Notice2022-20626
Agency Information Collection Activities; Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
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
September 23, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on "Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey."
Full Text
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<title>Federal Register, Volume 87 Issue 184 (Friday, September 23, 2022)</title>
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[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58106-58108]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20626]
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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.
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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
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1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``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 November 22, 2022.
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 November 22, 2022. 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. 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-2022-N-1894 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of
Excellence in Regulatory Science and Innovation (CERSI) 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 <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: 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#e6b6b4a7b592878080a6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="94c4c6d5c7e0f5f2f2d4f2f0f5bafcfce7baf3fbe2">[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 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 NEW
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 labelled for
pediatric patients. To address these challenges, this collection is
being done to survey industry and
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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\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \2\
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Phone Survey.................. 17 1 17 0.5 (30 minutes) 9
Online Survey................. 56 1 56 1............... 56
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Total..................... .............. .............. .............. ................ 65
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\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).
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20626 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P
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