The eRulemaking Program

02/01/2023 | Press release | Distributed by Public on 02/01/2023 07:00

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric[...]

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


Food and Drug Administration, HHS.




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.


Submit written comments (including recommendations) on the collection of information by March 3, 2023.


To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 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:

Table 1-Estimated Annual Reporting Burden  1
Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours  2
Phone Survey 17 1 17 0.5 (30 minutes) 9
Online Survey 56 1 56 1 56
Total 65

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]