Notice2024-15696
Platform Technology Designation Program; Draft Guidance for Industry; Extension of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 17, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry "Platform Technology Designation Program for Drug Development" that appeared in the Federal Register of May 29, 2024. In the notice of availability for the draft guidance, FDA requested comments on the proposed collection of information.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.
Full Text
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<title>Federal Register, Volume 89 Issue 137 (Wednesday, July 17, 2024)</title>
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[Federal Register Volume 89, Number 137 (Wednesday, July 17, 2024)]
[Notices]
[Pages 58166-58167]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15696]
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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Platform Technology Designation Program; Draft Guidance for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.
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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extending the comment period for the draft guidance for industry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availability for the draft guidance, FDA requested comments on the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DATES: FDA is extending the comment period on the draft guidance for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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
[[Page 58167]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 7-16-24; 8:45 am]
BILLING CODE 4164-01-P
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