Guidance for Center for Devices and Radiological Health Appeals Processes

Forms and Documents

Document Name	Status
0738_Supporting Statement.doc Supporting Statement A	2016-04-04

IC Document Collections

IC ID	Document Title	Status
206202	CDRH Appeals Processes Guidance Document	Modified

ICR Details

OMB Control No: 0910-0738	ICR Reference No: 201604-0910-002
Status: Historical Active	Previous ICR Reference No: 201303-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance for Center for Devices and Radiological Health Appeals Processes
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: 08/01/2016
	Date Received in OIRA: 04/15/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	07/31/2016
Responses	50	0	50
Time Burden (Hours)	400	0	400
Cost Burden (Dollars)	0	0	0

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Abstract: This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees. The Food and Drug Administration (FDA) is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in this guidance. Individuals outside of FDA who disagree with a decision or action taken by CDRH employees and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action, petitions, and hearings. Of these, by far the most commonly used is a request for supervisory review under 21 CFR 10.75 (a "10.75 appeal"). Section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 603 of the FDA Safety and Innovation Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of "significant decisions" regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs). In this guidance document, the term "significant decision" will refer to significant decisions pertaining to these submissions.

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Authorizing Statute(s): US Code: 21 USC 517A Name of Law: The Federal Food, Drug, and Cosmetic Act (FD&C Act)
   US Code: 21 USC 603 Name of Law: FDA Safety and Innovation Act
   US Code: 21 USC 301 Name of Law: The Federal Food, Drug, and Cosmetic Act (FD&C Act)
  

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:
	80 FR 63804	10/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 22277	04/15/2016
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
CDRH Appeals Processes Guidance Document

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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	50	50	0	0	0	0
Annual Time Burden (Hours)	400	400	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: $72,551

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: 04/15/2016

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