Institutional Review Board/Independent Ethics Committee Registration Form

Forms and Documents

Document Name	Status
0990-0279-IRB Registration PRA Supporting Statement 3- 13 March 09.doc Supporting Statement A	2009-03-24

IC Document Collections

IC ID	Document Title	Status
188543	FDA-IRA Other-Agreement	New
10412	Institutional Review Board/Independent Ethics Committee Registration Form Other-Agreement	Modified

ICR Details

OMB Control No: 0990-0279	ICR Reference No: 200903-0990-002
Status: Historical Active	Previous ICR Reference No: 200801-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Institutional Review Board/Independent Ethics Committee Registration Form
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: 06/15/2009
	Date Received in OIRA: 03/26/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2012	36 Months From Approved	03/31/2011
Responses	14,000	0	12,000
Time Burden (Hours)	14,000	0	12,000
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): US Code: 5 USC 301 Name of Law: null
   US Code: 42 USC 300V-1 Name of Law: null
   US Code: 42 USC 289 Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0940-AA06	Final or interim final rulemaking	74 FR 2399	01/15/2009

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Federal Register Notices & Comments
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 12362	03/24/2009
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/Independent Ethics Committee Registration Form
FDA-IRA

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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	14,000	12,000	0	2,000	0	0
Annual Time Burden (Hours)	14,000	12,000	0	2,000	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Increase by 2,000 burden hours, from 12,000 to 14,000. This is due to the expectation that up to an additional 1,000 IRBs - largely FDA-regulated - will register in compliance with the new IRB Registration requirements.

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Annual Cost to Federal Government: $1,992,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/26/2009

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