Genetic Information Nondiscrimination Act of 2008 Research Exception Notice
Extension without change of a currently approved collection
No
Regular
Approved without change
07/16/2025
03/31/2025
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
07/31/2028
36 Months From Approved
07/31/2025
35
0
48
9
0
12
199
0
185
The Genetic Information Nondiscrimination Act of 2008 (GINA), Public Law 110-233, was enacted on May 21, 2008. Title I of GINA amended the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), the Internal Revenue Code of 1986 (the Code), and the Social Security Act (SSA) to prohibit discrimination in health coverage based on genetic information. Sections 101 through 103 of Title I of GINA prevent employment-based group health plans and health insurance issuers in the group and individual markets from discriminating based on genetic information and from collecting such information.
GINA and the interim final regulations (29 CFR 2590.702-1(c)(5)) provide an exception to the limitations on requesting or requiring genetic testing that allows a group health plan or group health insurance issuer to request, but not require, a participant or beneficiary to undergo a genetic test if all of the following conditions of the research exception are satisfied.
First, the request must be made pursuant to research that complies with 45 CFR part 46 (or equivalent Federal regulations) and any applicable State or local law or regulations for the protection of human subjects in research. To comply with the informed consent requirements of 45 CFR 46.116(a)(8), a participant must receive a disclosure that participation in the research is voluntary, refusal to participate cannot involve any penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is entitled (the Participant Disclosure).
Second, the plan or issuer must make the request in writing and must clearly indicate to each participant or beneficiary (or in the case of a minor child, to the legal guardian of such beneficiary) to whom the request is made that compliance with the request is voluntary and noncompliance will have no effect on eligibility for benefits, premium, or contribution amounts.
Third, none of the genetic information collected or acquired as a result of the research may be used for underwriting purposes. Finally, the plan or issuer must complete a copy of the âNotice of Research Exception under the Genetic Information Nondiscrimination Actâ and provide it to the address specified in its instructions. The Notice and instructions are available on the Department's website.
There have been no program changes since the last submission. The average annual number of companies requesting genetic research disclosure has decreased by 13 responses. The labor rates and postage costs have also been adjusted. As a result, the hour burden has decreased by three hours and cost burden has decreased by $14.
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.
PC_202410-1210-006_043025_083552_1.pdf
1210-0136 GINA SS 3-20-2025.docx
Notice of Research Exception under the Genetic Information Nondiscrimination Act of