Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use -- Form FDA 356h

ICR 199703-0910-002

OMB: 0910-0338

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0338 199703-0910-002
Historical Active
HHS/FDA
Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use -- Form FDA 356h
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/23/1997
Retrieve Notice of Action (NOA) 03/07/1997
OMB approves this package as amended by the correspondence of April 23, 1997, denying FDA's request to exempt Form 356h from displaying the expiration date. In addition, OMB expects FDA to continue to submit Information Correction Worksheets (OMB 83-C) as additional forms begin using Form 356h, "zeroing- out" the burden numbers to avoid double-counting.
  Inventory as of this Action Requested Previously Approved
04/30/2000 04/30/2000
12,137 0 0
485,480 0 0
0 0 0

This harmonized form 356h will apply to a wide range of products regulated by both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

None
None


No

1
IC Title Form No. Form Name
Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use -- Form FDA 356h

  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 12,137 0 0 12,137 0 0
Annual Time Burden (Hours) 485,480 0 0 485,480 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.
03/07/1997


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