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OMB Control No: 0990-0279	ICR Reference No: 202505-0990-003
Status: Active	Previous ICR Reference No: 202205-0990-005
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Institutional Review Board Registration Form
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/02/2026
	Date Received in OIRA: 07/20/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2029	36 Months From Approved
Responses	5,350	0	0
Time Burden (Hours)	1,825	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The purpose of the Institutional Review Board (IRB) Registration Form is to provide a simplified procedure for: (1) IRBs to satisfy the requirements for IRB registration at 45 CFR part 46, subpart E; and (2) IRBs in the United States (US) to satisfy the FDA requirements for IRB registration at 21 CFR 56.106. The respondents for this information collection are institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS; or, in the case of FDA’s requirements, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products. Many of the IRBs also review research conducted or supported by other Federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (the Common Rule).

Authorizing Statute(s): PL: Pub.L. 115 - 180 289 Name of Law: Public Health Service Act

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:
	90 FR 21784	05/21/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 45279	07/20/2026
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Institutional Review Board (IRB) Registration Form_ Registration Updates or Renewals	0990-0279
Institutional Review Board (IRB) Registration Form_ new registrations	0990-0279

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	5,350	-6,650	12,000
Annual Time Burden (Hours)	1,825	-4,350	6,175
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: OHRP is requesting that IRB roster member information no longer be collected on the IRB registration form to reflect the 2018 Requirements at 45 CFR 46.103 and reduce burden on respondents. The burden calculation has been adjusted accounting for the number of IRBs that register with HHS, the average responses per institution annually, and the time required to complete an application in light of burden-reducing elimination of the IRB roster. The estimated time to complete and submit the IRB registration form electronically is expected to be the 30 minutes for respondents registering for the first time and 20 minutes for respondents updating or renewing their institution or organization's existing registration. The estimate of the number of respondents is based upon the current number of IRBs registered with HHS, approximately 4,988 (as of July 13, 2026), and projecting that the number of respondents may increase to 5,350. Of the approximately 4,988 registered IRBs, 100% submitted their registration information electronically. Of the 5,350 projected respondent IRBs annually, approximately 350 institutions or organizations are expected submit IRB registration information for the first time, and up to 5,000 institutions or organizations are expected to update or renew their existing IRB registration. The burden is estimated to average 0.5 hours for a new, initial IRB registration, and 0.33 hours for updating or renewing the registration of a previously registered IRB. If on average 5,000 previous respondents submit information once each year, and on average 350 institutions submit new registration information one time a year, the total annual burden hours are projected to be 1,825 hours. This represents a decrease in annual burden hours of 4,350 hours compared to the previously approved burden.

Annual Cost to Federal Government: $152,334

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: Natalie Klein 301 284-2272 natalie.klein@hhs.gov

View ICR - OIRA Conclusion