Antheimintic Drug Products for OTC Human Use

ICR 199509-0910-021

OMB: 0910-0232

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109912
Migrated
ICR Details
0910-0232 199509-0910-021
Historical Active 198703-0910-004
HHS/FDA
Antheimintic Drug Products for OTC Human Use
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 09/30/1995
Retrieve Notice of Action (NOA) 09/20/1995
OMB approves the package for one year. Prior to re-submission for approval, FDA will solicit comment on, evaluate, and report on the accuracy of their burden estimates. Furthermore, if FDA receives any comments on this submission, they are to immediately forward them to OMB.
  Inventory as of this Action Requested Previously Approved
09/30/1996 09/30/1996
1 0 0
24 0 0
0 0 0

The existing rule provides conditions for the marketing of antheimintic drug products for OTC use. One provision of the regulation requires the preparation and distribution of a consumer package insert related to the use of the drug by discussing pinworm infestation and its symptoms, identification, detection, and treatment.

None
None


No

1
IC Title Form No. Form Name
Antheimintic Drug Products for OTC Human Use

  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 1 0 0 1 0 0
Annual Time Burden (Hours) 24 0 0 24 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.
09/20/1995


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