52614 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 

TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS—Continued 

Test guideline 

No. Data requirement All use patterns 

Test substance Test 

notes MP EP 

Physical and Chemical Characteristics 

830.6302 ...... Color ....................................................................... R TGAI ............................... TGAI ............................... ............

830.6303 ...... Physical state ......................................................... R TGAI ............................... TGAI ............................... ............

830.6304 ...... Odor ....................................................................... R TGAI ............................... TGAI ............................... ............

830.6313 ...... Stability to normal and elevated temperatures, 

metals, and metal ions.

R TGAI ............................... TGAI ............................... ............

830.6317 ...... Storage stability ...................................................... R TGAI and MP ................. TGAI and EP ................. ............

830.6319 ...... Miscibility ................................................................ R MP .................................. EP .................................. 5 

830.6320 ...... Corrosion characteristics ........................................ R MP .................................. EP .................................. 6 

830.7000 ...... pH ........................................................................... R TGAI ............................... TGAI ............................... ............

830.7100 ...... Viscosity ................................................................. R MP .................................. EP .................................. 7 

830.7300 ...... Density/relative density/bulk density (specific gravity).R TGAI ............................... TGAI ............................... ............

(d) * * * 

3. Required for each isolate of a 

microbial pesticide. Isolates must be 

deposited with an agreement to ensure 

that the sample will be maintained and 

will not be discarded for the duration of 

the associated experimental use 

permit(s). 

* * * * * 

[FR Doc. 2012–21430 Filed 8–29–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 152 

[CMS–9995–IFC2] 

RIN 0938–AQ70 

Pre-Existing Condition Insurance Plan 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Amendment to interim final 

rule with request for comments. 

SUMMARY: This document contains an 

amendment regarding program 

eligibility to the interim final regulation 

implementing the Pre-Existing 

Condition Plan program under 

provisions of the Patient Protection and 

Affordable Care Act. In light of a new 

process recently announced by the 

Department of Homeland Security, 

eligibility for the program is being 

amended so that the program does not 

inadvertently expand the scope of that 

process. 

DATES: Effective date. These interim 

final regulations are effective on August 

30, 2012. 

Comment date. Comments are due on 

or before October 29, 2012. 

Applicability date. This amendment 

to the interim final regulation generally 

applies to individuals on August 30, 

2012. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. 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. 

In commenting, please refer to file 

code CMS–9995–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–9995–IFC2, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

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–9995–IFC2, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments only to the 

following addresses prior to the close of 

the comment period: 

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 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. 

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 


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Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 52615 

1Section 1411 of the Affordable Care Act 

describes the procedures to be employed for 

determining eligibility for coverage through the 

Affordable Insurance Exchanges, and for the 

premium tax credits and cost-sharing reductions 

that will help eligible individuals afford such 

coverage. 

2See State Health Official (SHO) Letter #10–006/ 

CHIPRA #17 at: http://downloads.cms.gov/cmsgov/ 

archived-downloads/SMDL/downloads/ 

SHO10006.pdf. 

3 June 15, 2012 Memorandum of Secretary of 

Homeland Security Janet Napolitano, at: http:// 

www.dhs.gov/xlibrary/assets/s1-exercisingprosecutorial-discretion-individuals-who-came-tous-as-children.pdf. 

4Consideration of Deferred Action for Childhood 

Arrivals, at: http://www.uscis.gov/ 

childhoodarrivals. 

5See supra nn. 4–5. 

6http://www.medicaid.gov/Federal-PolicyGuidance/Downloads/SHO-12-002.pdf. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Alexis Ahlstrom, Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, at (202) 

690–7506. 

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 (Reconciliation Act), Public Law 

111–152, was enacted on March 30, 

2010 (collectively, ‘‘Affordable Care 

Act’’). Section 1201 of the Affordable 

Care Act prohibits issuers of nongrandfathered health insurance coverage 

from denying coverage or inflating rates 

based on health status or medical 

history in policy years beginning on or 

after January 1, 2014. In light of the fact 

that these protections will not take 

effect until 2014, section 1101 of the 

Affordable Care Act directs the 

Secretary of Health and Human Services 

to establish, either directly or through 

contracts with states or nonprofit 

private entities, a temporary high risk 

health insurance pool program to 

provide immediate access to coverage 

for eligible uninsured Americans with 

pre-existing conditions. (Hereafter, we 

generally refer to this program as the 

Pre-Existing Condition Insurance Plan 

program, or the PCIP program.) The 

PCIP program provides coverage to 

eligible uninsured Americans with preexisting conditions until 2014, when the 

protections under section 1201 of the 

Affordable Care Act referenced above 

take effect and coverage is available 

through the Affordable Insurance 

Exchanges established under section 

1311 or 1321 of the Act. 

