Foreign Clinical Studies Not Conducted Under an IND

ICR 201306-0910-008

OMB: 0910-0622

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-06-14
IC Document Collections
ICR Details
0910-0622 201306-0910-008
Historical Active 200804-0910-001
HHS/FDA 19758
Foreign Clinical Studies Not Conducted Under an IND
Existing collection in use without an OMB Control Number   No
Regular
Approved without change 08/16/2013
Retrieve Notice of Action (NOA) 06/14/2013
  Inventory as of this Action Requested Previously Approved
08/31/2016 36 Months From Approved
1,185 0 0
37,920 0 0
0 0 0

Under Section 312.120, sponsors submit foreign clinical studies not conducted under an Investigational New Drug as support for an IND or application for marketing approval for a drug or biological product. The studies must be conducted in accordance with Good Clinical Practice, including review and approval by an independent ethics committee.

None
None

Not associated with rulemaking

  78 FR 13067 02/26/2013
78 FR 33847 06/05/2013
No

1
IC Title Form No. Form Name
Foreign Clinical Studies Not Conducted Under an IND - 312.120

  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 1,185 0 0 0 1,185 0
Annual Time Burden (Hours) 37,920 0 0 0 37,920 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden estimates preapproved by the Office of Management and Budget in the April 28, 2008 final rule have been updated by FDA's Economics Staff to reflect current burdens.

$0
No
Yes
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
06/14/2013


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