Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 16501 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

RIN 1545–BJ60 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AB44 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 147 

[CMS–9968–ANPRM] 

RIN 0938–AR42 

Certain Preventive Services Under the 

Affordable Care Act 

AGENCIES: Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services. 

ACTION: Advance notice of proposed 

rulemaking (ANPRM). 

SUMMARY: This advance notice of 

proposed rulemaking announces the 

intention of the Departments of Health 

and Human Services, Labor, and the 

Treasury to propose amendments to 

regulations regarding certain preventive 

health services under provisions of the 

Patient Protection and Affordable Care 

Act (Affordable Care Act). The proposed 

amendments would establish alternative 

ways to fulfill the requirements of 

section 2713 of the Public Health 

Service Act and companion provisions 

under the Employee Retirement Income 

Security Act and the Internal Revenue 

Code when health coverage is sponsored 

or arranged by a religious organization 

that objects to the coverage of 

contraceptive services for religious 

reasons and that is not exempt under 

the final regulations published February 

15, 2012. This document serves as a 

request for comments in advance of 

proposed rulemaking on the potential 

means of accommodating such 

organizations while ensuring 

contraceptive coverage for plan 

participants and beneficiaries covered 

under their plans (or, in the case of 

student health insurance plans, student 

enrollees and their dependents) without 

cost sharing. 

DATES: Comments are due on or before 

June 19, 2012. 

ADDRESSES: Written comments may be 

submitted as specified below. Any 

comment that is submitted will be 

shared with the other Departments. 

Please do not submit duplicate 

comments. 

All comments will be made available 

to the public. Please Note: Do not 

include any personally identifiable 

information (such as name, address, or 

other contact information) or 

confidential business information that 

you do not want publicly disclosed. All 

comments are posted on the Internet 

exactly as received, and can be retrieved 

by most Internet search engines. No 

deletions, modifications, or redactions 

will be made to the comments received, 

as they are public records. Comments 

may be submitted anonymously. 

In commenting, please refer to file 

code CMS–9968–ANPRM. Because of 

staff and resource limitations, the 

Departments cannot accept comments 

by facsimile (FAX) transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this ANPRM to 

http://www.regulations.gov. Follow the 

instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9968–ANPRM, P.O. Box 8016, 

Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–9968– 

ANPRM, Mail Stop C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping and retaining an extra 

copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

(410) 786–9994 in advance to schedule 

your arrival with one of our staff 

members. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. The Departments post all 

comments received before the close of 

the comment period on the following 

Web site as soon as possible after they 

have been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately three weeks after 

publication of a document, at the 

headquarters of the Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Baltimore, Maryland 21244, 

Monday through Friday of each week 

from 8:30 a.m. to 4 p.m. EST. To 

schedule an appointment to view public 

comments, call 1–800–743–3951. 

FOR FURTHER INFORMATION CONTACT: 

Amy Turner or Beth Baum, Employee 

Benefits Security Administration 

(EBSA), Department of Labor, at (202) 

693–8335; Karen Levin, Internal 

Revenue Service, Department of the 

Treasury, at (202) 927–9639; Jacob 

Ackerman, Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS), at 

(410) 786–1565. 

Customer Service Information: 

Individuals interested in obtaining 

information from the Department of 

Labor concerning employment-based 

health coverage laws may call the EBSA 

Toll-Free Hotline at 1–866–444–EBSA 

(3272) or visit the Department of Labor’s 

Web site (http://www.dol.gov/ebsa). In 


srobinson on DSK4SPTVN1PROD with PROPOSALS
16502 Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 

1The HRSA Guidelines are available at: http:// 

www.hrsa.gov/womensguidelines. 

2Note: This excludes items and services such as 

vasectomies and condoms. 

3The interim final regulations published by the 

Departments on July 19, 2010, generally provide 

that plans and issuers must cover a newly 

recommended preventive service starting with the 

first plan year (or, in the individual market, policy 

year) that begins on or after the date that is one year 

after the date on which the new recommendation 

or guideline is issued. 26 CFR 54.9815–2713T(b)(1); 

29 CFR 2590.715–2713(b)(1); 45 CFR 147.130(b)(1). 

4The amendment to the interim final rules was 

published on August 3, 2011, at 76 FR 46621. 

5The bulletin can be found at: http:// 

cciio.cms.gov/resources/files/Files2/02102012/ 

20120210-Preventive-Services-Bulletin.pdf. 

addition, information from HHS on 

private health insurance for consumers 

can be found on the CMS Web site 

(www.cciio.cms.gov), and information 

on health reform can be found at 

http://www.HealthCare.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Patient Protection and Affordable 

Care Act, Public Law 111–148, was 

enacted on March 23, 2010; the Health 

Care and Education Reconciliation Act 

of 2010, Public Law 111–152, was 

enacted on March 30, 2010 (collectively, 

the Affordable Care Act). The Affordable 

Care Act reorganizes, amends, and adds 

to the provisions of part A of title XXVII 

of the Public Health Service Act (PHS 

Act) relating to group health plans and 

health insurance issuers in the group 

and individual markets. The Affordable 

Care Act adds section 715(a)(1) to the 

Employee Retirement Income Security 

Act (ERISA) and section 9815(a)(1) to 

the Internal Revenue Code (Code) to 

incorporate the provisions of part A of 

title XXVII of the PHS Act into ERISA 

and the Code, and make them 

applicable to group health plans. 

Section 2713 of the PHS Act, as added 

by the Affordable Care Act and 

incorporated into ERISA and the Code, 

requires that non-grandfathered group 

health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance 

coverage provide benefits for certain 

preventive health services without the 

imposition of cost sharing. These 

preventive health services include, with 

respect to women, preventive care and 

screening provided for in the 

comprehensive guidelines supported by 

the Health Resources and Services 

Administration (HRSA) that were issued 

on August 1, 2011 (HRSA Guidelines).1

As relevant here, the HRSA Guidelines 

require coverage, without cost sharing, 

for ‘‘[a]ll Food and Drug Administration 

[(FDA)] approved contraceptive 

methods, sterilization procedures, and 

patient education and counseling for all 

women with reproductive capacity,’’ as 

prescribed by a provider.2 Except as 

discussed below, non-grandfathered 

group health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance 

coverage are required to provide 

coverage consistent with the HRSA 

Guidelines, without cost sharing, in 

plan years (or, in the individual market, 

policy years) beginning on or after 

August 1, 2012.3 These guidelines were 

based on recommendations of the 

independent Institute of Medicine, 

which undertook a review of the 

scientific and medical evidence on 

women’s preventive services. 

