[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
                                              ----------------------------------------------------------------------------------------------------------
    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