[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6745-6746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02057]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1894]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 March 3, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Yale-Mayo Clinic Centers of Excellence in
Regulatory Science and Innovation B12 Pediatric Device Survey.'' 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,
[email protected].
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.
Yale-Mayo Clinic Centers of Excellence in Regulatory Science and
Innovation (CERSI) B12 Pediatric Device Survey
OMB Control Number 0910-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 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.
In the Federal Register of September 23, 2022 (87 FR 58106), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 6746]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \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: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02057 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P