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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0130
ICR Reference No:
202311-0910-012
Status:
Active
Previous ICR Reference No:
202301-0910-012
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CROSS CENTER
Title:
Protection of Human Subjects and Institutional Review Boards
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/26/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/27/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2026
36 Months From Approved
03/31/2026
Responses
347,930
0
346,828
Time Burden (Hours)
1,627,905
0
1,626,803
Cost Burden (Dollars)
0
0
0
Abstract:
The information collection supports implementation of statutory and regulatory requirements pertaining to the rights and welfare of human subjects involved in FDA-regulated research, and applicable to Institutional Review Boards that oversee such research.
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
PL: Pub.L. 114 - 255 3024 Name of Law: 21st Century Cures Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AH52
Final or interim final rulemaking
88 FR 88228
12/21/2023
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 57378
11/15/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 57378
11/15/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Disclosures associated with 21 CFR parts 50 and 56
FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation
Recordkeeping associated with 21 CFR parts 50 and 56
Reporting associated with 21 CFR parts 50 and 56
Requests for Discretionary Certificates of Confidntiality
ICR Summary of Burden
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
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$8,750,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
11/27/2023
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