Companion Proposed Rule: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

Forms and Documents

Document Name	Status
Direct Final Rule Procedures.mht Supplementary Document	2010-04-26
SS Pediatric Tracking.DOC Supporting Statement A	2010-04-23

IC Document Collections

IC ID	Document Title	Status
192788	Humanitarian Device Exemption Applications (HDE) - Requirement to Include Readily Available Information Concerning Actual and Potential Uses of the Device	New
192787	PMA Supplements - Requirement for Submission of All Changes That Affect Safety and Efficacy	New
192786	Procedures for Amending an Incomplete PMA or Resubmitting a Withdrawn PMA With any Information Concerning Potential Pediatric Uses	New
192785	Premarket Approval Applications (PMA) - Specifies Submission of Certain Information on Pediatric Subpopulations , if Readily Available, Concerning Potential Pediatric Uses	New

ICR Details

OMB Control No: 0910-0748	ICR Reference No: 201005-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Companion Proposed Rule: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 10/01/2010
	Date Received in OIRA: 05/03/2010
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the agency should resubmit this ICR at the final rule stage.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: On September 27, 2007, the Food and Drug Administration Amendments Act of 2007(FDAAA)(Public Law 110-85,)amended the Federal Food Drug and Cosmetic Act(the act) by adding among other things, a new section 515A (a) of the act (21 U.S.C. 360e-1). Section 515A(a) of the act requires persons who submit certain medical device applications to include 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 360-e-1 Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 360-e-1 Name of Law: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG29	Proposed rulemaking	75 FR 16365	04/01/2010

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Federal Register Notices & Comments

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
Premarket Approval Applications (PMA) - Specifies Submission of Certain Information on Pediatric Subpopulations , if Readily Available, Concerning Potential Pediatric Uses
Procedures for Amending an Incomplete PMA or Resubmitting a Withdrawn PMA With any Information Concerning Potential Pediatric Uses
PMA Supplements - Requirement for Submission of All Changes That Affect Safety and Efficacy
Humanitarian Device Exemption Applications (HDE) - Requirement to Include Readily Available Information Concerning Actual and Potential Uses of the Device

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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: This is a new collection of information.

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Annual Cost to Federal Government: $36,300

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]? Uncollected

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: 05/03/2010

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