Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 46621 

however, no market value threshold 

need be satisfied in connection with 

non-convertible securities eligible for 

registration on Form F–9 (§ 239.39 of 

this chapter)’’. 

■ 34. Effective December 31, 2012, 

amend Form 40–F (referenced in 17 CFR 

249.240f) by: 

■ a. In General Instruction A.(i), 

removing ‘‘F–9’’; 

■ b. Removing from paragraph (2)(iv) of 

General Instruction A. the phrase ‘‘; 

provided, however, that no market value 

threshold need be satisfied in 

connection with non-convertible 

securities eligible for registration on 

Form F–9’’ and adding in its place the 

phrase ‘‘or the Registrant filed a Form 

F–9 with the Commission on or before 

December 30, 2012’’; and 

■ c. Revising paragraph (2) of General 

Instruction C. to read as follows: 

(2) Any financial statements, other 

than interim financial statements, 

included in this Form by registrants 

registering securities pursuant to 

Section 12 of the Exchange Act or 

reporting pursuant to the provisions of 

Section 13(a) or 15(d) of the Exchange 

Act must be reconciled to U.S. GAAP as 

required by Item 17 of Form 20–F under 

the Exchange Act, unless this Form is 

filed with respect to a reporting 

obligation under Section 15(d) that 

arose solely as a result of a filing made 

on Form F–7, F–8, F–9 or F–80, in 

which case no such reconciliation is 

required. 

Note: The text of Form 40–F does not, and 

this amendment will not, appear in the Code 

of Federal Regulations. 

Dated: July 27, 2011. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2011–19421 Filed 8–2–11; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[TD 9541] 

RIN 1545–BJ60 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AB44 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[CMS–9992–IFC2] 

45 CFR Part 147 

RIN 0938–AQ07 

Group Health Plans and Health 

Insurance Issuers Relating to 

Coverage of Preventive Services Under 

the Patient Protection and 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: Interim final rules with request 

for comments. 

SUMMARY: This document contains 

amendments to the interim final 

regulations implementing the rules for 

group health plans and health insurance 

coverage in the group and individual 

markets under provisions of the Patient 

Protection and Affordable Care Act 

regarding preventive health services. 

DATES: Effective date. These interim 

final regulations are effective on August 

1, 2011. 

Comment date. Comments are due on 

or before September 30, 2011. 

Applicability dates. These interim 

final regulations generally apply to 

group health plans and group health 

insurance issuers on August 1, 2011. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. Any comment that is 

submitted to any Department will be 

shared with the other Departments. 

Please do not submit duplicates. 

All comments will be made available 

to the public. WARNING: 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. 

Department of Labor. Comments to 

the Department of Labor, identified by 

RIN 1210–AB44, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: EOHPSCA2713.EBSA@dol.gov. 

• Mail or Hand Delivery: Office of 

Health Plan Standards and Compliance 

Assistance, Employee Benefits Security 

Administration, Room N–5653, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Washington, DC 20210, 

Attention: RIN 1210–AB44. 

Comments received by the 

Department of Labor will be posted 

without change to http:// 

www.regulations.gov and http:// 

www.dol.gov/ebsa, and available for 

public inspection at the Public 

Disclosure Room, N–1513, Employee 

Benefits Security Administration, 200 

Constitution Avenue, NW., Washington, 

DC 20210. 

Department of Health and Human 

Services. In commenting, please refer to 

file code CMS–9992–IFC2. Because of 

staff and resource limitations, we 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 regulation 

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

the ‘‘Submit a comment’’ instructions. 

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–9992–IFC2, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

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–9992–IFC2, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 


srobinson on DSK4SPTVN1PROD with RULES
46622 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 

1The term ‘‘group health plan’’ is used in title 

XXVII of the PHS Act, part 7 of ERISA, and chapter 

100 of the Code, and is distinct from the term 

‘‘health plan,’’ as used in other provisions of title 

I of the Affordable Care Act. The term ‘‘health plan’’ 

does not include self-insured group health plans. 

