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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106516-106518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31305]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-4490]

Combined Food and Drug Administration and Sponsor Oncologic Drugs 
Advisory Committee Briefing Document; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Combined 
FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing 
Document.'' This draft guidance provides recommendations to sponsors 
regarding use and development of a combined version of the ODAC 
briefing document, as part of the Oncology Center of Excellence's (OCE) 
Project Point/Counterpoint initiative. This single document includes 
information that customarily would be contained in separate briefing 
documents prepared individually by the Sponsor and FDA. Project Point/
Counterpoint is an option for advisory committee meetings for oncology 
products. Sponsors in non-oncology therapeutic areas who want to 
discuss whether a combined advisory committee briefing document may be 
appropriate for their applications should contact the relevant review 
division. This briefing document format may provide efficiencies by 
allowing Sponsors and FDA to choose to use a single document that 
provides the views of the Sponsor and FDA on key issues.

[[Page 106517]]

DATES: Submit either electronic or written comments on the draft 
guidance by February 28, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2024-D-4490 for ``Combined FDA and Sponsor Oncologic Drugs Advisory 
Committee (ODAC) Briefing Document.'' 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)).
    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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Gao or Jamie Brewer, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-4683 or 240-
402-4463; or James Myers, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993, 240-402-5923.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Combined FDA and Sponsor Oncologic Drugs Advisory Committee 
(ODAC) Briefing Document.'' This guidance provides recommendations to 
sponsors regarding use and development of a combined version of the 
briefing document for matters before the ODAC, as part of the OCE 
Project Point/Counterpoint initiative. This single briefing document 
includes information that customarily would be contained in separate 
briefing documents prepared individually by the Sponsor and FDA. 
Project Point/Counterpoint is an option for advisory committee meetings 
for oncology products. Sponsors in non-oncology therapeutic areas who 
want to discuss whether a combined advisory committee briefing document 
may be appropriate for their applications should contact the relevant 
review division.
    Sponsors and FDA customarily prepare their own separate ODAC 
briefing documents. This can lead to repetition of information (i.e., 
trial design, endpoints, eligibility criteria, etc.) and increases the 
number of documents that ODAC committee members need to review. 
Additionally, ODAC committee members may need to go back and forth from 
each briefing document to consider the Sponsor's and FDA's position on 
each issue. Project Point/Counterpoint may provide efficiencies by 
allowing Sponsors and FDA to choose to use a single document that 
provides the views of the Sponsor and FDA on key issues.
    The combined briefing document was first piloted for use at an ODAC 
meeting in December 2019. This format decreases the number of documents 
ODAC members must review by providing the applicant's and FDA's 
positions in one document. It serves as a stand-alone document 
containing the background information and an objective description of 
the data for the clinical trial or topic under discussion at ODAC, 
followed by the positions of the Sponsor and FDA.
    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 ``Combined FDA 
and Sponsor

[[Page 106518]]

Oncologic Drugs Advisory Committee (ODAC) Briefing Document.'' 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. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 18, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31305 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
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