Agency Information Collection Activities; Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey, 44993-44994 [2024-11234]
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
addition, manufacturers of medical
devices are required to submit to FDA
individual adverse event reports of
death, serious injury, and malfunctions
(§ 803.50).
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
510(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
part 803).
Based on a review of the information
collection from our last request for OMB
approval, we estimate that the number
of manufacturers of automated blood
cell separator devices remains
unchanged. As a result, we have made
no adjustments to our burden estimates.
Dated: May 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11237 Filed 5–21–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1894]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Yale-Mayo Clinic
Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric
Device Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 reinstatement
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
collections associated with the ‘‘YaleMayo Clinic Centers of Excellence in
Regulatory Science and Innovation
(CERSI) B12 Pediatric Device Survey.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by July
22, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:06 May 21, 2024
Jkt 262001
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
July 22, 2024. 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.
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–
2022–N–1894 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; YaleMayo Clinic Centers of Excellence in
Regulatory Science and Innovation B12
Pediatric Device Survey.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
44993
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-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:
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, 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
E:\FR\FM\22MYN1.SGM
22MYN1
44994
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
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 reinstatement
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 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.
Yale-Mayo Clinic Centers of Excellence
in Regulatory Science and Innovation
(CERSI) B12 Pediatric Device Survey
OMB Control Number 0910–0912—
Reinstatement
Despite numerous legislative,
regulatory, and scientific efforts, there
has been little change in the number of
devices approved for use in pediatric
patients. This has often led to devices
being adapted for use in children
without an appropriate level of
evidence, exposing them to inconsistent
benefit risk profiles. This health
inequity highlights the need for devices
that are designed, evaluated, and
labeled for pediatric patients. To
address these challenges, this collection
is being done to survey industry and
other key stakeholders in the medical
device ecosystem to identify the barriers
that prevent product developers from
entering the pediatric device market as
well as the proper incentives that would
motivate them to innovate and sustain
within this market.
This survey is a followup to the
public meeting that FDA held in August
2018, entitled, ‘‘Pediatric Medical
Device Development.’’ As mandated by
section 502(d) of the FDA
Reauthorization Act of 2017 (Pub. L.
115–52) the meeting was convened to
address several topics, including
consideration of ways to: (1) increase
FDA assistance to medical device
manufacturers in developing devices for
pediatric populations that are approved
or cleared, and labeled, for their use and
(2) identify current barriers to pediatric
device development and incentives to
address such barriers.
Feedback from this meeting clarified
the need to better understand factors
influencing suboptimal engagement and
participation by diverse innovators in
the pediatric medical device space.
Information garnered from this survey
may help inform strategic plans to
optimize existing programs for the
needs of pediatric medical device
innovators and develop new programs
that will support sustained development
in this space.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours 2
Phone Survey ..............................................................
Online Survey ..............................................................
17
56
1
1
17
56
0.5 (30 minutes) .....
1 .............................
9
56
Total ......................................................................
........................
........................
........................
................................
65
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest hour.
khammond on DSKJM1Z7X2PROD with NOTICES
2 Rounded
The targeted groups for this collection
of information include representatives
from the medical device industry,
academia, recipients of funding under
section 305 of the Pediatric Medical
Device Safety and Improvement Act of
2007 (Pub. L. 110–85; 42 U.S.C. 282
note), and trade organizations, medical
provider organizations, organizations
and individuals involved with financing
and reimbursement associated with
medical devices, pediatric healthcare
leaders, clinicians who regularly use
medical devices in caring for children,
and organizations and individuals
representing patients and consumers.
Phone survey: Respondents
participating in the phone survey will
be executives from companies either
producing products in pediatrics or
VerDate Sep<11>2014
17:06 May 21, 2024
Jkt 262001
from companies that produce products
that could be used in pediatrics.
Executives will be invited to engage in
the 30-minute phone survey.
Online survey: The 1-hour online
survey will be administered to leaders
within pediatric companies and key
decision makers in the pediatric
medical device industry (e.g., venture
capitalists, banking investors, leaders in
children’s hospitals and research
networks, and pediatric patient
advocates).
