[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40273-40275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 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 [email protected] 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