[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49467-49469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) 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 September 29, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 29, 2023. 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

[[Page 49468]]

Comments submitted electronically, including attachments, to https://www.regulations.gov 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 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-2023-N-2459 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 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.

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, 
[email protected].

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 extension of 
the existing 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 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].

[[Page 49469]]

    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.
    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: July 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16150 Filed 7-28-23; 8:45 am]
BILLING CODE 4164-01-P


