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

ICR 202204-2070-004

OMB: 2070-0169

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2022-04-20
Supplementary Document
2022-04-20
Supplementary Document
2022-04-20
Supplementary Document
2022-04-20
Supplementary Document
2022-04-20
Supplementary Document
2022-04-20
Supplementary Document
2022-04-20
Supporting Statement A
2022-04-20
IC Document Collections
ICR Details
2070-0169 202204-2070-004
Received in OIRA 201608-2070-001
EPA/OCSPP 2195.06
Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects
Extension without change of a currently approved collection   No
Regular 04/26/2022
  Requested Previously Approved
36 Months From Approved 04/30/2022
14 17
8,276 10,242
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: 7 USC 136 Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
   US Code: 21 USC 346a Name of Law: Federal Food, Drug and Cosmetic Act (FFDCA)
  
None

Not associated with rulemaking

  86 FR 49022 09/01/2021
87 FR 24297 04/25/2022
Yes

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

  Total Request 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 14 17 0 0 -3 0
Annual Time Burden (Hours) 8,276 10,242 0 0 -1,966 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
There is an estimated decrease of 1,966 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is a result of the anticipated number of responses per year for the next three years based on comments received from stakeholders. This change is an adjustment.

$372,104
No
    No
    No
No
No
No
No
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.
04/26/2022


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