NEW DRUG AND ANTIBIOTIC APPLICATION AND REGULATIONS

ICR 198904-0910-017

OMB: 0910-0001

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
165335 Migrated
ICR Details
0910-0001 198904-0910-017
Historical Active 198608-0910-006
HHS/FDA
NEW DRUG AND ANTIBIOTIC APPLICATION AND REGULATIONS
No material or nonsubstantive change to a currently approved collection   No
Emergency 04/07/1989
Approved with change 04/07/1989
Retrieve Notice of Action (NOA) 04/07/1989
  Inventory as of this Action Requested Previously Approved
08/31/1989 08/31/1989 08/31/1989
84,754 0 84,754
5,132,764 0 5,132,764
0 0 0

THE PHARMACEUTICAL INDUSTRY MUST DEMONSTRATE, TO THE SATISFACTION OF FDA, THAT A NEW DRUG IS SAFE AND EFFECTIVE. ABSENT SUCH DEMONSTRATION, A NEW DRUG MAY NOT BE MARKETED. THESE INFORMATION REQUIREMENTS PROVIDE THE MEANS FOR DEMONSTRATION OF DRUG SAFETY AND EFFECTIVENESS.

None
None


No

1
IC Title Form No. Form Name
NEW DRUG AND ANTIBIOTIC APPLICATION AND REGULATIONS FDA-356-H, 1639, 1675, 2252, 2253

  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 84,754 84,754 0 0 0 0
Annual Time Burden (Hours) 5,132,764 5,132,764 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.
04/07/1989


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