Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

Forms and Documents

Document Name	Status
0748_Supporting Statement_3-2017.doc Supporting Statement A	2017-03-15

IC Document Collections

IC ID	Document Title	Status
192788	Pediatric information in an HDE	Modified
192787	Pediatric information in a PMA supplement	Modified
192786	Pediatric information in a PMA amendment	Modified
192785	Pediatric information in an original PMA or PDP	Modified

ICR Details

OMB Control No: 0910-0748	ICR Reference No: 201703-0910-003
Status: Historical Active	Previous ICR Reference No: 201401-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2017
	Date Received in OIRA: 03/15/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	745	0	738
Time Burden (Hours)	1,760	0	1,746
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from medical device manufacturers who wish to obtain market clearance for a device. Respondents must submit, as part of their premarket approval application (PMA) or product development protocol (PDP), PMA amendment, PMA supplement, or humanitarian device exemption (HDE), readily available information providing a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected pediatric patients.

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Authorizing Statute(s): US Code: 21 USC 360e Name of Law: FFDCA
  

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:
	81 FR 91181	12/16/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 13825	03/15/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Pediatric information in an original PMA or PDP
Pediatric information in a PMA amendment
Pediatric information in a PMA supplement
Pediatric information in an HDE

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ICR Summary of Burden

	Total Approved	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	745	738	0	0	7	0
Annual Time Burden (Hours)	1,760	1,746	0	0	14	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: We made a minor adjustment to the number of respondents which caused a 14-hour increase in the total burden estimate.

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Annual Cost to Federal Government: $10,676

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 03/15/2017

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