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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:
0990-0260
ICR Reference No:
202104-0990-003
Status:
Active
Previous ICR Reference No:
201803-0990-003
Agency/Subagency:
HHS/HHSDM
Agency Tracking No:
Title:
Protection of Human Subjects: Common Rule (56 FR 28001)
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:
08/03/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/25/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2024
36 Months From Approved
08/31/2021
Responses
611,500
0
328,980
Time Burden (Hours)
1,442,350
0
1,138,230
Cost Burden (Dollars)
0
0
0
Abstract:
The Common Rule (56 FR 27003) establishes Federal policy for the protection of human subjects of Federally conducted or sponsored research. The common rule, published in 1991, revised in 2017, and amended two times in 2018, requires applicant and awardee institutions to establish procedures to report, disclose and maintain required information including informed consent and assurance of the establishment of an Institutional Review Board.
Authorizing Statute(s):
US Code:
42 USC 289
Name of Law: IRB
PL:
Pub.L. 99 - 158 491(a)
Name of Law: Health Research Extension Act
EO: EO 12333 Name/Subject of EO: Common Rule
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
86 FR 19627
04/14/2021
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 33320
06/24/2021
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting
.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research
.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities
.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent
.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent
.46.116(h) – [2018 Requirements] – Posting clinical trial consent form
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
611,500
328,980
0
282,520
0
0
Annual Time Burden (Hours)
1,442,350
1,138,230
0
304,120
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The information collection reflects changes, for Pre-2018 Requirements and 2018 Requirements. The burden hours increased by 304,120 hours and $35,611,450.
Annual Cost to Federal Government:
$1,992,000
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:
Sherette Funn-Coleman
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:
06/25/2021
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