Institutional Review Board Registration Form

Forms and Documents

Document Name	Status
Supporting Statement_0990-0279-IRB Registration _October 2018 (1).doc Supporting Statement A	2018-10-31
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: 201808-0990-002
Status: Active	Previous ICR Reference No: 201509-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Institutional Review Board Registration Form
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/04/2019
	Date Received in OIRA: 10/31/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	36 Months From Approved	02/28/2019
Responses	12,000	0	12,800
Time Burden (Hours)	6,175	0	12,800
Cost Burden (Dollars)	0	0	0

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Abstract: The respondents for this collection are institutions or organizations operating IRBs designated by an institution under an assurance of compliance approved for federalwide use by OHRP under 45 CFR 46.103(a) and 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:
	83 FR 41080	08/17/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 53883	10/25/2018
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
new registrations
Institutional Review Board (IRB) Registration form

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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	12,000	12,800	0	0	-800	0
Annual Time Burden (Hours)	6,175	12,800	0	0	-6,625	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Program or Burden Changes: The annual burden estimate reduced a small amount compared to the current burden estimate. The total annual burden in the current information collection (12, 800 hours and $320,000, respectively) is projected to decrease to be 6,175 hours and $167,500, respectively in this requested collection. This is due to an adjustment in agency estimate in this request.

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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? Uncollected

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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: 10/31/2018

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