Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations 56995 

§ 81.344 Texas. 

* * * * * 

TEXAS—OZONE (8-HOUR STANDARD) 

Designated area 

Designation a Classification 

Date 1 Type Date 1 Type 

* * * * * * * 

Houston-Galveston-Brazoria, TX: 

Brazoria County .................................................... ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Chambers County ................................................. ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Fort Bend County ................................................. ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Galveston County ................................................. ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Harris County ........................................................ ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Liberty County ...................................................... ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Montgomery County ............................................. ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

Waller County ....................................................... ........................ Nonattainment .................. (4) Subpart 2/Severe 15. 

* * * * * * * 

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is June 15, 2004, unless otherwise noted. 

*****

4October 31, 2008. 

* * * * * 

[FR Doc. E8–22685 Filed 9–30–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0381; FRL–8383–9] 

Aspergillus flavus NRRL 21882; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the fungal 

active ingredient Aspergillus flavus 

NRRL 21882 on the food and feed 

commodities of corn: Corn, field, forage; 

corn, field, grain; corn, field, stover; 

corn, field, aspirated grain fractions; 

corn, sweet, kernel plus cob with husk 

removed; corn, sweet, forage; corn, 

sweet, stover; corn, pop, grain; and corn, 

pop, stover when applied/used as an 

anti-fungal agent to displace aflatoxinproducing Aspergillus flavus from 

treated commodities. Circle One Global, 

Inc. submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), requesting an exemption 

from the requirement of a tolerance. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of Aspergillus flavus NRRL 

21882. 

DATES: This regulation is effective 

October 1, 2008. Objections and 

requests for hearings must be received 

on or before December 1, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0381. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Shanaz Bacchus, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8097; e-mail address: 

bacchus.shanaz@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

•Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 


ebenthall on PROD1PC60 with RULES
56996 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0381 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before December 1, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0381, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of June 18, 

2008 (72 FR 34734) (FRL–8366–9), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 7F7302) 

by Circle One Global, Inc. (Circle One), 

P.O. Box 28, Shellman, GA 39886–0028. 

The petition requested that 40 CFR 

180.1254 be amended by expanding the 

existing exemption from the 

requirement of a tolerance for residues 

of Aspergillus flavus NRRL 21882 on 

corn. A summary of the petition 

prepared by the petitioner Danny Gay, 

Acta Group, 1203 Nineteenth St., NW., 

Suite 300, Washington DC 20036, on 

behalf of Circle One Global, Inc., was 

included in the docket at 

www.regulations.gov (Docket No. EPA– 

HQ–OPP–2008–0381). On July 9, 2008, 

Acta Group posted a comment to this 

docket to clarify that the pending 

amendment to the current exemption 

from tolerance for Aspergillus flavus 

NRRL 21882 is intended to apply to 

field corn, sweet corn, and pop corn as 

harvested. The tolerance exemption is 

being granted for these food 

commodities on the basis of the 

toxicology studies which support all 

food commodities. 

A temporary exemption from the 

requirement of tolerance for Aspergillus 

flavus NRRL 21882 on corn currently 

exists at 40 CFR 180.1254(b). That 

temporary tolerance is connected with 

Experimental Use Permit No. 75624- 

EUP-2 and is set to expire on May 2, 

2009. The Agency issued this temporary 

rule on May 16, 2007, after determining 

that the temporary exemption from the 

requirement of tolerance was safe (72 FR 

27460, May 16, 2007). 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . . ’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

Aspergillus flavus NRRL 21882 is a 

non-aflatoxin-producing fungal active 

ingredient for use in microbial 

pesticides. It will be used to displace 

the ubiquitous Aspergillus flavus group 

of microbes, many of which can 

produce aflatoxin, a potent carcinogen. 

The toxicological profile of this 

conditionally registered active 

ingredient has been previously 

described in the final rule of the Federal 

Register of June 30, 2004, (69 FR 39341) 

(FRL–7364–2). On the basis of those 

studies, the exemption from tolerance of 

Aspergillus flavus NRRL 21882, a nonaflatoxin-producing strain of Aspergillus 

flavus, on peanuts was established in 40 

CFR 180.1254. 

