Investigational New Drug (IND) Regulations

ICR 199907-0910-007

OMB: 0910-0014

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
5667 Migrated
ICR Details
0910-0014 199907-0910-007
Historical Active 199610-0910-007
HHS/FDA
Investigational New Drug (IND) Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 09/22/1999
Retrieve Notice of Action (NOA) 07/28/1999
  Inventory as of this Action Requested Previously Approved
09/30/2002 09/30/2002 12/31/1999
372,620 0 103,226
17,240,565 0 6,238,858
0 0 0

Provides the needed information on drug safety, drug effectiveness, and clinical testing to conduct clinical trials, investigational new drug studies, pharmacological research, and for the protection of human subjects. Provides data needed by FDA medical officers in order to determine whether and how a proposed new drug may be tested for safety and effectiveness.

None
None


No

1
IC Title Form No. Form Name
Investigational New Drug (IND) Regulations FDA-1571, FDA-1572

  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 372,620 103,226 0 0 269,394 0
Annual Time Burden (Hours) 17,240,565 6,238,858 0 0 11,001,707 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.
07/28/1999


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