The Departments of Health and 

Human Services (HHS), Labor, and the 

Treasury (the Departments) published 

interim final regulations implementing 

section 2713 of the PHS Act on July 19, 

2010 (75 FR 41726). In response to 

comments, the Departments amended 

the interim final regulations on August 

1, 2011.4 The amendment provided 

HRSA with discretion to establish an 

exemption for group health plans 

established or maintained by certain 

religious employers (and any group 

health insurance coverage provided in 

connection with such plans) with 

respect to any contraceptive services 

that they would otherwise be required 

to cover consistent with the HRSA 

Guidelines. The amended interim final 

regulations further specified that, for 

purposes of this exemption only, a 

religious employer is one that—(1) has 

the inculcation of religious values as its 

purpose; (2) primarily employs persons 

who share its religious tenets; (3) 

primarily serves persons who share its 

religious tenets; and (4) is a non-profit 

organization described in section 

6033(a)(1) and section 6033(a)(3)(A)(i) 

or (iii) of the Code. Section 

6033(a)(3)(A)(i) and (iii) of the Code 

refers to churches, their integrated 

auxiliaries, and conventions or 

associations of churches, as well as to 

the exclusively religious activities of 

any religious order. This religious 

exemption is consistent with the 

policies in some States that currently 

both require contraceptive coverage and 

provide for some type of religious 

exemption from their contraceptive 

coverage requirement. 

In the HRSA Guidelines, HRSA 

exercised its discretion under the 

amended interim final regulations such 

that group health plans established or 

maintained by these religious employers 

(and any group health insurance 

coverage provided in connection with 

such plans) are not required to cover 

any contraceptive services. In the final 

regulations published on February 15, 

2012 (77 FR 8725), the Departments 

adopted the definition of religious 

employer in the amended interim final 

regulations. 

The Departments emphasize that this 

religious exemption is intended solely 

for purposes of the contraceptive 

coverage requirement pursuant to 

section 2713 of the PHS Act and the 

companion provisions of ERISA and the 

Code. Whether an employer is 

designated as ‘‘religious’’ for these 

purposes is not intended as a judgment 

about the mission, sincerity, or 

commitment of the employer, and the 

use of such designation is limited to 

defining the class that qualifies for this 

specific exemption. The designation 

will not be applied with respect to any 

other provision of the PHS Act, ERISA, 

or the Code, nor is it intended to set a 

precedent for any other purpose. 

In addition, we note that this 

exemption is available to religious 

employers in a variety of arrangements. 

For example, a Catholic elementary 

school may be a distinct common-law 

employer from the Catholic diocese 

with which it is affiliated. If the school’s 

employees receive health coverage 

through a plan established or 

maintained by the school, and the 

school meets the definition of a 

religious employer in the final 

regulations, then the religious employer 

exemption applies. If, instead, the same 

school provides health coverage for its 

employees through the same plan under 

which the diocese provides coverage for 

its employees, and the diocese is 

exempt from the requirement to cover 

contraceptive services, then neither the 

diocese nor the school is required to 

offer contraceptive coverage to its 

employees. 

On February 10, 2012, when the final 

regulations concerning the exemption 

were posted, HHS issued a bulletin 

entitled ‘‘Guidance on the Temporary 

Enforcement Safe Harbor for Certain 

Employers, Group Health Plans and 

Group Health Insurance Issuers with 

Respect to the Requirement to Cover 

Contraceptive Services Without Cost 

Sharing Under Section 2713 of the 

Public Health Service Act, Section 

715(a)(1) of the Employee Retirement 

Income Security Act, and Section 

9815(a)(1) of the Internal Revenue 

Code.’’ 5 The bulletin established a 

temporary enforcement safe harbor for 

group health plans sponsored by nonprofit organizations that, on and after 

February 10, 2012, do not provide some 

or all of the contraceptive coverage 

otherwise required, consistent with any 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 16503 

6Bertko, John, F.S.A., M.A.A.A., Director of 

Special Initiatives and Pricing, Center for Consumer 

Information and Insurance Oversight, Centers for 

Medicare & Medicaid Services, Glied, Sherry, Ph.D., 

Assistant Secretary for Planning and Evaluation, 

Department of Health and Human Services (ASPE/ 

HHS), Miller, Erin, MPH, ASPE/HHS, Wilson, Lee, 

ASPE/HHS, Simmons, Adelle, ASPE/HHS, ‘‘The 

Cost of Covering Contraceptives Through Health 

Insurance,’’ (February 9, 2012), available at: http:// 

aspe.hhs.gov/health/reports/2012/contraceptives/ 

ib.shtml. 

applicable State law, because of the 

religious beliefs of the organization (and 

any group health insurance coverage 

provided in connection with such 

plans). The temporary enforcement safe 

harbor is in effect until the first plan 

year that begins on or after August 1, 

2013. The bulletin confirmed that all 

three Departments will not take any 

enforcement action against an employer, 

group health plan, or health insurance 

issuer that complies with the conditions 

of the temporary enforcement safe 

harbor described in the bulletin. 

