Notice of Research Exception under the Genetic Information Nondiscrimination Act (CMS-10286)

ICR 202205-0938-013

OMB: 0938-1077

Federal Form Document

Forms and Documents
ICR Details
0938-1077 202205-0938-013
Received in OIRA 201902-0938-014
Notice of Research Exception under the Genetic Information Nondiscrimination Act (CMS-10286)
Extension without change of a currently approved collection   No
Regular 05/10/2022
  Requested Previously Approved
36 Months From Approved 06/30/2022
2 2
1 1
0 0

Under the Genetic Information Nondiscrimination Act of 2008 (GINA), 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 Secretary of Labor or the Secretary of Health and Human Services is required to be notified if a group health plan or health insurance issuer intends to claim the research exception permitted under Title I of GINA. Nonfederal governmental group health plans and issuers solely in the individual health insurance market or Medigap market will be required to file with the Centers for Medicare & Medicaid Services (CMS). The Notice of Research Exception under the Genetic Information Nondiscrimination Act 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.

US Code: 42 USC 300 Name of Law: 300gg-1(c)(4)(D) and 300gg-51(d)(4)(D)
   PL: Pub.L. 110 - 223 102(a)(2)and(b)(a)(B) Name of Law: The Genetic Information Nondiscrimination Act of 2008

Not associated with rulemaking

  87 FR 1415 01/11/2022
87 FR 28014 05/10/2022

IC Title Form No. Form Name
Notice of Research Exception under the Genetic Information Nondiscrimination Act (GINA) CMS-10286 GINA Research Execption Notice

  Total Request 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 2 0 0 0 0
Annual Time Burden (Hours) 1 1 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Jamaa Hill 301 492-4190


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.

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