TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OTC DRUG AND COSMETIC PRODUCTS

ICR 198905-0910-012

OMB: 0910-0149

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
0910-0149 198905-0910-012
Historical Active 198712-0910-004
HHS/FDA
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OTC DRUG AND COSMETIC PRODUCTS
No material or nonsubstantive change to a currently approved collection   No
Emergency 05/04/1989
Approved with change 05/04/1989
Retrieve Notice of Action (NOA) 05/04/1989
  Inventory as of this Action Requested Previously Approved
02/28/1991 02/28/1991 02/28/1991
500 0 500
2,000 0 2,000
0 0 0

THIS REGULATION REQUIRES CERTAIN OVER-THE-COUNTER HUMAN DRUG AND COSMETIC PRODUCTS TO BE APPROPRIATELY LABELED, ALERTING CONSUMERS TO THE TAMPER-RESISTANT PACKAGING.

None
None


No

1
IC Title Form No. Form Name
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OTC DRUG AND COSMETIC PRODUCTS

  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 500 500 0 0 0 0
Annual Time Burden (Hours) 2,000 2,000 0 0 0 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.
05/04/1989


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