Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey

Forms and Documents

Document Name	Status
Medical Device Industry Profile.pdf Supplementary Document	2024-08-23
CERSI ss part B 2-8-23.docx Supporting Statement B	2023-02-27
0912 SSAv2.docx Supporting Statement A	2024-09-06

IC Document Collections

IC ID	Document Title	Status
258779	Screening and survey - Regulatory Science and Innovation B12 Pediatric Device Other-Survey script-online	Modified

ICR Details

OMB Control No: 0910-0912	ICR Reference No: 202408-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202301-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/06/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	73	0
Time Burden (Hours)	65	0
Cost Burden (Dollars)	0	0

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Abstract: This ICR will allow FDA to conduct surveys to 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 the pediatric medical device industry.

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Authorizing Statute(s): PL: Pub.L. 115 - 52 502(d) Name of Law: FDARA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 44993	05/22/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 72407	09/05/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Screening and survey - Regulatory Science and Innovation B12 Pediatric Device

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	73	0	0	73	0	0
Annual Time Burden (Hours)	65	0	0	65	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection that FDA did not have an opportunity to complete before the OMB approval expiration date. 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.

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Annual Cost to Federal Government: $595,122

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/06/2024

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