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

ICR 199303-0910-005

OMB: 0910-0032

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
0910-0032 199303-0910-005
Historical Active 199210-0910-007
HHS/FDA
NEW ANIMAL DRUG REGULATIONS -- 21 CFR PART 514 (PROPOSED RULE)
No material or nonsubstantive change to a currently approved collection   No
Emergency 03/04/1993
Approved with change 03/04/1993
Retrieve Notice of Action (NOA) 03/04/1993
  Inventory as of this Action Requested Previously Approved
09/30/1993 09/30/1993 04/30/1993
1,387 0 1
336,493 0 1
0 0 0

FOOD AND DRUG, DRUG RESIDUES, ANIMAL DRUGS, MEDICATED FEEDS, LABELING APPLICANTS PROPOSING TO MARKET ANIMAL DRUGS MUST DETAIL (1) THE SCIENTIFIC AND TECHNICAL INFORMATION REQUIRED FOR THE PHYSICAL MANUFACTURE OF THE DRUG PRODUCT AND (2) SCIENTIFIC INFORMATION RELATIV TO THE SAFETY AND EFFECTIVENESS OF THE DRUG USE.

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 1,387 1 0 1,386 0 0
Annual Time Burden (Hours) 336,493 1 0 336,492 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.
03/04/1993


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