Institutional Review Board Registration Form

Forms and Documents

Document Name	Status
0990-0279_Supporting Statement_May 2022.pdf Supporting Statement A	2022-05-20
FRN 30-Day 0990-0279.pdf Supplementary Document	2018-10-25
FRN_60-Day_0990-0279.pdf Supplementary Document	2018-08-17
21 CFR part 56 Regulations August 2018.mht Supplementary Document	2018-08-16
45 CFR part 46 Regulations August 2018.pdf Supplementary Document	2018-08-16
42 U S C Section 289 August 2018.docx Supplementary Document	2018-08-16
IRB Registration_Form_0990-0279_Instructions_Proposed_August 2018.doc Supplementary Document	2018-08-16
IRB Registration_Form_0990-0279_Proposed_August 2018.doc Supplementary Document	2018-08-16

IC Document Collections

IC ID	Document Title	Status
218331	new registrations	Modified
218328	Institutional Review Board (IRB) Registration form Other-form	Modified

ICR Details

OMB Control No: 0990-0279	ICR Reference No: 202205-0990-005
Status: Received in OIRA	Previous ICR Reference No: 201808-0990-002
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Institutional Review Board Registration Form
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/24/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	12,000	0
Time Burden (Hours)	6,175	0
Cost Burden (Dollars)	0	0

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Abstract: The respondents for this collection are institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS, or, in the case of FDA's regulation, 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.

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

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:
	87 FR 8853	02/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 31569	05/24/2022
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Institutional Review Board (IRB) Registration form
new registrations

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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	12,000	0	0	0	0	12,000
Annual Time Burden (Hours)	6,175	0	0	0	0	6,175
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:

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Annual Cost to Federal Government: $353,000

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: 05/24/2022

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