INTRAOCULAR LENS INVESTIGATIONAL DEVICE EXEMPTION APPLICATION

ICR 199106-0910-002

OMB: 0910-0067

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
0910-0067 199106-0910-002
Historical Active 198708-0910-001
HHS/FDA
INTRAOCULAR LENS INVESTIGATIONAL DEVICE EXEMPTION APPLICATION
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 08/20/1991
Retrieve Notice of Action (NOA) 06/17/1991
  Inventory as of this Action Requested Previously Approved
08/31/1994 08/31/1994
648 0 0
16,920 0 0
0 0 0

THE INTRAOCULAR LENS INVESTIGATIONAL DEVICE EXEMPTION APPLICATION EXEMPTS DEVICES FROM SEVERAL PROVISIONS OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. THE APPLICATION CONTAINS INFORMATION NECESSARY TO EVALUATE THE POTENTIAL AND CONTINUING SAFETY OF THE LENSES DURING THE INVESTIGATIONAL STAGE.

None
None


No

1
IC Title Form No. Form Name
INTRAOCULAR LENS INVESTIGATIONAL DEVICE EXEMPTION APPLICATION

  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 648 0 0 648 0 0
Annual Time Burden (Hours) 16,920 0 0 16,920 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.
06/17/1991


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