Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with product jurisdiction and combination product regulations.

Full Text

<html>
<head>
<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Notices]
[Pages 66852-66854]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21713]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-11261]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Product Jurisdiction and Combination Products

AGENCY: Food and Drug Administration, HHS.

[[Page 66853]]


ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection associated with 
product jurisdiction and combination product regulations.

DATES: Either electronic or written comments on the collection of 
information must be submitted by December 22, 2026.

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 December 22, 2026. 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-2026-N-11261 for ``Product Jurisdiction and Combination Products.'' 
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 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: 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, 
<a href="/cdn-cgi/l/email-protection#217173607255404747614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the 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, including 
each proposed extension of an existing 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.

Product Jurisdiction and Combination Products--21 CFR Parts 3 and 4

OMB Control Number 0910-0523--Extension

    This information collection helps support implementation of 
statutory requirements that govern product jurisdiction and combination 
products. Congress expressly directed FDA to

[[Page 66854]]

assign combination products to the appropriate Agency component for 
regulation as set forth in section 503(g) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)). Congress also expressly 
directed FDA to determine the classification of a product as a drug, 
biological product, device, or combination product, or the component of 
the Agency that will regulate the product, as applicable, in response 
to a request submitted under section 563 of the FD&C Act (21 U.S.C. 
360bbb-2). Regulations in 21 CFR part 3 provide for product 
classification determinations and FDA designation on which Agency 
component will have primary jurisdiction for any drug, device, 
biological, or combination product, where such jurisdiction is unclear 
or in dispute. These determinations are made by our Office of 
Combination Products (OCP) upon receiving Requests for Designation 
(RFDs). We maintain a web page that includes contact and resource 
information pertaining to the RFDs process at <a href="https://www.fda.gov/combination-products/jurisdictional-information">https://www.fda.gov/combination-products/jurisdictional-information</a>. As communicated on our 
web page, FDA welcomes comments from interested stakeholders on issues 
pertaining to OCP and encourages medical product developers to contact 
us if they are uncertain about the classification or assignment of 
their products and with questions regarding premarket or postmarket 
considerations for combination products. A dedicated mailbox is 
established at <a href="/cdn-cgi/l/email-protection#b6d5d9dbd4dfd8d7c2dfd9d8f6d0d2d798d1d9c0"><span class="__cf_email__" data-cfemail="81e2eeece3e8efe0f5e8eeefc1e7e5e0afe6eef7">[email&#160;protected]</span></a>.
    Similar to the RFD process, we have established the Pre-RFD process 
for sponsors to obtain preliminary, nonbinding feedback regarding 
medical product classification and assignment. Forms FDA 5003 and 5004 
(RFD and Pre-RFD forms) have been developed to facilitate information 
collection for RFDs and Pre-RFDs, we expect to explore implementing the 
forms as resources become available. At the same time, we have more 
recently issued the following Agency guidance documents to provide 
instruction and recommendations to respondents regarding the submission 
of RFDs and Pre-RFDs.
    <bullet> The guidance document entitled, ``How to Write a Request 
for Designation'' (April 2011), provides instruction regarding the 
information that needs to be submitted to OCP in an RFD as described in 
21 CFR 3.7. The guidance is available at <a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd">http://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd</a>.
    <bullet> The guidance document entitled ``How to Prepare a Pre-
Request for Designation,'' (revised November 2025) assists sponsors in 
obtaining a preliminary, non-binding assessment regarding the 
classification and assignment of products from OCP through the Pre-RFD 
process. The guidance explains the Pre-RFD process and helps a sponsor 
understand the type of information to provide in a Pre-RFD submission. 
The guidance is available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd</a>.
    <bullet> This information collection also includes burden 
associated with Combination Product Agreement Meetings (CPAM) requests. 
The guidance document entitled, ``Requesting FDA Feedback on 
Combination Products,'' (issued December 2020) addresses ways in which 
combination product sponsors can obtain feedback from FDA on scientific 
and regulatory questions and describes best practices for FDA and 
sponsors when interacting on these topics. The guidance is available at 
<a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products">http://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products</a>.
    The guidance documents were issued consistent with sections 503(g) 
and 563 of the FD&C Act and with our good guidance practice regulations 
in 21 CFR 10.115, which provide for public comment at any time.
    The information collection also includes regulations in 21 CFR part 
4 that govern current good manufacturing practice requirements and 
postmarketing safety requirements for combination products. We expect, 
however, that burden attendant to the associated recordkeeping, 
reporting, and/or disclosure activities is already accounted for in 
approved information collections that apply to drug, device, and/or 
biologic products specifically and respectively. Therefore, we do not 
ascribe separate burden in this information collection request for the 
activities generated by these requirements.
    Respondents to the information collection are sponsors of medical 
products, including combination products. Based on submissions received 
by OCP during fiscal years 2022, 2023, and 2024, we account for 149 
respondents annually.
    We estimate the burden of this collection of information as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
3.7; request for designation                  52               1              52              24           1,248
 (RFD)..........................
Pre-RFD submissions.............              94               1              94              24           2,256
CPAM requests...................               3               1               3              25              75
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,579
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase of 336 hours and a corresponding increase of 14 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years. Our estimated annual 
burden for CPAM requests remains unchanged.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21713 Filed 10-22-26; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>