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

Forms and Documents

Document	Type	Status	Availability
0748 Pediatric Device Use SSA 2020 REV.pdf	Supporting Statement A	Uploaded 2020-05-28	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
242006	Pediatric uses outside approved indication	Other-Agency Guidance Document	New
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: 202005-0910-007
Status: Active	Previous ICR Reference No: 201703-0910-003
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/02/2020
	Date Received in OIRA: 05/28/2020
Terms of Clearance: FDA will discontinue control number 0910-0762 upon approval of this request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	1,745	0	745
Time Burden (Hours)	2,392	0	1,760
Cost Burden (Dollars)	0	0	0

---

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.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 65986	12/02/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 21241	04/16/2020
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 5

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
Pediatric uses outside approved indication

---

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	1,745	745	0	0	1,000	0
Annual Time Burden (Hours)	2,392	1,760	0	0	632	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: The information collection reflects changes and adjustments. We have consolidated burden from 0910-0762, and adjusted individual elements to reflect current data values. This results in an additional 1,000 responses and 632 hours annually to this information collection, and we will discontinue control number 0910-0762 upon approval of our request.

---

Annual Cost to Federal Government: $25,026

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

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

---

Common Form ICR:  No

---

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: 05/28/2020

---