TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OTC HUMAN DRUG AND COSMETIC PRODUCTS

ICR 198211-0910-002

OMB: 0910-0149

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
0910-0149 198211-0910-002
Historical Active
HHS/FDA
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OTC HUMAN DRUG AND COSMETIC PRODUCTS
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 11/03/1982
Retrieve Notice of Action (NOA) 11/01/1982
  Inventory as of this Action Requested Previously Approved
10/31/1984 10/31/1984
500 0 0
2,000 0 0
0 0 0

THE EXEMPTION SECTION OF THE REGULATION ON TAMPER RESISTANT PACKAGING REQUIREMENT WILL PROVIDE A MEANS WHEREBY MANUFACTURERS CAN PETITION THE AGENCY TO CONSIDER EXEMPTING THEM FROM THE PACKAGING REQUIREMENTS.

None
None


No

1
IC Title Form No. Form Name
TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OTC HUMAN 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 0 0 500 0 0
Annual Time Burden (Hours) 2,000 0 0 2,000 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.
11/01/1982


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