[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Notices]
[Pages 72407-72408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19865]


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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 or we) 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 October 7, 2024.

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 OMB control number for 
this information collection is 0910-0912. 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 0910-0912--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.
    In the Federal Register of May 22, 2024 (89 FR 44993), 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 72408]]



                                                     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).
    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: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19865 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P