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Federal forms, ICRs, and supporting documents

Information Collection Request

Center for Devices and Radiological Health Appeals Processes

ICR 201907-0910-014 · OMB 0910-0738 · Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-07-23
IC Document Collections
IC ID
Document
Title
Status
206202 Modified
ICR Details
0910-0738 201907-0910-014
Active 201604-0910-002
HHS/FDA CDRH
Center for Devices and Radiological Health Appeals Processes
Extension without change of a currently approved collection   No
Regular
Approved without change 08/27/2019
Retrieve Notice of Action (NOA) 07/24/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 08/31/2019
35 0 50
280 0 400
0 0 0
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.
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)
  
None
Not associated with rulemaking
  84 FR 8530 03/08/2019
84 FR 34399 07/18/2019
No
1
IC Title Form No. Form Name
CDRH Appeals Processes Guidance Document
  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 35 50 0 0 -15 0
Annual Time Burden (Hours) 280 400 0 0 -120 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The number of appeals that the Center receives fluctuates from year to year but the trend has been pointing down since 2012. Based on our data from the last 3 years we have revised the No. of Respondents and Total Annual Responses from 50 to 35. This adjustment has caused a decrease of 120 hours to the estimated Total Hours.
$135,153
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/24/2019