Protection of Human Subjects and Institutional Review Boards

ICR 202311-0910-012

OMB: 0910-0130

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2023-11-27
Supporting Statement A
2023-11-27
ICR Details
0910-0130 202311-0910-012
Received in OIRA 202301-0910-012
HHS/FDA CROSS CENTER
Protection of Human Subjects and Institutional Review Boards
Revision of a currently approved collection   No
Regular 11/27/2023
  Requested Previously Approved
36 Months From Approved 03/31/2026
347,930 346,828
1,627,905 1,626,803
0 0

The information collection supports FDA rulemaking 0910-AH52

US Code: 21 USC 301 et. seq. Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 241; 289 Name of Law: Public Health and Welfare; Institutional Review Boards
  
PL: Pub.L. 114 - 255 3024 Name of Law: 21st Century Cures Act

0910-AH52 Final or interim final rulemaking

Yes

  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 347,930 346,828 0 0 1,102 0
Annual Time Burden (Hours) 1,627,905 1,626,803 0 0 1,102 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We estimate the rulemaking will result in an annual burden increase of 1,102 responses and 1,102 hours from recordkeeping and disclosure activity relating to the revised regulations in 21 CFR parts 50 and 56.

$8,750,000
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@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.
11/27/2023


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