Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program

ICR 199603-0910-001

OMB: 0910-0318

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0318 199603-0910-001
Historical Active
HHS/FDA
Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program
New collection (Request for a new OMB Control Number)   No
Emergency 03/25/1996
Approved without change 03/22/1996
Retrieve Notice of Action (NOA) 03/11/1996
OMB approves this emergency collection contingent upon FDA making the changes outlined in the correspondences of March 6, 7 and 22, 1996. As part of the approval process for this collection, FDA is simultaneously seeking approval through the regular process and soliciting comment from the public. OMB will have the opportunity to review this collection under the regular process, taking into consideration any comments from the public.
  Inventory as of this Action Requested Previously Approved
06/30/1996 06/30/1996
532 0 0
20,836 0 0
86,000 0 0

This Federal Register notice announces a 2-year, voluntary pilot program to test the feasibility of using third-party reviews to improve the efficiency of FDA's review of premarket notifications under section 510(k) of the Federal Food, Drug, and Comestic Act. Participating third parties are subject to information collection requirements.

None
None


No

1
IC Title Form No. Form Name
Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program

  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 532 0 0 532 0 0
Annual Time Burden (Hours) 20,836 0 0 20,836 0 0
Annual Cost Burden (Dollars) 86,000 0 0 86,000 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
03/11/1996


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