At the same time, the Departments 

announced plans to expeditiously 

develop and propose changes to the 

final regulations implementing section 

2713 of the PHS Act that would meet 

two goals—accommodating non-exempt, 

non-profit religious organizations’ 

religious objections to covering 

contraceptive services and assuring that 

participants and beneficiaries covered 

under such organizations’ plans receive 

contraceptive coverage without cost 

sharing. The Departments intend to 

finalize these amendments to the final 

regulations such that they are effective 

by the end of the temporary 

enforcement safe harbor; that is, the 

amended final regulations would apply 

to plan years starting on or after August 

1, 2013. This advance notice of 

proposed rulemaking (ANPRM) is the 

first step toward promulgating these 

amended final regulations. Following 

the receipt of public comment, a notice 

of proposed rulemaking (NPRM) will be 

published, which will permit additional 

public comment, followed by amended 

final regulations. 

II. Overview of Intended Regulations 

On February 10, 2012, the 

Departments committed to working with 

stakeholders to develop alternative ways 

of providing contraceptive coverage 

without cost sharing in order to 

accommodate non-exempt, non-profit 

religious organizations with religious 

objections to such coverage. 

Specifically, the Departments indicated 

their plans for a rulemaking to require 

issuers to offer group health insurance 

coverage without contraceptive coverage 

to such an organization (or its plan 

sponsor) and simultaneously to provide 

contraceptive coverage directly to the 

participants and beneficiaries covered 

under the organization’s plan with no 

cost sharing. Under this approach, the 

Departments would require that, in this 

circumstance, there be no premium 

charge for the separate contraceptive 

coverage. Actuaries and experts have 

found that coverage of contraceptives is 

at least cost neutral, and may save 

money, when taking into account all 

costs and benefits for the issuer.6 If the 

cost of coverage is reduced, savings may 

accrue to employers, plan participants 

and beneficiaries, and the health care 

system. The Departments indicated their 

intent to develop policies to achieve the 

same goals with respect to self-insured 

group health plans sponsored by nonexempt, non-profit religious 

organizations with religious objections 

to contraceptive coverage. 

In the time since this announcement, 

the Departments have met with 

representatives of religious 

organizations, insurers, women’s 

groups, insurance experts, and other 

interested stakeholders. These initial 

meetings were used to help identify 

issues relating to the accommodation to 

be developed with respect to nonexempt, non-profit religious 

organizations with religious objections 

to contraceptive coverage. These 

consultations also began to provide 

more detailed information on how 

health coverage arrangements are 

currently structured, how religious 

accommodations work in States with 

contraceptive coverage requirements, 

and the landscape with respect to 

religious organizations that offer health 

benefits today. These discussions have 

informed this ANPRM. 

As the consultations with interested 

parties continue, this ANPRM presents 

questions and ideas to help shape these 

discussions as well as an early 

opportunity for any interested 

stakeholder to provide advice and input 

into the policy development relating to 

the accommodation to be made with 

respect to non-exempted, non-profit 

religious organizations with religious 

objections to contraceptive coverage. 

The Departments welcome all points of 

view on how to provide women access 

to the important preventive services at 

issue without cost sharing while 

accommodating religious liberty 

interests. 

The starting point for this policy 

development includes two goals and 

several ideas about how to achieve 

them. First, the Departments aim to 

maintain the provision of contraceptive 

coverage without cost sharing to 

individuals who receive coverage 

through non-exempt, non-profit 

religious organizations with religious 

objections to contraceptive coverage in 

the simplest way possible. Second, the 

Departments aim to protect such 

religious organizations from having to 

contract, arrange, or pay for 

contraceptive coverage. As described 

below, the Departments intend to 

propose a requirement that health 

insurance issuers providing coverage for 

insured group health plans sponsored 

by such religious organizations assume 

the responsibility for the provision of 

contraceptive coverage without cost 

sharing to participants and beneficiaries 

covered under the plan, independent of 

the religious organization, as a means of 

meeting these goals. HHS also intends to 

propose a comparable requirement with 

respect to student health insurance 

plans arranged by such religious 

organizations. For such religious 

organizations that sponsor self-insured 

plans, the Departments intend to 

propose that a third-party administrator 

of the group health plan or some other 

independent entity assume this 

responsibility. The Departments suggest 

multiple options for how contraceptive 

coverage in this circumstance could be 

arranged and financed in recognition of 

the variation in how such self-insured 

plans are structured and different 

religious organizations’ perspectives on 

what constitutes objectionable 

cooperation with the provision of 

contraceptive coverage. The 

Departments seek input on these 

options, particularly how to enable 

religious organizations to avoid such 

objectionable cooperation when it 

comes to the funding of contraceptive 

coverage, as well as new ideas to inform 

the next stage of the rulemaking process. 

The following sections set forth 

questions the Departments believe will 

help inform the development of 

proposed regulations, including the 

policy options the Departments are 

considering and potential language 

related to such options. Throughout this 

ANPRM, the term ‘‘accommodation’’ is 

used to refer to an arrangement under 

which contraceptive coverage is 

provided without cost sharing to 

participants and beneficiaries covered 

under a plan independent of the 

objecting religious organization that 

sponsors the plan, which would 

effectively exempt the religious 

organization from the requirement to 

cover contraceptive services. The term 

‘‘religious organization’’ is used to 

describe the class of organizations that 

qualifies for the accommodation. An 

‘‘independent entity’’ is an issuer, thirdparty administrator, or other provider of 

contraceptive coverage that is not a 


srobinson on DSK4SPTVN1PROD with PROPOSALS
16504 Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 

7 26 CFR 54.9815–2713T(a)(4), 29 CFR 2590.715– 

2713(a)(4), and 45 CFR 147.130(a)(4). 

8See also the Departments’ guidance in FAQ–8 at 

http://www.dol.gov/ebsa/pdf/faq-aca2.pdf and 

FAQ–1 at http://www.dol.gov/ebsa/pdf/faqaca5.pdf. 

9Note that, even if the definition of religious 

organization for purposes of the accommodation 

were to include religious employers eligible for the 

exemption, nothing in the proposed regulations 

would limit eligibility of religious employers for the 

exemption. 

religious organization. And 

‘‘contraceptive coverage’’ means the 

contraceptive coverage required under 

the HRSA Guidelines. 

