EXOCRINE PANCREATIC INSUFFICIENCY DRUG PRODUCTS FOR OTC HUMAN USE - NPRM

ICR 198906-0910-002

OMB: 0910-0225

Federal Form Document

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Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0225 198906-0910-002
Historical Active 198511-0910-003
HHS/FDA
EXOCRINE PANCREATIC INSUFFICIENCY DRUG PRODUCTS FOR OTC HUMAN USE - NPRM
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 08/17/1989
Retrieve Notice of Action (NOA) 06/14/1989
  Inventory as of this Action Requested Previously Approved
08/31/1992 08/31/1992
1 0 0
1 0 0
0 0 0

THIS PROPOSED RUL ESTABLISHES CONDITIONS FOR THE MARKETING OF EXOCRINE PANCRETIC INSUFFICIENCY DRUG PRODUCTS FOR OTC USE. ONE PROVISION OF THE PROPOSE RULE IS FOR THE LABEL TO DECLARE THE LEVEL OF ENZYME ACTIVITY PER DOSA UNIT.

None
None


No

1
IC Title Form No. Form Name
EXOCRINE PANCREATIC INSUFFICIENCY DRUG PRODUCTS FOR OTC HUMAN USE - NPRM

  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 0 1 0
Annual Time Burden (Hours) 1 0 0 0 1 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.
06/14/1989


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