Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Processes

ICR 199905-0910-004

OMB: 0910-0405

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0405 199905-0910-004
Historical Active
HHS/FDA
Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Processes
New collection (Request for a new OMB Control Number)   No
Emergency 05/14/1999
Approved without change 06/03/1999
Retrieve Notice of Action (NOA) 05/06/1999
Approved as amended by FDA's revisions of 5/25/99 and 6/3/99.
  Inventory as of this Action Requested Previously Approved
11/30/1999 11/30/1999
20,000 0 0
260,000 0 0
0 0 0

This program will use information provided by manufacturers to add a comprehensive listing of Year 2000-compliant firms to the FDA-operated Federal Year 2000 Biomedical Clearinghouse. The Clearinghouse, available on the World Wide Web, will allow Government agencies, health care facilities, and others to assess their vulnerability to Year 2000 problems and to take corrective actions, if necessary, in advance of January 1, 2000.

None
None


No

1
IC Title Form No. Form Name
Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Processes

  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 20,000 0 0 20,000 0 0
Annual Time Burden (Hours) 260,000 0 0 260,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 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.
05/06/1999


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