Notice of Research Exception under the Genetic Information Nondiscrimination Act of 2008

Forms and Documents

Document Name	Status
SSGINARESEARCH.doc Supporting Statement A	2009-05-12

IC Document Collections

IC ID	Document Title	Status
189114	Notice of Research Exception under the Genetic Information Nondiscrimination Act of Other-Notice of Research Exception	New

ICR Details

OMB Control No: 1210-0136	ICR Reference No: 200910-1210-001
Status: Historical Active	Previous ICR Reference No: 200905-1210-001
Agency/Subagency: DOL/EBSA	Agency Tracking No:
Title: Notice of Research Exception under the Genetic Information Nondiscrimination Act of 2008
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/07/2009
	Date Received in OIRA: 10/07/2009
Terms of Clearance: This ICR is pre-approved, consistent with provisions of the interim final rule it is associated with.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	36 Months From Approved
Responses	3	0	0
Time Burden (Hours)	1	0	0
Cost Burden (Dollars)	10	0	0

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Abstract: The Notice must be sent to the Department in order for group health plans and group health insurance issuers to use GINA's research exception to GINA's prohibitions on requesting or requiring genetic testing.

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Authorizing Statute(s): PL: Pub.L. 110 - 233 101(f) Name of Law: Genetic Information Nondiscrimination Act of 2008
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 233 101(f) Name of Law: Genetic Information Nondiscrimination Act of 2008

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1210-AB27	Final or interim final rulemaking	74 FR 51663	10/07/2009

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Federal Register Notices & Comments

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
Notice of Research Exception under the Genetic Information Nondiscrimination Act of

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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	3	0	0	3	0	0
Annual Time Burden (Hours)	1	0	0	1	0	0
Annual Cost Burden (Dollars)	10	0	0	10	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new collection. Congress required the Deparment to issue final regulations by May 21, 2009. Regulations provided guidance and clarification regarding GINA’s prohibition against discrimination in group premiums based on genetic information, its limitations on genetic testing, its prohibition on collection of genetic information, and its new civil monetary penalties under ERISA.

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Annual Cost to Federal Government: $0

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: 05/12/2009

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