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OMB Control No: 0938-1077	ICR Reference No: 202507-0938-020
Status: Received in OIRA	Previous ICR Reference No: 202205-0938-013
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO - 10286
Title: Notice of Research Exception under the Genetic Information Nondiscrimination Act (CMS-10286)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 07/15/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2	0
Time Burden (Hours)	1	0
Cost Burden (Dollars)	0	0

Abstract: 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.

Authorizing Statute(s): 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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 16685	04/21/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 30939	07/11/2025
Did the Agency receive public comments on this ICR? No

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 (GINA)	CMS-10286	GINA Research Execption Notice

ICR Summary of Burden

	Total Request	Change Due to Potential Violation of the PRA
Annual Number of Responses	2	2
Annual Time Burden (Hours)	1	1
Annual Cost Burden (Dollars)	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

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? No

Agency Contact: Jamaa Hill 301 492-4190

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