Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products, 49467-49469 [2023-16150]
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Federal Register / Vol. 88, No. 145 / Monday, July 31, 2023 / Notices
determined necessary and appropriate
by the Secretaries.
• Ali Khawar—Secretary of Labor’s
Designee.
• Carol Weiser—Secretary of the
Treasury’s Designee.
• Rogelyn McLean—Secretary of
Health and Human Services’ Designee.
• Gamunu Wijetunge—Department of
Transportation—National Highway
Traffic Safety Administration.
• Suzanne Prentiss—State Insurance
Regulators.
• Adam Beck—Health Insurance
Providers.
• Patricia Kelmar—Consumer
Advocacy Groups.
• Gary Wingrove—Patient Advocacy
Groups.
• Ayobami Ogunsola—State and
Local Governments.
• Ritu Sahni—Physician specializing
in emergency, trauma, cardiac, or stroke.
• Peter Lawrence—State Emergency
Medical Services Officials.
• Shawn Baird—Emergency Medical
Technicians, Paramedics, and Other
Emergency Medical Services Personnel.
• Edward Van Horne—Representative
of Various Segments of the Ground
Ambulance Industry.
• Regina Godette-Crawford—
Representative of Various Segments of
the Ground Ambulance Industry.
• Rhonda Holden—Representative of
Various Segments of the Ground
Ambulance Industry.
• Loren Adler—Additional
Representative determined necessary
and appropriate by the Secretaries
The GAPB Advisory Committee
Roster is also available on the GAPB
Advisory Committee website at: https://
www.cms.gov/regulations-guidance/
advisory-committees/advisorycommittee-ground-ambulance-andpatient-billing-gapb. All future updates
to the Advisory Committee Roster will
be published on this website.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Meeting Agenda
The second public meeting of the
GAPB Advisory Committee will take
place on August 16, 2023. During this
meeting, the Committee will review and
discuss preliminary findings and
recommendations from its two
subcommittees. The agenda will cover
the following topics:
• Preliminary findings and
recommendations of the GAPB Advisory
Committee’s subcommittee on Network
Adequacy and Cost/Payment Structures.
• Preliminary findings and
recommendations of the GAPB Advisory
Committee’s subcommittee on Public/
Consumer Disclosures and Protections.
A more detailed agenda and materials
will be made available prior to the
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meeting on the GAPB Advisory
Committee website (listed previously).
Anticipated Dates for Future GAPB
Advisory Committee Meetings
The Centers for Medicare & Medicaid
Services (CMS) expects to convene
future GAPB Advisory Committee
Meetings on the following dates:
October 31, 2023 and November 1, 2023.
Agendas and registration information
for future meeting dates will be
published in the Federal Register and
on the GAPB Advisory Committee
website closer to the anticipated
meeting dates, which are subject to
change.
IV. Public Participation
The August 16, 2023, GAPB Advisory
Committee meeting will be open to the
public. Attendance may be limited due
to virtual meeting constraints. Interested
parties are encouraged to register as far
in advance of the meeting as possible.
To register for the meeting visit: https://
www.cms.gov/regulations-guidance/
advisory-committees/advisorycommittee-ground-ambulance-andpatient-billing-gapb. CMS is committed
to providing equal access to this
meeting for all participants and to
ensuring section 508 compliance.
Closed captioning will be provided. To
request alternative formats or services
because of a disability, such as sign
language interpreters or other ancillary
aids, refer to the appropriate contact
listed in the FOR FURTHER INFORMATION
CONTACT section.
V. Submitting Written Comments
Members of the public may submit
written comments for consideration by
the Committee at any time via email to
gapbadvisorycommittee@cms.hhs.gov.
Additionally, members of the public
will have the opportunity to submit
comments during the August 16, 2023,
virtual meeting through the chat feature
of the Zoom webinar platform. Members
of the public are encouraged to submit
lengthy written comments on topics
discussed during the meeting to the
email address in the DATES section by
September 5, 2023, to ensure timely
consideration by the Committee.
VI. Viewing Documents
You may view the documents
discussed in this notice at https://
www.cms.gov/regulations-guidance/
advisory-committees/advisorycommittee-ground-ambulance-andpatient-billing-gapb.
The Administrator of CMS, Chiquita
Brooks-LaSure, having reviewed and
approved this document, authorizes
Evell J. Barco Holland, who is the
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49467
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–16146 Filed 7–28–23; 8:45 am]
BILLING CODE 4120–01–P
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.
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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Federal Register / Vol. 88, No. 145 / Monday, July 31, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
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18:11 Jul 28, 2023
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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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/jurisdictionalinformation. 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 combination@
fda.gov.
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Federal Register / Vol. 88, No. 145 / Monday, July 31, 2023 / Notices
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/howwrite-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/regulatoryinformation/search-fda-guidancedocuments/how-prepare-pre-requestdesignation-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/regulatoryinformation/search-fda-guidancedocuments/requesting-fda-feedbackcombination-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
Number of
respondents
21 CFR section; activity
Total annual
responses
Average
burden per
response
Total hours
3.7; request for designation (RFD) ......................................
Pre-RFD submissions ..........................................................
CPAM requests ....................................................................
55
77
3
1
1
1
55
77
3
24
24
25
1,320
1,848
75
Total ..............................................................................
........................
........................
........................
........................
3,243
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.
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2707]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2023–16150 Filed 7–28–23; 8:45 am]
ACTION:
BILLING CODE 4164–01–P
SUMMARY:
VerDate Sep<11>2014
18:11 Jul 28, 2023
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
Jkt 259001
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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 the information
collection provisions of our reporting
requirements contained in FDA
regulations governing state petitions for
exemption from preemption.
Either electronic or written
comments on the collection of
information must be submitted by
September 29, 2023.
DATES:
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
ADDRESSES:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