The Departments note that a number 

of questions have been raised about the 

scope and application of the 

contraceptive coverage requirement 

more generally (that is, questions apart 

from the religious accommodation). The 

Departments’ interim final regulations 

implementing section 2713 of the PHS 

Act provide that ‘‘[n]othing prevents a 

plan or issuer from using reasonable 

medical management techniques to 

determine the frequency, method, 

treatment, or setting for an item or 

service * * * to the extent not specified 

in the recommendation or guideline.’’7

The preamble to the interim final 

regulations further provides: 

‘‘The use of reasonable medical 

management techniques allows plans and 

issuers to adapt these recommendations and 

guidelines to coverage of specific items and 

services where cost sharing must be waived. 

Thus, under these interim final regulations, 

a plan or issuer may rely on established 

techniques and the relevant evidence base to 

determine the frequency, method, treatment, 

or setting for which a recommended 

preventive service will be available without 

cost sharing requirements to the extent not 

specified in a recommendation or guideline.’’ 

(75 FR 41728–29).8

This policy applies to contraceptive 

coverage. The Departments plan to issue 

further guidance on section 2713 of the 

PHS Act more generally. 

A. Who qualifies for the 

accommodation? 

As previously described, group health 

plans sponsored by certain religious 

employers (and any group health 

insurance coverage provided in 

connection with such plans) are exempt 

from the requirement to offer coverage 

of contraceptive services that would 

otherwise be required under the HRSA 

Guidelines for plan years beginning on 

or after August 1, 2012. A second set of 

organizations qualifies for a temporary 

enforcement safe harbor: group health 

plans sponsored by non-exempt, nonprofit organizations, that, consistent 

with any applicable State law, do not, 

on or after February 10, 2012 (the date 

of the posting of the final regulations), 

cover some or all forms of 

contraceptives due to the organization’s 

religious objections to them (and any 

group health insurance coverage 

provided in connection with such 

plans). The temporary enforcement safe 

harbor also applies to student health 

insurance plans arranged by non-profit 

institutions of higher education that 

meet comparable criteria. The 

temporary enforcement safe harbor 

applies for plan years beginning on or 

after August 1, 2012, and before August 

1, 2013. 

On February 10, 2012, the 

Departments also announced their 

intention to provide an accommodation 

with respect to non-exempt, non-profit 

religious organizations with religious 

objections to contraceptive coverage. 

The final regulation concerning student 

health insurance plans, published 

elsewhere in this issue of the Federal 

Register, states that this intention 

extends to student health insurance 

plans arranged by non-profit religious 

institutions of higher education with 

such objections. This accommodation 

would apply to some or all 

organizations that qualify for the 

temporary enforcement safe harbor, and 

possibly to additional organizations. 

Thus, a question for purposes of the 

intended regulations is: What entities 

should be eligible for the new 

accommodation (that is, what is a 

‘‘religious organization’’)? 9

One approach would be to adopt the 

definition of religious organization used 

in another statute or regulation. For 

example, the definition used in one or 

more State laws to afford a religious 

exemption from a contraceptive 

coverage requirement could be adopted. 

Alternatively, the intended regulations 

could base their definition on another 

Federal law, such as section 414(e) the 

Code and section 3(33) of ERISA, which 

set forth definitions for purposes of 

‘‘church plans.’’ A definition based on 

these provisions may include 

organizations such as hospitals, 

universities, and charities that are 

exempt from taxation under section 501 

of the Code and that are controlled by 

or associated with a church or a 

convention or association of churches. 

In developing a definition of religious 

organization, we are cognizant of the 

important role of ministries of churches 

and, as such, seek to accommodate their 

religious objections to contraceptive 

coverage. The Departments seek 

comment on which religious 

organizations should be eligible for the 

accommodation and whether, as some 

religious stakeholders have suggested, 

for-profit religious employers with such 

objections should be considered as well. 

The Departments underscore, as we 

did with respect to the definition of 

religious employer in the final 

regulations, that whatever definition of 

religious organization is adopted will 

not be applied with respect to any other 

provision of the PHS Act, ERISA, or the 

Code, nor is it intended to set a 

precedent for any other purpose. And, 

while the participants and beneficiaries 

covered under the health plans offered 

by a ‘‘religious employer’’ compared to 

those covered under the health plans 

offered by a ‘‘religious organization’’ 

will have differential access to 

contraceptive coverage, nothing in the 

final regulations or the forthcoming 

regulations is intended to differentiate 

among the religious merits, 

commitment, mission, or public or 

private standing of the organizations 

themselves. 

Regardless of the definition of 

religious organization that is proposed, 

the Departments are considering 

proposing the same or a similar process 

for self-certification that will be used for 

the temporary enforcement safe harbor 

referenced in the final regulations. 

Under that process, an individual 

authorized by the organization certifies 

that the organization satisfies the 

eligibility criteria, and the selfcertification is made available for 

examination. The Departments expect 

that, for purposes of the proposed 

accommodation, religious organizations 

would make a similar self-certification, 

and similarly make the self-certification 

available for examination. The selfcertification would be used to put the 

independent entity responsible for 

providing contraceptive coverage on 

notice that the religious organization 

has invoked the accommodation. The 

future rulemaking would require that 

the independent entity be responsible 

for providing the contraceptive coverage 

in this case. 

Under the temporary enforcement safe 

harbor, an organization that self-certifies 

must also provide (or arrange to 

provide) notice to plan participants and 

beneficiaries that its plan qualifies for 

the one-year enforcement safe harbor. 

As the Departments noted in the 

bulletin establishing the temporary 

enforcement safe harbor, nothing 

precludes any organization or 

individual from expressing opposition, 

if any, to the regulations or to the use 

of contraceptives. The Departments do 

not anticipate that religious 

organizations would be required to 

provide such notice to plan participants 

and beneficiaries beyond the one-year 

transition period because the 


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Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 16505 

responsibility to provide notice to plan 

participants and beneficiaries about the 

contraceptive coverage would be 

assumed by the independent entity. The 

Departments seek comment on how this 

notice should be provided. 

