Protection of Human Subjects: Common Rule (56 FR 28001)

Forms and Documents

Document Name	Status
Supporting Statement_0990-0260_Common Rule_30-Day PRA_15Aug2024.docx Supporting Statement A	2024-08-15
2018 Requirements - 2018 Common Rule_June 2021.pdf Supplementary Document	2021-06-21
Pre-2018 Requirements - Pre-2018 Common Rule_ June 2021.pdf Supplementary Document	2021-06-21
42 U S C Section 289_0990-0260_ June 2021.pdf Supplementary Document	2021-06-21

IC Document Collections

IC ID	Document Title	Status
246949	.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived	Modified
246948	.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent	Modified
246947	.46.116(h) – [2018 Requirements] – Posting clinical trial consent form	Modified
246944	.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent	Unchanged
187692	.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research	Unchanged
187691	.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities	Modified
10389	.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting Other-cfr	Removed

ICR Details

OMB Control No: 0990-0260	ICR Reference No: 202407-0990-001
Status: Received in OIRA	Previous ICR Reference No: 202104-0990-003
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Protection of Human Subjects: Common Rule (56 FR 28001)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/21/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	548,125	611,500
Time Burden (Hours)	1,378,063	1,442,350
Cost Burden (Dollars)	0	0

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Abstract: The Federal Policy for the Protection of Human Subjects, codified for HHS at 45 CFR part 46, subpart A (also known as the Common Rule) adopted in June 1991 (56 FR 28001), establishes Federal policy for the protection of human subjects involved in Federally conducted or supported research. The Common Rule requires applicant and awardee institutions to establish procedures to report, disclose, and maintain required information, including information related to informed consent and an assurance of compliance with the regulatory requirements.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 47578	06/03/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 67095	08/19/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

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

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ICR Summary of Burden

	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	548,125	611,500	0	-58,175	-5,200	0
Annual Time Burden (Hours)	1,378,063	1,442,350	0	-59,087	-5,200	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Cutting Redundancy

Short Statement: The burden calculations have been adjusted to include more accurate estimates. We estimate fewer responses to provisions at sections .117(a) and .117(c)(2) compared to the previously approved collection. Also, we adjusted the burden to omit responses to the provisions at sections .103(b)(5) and .103(a)(4) because that information is collected separately in OMB.0990-0477. Lastly, the burden reflects increases in responses to the provision at section .117(h) for clinical trial consent form postings. The burden calculation for this provision is estimated based on current data from clinicaltrials.gov.

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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

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Common Form ICR:  No

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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: 08/21/2024

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