Investigational Device Exemptions, Modifications

ICR 199811-0910-005

OMB: 0910-0391

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
6045
Migrated
ICR Details
0910-0391 199811-0910-005
Historical Active
HHS/FDA
Investigational Device Exemptions, Modifications
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/25/1999
Retrieve Notice of Action (NOA) 11/24/1998
  Inventory as of this Action Requested Previously Approved
01/31/2002 01/31/2002
300 0 0
3,000 0 0
0 0 0

Section 201 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended the Federal Food, Drug, and Cosmetic Act to provide that sponsors of investigational devices may make developmental changes in a device or changes to the protocol that do not affect the validity of the data, the soundness of the investigational plan, or the safety or welfare of patients without FDA approval provided that the sponsor notifies FDA within 5 days after making the change. The sponsor would be required to submit information about the nature of the change and how it meets....

None
None


No

1
IC Title Form No. Form Name
Investigational Device Exemptions, Modifications

  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 300 0 0 300 0 0
Annual Time Burden (Hours) 3,000 0 0 3,000 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.
11/24/1998


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