[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Advisory Committee Briefing Document; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``Combined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 This draft guidance provides recommendations to sponsors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DATES: Submit either electronic or written comments on the draft
guidance by February 28, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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]
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