51710 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Proposed Rules 

9. In § 164.514, revise paragraph (g) to 

read as follows: 

§ 164.514 Other requirements relating to 

uses and disclosures of protected health 

information. 

* * * * * 

(g) Standard: Uses and disclosures for 

activities relating to the creation, 

renewal, or replacement of a contract of 

health insurance or health benefits. If a 

health plan receives protected health 

information for the purpose of premium 

rating or other activities relating to the 

creation, renewal, or replacement of a 

contract of health insurance or health 

benefits, and if such health insurance or 

health benefits are not placed with the 

health plan, such health plan may only 

use or disclose such protected health 

information for such purpose or as may 

be required by law, subject to the 

prohibition at § 164.502(a)(3) with 

respect to genetic information included 

in the protected health information. 

* * * * * 

10. In § 164.520, add a new paragraph 

(b)(1)(iii)(D) to read as follows: 

§ 164.520 Notice of privacy practices for 

protected health information. 

* * * * * 

(b) * * * 

(1) * * * 

(iii) * * * 

(D) If a covered entity that is a health 

plan intends to use or disclose protected 

health information for underwriting 

purposes, a statement that the covered 

entity is prohibited from using or 

disclosing protected health information 

that is genetic information of an 

individual for such purposes. 

Dated: June 5, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–22492 Filed 10–1–09; 11:15 am] 

BILLING CODE 4153–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[REG–123829–08] 

RIN 1545–BI02 

Genetic Information Nondiscrimination 

Act 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

by cross-reference to temporary 

regulations. 

SUMMARY: Elsewhere in this issue of the 

Federal Register, the IRS is issuing 

temporary and final regulations 

governing the provisions of the Genetic 

Information Nondiscrimination Act 

(GINA) prohibiting discrimination based 

on genetic information for group health 

plans. The IRS is issuing the temporary 

and final regulations at the same time 

that the Employee Benefits Security 

Administration of the U.S. Department 

of Labor and the Centers for Medicare & 

Medicaid Services of the U.S. 

Department of Health and Human 

Services are issuing substantially 

similar interim final regulations with 

respect to GINA for group health plans 

and issuers of health insurance coverage 

offered in connection with a group 

health plan under the Employee 

Retirement Income Security Act of 1974 

and the Public Health Service Act. The 

temporary regulations provide guidance 

to employers and group health plans 

relating to the group health plan genetic 

nondiscrimination requirements. The 

text of those temporary regulations also 

serves as the text of these proposed 

regulations. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by January 5, 2010. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–123829–08), Room 

5205, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may be hand-delivered to: 

CC:PA:LPD:PR (REG–123829–08), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC 20224. 

Alternatively, taxpayers may submit 

comments electronically via the Federal 

eRulemaking Portal at http:// 

www.regulations.gov (IRS REG–123829– 

08). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the regulations, Russ 

Weinheimer at 202–622–6080; 

concerning submissions of comments, 

Oluwafumilayo Taylor at (202) 622– 

7180 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Paperwork Reduction Act 

The collection of information 

referenced in this notice of proposed 

rulemaking has been submitted to the 

Office of Management and Budget for 

review in accordance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3507(d)). Comments on the 

collection of information should be sent 

to the Office of Management and 

Budget, Attn: Desk Officer for the 

Department of the Treasury, Office of 

Information and Regulatory Affairs, 

Washington, DC 20503, with copies to 

the Internal Revenue Service, Attn: IRS 

Reports Clearance Officer, 

SE:W:CAR:MP:T:T:SP, Washington, DC 

20224. Comments on the collection of 

information should be received by 

December 7, 2009. Comments are 

specifically requested concerning: 

• Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Internal Revenue Service, including 

whether the information will have 

practical utility; 

• The accuracy of the estimated 

burden associated with the proposed 

collection of information (see the 

preamble to the temporary regulations 

published elsewhere in this issue of the 

Federal Register); 

• How to enhance the quality, utility, 

and clarity of the information to be 

collected; 

• How to minimize the burden of 

complying with the proposed collection 

of information, including the 

application of automated collection 

techniques or other forms of information 

technology; and 

• Estimates of capital or start-up costs 

and costs of operation, maintenance, 

and purchase of services to provide 

information. 