2Code section 9815 incorporates the preemption 

provisions of PHS Act section 2724. Prior to the 

Affordable Care Act, there were no express 

preemption provisions in chapter 100 of the Code. 

3Under PHS Act section 2713(a)(5), the Task 

Force recommendations regarding breast cancer 

screening, mammography, and prevention issued in 

or around November of 2009 are not to be 

considered current recommendations on this 

subject for purposes of PHS Act section 2713(a)(1). 

following addresses prior to the close of 

the comment period: 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 in 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 

telephone number (410) 786–4492 in 

advance to schedule your arrival with 

one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

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. We 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, phone 1–800–743–3951. 

Internal Revenue Service. Comments 

to the IRS, identified by REG–120391– 

10, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: CC:PA:LPD:PR (REG–120391– 

10), room 5205, Internal Revenue 

Service, P.O. Box 7604, Ben Franklin 

Station, Washington, DC 20044. 

• Hand or courier delivery: Monday 

through Friday between the hours of 8 

a.m. and 4 p.m. to: CC:PA:LPD:PR 

(REG–120391–10), Courier’s Desk, 

Internal Revenue Service, 1111 

Constitution Avenue, NW., Washington 

DC 20224. 

All submissions to the IRS will be 

open to public inspection and copying 

in room 1621, 1111 Constitution 

Avenue, NW., Washington, DC from 9 

a.m. to 4 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Amy Turner or Beth Baum, Employee 

Benefits Security Administration, 

Department of Labor, at (202) 693–8335; 

Karen Levin, Internal Revenue Service, 

Department of the Treasury, at (202) 

622–6080; Robert Imes, Centers for 

Medicare & Medicaid Services (CMS), 

Department of Health and Human 

Services, 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 

addition, information from HHS on 

private health insurance for consumers 

can be found on the Centers for 

Medicare & Medicaid Services (CMS) 

Web site (http://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 

(the Reconciliation Act), Public Law 

111–152, was enacted on March 30, 

2010 (collectively known as 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 term 

‘‘group health plan’’ includes both 

insured and self-insured group health 

plans.1 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 (the 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, and health 

insurance issuers providing health 

insurance coverage in connection with 

group health plans. The PHS Act 

sections incorporated by this reference 

are sections 2701 through 2728. PHS 

Act sections 2701 through 2719A are 

substantially new, though they 

incorporate some provisions of prior 

law. PHS Act sections 2722 through 

2728 are sections of prior law 

renumbered, with some, mostly minor, 

changes. 

Subtitles A and C of title I of the 

Affordable Care Act amend the 

requirements of title XXVII of the PHS 

Act (changes to which are incorporated 

into ERISA section 715). The 

preemption provisions of ERISA section 

731 and PHS Act section 2724 2

(implemented in 29 CFR 2590.731(a) 

and 45 CFR 146.143(a)) apply so that the 

requirements of part 7 of ERISA and 

title XXVII of the PHS Act, as amended 

by the Affordable Care Act, are not to be 

‘‘construed to supersede any provision 

of State law which establishes, 

implements, or continues in effect any 

standard or requirement solely relating 

to health insurance issuers in 

connection with group or individual 

health insurance coverage except to the 

extent that such standard or 

requirement prevents the application of 

a requirement’’ of the Affordable Care 

Act. Accordingly, State laws that 

impose requirements on health 

insurance issuers that are stricter than 

the requirements imposed by the 

Affordable Care Act are not superseded 

by the Affordable Care Act. 

