Protection of Human Subjects and Institutional Review Boards

ICR 201912-0910-008

OMB: 0910-0130

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-01-14
IC Document Collections
ICR Details
0910-0130 201912-0910-008
Active 201704-0910-001
HHS/FDA CROSS CENTER
Protection of Human Subjects and Institutional Review Boards
Revision of a currently approved collection   No
Regular
Approved without change 01/21/2020
Retrieve Notice of Action (NOA) 01/15/2020
Approved with the understanding that, upon approval, FDA will discontinue OMB control number 0910-0755, which currently accounts for 104,679 responses and 108,392 hours associated with recordkeeping requirements in 21 CFR part 56.
  Inventory as of this Action Requested Previously Approved
01/31/2023 36 Months From Approved 06/30/2020
346,800 0 36,792
1,731,430 0 3,679,200
147,171,550 0 0

The information collection supports FDA regulations governing Institutional Review Boards and the rights and welfare of human subjects involved in FDA-regulated research. Respondents to the collection are sponsors, members, or other individuals subject to the requirements of 21 CFR parts 50 and 56..

US Code: 42 USC 289 Name of Law: Public Health and Welfare; Institutional Review Boards
   US Code: 21 USC 301 et. seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  84 FR 40421 08/14/2019
84 FR 69748 12/19/2019
No

3
IC Title Form No. Form Name
Reporting under 21 CFR 56
Recordkeeping under 21 CFR parts 50 and 56
Disclosures under 21 CFR parts 50 and 56

  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 346,800 36,792 0 0 310,008 0
Annual Time Burden (Hours) 1,731,430 3,679,200 0 0 -1,947,770 0
Annual Cost Burden (Dollars) 147,171,550 0 0 0 147,171,550 0
No
No
The information collection reflects both changes and adjustments. We revised the information collection to consolidate it with control no. 0910-0755. In this request, our estimate reflects a decrease in the average number of annual responses by 1,947,770, but an increase in the average number of annual hours by 310,008.

$0
No
    No
    No
No
No
No
Uncollected
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.
01/15/2020


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