NEW ANIMAL DRUG REGULATIONS -- 21 CFR PART 514 (PROPOSED RULE)

ICR 199509-0910-012

OMB: 0910-0289

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
0910-0289 199509-0910-012
Historical Active 199303-0910-001
HHS/FDA
NEW ANIMAL DRUG REGULATIONS -- 21 CFR PART 514 (PROPOSED RULE)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/30/1995
Retrieve Notice of Action (NOA) 09/30/1995
  Inventory as of this Action Requested Previously Approved
03/31/1996 03/31/1996 12/31/1995
1 0 1
1 0 1
0 0 0

THE FEDERAL FOOD, DRUG, AND COSMETIC ACT REQUIRES THAT A NEW ANIMAL DRUG MAY NOT BE MARKETED UNLESS THE MANUFACTURER PROVIDES FDA WITH SCIENTIFIC EVIDENCE THAT THE PRODUCT IS BOTH SAFE AND EFFECTIVE. THESE INFORMATION REQUIREMENTS PROVIDE THE MEANS FOR THE DEMONSTRATION OF DRUG SAFETY AND EFFECTIVENESS.

None
None


No

1
IC Title Form No. Form Name
NEW ANIMAL DRUG REGULATIONS -- 21 CFR PART 514 (PROPOSED RULE) FDA 356V, 1932 & 2301

  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.
09/30/1995


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