The Departments also intend to 

propose an accommodation for religious 

organizations that are non-profit 

institutions of higher education with 

religious objections to contraceptive 

coverage with respect to the student 

health insurance plans that they 

arrange. In the final regulation 

published elsewhere in this issue of the 

Federal Register, ‘‘student health 

insurance coverage’’ is defined as a type 

of individual market health insurance 

coverage offered to students and their 

dependents under a written agreement 

between an institution of higher 

education and an issuer. Some nonprofit religious colleges and universities 

object to signing a written agreement 

providing for student health insurance 

coverage that includes contraceptive 

coverage. Some non-profit religious 

colleges and universities include 

funding for their student health 

insurance plans in their student aid 

packages and would object if 

contraceptive coverage were included in 

the student health insurance plan. The 

preamble to the final regulation on 

student health insurance plans provides 

that the temporary enforcement safe 

harbor announced on February 10, 2012, 

with respect to certain non-exempt, 

non-profit organizations with religious 

objections to contraceptive coverage 

extends on comparable terms to student 

health insurance plans if offered 

through non-profit institutions of higher 

education with such objections. After 

the one-year transition period, the 

Departments would propose to treat 

student health insurance plans arranged 

by non-profit religious institutions of 

higher education that object to 

contraceptive coverage on religious 

grounds in a manner comparable to that 

in which insured group health plans 

sponsored by religious organizations 

eligible for the accommodation are 

treated. This means that the issuer of the 

student health insurance plan would, 

independent of the agreement with the 

institution of higher education, provide 

student enrollees and their dependents 

with contraceptive coverage without 

cost sharing and without charge. 

The Departments seek comment on 

whether the definition of religious 

organization should include religious 

organizations that provide coverage for 

some, but not all, FDA-approved 

contraceptives consistent with their 

religious beliefs. That is, under the 

forthcoming proposed regulations, the 

Departments could allow religious 

organizations to continue to provide 

coverage for some forms of 

contraceptives without cost sharing, and 

allow them to qualify for the 

accommodation with respect to other 

forms of contraceptives consistent with 

their religious beliefs. 

B. Who administers the 

accommodation? 

The accommodation aims to 

simultaneously fulfill the requirement 

that plan participants and beneficiaries 

be offered contraceptive coverage 

without cost sharing and without 

charge, and protect a non-profit 

religious organization that objects on 

religious grounds from having to 

provide contraceptive coverage. To 

achieve these goals, an independent 

entity is needed to assume certain 

functions. This entity would, separate 

from the religious organization and as 

directed by regulations and guidance, 

notify plan participants and 

beneficiaries of the availability of 

separate contraceptive coverage, provide 

this coverage automatically to 

participants and beneficiaries covered 

under the organization’s plan (for 

example, without an application or 

enrollment process), and protect the 

privacy of participants and beneficiaries 

covered under the plan who use 

contraceptive services. 

Today, in most instances, an 

independent entity either provides or 

administers health coverage for group 

health plans. Such group coverage falls 

into two categories: Insured coverage 

and self-insured coverage. A group that 

buys insured coverage pays a premium 

to a State-licensed and State-regulated 

health insurance issuer which bears the 

risk of claims for that coverage. A group 

that self-insures its coverage does not 

pay premiums to a health insurance 

issuer; instead, employer and/or 

employee contributions fund the health 

claims of participants and beneficiaries 

covered under the plan. Typically, selfinsured plans contract with a thirdparty administrator, under a fee 

arrangement, for administrative 

services, such as network contracting, 

managed care services, and payment of 

claims. Insured group health plans and 

self-insured group health plans that are 

not church plans or governmental plans 

are generally subject to Title I of ERISA. 

Because there is no insurance provided 

by a health insurance issuer, selfinsured plans are not subject to State 

insurance laws. 

The Departments intend to propose 

that, when offering insured coverage to 

a religious organization that selfcertifies as qualifying for the 

accommodation, a health insurance 

issuer may not include contraceptive 

coverage in that organization’s insured 

coverage. This means that contraceptive 

coverage would not be included in the 

plan document, contract, or premium 

charged to the religious organization. 

Instead, the issuer would be required to 

provide participants and beneficiaries 

covered under the plan separate 

coverage for contraceptive services, 

potentially as excepted benefits, without 

cost sharing, and notify plan 

participants and beneficiaries of its 

availability. The issuer could not charge 

a premium to the religious organization 

or plan participants or beneficiaries for 

the contraceptive coverage. To 

incorporate this proposal into 

regulations with respect to insured 

group health plans (comparable 

regulatory language would be developed 

with respect to student health insurance 

plans), the Departments are considering 

proposing new language in the existing 

preventive services regulations at 45 

CFR 147.130, 29 CFR 2590.715–2713 

and 26 CFR 54.9815–2713 providing: 

‘‘In the case of an insured group health 

plan established or maintained by a 

religious organization— 

• The group health plan established 

or maintained by the religious 

organization (and the group health 

insurance coverage provided in 

connection with the plan) need not 

comply with any requirement under this 

section to provide coverage for 

contraceptive services with respect to 

the insured group coverage if all of the 

following conditions are satisfied: 

Æ The organization provides the 

issuer with written notice that the 

organization is a religious organization, 

and will not act as the designated plan 

administrator or claims administrator 

with respect to claims for contraceptive 

benefits. 

Æ The issuer has access to 

information necessary to communicate 

with the plan’s participants and 

beneficiaries and to act as a claims 

administrator and plan administrator 

with respect to contraceptive benefits. 

• An issuer that receives the notice 

described above must offer to the 

religious organization group health 

insurance coverage that does not 

include coverage for contraceptive 

services otherwise required to be 

covered under this section. The issuer 

must additionally provide to the 

participants and beneficiaries covered 

under the plan separate health 

insurance coverage consisting solely of 

coverage for contraceptive services 

required to be covered under this 

section. The issuer must make such 

health insurance coverage for 


srobinson on DSK4SPTVN1PROD with PROPOSALS
16506 Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 

10A church plan as defined under section 3(33) 

of ERISA is exempt from ERISA’s requirements 

under section 4(b) of ERISA, and, therefore, any 

proposed ERISA regulations would not apply to 

church plans. Comments are sought on potential 

options for church plans. 

contraceptive services available without 

any charge to the organization, group 

health plan, or plan participants or 

beneficiaries. The issuer must notify 

plan participants and beneficiaries of 

the availability of such coverage for 

contraceptive services in accordance 

with guidance issued by the Secretary. 

