Notice2023-26262
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 30, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 229 (Thursday, November 30, 2023)</title>
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[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83554-83555]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="68383a293b1c090e0e280e0c094600001b460f071e">[email protected]</span></a>.
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 <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#c3a0acaea1aaada2b7aaacad83a5a7a2edababb0eda4acb5"><span class="__cf_email__" data-cfemail="187b77757a7176796c717776587e7c793670706b367f776e">[email 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. 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.
<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="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd">https://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,'' (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 <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,'' (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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products</a>.
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]
BILLING CODE 4164-01-P
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