Draft Guidance: Emergency Use Authorization of Medical Products

ICR 201212-0910-008

OMB: 0910-0595

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-12-12
Justification for No Material/Nonsubstantive Change
2012-12-12
ICR Details
0910-0595 201212-0910-008
Historical Active 201010-0910-001
HHS/FDA
Draft Guidance: Emergency Use Authorization of Medical Products
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/17/2012
Retrieve Notice of Action (NOA) 12/13/2012
  Inventory as of this Action Requested Previously Approved
01/31/2013 01/31/2013 01/31/2013
496 0 496
4,804 0 4,804
0 0 0

The Commissioner of Food and Drugs may authorize the emergency use of unapproved medical products and unapproved uses of approved products if, among other things, data are submitted supporting a conclusion that statutory criteria for issuance of an authorization are met. The Commissioner also may establish conditions on the authorization, including recordkeeping and reporting requirements. Respondents include medical countermeasure manufacturers, as well as Federal, State, and local public health officials.

US Code: 21 USC 360bbb Name of Law: FFDCA
  
None

Not associated with rulemaking

No

  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 496 496 0 0 0 0
Annual Time Burden (Hours) 4,804 4,804 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$8,500,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
12/13/2012


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