88 FR 118 pgs. 40273-40275 - Oncology Drug Products Used With Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability
Type: NOTICEVolume: 88Number: 118Pages: 40273 - 40275
Pages: 40273, 40274, 40275Docket number: [Docket No. FDA-2022-D-2275]
FR document: [FR Doc. 2023-13134 Filed 6-20-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
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.
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:
[top]
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 (§?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 (§?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 CDRH-Guidance@fda.hhs.gov 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:
| 21 CFR part; guidance; or FDA form | Topic | OMB control No. |
|---|---|---|
| 807, subpart E | Premarket notification | 0910-0120 |
| 814, subparts A through E | Premarket approval | 0910-0231 |
| 860, subpart D | De Novo classification process | 0910-0844 |
| 312 | Investigational new drug applications | 0910-0014 |
| 314 | New drug applications | 0910-0001 |
| 601 | Biologic license applications | 0910-0338 |
[top]
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13134 Filed 6-20-23; 8:45 am]
BILLING CODE 4164-01-P