[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Pages 46406-46408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11686]
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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Platform Technology Designation Program; Draft Guidance for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; Availability; Agency Information Collection Activities;
Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Platform Technology Designation Program for Drug Development.'' The
purpose of this draft guidance is to provide details about the
implementation of the Platform Technology Designation Program
established by the PREVENT Pandemics Act. This draft guidance outlines
eligibility factors for receiving a platform technology designation,
potential benefits of receiving a designation, how to leverage data
from designated platform technologies, how to discuss the planned
designation request as part of a milestone meeting, the recommended
content of a designation request submission, and the review timelines
for a designation request. This draft guidance, when finalized, will
represent the current thinking of FDA.
DATES: Submit either electronic or written comments on the draft
guidance by July 29, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by July 29,
2024.
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
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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 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 this draft guidance to
the Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4162, Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your request or include a fax number to which the
draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
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.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Platform Technology Designation Program for Drug
Development.'' This draft guidance provides details about the
implementation of the Platform Technology Designation Program under
section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 356k), which was established by section 2503 of the PREVENT
Pandemics Act (2022) and enacted as part of Public Law 117-328. This
draft guidance, when finalized, will outline criteria for receiving a
platform technology designation, benefits of receiving a designation,
how to leverage data from designated platform technologies, how to
discuss the planned designation request as part of a milestone meeting,
the recommended content of a designation request submission, and the
review timelines for a designation request.
To determine eligibility for designation as a designated platform
technology, FDA will first determine whether the technology qualifies
as a platform technology. Under section 506K(h)(1) of the FD&C Act, a
platform technology is a well understood and reproducible technology,
which can may include a nucleic acid sequence, molecular structure,
mechanism of action, delivery method, vector, or a combination of any
such technologies that FDA determines to be appropriate, where it: (1)
is incorporated in or utilized by a drug and is essential to the
structure or function of such drug; (2) can be adapted for,
incorporated into, or utilized by, more than one drug sharing common
structural elements; and (3) facilitates the manufacture or development
of more than one drug through a standardized production or
manufacturing process or processes. A platform technology designation
does not affect product eligibility for any expedited approval pathways
if it is otherwise eligible. Sponsors of applications or emergency use
authorization requests will also be allowed under certain circumstances
to leverage data related to designated platform technologies previously
submitted to FDA.
Under section 506K(b) of the FD&C Act, a platform technology is
eligible for designation by FDA if: (1) it is incorporated in, or
utilized by, an approved drug; (2) preliminary evidence demonstrates
that the platform technology has the potential to be incorporated in,
or utilized by, more than one drug without an adverse effect on
quality, manufacturing, or safety; and (3) data or information
submitted by the same party indicates that incorporation or utilization
of the platform technology has a reasonable likelihood to bring
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significant efficiencies to the drug development or manufacturing
process and to the review process.
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 the ``Platform
Technology Designation 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. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Investigational New Drug Regulations
OMB Control Number 0910-0014--Revision
This information collection supports implementation of the Platform
Technology Designation Program under section 506K of the FD&C Act. FDA
recommends requesting designation of a platform technology during the
investigational new drug phase of drug development for a planned new
drug application (NDA) or biologics license application (BLA). Any
request for platform technology designation will be reviewed by a team
of FDA experts to evaluate the data and information submitted and to
examine if the platform technology meets the definitional and
eligibility criteria outlined in sections 506K(h)(1) and (b),
respectively, of the FD&C Act. If the sponsor receives a platform
technology designation, then information about the platform designation
can be leveraged in subsequent applications from the same sponsor. A
different sponsor may be able to leverage platform technology data if
they receive a full right of reference to the leveraged data under a
business arrangement with the originator of the platform technology. If
a platform technology receives a platform technology designation, then
FDA may take actions to expedite the development and review of any
subsequent application submitted under section 505(b) of the FD&C Act
or section 351(a) of the Public Health Service Act for a drug that uses
or incorporates the designated platform technology pursuant to section
506K(e) of the FD&C Act.
We are issuing a draft guidance for industry entitled ``Platform
Technology Designation Program for Drug Development,'' which outlines:
(1) criteria for receiving a platform technology designation, (2)
potential benefits of receiving a designation, (3) how to leverage data
from designated platform technologies, (4) how to discuss a planned
designation request as part of a milestone meeting, (5) the recommended
content of a designation request submission, and (6) the review
timelines for a designation request.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\--Platform Technology Designation Program
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Number of
Section 506K of the FD&C act Number of records per Total annual Average burden Total hours
respondents respondents records per record
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Platform technology designation request; Guidance for industry 10 1 10 60 600
section II.C......................................................
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
Our updated figures are based on our experience with the
information collection along with Agency data and reflect burden we
attribute to the applicable reporting requirements and to those
respondents we believe may incur such burden. These activities include
submitting a request for platform technology designation to FDA. These
estimates are based on historical metrics obtained during the first
year of the Platform Technology Designation Program. We estimate that
the number of platform technology designation requests received will
increase after the publication of this guidance.
This draft guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 314 relating to the submissions of NDAs have been approved under
OMB control number 0910-0001. The collections of information in 21 CFR
part 601 relating to the submissions of BLAs have been approved under
OMB control number 0910-0338. The collections of information in 21 CFR
parts 210 and 211 relating to current good manufacturing practice have
been approved under OMB control number 0910-0139.
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: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11686 Filed 5-28-24; 8:45 am]
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