Section 2713 of the PHS Act, as added 

by the Affordable Care Act and 

incorporated under section 715(a)(1) of 

ERISA and section 9815(a)(1) of the 

Code, specifies that a group health plan 

and a health insurance issuer offering 

group or individual health insurance 

coverage provide benefits for and 

prohibit the imposition of cost-sharing 

with respect to: 

• Evidence-based items or services 

that have in effect a rating of A or B in 

the current recommendations of the 

United States Preventive Services Task 

Force (Task Force) with respect to the 

individual involved.3


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 46623 

Thus, the recommendations regarding breast cancer 

screening, mammography, and prevention issued by 

the Task Force prior to those issued in or around 

November of 2009 (that is, those issued in 2002) 

will be considered current until new 

recommendations in this area are issued by the 

Task Force or appear in comprehensive guidelines 

supported by HRSA concerning preventive care and 

screenings for women, which will be commonly 

known as HRSA’s Women’s Preventive Services: 

Required Health Plan Coverage Guidelines. 

4See 26 CFR 54.9815–1251T, 29 CFR 2590.715– 

1251 and 45 CFR 147.140 (75 FR 34538, June 17, 

2010). 

• Immunizations for routine use in 

children, adolescents, and adults that 

have in effect a recommendation from 

the Advisory Committee on 

Immunization Practices of the Centers 

for Disease Control and Prevention 

(Advisory Committee) with respect to 

the individual involved. A 

recommendation of the Advisory 

Committee is considered to be ‘‘in 

effect’’ after it has been adopted by the 

Director of the Centers for Disease 

Control and Prevention. A 

recommendation is considered to be for 

routine use if it appears on the 

Immunization Schedules of the Centers 

for Disease Control and Prevention. 

• With respect to infants, children, 

and adolescents, evidence-informed 

preventive care and screenings provided 

for in the comprehensive guidelines 

supported by the Health Resources and 

Services Administration (HRSA). 

• With respect to women, preventive 

care and screening provided for in 

comprehensive guidelines supported by 

HRSA (not otherwise addressed by the 

recommendations of the Task Force), 

which will be commonly known as 

HRSA’s Women’s Preventive Services: 

Required Health Plan Coverage 

Guidelines. 

The requirements to cover 

recommended preventive services 

without any cost-sharing do not apply to 

grandfathered health plans.4 The 

Departments previously issued interim 

final regulations implementing PHS Act 

section 2713; these interim final rules 

were published in the Federal Register 

on July 19, 2010 (75 FR 41726). For the 

reasons explained below, the 

Departments are now issuing an 

amendment to these interim final rules. 

II. Overview of the Amendment to the 

Interim Final Regulations 

The interim final regulations provided 

that a group health plan or health 

insurance issuer must cover certain 

items and services, without costsharing, as recommended by the U.S. 

Preventive Services Task Force, the 

Advisory Committee on Immunization 

Practices of the Centers for Disease 

Control and Prevention, and the Health 

Resources and Services Administration. 

Notably, to the extent not described in 

the U.S. Preventive Services Task Force 

recommendations, HRSA was charged 

with developing comprehensive 

guidelines for preventive care and 

screenings with respect to women (i.e., 

the Women’s Preventive Services: 

Required Health Plan Coverage 

Guidelines or ‘‘HRSA Guidelines’’). The 

interim final regulations also require 

that changes in the required items and 

services be implemented no later than 

plan years (in the individual market, 

policy years) beginning on or after the 

date that is one year from when the new 

recommendation or guideline is issued. 

In response to the request for 

comments on the interim final 

regulations, the Departments received 

considerable feedback regarding which 

preventive services for women should 

be considered for coverage under PHS 

Act section 2713(a)(4). Most 

commenters, including some religious 

organizations, recommended that HRSA 

Guidelines include contraceptive 

services for all women and that this 

requirement be binding on all group 

health plans and health insurance 

issuers with no religious exemption. 

However, several commenters asserted 

that requiring group health plans 

sponsored by religious employers to 

cover contraceptive services that their 

faith deems contrary to its religious 

tenets would impinge upon their 

religious freedom. One commenter 

noted that some religious employers do 

not currently cover such benefits under 

their group health plan due to their 

religious beliefs. 