The issuer must not impose any cost 

sharing requirements (such as a 

copayment, coinsurance, or a 

deductible) on such coverage for 

contraceptive services and must comply 

with all other requirements of this 

section with respect to coverage for 

contraceptive services.’’ 

Additionally, to ensure that 

contraceptive coverage offered by a 

health insurance issuer under these 

circumstances does not confront 

obstacles due to other Federal 

requirements (such as the guaranteed 

issue requirement under section 2702 of 

the PHS Act, the single risk pool 

requirement under section 1312(c) of 

the Affordable Care Act, and the 

essential health benefits requirement 

under section 2707 of the PHS Act), the 

Departments are considering adding by 

regulation contraceptive coverage to the 

types of excepted benefits in the 

individual market at 45 CFR 148.220(b). 

In so doing, the Departments would 

consider preserving certain PHS Act 

protections such as appeals and 

grievances rights while ensuring relief 

from others such as the requirement to 

provide essential health benefits. The 

Departments seek comment on whether 

and how to structure such a change to 

the excepted benefits regulations, and 

what PHS Act protections should (or 

should not) continue to apply. In 

addition, the Departments seek 

comment on ways to structure the 

contraceptive-only benefit as a benefit 

separate from the insured group 

coverage other than as an excepted 

benefit. 

Issuers would pay for contraceptive 

coverage from the estimated savings 

from the elimination of the need to pay 

for services that would otherwise be 

used if contraceptives were not covered. 

Typically, issuers build into their 

premiums projected costs and savings 

from a set of services. Premiums from 

multiple organizations are pooled in a 

‘‘book of business’’ from which the 

issuer pays for services. To the extent 

that contraceptive coverage lowers the 

draw-down for other health care 

services from the pool, funds would be 

available to pay for contraceptive 

services without an additional premium 

charged to the religious organization or 

plan participants or beneficiaries. 

Actuaries, insurers, and economists 

estimate that covering contraceptive 

services is at least cost neutral. 

For a religious organization that 

sponsors a self-insured group health 

plan, the Departments aim to similarly 

shield it from contracting, arranging, 

paying, or referring for contraceptive 

coverage. The Departments intend to 

propose, and invite comments on, 

having the third-party administrator of 

an objecting religious organization 

fulfill such responsibility. For ERISA 

plans,10 the Departments are 

considering proposing that the selfcertification of the religious 

organization, described above, would 

serve as a notice to the third-party 

administrator that the requirement to 

provide contraceptive coverage will not 

be fulfilled by the religious 

organization. The proposed regulations, 

in this circumstance, would set forth the 

circumstances and criteria under which 

the third-party administrator would be 

designated as the plan administrator for 

ERISA plans solely for the purpose of 

fulfilling the requirement to provide 

contraceptive coverage. As prescribed 

by the proposed regulations, the thirdparty administrator would provide or 

arrange for such coverage in such 

circumstances. The third-party 

administrator would notify plan 

participants and beneficiaries of this 

coverage. The religious organization 

would take no action other than selfcertification. 

To incorporate this proposal into 

regulations with respect to self-insured 

group health plans, the Departments are 

considering proposing new language in 

the existing preventive services 

regulations at 29 CFR 2590.715–2713 

and 26 CFR 54.9815–2713 providing 

that: ‘‘A religious organization 

maintaining a self-insured group health 

plan is not responsible for compliance 

with any requirement under this section 

to provide coverage for contraceptive 

services if all of the following 

conditions are satisfied: 

• The plan contracts with one or 

more third parties for processing of 

benefit claims, 

• Before entering into each such 

contract, the employer provides each 

third party administrator (TPA) with 

written notice that the employer: (1) Is 

a religious organization, (2) will not act 

as the designated plan administrator or 

claims administrator with respect to 

claims for contraceptive services, (3) 

will not contribute to the funding of 

contraceptive services, and (4) will not 

participate in claims processing with 

respect to claims for contraceptive 

services. 

• With respect to contraceptive 

benefits, the TPAs have authority and 

control over the funds available to pay 

the benefit, authority to act as a claims 

administrator and plan administrator, 

and access to information necessary to 

communicate with the plan’s 

participants and beneficiaries.’’ 

In addition, with respect to ERISA 

plans, the Department of Labor is 

considering proposing a new regulation 

at 29 CFR 2510.3–16 providing: ‘‘In the 

case of a group health plan established 

or maintained by a religious 

organization that is not responsible for 

compliance with any requirement under 

§ 2590.715–2713 of this part to provide 

coverage for contraceptive services, the 

required notice from the religious 

organization provided to a third party 

administrator (TPA) of the religious 

organization’s refusal to provide and 

fund such benefits shall be an 

instrument under which the plan is 

operated and shall have the effect of 

designating such TPA as the plan 

administrator under section 3(16) of 

ERISA for those contraceptive benefits 

for which that TPA processes claims in 

its normal course of business. A TPA 

that becomes a plan administrator 

pursuant to this section shall be 

responsible for— 

• The plan’s compliance with section 

2713 of the Public Health Service Act 

(as incorporated into section 715 of 

ERISA and § 2590.715–2713 of this part) 

as to those categories of contraceptive 

benefits for which the TPA processes 

claims in its normal course of business 

(for example, surgical procedures, nonsurgical procedures, patient education 

and counseling, prescription benefits 

and non-prescription benefits). 

• Establishing and operating a 

procedure for determining such claims 

for contraceptive benefits in accordance 

with § 2560.503–1 of this title. 

• Complying with disclosure 

requirements and other requirements 

under Title I of ERISA for such benefits 

to participants and beneficiaries.’’ 

