Medical Devices; Exception from General Requirements for Informed Consent

ICR 201407-0910-015

OMB: 0910-0586

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-07-23
IC Document Collections
ICR Details
0910-0586 201407-0910-015
Historical Active 201106-0910-006
HHS/FDA CDRH
Medical Devices; Exception from General Requirements for Informed Consent
Extension without change of a currently approved collection   No
Regular
Approved without change 08/21/2014
Retrieve Notice of Action (NOA) 07/23/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 09/30/2014
1,350 0 1,350
1,463 0 1,463
200 0 200

This ICR collects information related to exceptions to the general requirement to obtain informed consent from the subject of an investigation involving an unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent. The investigator and an independent licensed physician make the determination and certify in writing certain facts concerning the need for use of the investigational in vitro diagnostic device without informed consent. The investigator would submit this written certification to the institutional review board (IRB) and also to FDA. An investigator must disclose the investigational status of the device and what is known about the performance characteristics of the device at the time test results are reported to the subject's health care provider and public health authorities. The investigator must provide the IRB with certain information regarding elements of informed consent and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative.

Statute at Large: 21 Stat. 360 Name of Statute: null
  
US Code: 21 USC 360j Name of Law: Section 520

Not associated with rulemaking

  79 FR 19915 04/10/2014
79 FR 41580 07/16/2014
No

1
IC Title Form No. Form Name
Medical Devices; Exception from General Requirements for Informed Consent

  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 1,350 1,350 0 0 0 0
Annual Time Burden (Hours) 1,463 1,463 0 0 0 0
Annual Cost Burden (Dollars) 200 200 0 0 0 0
No
No

$209,632
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
07/23/2014


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