The Departments note that PHS Act 

section 2713(a)(4) gives HRSA the 

authority to develop comprehensive 

guidelines for additional preventive care 

and screenings for women ‘‘for purposes 

of this paragraph.’’ In other words, the 

statute contemplated HRSA Guidelines 

that would be developed with the 

knowledge that certain group health 

plans and health insurance issuers 

would be required to cover the services 

recommended without cost-sharing, 

unlike the other guidelines referenced 

in section 2713(a), which pre-dated the 

Affordable Care Act and were originally 

issued for purposes of identifying the 

non-binding recommended care that 

providers should provide to patients. 

These HRSA Guidelines exist solely to 

bind non-grandfathered group health 

plans and health insurance issuers with 

respect to the extent of their coverage of 

certain preventive services for women. 

In the Departments’ view, it is 

appropriate that HRSA, in issuing these 

Guidelines, takes into account the effect 

on the religious beliefs of certain 

religious employers if coverage of 

contraceptive services were required in 

the group health plans in which 

employees in certain religious positions 

participate. Specifically, the 

Departments seek to provide for a 

religious accommodation that respects 

the unique relationship between a house 

of worship and its employees in 

ministerial positions. Such an 

accommodation would be consistent 

with the policies of States that require 

contraceptive services coverage, the 

majority of which simultaneously 

provide for a religious accommodation. 

In light of the above, the Departments 

are amending the interim final rules to 

provide HRSA additional discretion to 

exempt certain religious employers from 

the Guidelines where contraceptive 

services are concerned. The amendment 

to the interim final rules provides HRSA 

with the discretion to establish this 

exemption. Consistent with most States 

that have such exemptions, as described 

below, the amended regulations specify 

that, for purposes of this policy, 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 under section 6033(a)(1) 

and section 6033(a)(3)(A)(i) or (iii) of the 

Code. Section 6033(a)(3)(A)(i) and (iii) 

refer to churches, their integrated 

auxiliaries, and conventions or 

associations of churches, as well as to 

the exclusively religious activities of 

any religious order. The definition of 

religious employer, as set forth in the 

amended regulations, is based on 

existing definitions used by most States 

that exempt certain religious employers 

from having to comply with State law 

requirements to cover contraceptive 

services. We will be accepting 

comments on this definition as well as 

alternative definitions, such as those 

that have been developed under Title 26 

of the United States Code. The 

definition set forth here is intended to 

reasonably balance the extension of any 

coverage of contraceptive services under 

the HRSA Guidelines to as many 

women as possible, while respecting the 

unique relationship between certain 

religious employers and their employees 

in certain religious positions. The 

change in policy effected by this 

amendment to these interim final rules 

is intended solely for purposes of PHS 

Act section 2713 and the companion 

provisions of ERISA and the Internal 

Revenue Code. 

Because HRSA’s discretion to 

establish an exemption applies only to 

group health plans sponsored by certain 


srobinson on DSK4SPTVN1PROD with RULES
46624 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 

5 Department of Health and Human Services, 

Notice of Proposed Rulemaking on Student Health 

Insurance Coverage (76 FR 7767, February 22, 

2011). 

religious employers and group health 

insurance offered in connection with 

such plans, health insurance issuers in 

the individual health insurance market 

would not be covered under any such 

exemption. 

III. Interim Final Regulations and 

Waiver of Delay of Effective Date 

Section 9833 of the Code, section 734 

of ERISA, and section 2792 of the PHS 

Act authorize the Secretaries of the 

Treasury, Labor, and HHS (collectively, 

the Secretaries) to promulgate any 

interim final rules that they determine 

are appropriate to carry out the 

provisions of chapter 100 of the Code, 

part 7 of subtitle B of title I of ERISA, 

and part A of title XXVII of the PHS Act, 

which include PHS Act sections 2701 

through 2728 and the incorporation of 

those sections into ERISA section 715 

and Code section 9815. The 

amendments promulgated in this 

rulemaking carry out the provisions of 

these statutes. Therefore, the foregoing 

interim final rule authority applies to 

these amendments. 