We note that there is no obligation for 

a TPA to enter into such a contract if it 

objects to these terms. 

Providing for an independent entity to 

assume responsibility for plan-related 

functions when other plan sponsors or 

officials fail or refuse to do so would not 

be unique to the instant context. For 

example, where certain retirement 

savings plans have been abandoned by 

their sponsors, Department of Labor 

regulations authorize asset custodians to 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 16507 

distribute plan benefits and wind up the 

plan’s affairs. 29 CFR 2578.1. 

The Departments seek comment on 

the following possible approaches that a 

third-party administrator could use to 

fund the contraceptive coverage without 

using funds provided by the religious 

organization. The third-party 

administrator could use revenue that is 

not already obligated to plan sponsors 

such as drug rebates, service fees, 

disease management program fees, or 

other sources. These funds may inure to 

the third-party administrator rather than 

the plan or its sponsor and drug rebates, 

for example, could be larger if 

contraceptive coverage were provided. 

Additionally, nothing precludes a thirdparty administrator from receiving 

funds from a private, non-profit 

organization to pay for contraceptive 

services for the participants and 

beneficiaries covered under the plan of 

a religious organization. Comments 

should address the ways in which thirdparty administrators generally receive 

funding to pay benefits, other flows of 

funds, the extent to which funding from 

other sources may be available for 

payment of claims, and the monitoring 

responsibilities and oversight that 

would be associated with such 

arrangements. 

Another option under consideration 

would be to have the third-party 

administrator receive a credit or rebate 

on the amount that it pays under the 

reinsurance program under Affordable 

Care Act section 1341 in order to fund 

contraceptive coverage for participants 

and beneficiaries covered under the 

plan of a religious organization that 

sponsors a self-insured plan. Section 

1341 of the Affordable Care Act creates 

a reinsurance program to balance out 

risk selection from 2014 through 2016. 

Payments from health insurance issuers 

and third-party administrators on behalf 

of group health plans will be made to 

a reinsurance entity. Payments are used, 

among other things, to offset the cost of 

reinsurance for health insurance issuers. 

While the reinsurance program does not 

provide payments to group health plans, 

it collects payments from third-party 

administrators to support the program. 

Under this proposal, a third-party 

administrator that funds contraceptive 

coverage separate from a religious 

organization could offset the amount of 

this cost with a credit or rebate against 

its assessments under the reinsurance 

program. Such a policy could help 

advance the goals of the reinsurance 

program, which is one of many in the 

Act designed to make health insurance 

affordable, accessible, meaningful, and 

stable. The Departments seek comments 

on such an interpretation of Affordable 

Care Act section 1341and on ideas of 

alternative sources of funding once this 

temporary program ends. 

An additional option would have the 

third-party administrator separately 

arrange for contraceptive coverage. In 

this case, an additional independent 

entity other than a third-party 

administrator would be needed. The 

Departments are considering having the 

Office of Personnel Management (OPM) 

identify a private insurer to provide this 

coverage. Under section 1334 of the 

Affordable Care Act, OPM is responsible 

for contracting with at least two insurers 

to offer multi-State plans in each 

Exchange in each State to promote 

choice, competition, and access to 

health services. The OPM Director, in 

consultation with the HHS Secretary, 

has the authority to impose appropriate 

requirements on the insurers that offer 

multi-State plans. Accordingly, OPM 

could incentivize or require one or more 

of the insurers offering a multi-State 

plan also to provide, at no additional 

charge, contraceptive coverage to 

participants and beneficiaries covered 

under religious organizations’ selfinsured plans. The third-party 

administrator would send a copy of the 

religious organization’s self-certification 

to OPM along with information on plan 

participants and beneficiaries. One 

option for covering the cost of the 

contraceptive coverage would be a 

credit against any user fees such an 

insurer would be required to pay in 

order to offer coverage on the 

Exchanges. The Departments seek 

comment on the impact of this proposal 

on the multi-State plan program, ways 

to administer it, and additional funding 

ideas. 

If adopted, the reinsurance program 

and multi-State plan options may 

require amendments to the regulations 

and guidance governing those programs. 

In addition, these programs start on 

January 1, 2014. There may be some 

religious organizations with plan years 

that begin on or after August 1, 2013, 

but before those programs begin, so, 

should the Departments propose these 

options, we would also propose a means 

of resolving this gap in relief. The 

Departments seek input on such means 

as well as how many religious 

organizations have plan years that start 

between August 1 and December 31. 

The Departments welcome ideas on 

other options for the source of funds for 

contraceptive coverage. Some religious 

stakeholders have suggested, for 

example, the use of tax-preferred 

accounts that employees may in their 

discretion use for a range of medical 

services that neither precludes nor 

obligates funds to be used for 

contraceptive services. A number of 

religious stakeholders have also 

suggested that public funding to support 

coverage of contraceptive services is not 

objectionable. The Departments seek 

comment on these and other proposals. 

Comments are also requested on 

additional considerations that should be 

taken into account with respect to these 

and other proposals and on suggestions 

for structuring the implementation of 

the proposals in light of these 

considerations. 

The Departments expect that the 

third-party administrator could use 

these sources of funds individually or in 

combination. The Departments also note 

that nothing precludes a religious 

organization from switching from a selfinsured plan to an insured plan such 

that a health insurance issuer rather 

than a third-party administrator is 

responsible for providing the 

contraceptive coverage. 

The Departments also seek 

information on coordination when there 

are multiple third-party administrators 

and on the prevalence of multi-year 

contracts as well as options for 

addressing the application of these 

proposals in such instances. The 

Departments invite comment on the 

extent to which there are self-insured 

health plans without a third-party 

administrator as well as options for how 

the accommodation would work in 

these rare circumstances. One option 

would be to have a religious 

organization send its self-certification to 

OPM, which would be directed to 

independently arrange for contraceptive 

coverage through a private insurer. The 

Departments seek comment on the 

prevalence and number of participants 

and beneficiaries of health plans 

sponsored by religious organizations 

without a third-party administrator. 

