Federalwide Assurance (FWA)

Forms and Documents

Document Name	Status
Form 0990-0278 Federalwide Assurance (FWA) Form and Instruction	Modified
0990-0278-PHSA Section 491_to Toni 31 March 2011.doc Supplementary Document	2011-05-02
0990-0278-IRB Authorization Agreement_to Toni 31 March 2011.rtf Supplementary Document	2011-05-02
0990-0278-Individual Investigator Agreement_to Toni 31 March 2011.rtf Supplementary Document	2011-05-02
Supporting Statement_0990-0278- Federalwide Assurance PRA__May2_ 2011.doc Supporting Statement A	2011-05-02

IC Document Collections

IC ID	Document Title	Status
10411	Federalwide Assurance (FWA) Form and Instruction	Modified

ICR Details

OMB Control No: 0990-0278	ICR Reference No: 201105-0990-001
Status: Historical Active	Previous ICR Reference No: 200801-0990-002
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Federalwide Assurance (FWA)
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: 06/02/2011
	Date Received in OIRA: 05/02/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved	06/30/2011
Responses	22,000	0	20,000
Time Burden (Hours)	11,000	0	15,000
Cost Burden (Dollars)	0	0	0

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Abstract: The FWA is designed to provide a simplified procedure for institutions engaged in HHS-conducted or supported research to satisfy the assurance requirements of Section 491(a) of the Public Health Service Act and of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents are institutions engaged in human subjects research conducted or supported by HHS.

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Authorizing Statute(s): PL: Pub.L. 99 - 158 491 Name of Law: Institutional Review Boards;Ethics Guidance Program
  

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:
	76 FR 4905	01/27/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 20988	04/14/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Federalwide Assurance (FWA)	0990-0278	FWA

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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	22,000	20,000	0	2,000	0	0
Annual Time Burden (Hours)	11,000	15,000	0	-4,000	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The annual burden will decrease from 15,000 hours to 11,000 hours a 4,000 burden hour decrease which resulted in a program change due to simplifying the form.

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Annual Cost to Federal Government: $400,000

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]? 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: 05/02/2011

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