Subpart C Research Certification Form

ICR 202004-0990-004

OMB: 0990-0473

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2020-04-14
Supplementary Document
2020-04-14
Supporting Statement A
2020-04-14
IC Document Collections
ICR Details
0990-0473 202004-0990-004
Active
HHS/HHSDM
Subpart C Research Certification Form
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 07/07/2020
Retrieve Notice of Action (NOA) 04/21/2020
  Inventory as of this Action Requested Previously Approved
07/31/2023 36 Months From Approved
80 0 0
80 0 0
0 0 0

The Office for Human Research Protections (OHRP) is requesting approval of the Department of Health and Human Services (HHS) Subpart C Research Certification Form. This form will facilitate collection of information relevant to an institutional request for OHRP authorization of research involving prisoners; the information in the form will be entered into OHRP’s prisoner research database, and will be used by OHRP to draft a response certification letter back to the institution. This is a new information collection request. The respondents for this collection are institutions or organizations operating Institutional Review Boards (IRBs) that have approved enrollment, or are planning to approve enrollment, of prisoners in human subjects research conducted or supported by HHS.

US Code: 42 USC Section 289 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  84 FR 178 09/13/2019
85 FR 76 04/20/2020
No

1
IC Title Form No. Form Name
Subpart C Research Certification Form

  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 80 0 0 80 0 0
Annual Time Burden (Hours) 80 0 0 80 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new ICR.

$42,914
No
    No
    No
No
No
No
No
Sherette Funn-Coleman

  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.
04/21/2020


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