C. Additional Questions 

To inform the notice of proposed 

rulemaking, the Departments seek 

information on several additional 

questions. One question that has arisen 

from religious stakeholders is whether 

an exemption or accommodation should 

be made for certain religious health 

insurance issuers or third-party 

administrators with respect to 

contraceptive coverage. The 

Departments have little information 

about the number and location of such 

issuers and administrators and whether 

and how such issuers operate in the 28 

States with contraceptive coverage 

requirements. 

The Departments also recognize that 

various denominations may offer 

coverage to institutions affiliated with 

those denominations. For example, their 


srobinson on DSK4SPTVN1PROD with PROPOSALS
16508 Federal Register / Vol. 77, No. 55 / Wednesday, March 21, 2012 / Proposed Rules 

plans may be offered as ‘‘church plans’’ 

(described above) to individual 

churches as a means of pooling their 

risk. The Departments seek comment on 

whether different accommodations are 

needed for such plans. 

In addition, the Departments are 

aware that 28 States have adopted laws 

requiring that certain health insurance 

issuers provide contraceptive coverage. 

Some of these laws contain exemptions 

related to religious organizations, but 

the scope of the exemptions varies 

among the States. Generally, Federal 

health insurance coverage regulation 

creates a floor to which States may add 

consumer protections, but may not 

subtract. This means that, in States with 

broader religious exemptions than that 

in the final regulations, the exemptions 

will be narrowed to align with that in 

the final regulations because this will 

help more consumers. Organizations 

that qualify for an exemption under 

State law but do not qualify for the 

exemption under the final regulations 

may be eligible for the temporary 

enforcement safe harbor. During this 

transition period, State laws that require 

contraceptive coverage with narrower or 

no religious exemptions will continue. 

The Departments seek comment on the 

interaction between these State laws 

and the intended regulations on which 

we are seeking comment in this notice 

and on the extent to which there is a 

need for consistency between any 

Federal regulations and these State 

laws. Similarly, the Departments solicit 

comment on what other Federal or State 

laws or accounting rules governing 

funding and accounting could affect the 

proposed options described herein. 

In addition, the Departments solicit 

information on the number of 

potentially affected issuers and religious 

organizations as well as their plan 

participants and beneficiaries; the 

administrative cost of providing 

separate contraceptive coverage, 

including details regarding the nature of 

the costs (for example, one-time systems 

changes or ongoing administrative 

costs); and the average costs and savings 

to health plans, plan participants and 

beneficiaries, and the public of 

providing contraceptive coverage. 

D. Additional Input 

The 90-day comment period is 

designed to encourage maximum input 

into the development of an 

accommodation for religious 

organizations with religious objections 

to providing contraceptive coverage 

while ensuring the availability of 

contraceptive coverage without cost 

sharing for plan participants and 

beneficiaries. The Departments seek 

comments on the ideas and questions 

outlined in this ANPRM as well as new 

suggestions to achieve its goals. The 

Departments also intend to hold 

listening sessions to ensure all voices 

are heard. This will not be the only 

opportunity for comment. The 

subsequent notice of proposed 

rulemaking will also include a public 

comment period. The Departments aim 

to ensure that the final accommodation 

is fully vetted and published in advance 

of the expiration of the temporary 

enforcement safe harbor. 

Steven T. Miller, 

Deputy Commissioner for Services and 

Enforcement, Internal Revenue Service. 

Signed this day of March 14, 2012. 

Phyllis C. Borzi. 

Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

Dated: March 15, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: March 15, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–6689 Filed 3–16–12; 4:15 pm] 

BILLING CODE 4120–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2011–0435; FRL–9650–3] 

RIN 2060–AR02 

National Emission Standards for 

Hazardous Air Pollutant Emissions: 

Group IV Polymers and Resins; 

Pesticide Active Ingredient Production; 

and Polyether Polyols Production 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Reopening of public comment 

period. 

SUMMARY: On January 9, 2012, the EPA 

proposed amendments to three national 

emission standards for hazardous air 

pollutants: National Emission Standards 

for Hazardous Air Pollutant Emissions: 

Group IV Polymers and Resins; National 

Emission Standards for Hazardous Air 

Pollutants for Pesticide Active 

Ingredient Production; and National 

Emission Standards for Hazardous Air 

Pollutants for Polyether Polyols 

Production. The EPA is reopening the 

comment period until March 30, 2012. 

The EPA received a request for this 

reopening from the Sierra Club. The 

Sierra Club requested the reopening in 

order to analyze data and review the 

proposed amendments. EPA finds this 

request to be reasonable due to the 

multiple source categories involved in 

this action. 

DATES: Comments must be received on 

or before March 30, 2012. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OAR–2011–0435, by one of the 

following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• Email: a-and-r-docket@epa.gov. 

Attention Docket ID No. EPA–HQ– 

OAR–2011–0435. 

• Fax: (202) 566–9744. Attention 

Docket ID No. EPA–HQ–OAR–2011– 

0435. 

• Mail: U.S. Postal Service, send 

comments to: EPA Docket Center, EPA 

West (Air Docket), Attention Docket ID 

No. EPA–HQ–OAR–2011–0435, U.S. 

Environmental Protection Agency, 

Mailcode: 2822T, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460. 

Please include a total of two copies. In 

addition, please mail a copy of your 

comments on the information collection 

provisions to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), Attn: 

Desk Officer for EPA, 725 17th Street 

NW., Washington, DC 20503. 

• Hand Delivery: U.S. Environmental 

Protection Agency, EPA West (Air 

Docket), Room 3334, 1301 Constitution 

Ave. NW., Washington, DC 20004. 

Attention Docket ID No. EPA–HQ– 

OAR–2011–0435. Such deliveries are 

only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions. Direct your comments to 

Docket ID No. EPA–HQ–OAR–2011– 

0435. The EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means the EPA will not know 

your identity or contact information 

unless you provide it in the body of 

your comment. If you send an email 

comment directly to the EPA without 


srobinson on DSK4SPTVN1PROD with PROPOSALS