordance with the Agency's good guidance practices.
DATES: The announcement of the guidance is published in the Federal
Register on June 21, 2023.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-2275 for ``Oncology Drug Products Used with Certain In Vitro
Diagnostic Tests: Pilot Program.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for single copies of the 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 to the Office of Policy, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Brittany Schuck, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-
796-5199 or Reena Philip, Oncology Center of Excellence, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-6179.
SUPPLEMENTARY INFORMATION:
[[Page 40274]]
I. Background
We are announcing the availability of a guidance for industry,
clinical laboratories, and FDA staff entitled ``Oncology Drug Products
Used with Certain In Vitro Diagnostic Tests: Pilot Program.'' We are
issuing this guidance consistent with our good guidance practices (GGP)
regulation (Sec. 10.115 (21 CFR 10.115)). We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). The pilot is intended to provide greater transparency
regarding performance characteristics that certain tests for oncology
biomarkers should meet. Although this guidance document is being
implemented without prior public comment, it remains subject to comment
in accordance with FDA's GGP regulation.
An in vitro companion diagnostic test (also known as an in vitro
companion diagnostic device) provides information that is essential for
the safe and effective use of a corresponding therapeutic product. FDA
is issuing this guidance to announce and describe FDA's voluntary pilot
program for drug product sponsors with regard to certain CDER-regulated
oncology drug products for which FDA determines that use of an in vitro
diagnostic test is needed to identify the intended patient population,
and corresponding clinical trial assay(s) that use the same technology
as a previously FDA-authorized companion diagnostic test for any
indication for which there is a well-validated reference method, well-
validated comparator method, and/or well-characterized materials that
can be used to support test accuracy. This pilot is intended for tests
for which FDA believes it is appropriate to extrapolate clinical
validity of the test(s) used to select patients in a drug trial to
other tests of the same type with similar analytical performance. In
this pilot, FDA will evaluate no more than nine sponsors for possible
acceptance into the pilot based on evaluation of the factors described
in the guidance. Sponsors who are interested in being considered for
the voluntary pilot program and who affirm their commitment to provide
information set forth in the guidance if FDA subsequently requests that
they do so should submit correspondence titled ``Statement of interest
in participation in the Oncology Drug Products Used with Certain In
Vitro Diagnostic Tests: Pilot Program'' to their Investigational New
Drug (IND) applications, New Drug Applications (NDA), or Biologic
License Applications (BLA), as appropriate.
Under this pilot, if FDA concludes that the drug product meets the
applicable standards for its approval, FDA intends to rely on the same
pivotal clinical trial(s) that support approval of the drug product to
establish the clinical validity for the clinical trial assays (CTAs)
used in those trial(s). Further, FDA intends to recommend minimum
analytical performance characteristics for other tests that, when
established through properly conducted validation studies, FDA believes
would support extrapolation of the clinical validity of the CTA(s) to
additional tests of the same type. If FDA approves an oncology drug
product enrolled in this pilot program, FDA intends to recommend
minimum performance characteristics for in vitro diagnostic tests to
identify patients for treatment with those drug products, and make this
information publicly available on FDA's website.
The guidance represents the current thinking of FDA on ``Oncology
Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot
Program.'' 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.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>. Persons unable to download an electronic copy of ``Oncology Drug
Products Used with Certain In Vitro Diagnostic Tests: Pilot Program''
may send an email request to <a href="/cdn-cgi/l/email-protection#b9fafdebf194feccd0ddd8d7dadcf9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="733037213b5e34061a17121d1016331517125d1b1b005d141c05">[email protected]</span></a> to receive an
electronic copy of the document. Please use the document number 22001
and complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
For this pilot, FDA will request information from no more than 9
sponsors. Initial statements of interest from sponsors interested in
being evaluated for participation in the pilot, as described in the
guidance, are not ``information'' in accordance with 5 CFR
1320.3(h)(1). Thus, this guidance contains no new collection of
information.
While this guidance contains no new collection of information, to
the extent the guidance does refer to previously approved FDA
collections of information, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations,
guidance, and forms have been approved by OMB as listed in the
following table:
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21 CFR part; guidance; or FDA
form Topic OMB control No.
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807, subpart E................ Premarket 0910-0120
notification.
814, subparts A through E..... Premarket approval... 0910-0231
860, subpart D................ De Novo 0910-0844
classification
process.
312........................... Investigational new 0910-0014
drug applications.
314........................... New drug applications 0910-0001
601........................... Biologic license 0910-0338
applications.
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[[Page 40275]]
Dated: June 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13134 Filed 6-20-23; 8:45 am]
BILLING CODE 4164-01-P
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