The collection of information is in 

§ 54.9802–3 (see the temporary 

regulations published elsewhere in this 

issue of the Federal Register). The 

collection of information is required so 

that the IRS can be apprised when a 

group health plan is conducting 

research with respect to genetic 

information of plan participants or 

beneficiaries to ensure that all the 

requirements of the research exception 

to GINA are being complied with. The 

likely respondents are business or other 

for-profit institutions, and nonprofit 

institutions. Responses to this collection 

of information are required if a plan 

wishes to conduct genetic research with 

respect to participants or beneficiaries 

of the plan. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a valid control 

number assigned by the Office of 

Management and Budget. 

Books or records relating to a 

collection of information must be 

retained as long as their contents may 

become material in the administration 

of any internal revenue law. Generally 

tax returns and tax return information 

are confidential, as required by 26 

U.S.C. 6103. 

Background 

The temporary regulations published 

elsewhere in this issue of the Federal 

Register add a new § 54.9802–3T to the 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Proposed Rules 51711 

Miscellaneous Excise Tax Regulations. 

In the same document, certain 

conforming changes are also being made 

to the final regulations under 

§§ 54.9801–1, 54.9801–2, 54.9802–1, 

and 54.9831–1. The proposed, 

temporary, and final regulations are 

being published as part of a joint 

rulemaking with the Department of 

Labor and the Department of Health and 

Human Services (the joint rulemaking). 

The text of those temporary regulations 

also serves as the text of these proposed 

regulations. The preamble to the 

temporary regulations explains the 

temporary regulations. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking is not a 

significant regulatory action as defined 

in Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

has also been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 

to this proposed regulation. It is hereby 

certified that the collection of 

information contained in this notice of 

proposed rulemaking will not have a 

significant impact on a substantial 

number of small entities. Accordingly, a 

regulatory flexibility analysis is not 

required. GINA requires group health 

plans claiming the research exception to 

GINA to notify the Secretary of the 

Treasury when the exception is being 

claimed. This notice of proposed 

rulemaking does not add to the 

reporting requirement imposed by the 

statute. Moreover, it is anticipated that 

very few and only the largest group 

health plans are likely to claim the 

research exception to GINA and thus be 

subject to the reporting requirement. For 

this reason, the burden imposed by the 

reporting requirement of the statute and 

this notice of proposed rulemaking on 

small entities is expected to be near 

zero. For further information and for 

analyses relating to the joint 

rulemaking, see the preamble to the 

joint rulemaking. Pursuant to section 

7805(f) of the Internal Revenue Code, 

this notice of proposed rulemaking will 

be submitted to the Chief Counsel for 

Advocacy of the Small Business 

Administration for comment on its 

impact on small business. 

Comments and Requests for a Public 

Hearing 

Before these proposed regulations are 

adopted as final regulations, 

consideration will be given to any 

written comments (a signed original and 

eight (8) copies) or electronic comments 

that are submitted timely to the IRS. 

Comments are specifically requested on 

the clarity of the proposed regulations 

and how they may be made easier to 

understand. All comments will be 

available for public inspection and 

copying. A public hearing may be 

scheduled if requested in writing by a 

person that timely submits written 

comments. If a public hearing is 

scheduled, notice of the date, time, and 

place for the hearing will be published 

in the Federal Register. 

Drafting Information 

The principal author of these 

proposed regulations is Russ 

Weinheimer, Office of the Division 

Counsel/Associate Chief Counsel (Tax 

Exempt and Government Entities), IRS. 

The proposed regulations, as well as the 

temporary and final regulations, have 

been developed in coordination with 

personnel from the U.S. Department of 

Labor and the U.S. Department of 

Health and Human Services. 

List of Subjects in 26 CFR Part 54 

Excise taxes, Health insurance, 

Pensions, Reporting and recordkeeping 

requirements. 

Proposed Amendments to the 

Regulations 

Accordingly, 26 CFR part 54 is 

proposed to be amended as follows: 

PART 54—PENSION EXCISE TAXES 

Paragraph 1. The authority citation 

for part 54 is amended by adding an 

entry in numerical order to read as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

Section 54.9802–3 also issued under 26 

U.S.C. 9833. * * * 

Par. 2. Section 54.9802–3 is added to 

read as follows: 

§ 54.9802–3 Additional requirements 

prohibiting discrimination based on genetic 

information. 

[The text of proposed § 54.9802–3 is 

the same as the text of § 54.9802–3T 

published elsewhere in this issue of the 

Federal Register]. 

Linda E. Stiff, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. E9–22512 Filed 10–1–09; 11:15 am] 

BILLING CODE 4830–01–P 


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