HHS previously issued an interim 

final regulation implementing section 

1101 of the Affordable Care Act. This 

interim final rule was published in the 

Federal Register on July 30, 2010 (75 FR 

45014). For the reasons explained 

below, HHS is now issuing an 

amendment to this interim final rule. 

II. Overview of the Amendment to the 

Interim Final Rule 

The interim final rule issued on July 

30, 2010, provided information on the 

administration of the PCIP program, 

eligibility for and enrollment in the 

program, program benefits, program 

oversight, program funding, 

coordination with state laws and 

programs, and the transition to coverage 

through the Affordable Insurance 

Exchanges. Under section 1101(d) of the 

Affordable Care Act and codified by the 

July 30, 2010 interim final rule at 45 

CFR 152.14(a)(1) through (3), an 

individual is eligible to enroll in a PCIP 

if he or she: (1) Is a citizen or national 

of the United States or is lawfully 

present in the United States (as 

determined in accordance with section 

1411 of the Affordable Care Act 1); (2) 

has not been covered under creditable 

coverage (as defined in section 

2701(c)(1) of the Public Health Service 

Act as of the date of enactment of the 

Affordable Care Act—that is, March 23, 

2010) during the 6-month period prior 

to the date on which he or she is 

applying for coverage through the PCIP; 

and (3) has a pre-existing condition, as 

determined in a manner consistent with 

guidance issued by the Secretary of 

HHS. We further provided in 

§ 152.14(a)(4) of the interim final rule 

that an individual must be a resident of 

a state that falls within the service area 

of the PCIP. 

In the interim final rule, HHS defined 

‘‘lawfully present’’ as having a similar 

meaning as that given to ‘‘lawfully 

residing’’ in Medicaid and the 

Children’s Health Insurance Program 

(CHIP), as set forth in a State Health 

Official letter issued by the Centers for 

Medicare & Medicaid Services (CMS) on 

July 1, 2010.2 The July 30, 2010 interim 

final rule codified that definition of 

‘‘lawfully present’’ at § 152.2. 

Subsequent regulations implementing 

the Affordable Insurance Exchanges, 45 

CFR 155.20 (77 FR 18310, March 27, 

2012), and the premium tax credits, 26 

CFR 1.36B–1(g) (77 FR 30377, May 23, 

2012), issued by HHS and the 

Department of the Treasury 

respectively, define ‘‘lawfully present’’ 

by a cross-reference to the definition in 

§ 152.2. 

On June 15, 2012, the Department of 

Homeland Security (DHS) announced 

that it will consider providing 

temporary relief from removal by 

exercising deferred action on a case-bycase basis with respect to certain 

individuals under age 31 who meet 

DHS’s guidelines, including that he or 

she came to the United States as 

children and does not present a risk to 

national security or public safety.3 This 

process is referred to by DHS as 

Deferred Action for Childhood Arrivals 

(DACA).4

As DHS has explained, the DACA 

process is designed to ensure that 

governmental resources for the removal 

of individuals are focused on high 

priority cases, including those involving 

a danger to national security or a risk to 

public safety, and not on low priority 

cases.5 Because the reasons that DHS 

offered for adopting the DACA process 

do not pertain to eligibility for Medicaid 

or CHIP, HHS has determined that these 

benefits should not be extended as a 

result of DHS deferring action under 

DACA. Concurrent with this 

amendment, CMS is issuing a State 

Health Official letter providing that 

individuals whose cases are deferred 

under DHS’s DACA process will not be 

eligible under the state option.6 As it 

also would not be consistent with the 

reasons offered for adopting the DACA 

process to extend health insurance 

subsidies under the Affordable Care Act 

to these individuals, HHS is amending 

its definition of ‘‘lawfully present’’ in 

the PCIP program, so that the PCIP 

program interim final rule does not 

inadvertently expand the scope of the 

DACA process. 

Under the amended rule, individuals 

with deferred action under the DACA 

process are not eligible to enroll in the 

PCIP program. As the PCIP program 

definition of ‘‘lawfully present’’ is 

incorporated into the rules governing 

the Affordable Insurance Exchanges and 

the premium tax credits, individuals 

whose cases are deferred under the 

DACA process also will not be eligible 

to enroll in coverage through the 

Affordable Insurance Exchanges and, 

therefore, will not receive coverage that 


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52616 Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Rules and Regulations 

7This is consistent with prior guidance issued by 

DHS: ‘‘If my case is deferred, will I be eligible for 

premium tax credits and reduced cost sharing 

through Affordable Insurance Exchanges starting in 

2014? No. The Departments of Health and Human 

Services and the Treasury intend to conform the 

relevant regulations to the extent necessary to 

exempt individuals with deferred action for 

childhood arrivals from eligibility for premium tax 

credits and reduced cost sharing. This is consistent 

with the policy under S. 3992, the Development, 

Relief, and Education for Alien Minors (DREAM) 

Act of 2010.’’ See Consideration of Deferred Action 

for Childhood Arrivals, http://www.uscis.gov/ 

childhoodarrivals. 

could make them eligible for premium 

tax credits under Treasury regulations 

(see 26 CFR 1.36–2(a)(1)) or for costsharing reductions starting in 2014.7

This is consistent with the rationale 

above. 

