[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]


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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 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\
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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).
    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