Under the Administrative Procedure 

Act (APA) (5 U.S.C. 551, et seq.), while 

a general notice of proposed rulemaking 

and an opportunity for public comment 

is generally required before 

promulgation of regulations, an 

exception is made when an agency, for 

good cause, finds that notice and public 

comment thereon are impracticable, 

unnecessary, or contrary to the public 

interest. The provisions of the APA that 

ordinarily require a notice of proposed 

rulemaking do not apply here because of 

the specific authority to issue interim 

final rules granted by section 9833 of 

the Code, section 734 of ERISA, and 

section 2792 of the PHS Act. 

Even if the APA requirements for 

notice and comment were applicable to 

these regulations, they have been 

satisfied. This is because the Secretaries 

find that providing for an additional 

opportunity for public comment is 

unnecessary, as the July 19, 2010 

interim final rules implementing section 

2713 of the PHS Act provided the public 

with an opportunity to comment on the 

implementation of the preventive 

services requirements in this provision, 

and the amendments made in these 

interim final rules in fact are based on 

such public comments. Specifically, 

commenters expressed concerns that 

HRSA-supported guidelines issued 

under section 2713(a)(4) that included 

coverage of contraceptive services could 

impinge upon the religious freedom of 

certain religious employers. The 

flexibility that is afforded under these 

amendments is being provided to HRSA 

in order to allow HRSA the discretion 

to accommodate, in a balanced way, as 

discussed above, these commenter 

concerns. 

In addition, the Departments have 

determined that an additional 

opportunity for public comment would 

be impractical and contrary to the 

public interest. The requirement in 

section 2713(a)(4) that preventive 

services supported by HRSA be 

provided without cost-sharing took 

effect at the beginning of the first plan 

or policy year beginning on or after 

September 23, 2010. At that time, 

however, HRSA had not issued any 

such guidelines. Under the July 19, 2010 

interim final rules, group health plans 

and insurance issuers do not have to 

begin covering preventive services 

supported in HRSA guidelines until the 

first plan or policy year that begins one 

year after the guidelines are issued. 

Thus, while the law requiring coverage 

of recommended women’s preventive 

health services was enacted on March 

23, 2010, and has been in effect since 

September 23, 2010, no such guidelines 

have yet been issued, and it will be at 

least a full year after they are issued 

before group health plans and issuers 

will be required to start covering 

preventive services recommended in the 

guidelines without cost sharing. 

The July 19, 2010 interim final rules 

indicated that HRSA expected to issue 

guidelines by August 1, 2011. After 

considering public comments raising 

the issue addressed in these 

amendments, however, the Departments 

determined that HRSA should be 

granted the discretion to address the 

commenter concerns at issue prior to 

issuing guidelines under section 

2713(a)(4). Many college student policy 

years begin in August and an estimated 

1.5 million young adults are estimated 

to be covered by such policies.5

Providing an opportunity for public 

comment as described above would 

mean that the guidelines could not be 

issued until after August of 2011. This 

delay would mean that many students 

could not benefit from the new 

prevention coverage without costsharing following from the issuance of 

the guidelines until the 2013–14 school 

year, as opposed to the 2012–13 school 

year. Similarly, 2008 data from the 

Department of Labor indicate that over 

4 million Americans have ERISA group 

health plan coverage that starts in 

August or September; they too would 

experience over a year’s delay in the 

receipt of the new benefit if the public 

comment period delayed the issuance of 

the guidance for over a month. The 

Departments have determined that such 

a delay in implementation of the 

statutory requirement that women 

receive vital preventive services without 

cost-sharing would be contrary to the 

public interest because it could result in 

adverse health consequences that may 

not otherwise have occurred. 

While the Departments have 

determined that, even if the APA were 

applicable, issuing these regulations in 

proposed form, so they would not 

become effective until after public 

comment, would be contrary to the 

public interest in the case of these 

amendments, the Departments are 

issuing these amendments as interim 

final rules so as to provide the public 

with an opportunity for public comment 

on these amendments. 

