Notice of Research Exception under the Genetic Information Nondiscrimination Act

ICR 200910-0938-010

OMB: 0938-1077

Federal Form Document

ICR Details
0938-1077 200910-0938-010
Historical Active
HHS/CMS
Notice of Research Exception under the Genetic Information Nondiscrimination Act
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/23/2009
Retrieve Notice of Action (NOA) 10/21/2009
  Inventory as of this Action Requested Previously Approved
12/31/2012 36 Months From Approved
2 0 0
1 0 0
0 0 0

A plan or issuer may request (but not require) a genetic test in connection with certain research activities so long as such activities comply with specific requirements, including (i) the research complies with 45 CFR part 46 or equivalent federal regulations and applicable State or local law or regulations for the protection of human subjects in research, (ii) the request for the participant or beneficiary (or in the case of a minor child, the legal guardian of such beneficiary) is made in writing and clearly indicates that compliance with the request is voluntary and that non-compliance will have no effect on eligibility for benefits or premium or contribution amounts; and (iii) no genetic information collected or acquired will be used for underwriting purposes. The Notice of Research Exception under the Genetic Information Nondiscrimination Act (the Notice) is a model notice that can be completed by group health plans and health insurance issuers and filed with either the Department of Labor or CMS to comply with the notification requirement.

PL: Pub.L. 110 - 223 102(a)(2)and(b)(a)(B) Name of Law: The Genetic Information Nondiscrimination Act of 2008
   US Code: 42 USC 300gg-1(c)(4)(D) Name of Law: null
  
PL: Pub.L. 110 - 223 102 Name of Law: The Genetic Information Nondiscrimination Act of 2008

0938-AP37 Final or interim final rulemaking 74 FR 51664 10/07/2009

No

  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 2 0 2 0 0 0
Annual Time Burden (Hours) 1 0 1 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The increase in the burden is arising from the new statutory requirement under the Genetic Information Nondiscrimination Act for group health plans and health insurance issuers to notify either the Secretary of Labor or the Secretary of HHS that they are conducting genetic research. ________________________________________________________________________________________________

$0
No
No
Uncollected
Uncollected
No
Uncollected
Bonnie Harkless 4107865666

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/21/2009


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