[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83554-83555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2459]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Product Jurisdiction 
and Combination Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by January 2, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0523. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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 https://www.fda.gov/combination-products/jurisdictional-information. 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 
[email protected].
    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. Although Forms FDA 5003, 
5004, and 5005 (pre-request and request for designation forms) were 
previously developed to facilitate information collection for Pre-RFDs 
and RFDs, 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.
     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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd.
     The guidance document entitled ``How to Prepare a Pre-
Request for Designation,'' (February 2018) was developed to assist 
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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd.
     This information collection also includes burden 
associated with Combination Product Agreement Meetings (CPAM) requests. 
The guidance document entitled, ``Requesting FDA Feedback on 
Combination Products,'' (December 2020) was developed to discuss ways 
in which combination product sponsors can obtain feedback from FDA on 
scientific and regulatory questions and to describe best practices for 
FDA and sponsors when interacting on these topics. The guidance is 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products.
    The guidance documents were issued consistent 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 2020, 2021, and 2022, we account for 135 
respondents annually.
    In the Federal Register of July 31, 2023 (88 FR 49467), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. One comment was received expressing interest in 
combination product

[[Page 83555]]

submissions, but was not responsive to the four information collection 
topics solicited in our notice and therefore we do not discuss the 
comment here.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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3.7; request for designation                  55               1              55              24           1,320
 (RFD)..........................
Pre-RFD submissions.............              77               1              77              24           1,848
CPAM requests...................               3               1               3              25              75
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    Total.......................  ..............  ..............  ..............  ..............           3,243
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden reflects a decrease in the number of 
respondents (four respondents) and a corresponding decrease in total 
hours (96 hours). Based on a recent evaluation of CPAM requests 
received from each product center in fiscal years 2020, 2021, and 2022, 
our estimated annual burden for CPAM requests remains unchanged.

    Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26262 Filed 11-29-23; 8:45 am]
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