The APA also generally requires that 

a final rule be effective no sooner than 

30 days after the date of publication in 

the Federal Register. This 30-day delay 

in effective date can be waived, 

however, if an agency finds good cause 

why the effective date should not be 

delayed, and the agency incorporates a 

statement of the findings and its reasons 

in the rule issued. 

As indicated above, many college 

student policy years begin in August. 

Delaying the effective date of this 

amendment by 30 days would mean that 

the HRSA guidelines could not be 

issued until after August of 2011. This 

delay would mean many students could 

not benefit from the new prevention 

coverage without cost-sharing following 

from the issuance of the guidelines until 

the 2013–14 school year, as opposed to 

the 2012–13 school year. As discussed 

above, all other participants, 

beneficiaries and enrollees in plans or 

policies with a plan or a policy year 

beginning in the months between 

August 1 and whenever a final rule 

would be published should the 

Departments provide a prepromulgation opportunity for public 

comment would face a similar one-year 

delay in receiving these important 

health benefits. The Departments have 

determined that such a delay in 

implementation of the statutory 

requirement that women receive vital 

preventive services without cost-sharing 

would be impracticable and contrary to 

the public interest because it could 

result in adverse health consequences 

that may not otherwise have occurred. 

Therefore, the Departments are waiving 

the 30-day delay in effective date of 

these amendments. 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 46625 

IV. Economic Impact and Paperwork 

Burden 

A. Executive Orders 13563 and 12866— 

Department of Labor and Department of 

Health and Human Services 

Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been designated a ‘‘significant 

regulatory action,’’ although not 

economically significant, under section 

3(f) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

1. Need for Regulatory Action 

As stated earlier in this preamble, the 

Departments previously issued interim 

final regulations implementing PHS Act 

section 2713 that were published in the 

Federal Register on July 19, 2010 (75 FR 

41726). Comments received in response 

to the interim final regulations raised 

the issue of imposing on certain 

religious employers through binding 

guidelines the requirement to cover 

contraceptive services that would be in 

conflict with the religious tenets of the 

employer. The Departments have 

determined that it is appropriate to 

amend the interim final rules to provide 

HRSA the discretion to exempt from its 

guidelines group health plans 

maintained by certain religious 

employers where contraceptive services 

are concerned. 

2. Anticipated Effects 

The Departments expect that this 

amendment will not result in any 

additional significant burden or costs to 

the affected entities. 

B. Special Analyses—Department of the 

Treasury 

Notwithstanding the determinations 

of the Department of Labor and 

Department of Health and Human 

Services, for purposes of the Department 

of the Treasury, it has been determined 

that this Treasury decision is not a 

significant regulatory action for 

purposes of Executive Order 12866. 

Therefore, a regulatory assessment is not 

required. It has also been determined 

that section 553(b) of the APA (5 U.S.C. 

chapter 5) does not apply to these 

interim final regulations. For the 

applicability of the RFA, refer to the 

Special Analyses section in the 

preamble to the cross-referencing notice 

of proposed rulemaking published 

elsewhere in this issue of the Federal 

Register. Pursuant to section 7805(f) of 

the Code, these temporary regulations 

have been submitted to the Chief 

Counsel for Advocacy of the Small 

Business Administration for comment 

on their impact on small businesses. 

C. Paperwork Reduction Act 

As stated in the previously issued 

interim final regulations, this rule is not 

subject to the requirements of the 

Paperwork Reduction Act of 1980 (44 

U.S.C. 3501 et seq.) because it does not 

contain a ‘‘collection of information’’ as 

defined in 44 U.S.C. 3502 (11). 

V. Statutory Authority 

The Department of the Treasury 

temporary regulations are adopted 

pursuant to the authority contained in 

sections 7805 and 9833 of the Code. 

