Notice2025-05433
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Genetic Information Nondiscrimination Act of 2008 Research Exception Notice
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 31, 2025
Issuing agencies
Labor Department
Abstract
The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Full Text
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<title>Federal Register, Volume 90 Issue 60 (Monday, March 31, 2025)</title>
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[Federal Register Volume 90, Number 60 (Monday, March 31, 2025)]
[Notices]
[Pages 14273-14274]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05433]
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DEPARTMENT OF LABOR
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Genetic Information Nondiscrimination Act of
2008 Research Exception Notice
ACTION: Notice of availability; request for comments.
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SUMMARY: The Department of Labor (DOL) is submitting this Employee
Benefits Security Administration (EBSA)-sponsored information
collection request (ICR) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act
of 1995 (PRA). Public comments on the ICR are invited.
DATES: The OMB will consider all written comments that the agency
receives on or before April 30, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Michael Howell by telephone at 202-
693-6782, or by email at <a href="/cdn-cgi/l/email-protection#7d393231222d2f3c222d283f31343e3d191211531a120b"><span class="__cf_email__" data-cfemail="a1e5eeedfef1f3e0fef1f4e3ede8e2e1c5cecd8fc6ced7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: 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 ``Notice of Research
Exception under the Genetic Information Nondiscrimination Act'' and
provide it to the address specified in its instructions. The Notice and
instructions are available on the Department's website. For additional
substantive information about this ICR, see the related notice
published in the Federal Register on July 9, 2024 (89 FR 56416).
Comments are invited on: (1) whether the collection of information
is necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility; (2) the accuracy of the agency's estimates of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
This information collection is subject to the PRA. A Federal agency
generally
[[Page 14274]]
cannot conduct or sponsor a collection of information, and the public
is generally not required to respond to an information collection,
unless the OMB approves it and displays a currently valid OMB Control
Number. In addition, notwithstanding any other provisions of law, no
person shall generally be subject to penalty for failing to comply with
a collection of information that does not display a valid OMB Control
Number. See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this information collection for
three (3) years. OMB authorization for an ICR cannot be for more than
three (3) years without renewal. The DOL notes that information
collection requirements submitted to the OMB for existing ICRs receive
a month-to-month extension while they undergo review.
Agency: DOL-EBSA.
Title of Collection: Genetic Information Nondiscrimination Act of
2008 Research Exception Notice.
OMB Control Number: 1210-0136.
Affected Public: Private sector, Businesses or other for-profits,
Not-for-profit institutions.
Total Estimated Number of Respondents: 35.
Total Estimated Number of Responses: 35.
Total Estimated Annual Time Burden: 9 hours.
Total Estimated Annual Other Costs Burden: $199.
(Authority: 44 U.S.C. 3507(a)(1)(D))
Michael Howell,
Senior Paperwork Reduction Act Analyst.
[FR Doc. 2025-05433 Filed 3-28-25; 8:45 am]
BILLING CODE 4510-29-P
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