Substantial turnover in the graduate
students administering the survey made
it necessary to bring in a new cohort of
students and train them in the issues
relevant to the survey. As a result, we
were unable to field the B12 Pediatrics
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
survey before the OMB approval
expiration date and are seeking a
reinstatement to complete data
collection. To better ensure timely
completion of the data collection, the
Yale CERSI team has shifted
responsibility for conducting the survey
and other aspects of the study to a Yale
Staff Associate Research Scientist.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11234 Filed 5–21–24; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44993-44994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1894]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric Device Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 reinstatement 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 collections associated with the
``Yale-Mayo Clinic Centers of Excellence in Regulatory Science and
Innovation (CERSI) B12 Pediatric Device Survey.''
DATES: Either electronic or written comments on the collection of
information must be submitted by July 22, 2024.
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 July 22, 2024. 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. 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-2022-N-1894 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of
Excellence in Regulatory Science and Innovation B12 Pediatric Device
Survey.'' 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: 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: 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
[[Page 44994]]
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 reinstatement 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 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.
Yale-Mayo Clinic Centers of Excellence in Regulatory Science and
Innovation (CERSI) B12 Pediatric Device Survey
OMB Control Number 0910-0912--Reinstatement
Despite numerous legislative, regulatory, and scientific efforts,
there has been little change in the number of devices approved for use
in pediatric patients. This has often led to devices being adapted for
use in children without an appropriate level of evidence, exposing them
to inconsistent benefit risk profiles. This health inequity highlights
the need for devices that are designed, evaluated, and labeled for
pediatric patients. To address these challenges, this collection is
being done to survey industry and other key stakeholders in the medical
device ecosystem to identify the barriers that prevent product
developers from entering the pediatric device market as well as the
proper incentives that would motivate them to innovate and sustain
within this market.
This survey is a followup to the public meeting that FDA held in
August 2018, entitled, ``Pediatric Medical Device Development.'' As
mandated by section 502(d) of the FDA Reauthorization Act of 2017 (Pub.
L. 115-52) the meeting was convened to address several topics,
including consideration of ways to: (1) increase FDA assistance to
medical device manufacturers in developing devices for pediatric
populations that are approved or cleared, and labeled, for their use
and (2) identify current barriers to pediatric device development and
incentives to address such barriers.
Feedback from this meeting clarified the need to better understand
factors influencing suboptimal engagement and participation by diverse
innovators in the pediatric medical device space. Information garnered
from this survey may help inform strategic plans to optimize existing
programs for the needs of pediatric medical device innovators and
develop new programs that will support sustained development in this
space.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phone Survey................................. 17 1 17 0.5 (30 minutes)......................... 9
Online Survey................................ 56 1 56 1........................................ 56
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 65
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest hour.
The targeted groups for this collection of information include
representatives from the medical device industry, academia, recipients
of funding under section 305 of the Pediatric Medical Device Safety and
Improvement Act of 2007 (Pub. L. 110-85; 42 U.S.C. 282 note), and trade
organizations, medical provider organizations, organizations and
individuals involved with financing and reimbursement associated with
medical devices, pediatric healthcare leaders, clinicians who regularly
use medical devices in caring for children, and organizations and
individuals representing patients and consumers.
Phone survey: Respondents participating in the phone survey will be
executives from companies either producing products in pediatrics or
from companies that produce products that could be used in pediatrics.
Executives will be invited to engage in the 30-minute phone survey.
Online survey: The 1-hour online survey will be administered to
leaders within pediatric companies and key decision makers in the
pediatric medical device industry (e.g., venture capitalists, banking
investors, leaders in children's hospitals and research networks, and
pediatric patient advocates).
Substantial turnover in the graduate students administering the
survey made it necessary to bring in a new cohort of students and train
them in the issues relevant to the survey. As a result, we were unable
to field the B12 Pediatrics survey before the OMB approval expiration
date and are seeking a reinstatement to complete data collection. To
better ensure timely completion of the data collection, the Yale CERSI
team has shifted responsibility for conducting the survey and other
aspects of the study to a Yale Staff Associate Research Scientist.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11234 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P
