[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Platform Technology Designation Program; Draft Guidance for 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announcing the availability of a draft guidance for industry entitled 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purpose of this draft guidance is to provide details about the 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 This draft guidance outlines 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 This draft guidance, when finalized, will 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DATES: Submit either electronic or written comments on the draft 
guidance by July 29, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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proposed collection of information in the draft guidance by July 29, 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

[[Page 46407]]

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

[[Page 46408]]

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]
BILLING CODE 4164-01-P