The Department of Labor interim final 

regulations are adopted pursuant to the 

authority contained in 29 U.S.C. 1027, 

1059, 1135, 1161–1168, 1169, 1181– 

1183, 1181 note, 1185, 1185a, 1185b, 

1185c, 1185d, 1191, 1191a, 1191b, and 

1191c; sec. 101(g), Pub. L. 104–191, 110 

Stat. 1936; sec. 401(b), Pub. L. 105–200, 

112 Stat. 645 (42 U.S.C. 651 note); sec. 

512(d), Pub. L. 110–343, 122 Stat. 3881; 

sec. 1001, 1201, and 1562(e), Pub. L. 

111–148, 124 Stat. 119, as amended by 

Pub. L. 111–152, 124 Stat. 1029; 

Secretary of Labor’s Order 3–2010, 75 

FR 55354 (September 10, 2010). 

The Department of Health and Human 

Services interim final regulations are 

adopted pursuant to the authority 

contained in sections 2701 through 

2763, 2791, and 2792 of the PHS Act (42 

U.S.C. 300gg through 300gg–63, 300gg– 

91, and 300gg–92), as amended. 

List of Subjects 

26 CFR Part 54 

Excise taxes, Health care, Health 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

29 CFR Part 2590 

Continuation coverage, Disclosure, 

Employee benefit plans, Group health 

plans, Health care, Health insurance, 

Medical child support, Reporting and 

recordkeeping requirements. 

45 CFR Part 147 

Health care, Health insurance, 

Reporting and recordkeeping 

requirements, and State regulation of 

health insurance. 

Department of the Treasury 

Internal Revenue Service 

26 CFR Chapter 1 

Accordingly, 26 CFR part 54 is 

amended as follows: 

PART 54—PENSION EXCISE TAXES 

■ Paragraph 1. The authority citation 

for part 54 continues to read as follows: 

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

■ Par. 2. Section 54.9815–2713T is 

amended by revising paragraph (a)(1)(iv) 

to read as follows: 

§ 54.9815–2713T Coverage of preventive 

health services (temporary). 

(a) * * * 

(1) * * * 

(iv) With respect to women, to the 

extent not described in paragraph 

(a)(1)(i) of this section, preventive care 

and screenings provided for in binding 

comprehensive health plan coverage 

guidelines supported by the Health 

Resources and Services Administration 

and developed in accordance with 45 

CFR 147.130(a)(1)(iv). 

* * * * * 

Department of Labor 

Employee Benefits Security 

Administration 

29 CFR Chapter XXV 

29 CFR part 2590 is amended as 

follows: 

PART 2590—RULES AND 

REGULATIONS FOR GROUP HEALTH 

PLANS 

■ 1. The authority citation for part 2590 

continues to read as follows: 

Authority: 29 U.S.C. 1027, 1059, 1135, 

1161–1168, 1169, 1181–1183, 1181 note, 

1185, 1185a, 1185b, 1185c, 1185d, 1191, 

1191a, 1191b, and 1191c; sec. 101(g), Pub. L. 

104–191, 110 Stat. 1936; sec. 401(b), Pub. L. 

105–200, 112 Stat. 645 (42 U.S.C. 651 note); 

sec. 512(d), Pub. L. 110–343, 122 Stat. 3881; 

sec. 1001, 1201, and 1562(e), Pub. L. 111– 

148, 124 Stat. 119, as amended by Pub. L. 

111–152, 124 Stat. 1029; Secretary of Labor’s 

Order 3–2010, 75 FR 55354 (September 10, 

2010). 

Subpart C—Other Requirements 

■ 2. Section 2590.715–2713 is amended 

by revising paragraph (a)(1)(iv) to read 

as follows: 

§ 2590.715–2713 Coverage of preventive 

health services. 

(a) * * * 

(1) * * * 

(iv) With respect to women, to the 

extent not described in paragraph 


srobinson on DSK4SPTVN1PROD with RULES
46626 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations 

(a)(1)(i) of this section, preventive care 

and screenings provided for in binding 

comprehensive health plan coverage 

guidelines supported by the Health 

Resources and Services Administration 

and developed in accordance with 45 

CFR 147.130(a)(1)(iv). 

