Dissemination of Information on Unapproval/New Uses for Marketed Drugs, Biologics, and Devices

ICR 200509-0910-007

OMB: 0910-0390

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0390 200509-0910-007
Historical Active 200210-0910-001
HHS/FDA
Dissemination of Information on Unapproval/New Uses for Marketed Drugs, Biologics, and Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 12/13/2005
Retrieve Notice of Action (NOA) 09/28/2005
  Inventory as of this Action Requested Previously Approved
12/31/2008 12/31/2008 12/31/2005
157 0 4,492
2,114 0 52,208
0 0 0

Sections 551 through 557 of the Federal Food, Drug and Cosmetic Act permit drug, biologic, and device manufacturers to disseminate certain written information concerning the safety, effectiveness, or benefits of a use that is not described in the product's approved labeling provided that the manufacturer has: (1) Submitted a supplemental application for the new use; (2) completed the studies needed for a supplemental application for the new use and certified that such studies are completed and that a supplemental application will be submitted within 6 months of the initial dissemination; (3) provided a proposed...

None
None


No

1
IC Title Form No. Form Name
Dissemination of Information on Unapproval/New Uses for Marketed Drugs, Biologics, and Devices

  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 157 4,492 0 0 -4,335 0
Annual Time Burden (Hours) 2,114 52,208 0 0 -50,094 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.
09/28/2005


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