Notice2023-16150
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
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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
July 31, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 145 (Monday, July 31, 2023)</title>
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[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49467-49469]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
[[Page 49468]]
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-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 <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#e3b3b1a2b097828585a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="93c3c1d2c0e7f2f5f5d3f5f7f2bdfbfbe0bdf4fce5">[email 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 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 <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#42212d2f202b2c23362b2d2c022426236c252d34"><span class="__cf_email__" data-cfemail="b2d1dddfd0dbdcd3c6dbdddcf2d4d6d39cd5ddc4">[email protected]</span></a>.
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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.
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
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