* * * * * 

Department of Health and Human 

Services 

For the reasons stated in the 

preamble, the Department of Health and 

Human Services amends 45 CFR part 

147 as follows: 

PART 147—HEALTH INSURANCE 

REFORM REQUIREMENTS FOR THE 

GROUP AND INDIVIDUAL HEALTH 

INSURANCE MARKETS 

■ 1. The authority citation for part 147 

continues to read as follows: 

Authority: 2701 through 2763, 2791, and 

2792 of the Public Health Service Act (42 

U.S.C. 300gg through 300gg–63, 300gg–91, 

and 300gg–92), as amended. 

■ 2. Section 147.130 is amended by 

revising paragraph (a)(1)(iv) to read as 

follows: 

§ 147.130 Coverage of preventive health 

services. 

(a) * * * 

(1) * * * 

(iv) With respect to women, to the 

extent not described in paragraph 

(a)(1)(i) of this section, preventive care 

and screenings provided for in binding 

comprehensive health plan coverage 

guidelines supported by the Health 

Resources and Services Administration. 

(A) In developing the binding health 

plan coverage guidelines specified in 

this paragraph (a)(1)(iv), the Health 

Resources and Services Administration 

shall be informed by evidence and may 

establish exemptions from such 

guidelines with respect to group health 

plans established or maintained by 

religious employers and health 

insurance coverage provided in 

connection with group health plans 

established or maintained by religious 

employers with respect to any 

requirement to cover contraceptive 

services under such guidelines. 

(B) For purposes of this subsection, a 

‘‘religious employer’’ is an organization 

that meets all of the following criteria: 

(1) The inculcation of religious values 

is the purpose of the organization. 

(2) The organization primarily 

employs persons who share the 

religious tenets of the organization. 

(3) The organization serves primarily 

persons who share the religious tenets 

of the organization. 

(4) The organization is a nonprofit 

organization as described in section 

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

or (iii) of the Internal Revenue Code of 

1986, as amended. 

* * * * * 

Steven T. Miller, 

Deputy Commissioner for Services and 

Enforcement, Internal Revenue Service. 

Approved: July 28, 2011. 

Emily S. McMahon, 

Acting Assistant Secretary of the Treasury 

(Tax Policy). 

Signed this 29th day of July 2011. 

Phyllis C. Borzi, 

Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

OCIIO–9992–IFC2 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: July 28, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: July 28, 2011. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2011–19684 Filed 8–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2011–0717] 

RIN 1625–AA00 

Safety Zone; Discovery World Private 

Wedding Firework Displays, 

Milwaukee, WI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the waters of Milwaukee Harbor in 

Milwaukee, Wisconsin. This zone is 

intended to restrict vessels from a 

portion of Milwaukee Harbor during 

two separate firework displays on July 

31, 2011 and August 26, 2011. This 

temporary safety zone is necessary to 

protect spectators and vessels from the 

hazards associated with these firework 

displays. 

DATES: This rule is in the CFR on August 

3, 2011 through 10:30 p.m. on August 

26, 2011. This rule is effective with 

actual notice for purposes of 

enforcement at 9:30 p.m. on July 31, 

2011. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2011– 

0717 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2011–0717 in the Docket ID box, 

and then clicking ‘‘search.’’ They are 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, contact or e-mail BM1 Adam Kraft, 

U.S. Coast Guard Sector Lake Michigan, 

at 414–747–7148 or 

Adam.D.Kraft@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because waiting 

for a notice and comment period to run 

would be impracticable and contrary to 

the public interest. Notice of this 

fireworks display was not received in 

sufficient time for the Coast Guard to 

solicit public comments before the start 

of the event. Thus, waiting for a notice 

and comment period to run would be 

impracticable and contrary to the public 

interest because it would inhibit the 

Coast Guard’s ability to protect the 

public from the hazards associated with 

these maritime fireworks displays. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30- 

days after publication in the Federal 

Register. For the same reasons 

discussed in the preceding paragraph, 

waiting for a 30 day notice period to run 


srobinson on DSK4SPTVN1PROD with RULES