BRONCHODILATOR DRUG PRODUCTS FOR OTC HUMAN USE

ICR 198906-0910-031

OMB: 0910-0237

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
165505
Migrated
ICR Details
0910-0237 198906-0910-031
Historical Active 198610-0910-001
HHS/FDA
BRONCHODILATOR DRUG PRODUCTS FOR OTC HUMAN USE
No material or nonsubstantive change to a currently approved collection   No
Emergency 06/27/1989
Approved with change 06/27/1989
Retrieve Notice of Action (NOA) 06/27/1989
  Inventory as of this Action Requested Previously Approved
12/31/1989 12/31/1989 12/31/1989
1 0 1
1 0 1
0 0 0

THIS FINAL RULE ESTABLISHES CONDITIONS FOR THE MARKETING OF BRONCHODILATOR DRUG PRODUCTS FOR OTC USE. ONE PROVISION THE FINAL RULE REQUIRES THE LABEL TO INCLUDE DIRECTIONS FOR THE USE AN CARE OF THE INHALER FOR METERED-DOSE INHALATION DOSAGE FORMS.

None
None


No

1
IC Title Form No. Form Name
BRONCHODILATOR 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 1 0 0 0 0
Annual Time Burden (Hours) 1 1 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.
06/27/1989


© 2024 OMB.report | Privacy Policy