Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

Forms and Documents

Document	Type	Status	Availability
eCopy Guidance.doc	Supplementary Document	Uploaded 2012-12-12	Available
eCopy 83c 0910-0661 12-12-12.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2012-12-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
192261	Reporting-FDAAA, Section 520(m)(6)( C ) - Petition Requirements for HDE Holders Seeking to Modify ADN	Other-Guidance: HDE Holders- Questions and Answers	Modified
192260	Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.	Other-Buidance: HDE Holders- Questions and Answers	Modified
192259	Reporting-FDAAA, Section 520(m)(6)(A)(ii)- Assignment of Annual distribution Number ( ADN) for Devices Indicated For Pediatric Patients	Other-Guidance: HDE-Questions and Answers	Modified
192258	Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.	Other-Guidance - Questions and Answers	Modified

ICR Details

OMB Control No: 0910-0661	ICR Reference No: 201212-0910-009
Status: Historical Active	Previous ICR Reference No: 201003-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance: Humanitarian Device Exemption Regulation: Questions and Answers
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/17/2012
	Date Received in OIRA: 12/13/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	05/31/2013	05/31/2013
Responses	14	0	14
Time Burden (Hours)	1,250	0	1,250
Cost Burden (Dollars)	0	0	0

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Abstract: Title III of the Food and Drug Administration Amemdments Act of 2007 (FDAAA) (Public Law 110-85) amended chapter V of the Federal Food and Drug Cosmetic Act(the act)(21 U.S.C.351 et seq.) by inserting section 515A, Pediatric Uses of Devices ( 21 U.S.C. 360e-1) The new privision requires that new applications under section 520(m) of the act (21U.S.C. 360j(m) include both a desciption of any pediatic subpopulation that suffers from: (1) A disease or condition that the device is intended to treat, diagnose, or cure and (2) the number of affected pediatic patients.

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Authorizing Statute(s): US Code: 21 USC 360j(m) Name of Law: null
  

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

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.
Reporting-FDAAA, Section 520(m)(6)(A)(ii)- Assignment of Annual distribution Number ( ADN) for Devices Indicated For Pediatric Patients
Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.
Reporting-FDAAA, Section 520(m)(6)( C ) - Petition Requirements for HDE Holders Seeking to Modify ADN

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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	14	14	0	0	0	0
Annual Time Burden (Hours)	1,250	1,250	0	0	0	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:

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Annual Cost to Federal Government: $2,704,080

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: 12/13/2012

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