We invite comment on the 

determination to exclude these 

individuals from eligibility for the PCIP 

program and from eligibility for 

coverage through the Affordable 

Insurance Exchanges, with the 

consequences noted above with respect 

to the premium tax credits and the costsharing reductions. 

III. Interim Final Regulation and 

Waiver of Delay of Effective Date 

Under the Administrative Procedure 

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

a notice of proposed rulemaking and an 

opportunity for public comment is 

generally required before promulgation 

of regulations, this is not required when 

an agency, for good cause, finds that 

notice and public comment thereon are 

impracticable, unnecessary, or contrary 

to the public interest. 

HHS has determined that issuing this 

regulation in proposed form, such that 

it would not become effective until after 

public comment, would be contrary to 

the public interest. Because the PCIP 

program—a temporary program with 

limited funding—is currently enrolling 

eligible individuals and providing 

benefits for such enrollees, it is 

important that we provide clarity with 

respect to eligibility for this new and 

unforeseen group of individuals as soon 

as possible, before anyone with deferred 

action under the DACA process applies 

to enroll in the PCIP program. 

HHS is issuing this amendment as an 

interim final rule with comment so as to 

provide the public with an opportunity 

for comment on the amendment, 

including to gather public comment on 

the implications of the amendment. 

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 

as to why the effective date should not 

be delayed, and the agency incorporates 

a statement of the finding and its reason 

in the rule issued. 

For the same reason that we are 

issuing an interim final rule, we are 

making it effective immediately; that is, 

because the PCIP program—a temporary 

program with limited funding—is 

currently enrolling eligible individuals 

and providing benefits for such 

enrollees, it is important that we 

provide clarity with respect to the 

eligibility of this new and unforeseen 

group of individuals as soon as possible, 

before anyone with deferred action 

under the DACA process applies to 

enroll in the PCIP program. 

IV. Executive Orders 13563 and 12866 

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. 

V. Statutory Authority 

The amendment to the interim final 

regulation is adopted pursuant to the 

authority contained in section 1101 of 

the Patient Protection and Affordable 

Care Act (Pub. L. 111–148). 

List of Subjects in 45 CFR Part 152 

Administrative practice and 

procedure, Health care, Health 

insurance, Penalties, Reporting and 

recordkeeping requirements. 

For the reasons stated in the 

preamble, the Department of Health and 

Human Services amends 45 CFR part 

152 as follows: 

PART 152—PRE-EXISTING CONDITION 

INSURANCE PLAN PROGRAM 

■ 1. The authority citation for part 152 

continues to read as follows: 

Authority: Sec. 1101 of the Patient 

Protection and Affordable Care Act (Pub. L. 

111–148). 

■ 2. Section 152.2 is amended by adding 

paragraph (8) to the definition of 

‘‘lawfully present’’ to read as follows: 

§ 152.2 Definitions. 

* * * * * 

Lawfully present means— * * * 

* * * * * 

(8) Exception. An individual with 

deferred action under the Department of 

Homeland Security’s deferred action for 

childhood arrivals process, as described 

in the Secretary of Homeland Security’s 

June 15, 2012, memorandum, shall not 

be considered to be lawfully present 

with respect to any of the above 

categories in paragraphs (1) through (7) 

of this definition. 

* * * * * 

Dated: August 24, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: August 27, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–21519 Filed 8–28–12; 4:15 pm] 

BILLING CODE 4120–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 54 

[WC Docket Nos. 10–90, 07–135, 05–337, 

03–109; GN Docket No. 09–51; CC Docket 

Nos. 01–92, 96–45; WT Docket No. 10–208; 

DA 12–1155] 

Connect America Fund 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this Order, the Wireline 

Competition Bureau (Bureau) clarifies 

certain rules relating to Phase I of the 

Connect America Fund. Commission 

staff have received informal inquiries 

from price cap companies on certain 

implementation aspects of the rules 

governing Connect America Fund Phase 

I. The Bureau also makes an amendment 

to one of the Commission’s rules to fix 

a clerical error relating to the support 

for carriers serving remote areas of 

Alaska. 

DATES: Effective October 1, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Cavender, Wireline Competition 

Bureau, (202) 418–7400 or TTY: (202) 

418–0484. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Wireline Competition 

Bureau Order in WC Docket Nos. 10–90, 

07–135, 05–337, 03–109; GN Docket No. 

09–51; CC Docket Nos. 01–92, 96–45; 

WT Docket No. 10–208; DA 12–1155, 

released on July 18, 2012. The full text 


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