TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS

ICR 198602-0910-004

OMB: 0910-0150

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
0910-0150 198602-0910-004
Historical Active 198410-0910-003
HHS/FDA
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS
No material or nonsubstantive change to a currently approved collection   No
Emergency 02/28/1986
Approved with change 02/28/1986
Retrieve Notice of Action (NOA) 02/28/1986
  Inventory as of this Action Requested Previously Approved
12/31/1987 12/31/1987 12/31/1987
30 0 30
350 0 150
0 0 0

THE REGULATION REQUIRES THAT CONTAINERS FOR CONTACT LENS SOLUTIONS AND/OR TABLETS BE TAMPER-RESISTANT, AND APPROPRIATELY LABELED AS SUCH. FIRMS MAY REQUEST AN EXEMPTION FROM THE REGULATIONS' REQUIREMENTS. EXEMPTING THEM FROM THE PACKAGING REQUIREMENTS.

None
None


No

1
IC Title Form No. Form Name
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS

  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 30 30 0 0 0 0
Annual Time Burden (Hours) 350 150 0 0 200 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
02/28/1986


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