TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS

ICR 198410-0910-003

OMB: 0910-0150

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
0910-0150 198410-0910-003
Historical Active 198211-0910-001
HHS/FDA
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS
Revision of a currently approved collection   No
Regular
Approved without change 12/21/1984
Retrieve Notice of Action (NOA) 10/31/1984
  Inventory as of this Action Requested Previously Approved
12/31/1987 12/31/1987 10/31/1984
30 0 25
150 0 100
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 25 0 0 5 0
Annual Time Burden (Hours) 150 100 0 0 50 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.
10/31/1984


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