Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects

ICR 201608-2070-001

OMB: 2070-0169

Federal Form Document

IC Document Collections
ICR Details
2070-0169 201608-2070-001
Active 201207-2070-004
EPA/OCSPP 2195.05
Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects
Extension without change of a currently approved collection   No
Regular
Approved without change 04/04/2019
Retrieve Notice of Action (NOA) 08/30/2016
  Inventory as of this Action Requested Previously Approved
04/30/2022 36 Months From Approved 04/30/2019
17 0 17
10,242 0 14,953
0 0 0

The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional dosing of human subjects, these individuals (respondents) are required to submit study protocols to EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to EPA.

US Code: 21 USC 346a Name of Law: Federal Food, Drug and Cosmetic Act (FFDCA)
   US Code: 7 USC 136 Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
  
None

Not associated with rulemaking

  80 FR 80360 12/24/2015
81 FR 59224 08/29/2016
No

2
IC Title Form No. Form Name
Research Involving Intentional Exposure of Human Subjects
All Other Submitted Research with Human Subjects

  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 17 17 0 0 0 0
Annual Time Burden (Hours) 10,242 14,953 0 0 -4,711 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
There is a decrease of 4,711 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease is due to a reduction in the preparation of protocols and studies. This change is an adjustment.

$338,854
No
    No
    No
No
No
No
Uncollected
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.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.
08/30/2016


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