OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Draft Guidance: Emergency Use Authorization of Medical Products

ICR 201010-0910-001 · OMB 0910-0595 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
0595_non-sub_change_justification HHS requested change 11-5-10.doc Justification for No Material/Nonsubstantive Change Uploaded 2010-11-05 Repair queued
0595_non-sub_change_justification HHS requested change 9-30-10.doc Justification for No Material/Nonsubstantive Change Uploaded 2010-09-30 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
43607 Requests for Consideration; Pending Application on file Other-guidance document Modified
191144 State and Local Public Health Officials; Unapproved EUA Product Other-guidance document Modified
191143 Manufacturers of an Unapproved EUA Product Other-guidance document Modified
191142 Pre-EUA Submissions; No Application pending Other-guidance document Modified
191141 Pre-EUA Submissions; Pending Application on file Other-guidance document Modified
191140 Requests for Consideration; No Application pending Other-guidance document Modified
ICR Details
0910-0595 201010-0910-001
Historical Active 200910-0910-002
HHS/FDA
Draft Guidance: Emergency Use Authorization of Medical Products
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 11/05/2010
Retrieve Notice of Action (NOA) 10/01/2010
  Inventory as of this Action Requested Previously Approved
01/31/2013 01/31/2013 01/31/2013
496 0 176
4,804 0 3,204
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 496 176 0 0 320 0
Annual Time Burden (Hours) 4,804 3,204 0 0 1,600 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$8,500,000
No
No
No
No
No
Uncollected
Jonnalynn Capezzuto 3018274659
  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.
10/01/2010