4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1829]
Platform Technology Designation Program; Draft Guidance for Industry; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the
comment period for the draft guidance for industry “Platform Technology Designation Program
for Drug Development” that appeared in the Federal Register of May 29, 2024. In the notice of
availability for the draft guidance, FDA requested comments on the proposed collection of
information. The Agency is taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the draft guidance for industry “Platform
Technology Designation Program for Drug Development” published May 29, 2024, 89 FR
46406. Either electronic or written comments must be submitted by August 28, 2024.
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of August 28, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions) will be considered timely
if they are received on or before that date.
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-1829

for “Platform Technology Designation Program for Drug Development.” Received comments,
those filed in a timely manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Melissa Furness, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4162,
Silver Spring, MD 20993, 240-402-8912; or James Myers, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 29, 2024, FDA
published a notice with a 60-day comment period to request comments on the draft guidance for
industry entitled “Platform Technology Designation Program for Drug Development.” The
Agency has received a request for a 30-day extension of the comment period. The request
conveyed concern that the current 60-day comment period does not allow sufficient time to
develop a meaningful or thoughtful response to the draft guidance.
FDA has considered the request and is extending the comment period for 30 days, until
August 28, 2024. . The Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments on this draft guidance.
Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15696 Filed: 7/16/2024 8:45 am; Publication Date: 7/17/2024]