The acute oral toxicology studies 

provided for peanuts are cited in 

support of the tolerance exemption for 

field, pop and sweet corn. Those studies 

placed Aspergillus flavus NRRL 21882 

in Toxicity Category IV for acute oral 

effects. This active ingredient was not 

toxic, infective or pathogenic to 

mammals on the basis of acute oral and 

pulmonary studies. That database 

supporting the exemption from 

tolerance on peanut also supports the 

proposed exemption of this active 

ingredient on corn. Even though the 

active ingredient has demonstrated toxic 

and infective effects in the acute 

intraperitoneal studies, there was 

clearance from all tissues by day 22. The 


ebenthall on PROD1PC60 with RULES
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations 56997 

results of these studies were considered 

a worse case scenario relevant to issues 

of occupational exposure for which the 

agency required appropriate Personal 

Protective Equipment (PPE) to mitigate 

risk to workers. In addition, the 

pesticide is not to be applied to 

residential areas, but rather to 

commercial corn fields. Thus, potential 

non-occupational exposure is not 

expected. For a summary of the studies 

and discussions of dietary and nondietary, non-occupational dermal and 

inhalation exposures, as well as 

aggregate and cumulative, exposures, 

and potential endocrine effects refer to 

the aforesaid June 30, 2004 final rule (69 

FR 39341). All studies met, and 

continue to meet, the safety standards of 

the Food Quality Protection Act (FQPA) 

of 1996. This pesticide has been used 

for more than a decade in experimental 

laboratory and field trials without any 

reports of adverse dermal irritation or 

hypersensitivity effects. 

The Agency has determined that the 

previously reviewed acute toxicological 

studies do support the proposed 

exemption from tolerance of Aspergillus 

flavus NRRL 21882 on corn. Summaries 

of the rationales for this determination 

may be found in the aforesaid Federal 

Register final rule of June 30, 2004. No 

further toxicological data are required 

for this exemption from the requirement 

of a tolerance for Aspergillus flavus 

NRRL 21882 on corn. The applicant 

must, however, report any incidents of 

hypersensitivity, or any other adverse 

effects to comply with the requirements 

of FIFRA section 6(a)(2). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

In evaluating dietary exposure to 

Aspergillus flavus NRRL 21882, EPA 

considered exposure under the 

petitioned-for tolerances as well as the 

existing Aspergillus flavus NRRL 21882 

tolerance for peanuts in (40 CFR 

180.1254(a)). 

1. Food. Pesticides containing 

Aspergillus flavus NRRL 21882 are to be 

applied aerially to corn once per season 

at the first sign of corn tasseling. 

Because there is a long period of time 

between application and harvesting, 

residues of Aspergillus flavus NRRL 

21882 are not expected to be greater 

than the normal background levels, 

when the food commodity is harvested. 

In addition, corn and its byproducts will 

be subject to several stages of food 

processing and manufacturing. These 

stages include washing, threshing, 

dehulling, dry and wet milling, and 

fractionation by aspiration and the other 

food manufacturing and processing 

technologies which are associated with 

preparing and marketing corn as a food 

commodity. Thus, because of the low 

application rate and food processing 

steps, this naturally occurring active 

ingredient is not expected to be present 

at greater than background levels on 

consumable corn commodities. Even if 

it is present, it is not likely to cause 

harm because it is not toxic, infective or 

pathogenic as demonstrated in the acute 

oral toxicity study in rats. 

These observations from the acute 

toxicology tests are also relevant to 

dietary exposure of human adults, 

infants and children to peanuts treated 

with Aspergillus flavus NRRL 21882. 

The Agency, taking both crops into 

consideration, concluded that the 

aggregate exposure to this active 

ingredient with low toxicity potential 

will not cause harm if the pesticide is 

used as labeled. 

2. Drinking water exposure. The 

analysis provided for the tolerance 

exemption for residues of Aspergillus 

flavus NRRL 21882 on peanuts also 

supports the drinking water exposure 

analysis for corn. As in the case of 

peanuts, the pesticide is to be applied 

in drought ridden areas and is not 

directly applied to crops grown in 

water. Thus accumulation in drinking 

water is not expected. Percolation 

through the soil and municipal 

treatment of drinking water are expected 

to preclude exposure of the U.S. 

population, infants and children to 

residues of the pesticide. Thus 

incremental exposure via drinking water 

is not expected when both corn and 

peanuts are treated. 

B. Other Non-Occupational Exposure 

Non-occupational dermal and 

inhalation exposure is expected to be 

minimal to non-existent when the 

microbial pesticide containing the 

active ingredient Aspergillus flavus 

NRRL 21882 is used as labeled on corn 

and peanuts. For both crops, the 

pesticide is to be applied to agricultural 

sites not in the proximity of residential 

areas, schools, nursing homes or 

daycares. While there is a potential for 

dermal sensitivity to the Aspergillus 

group of fungi, the specific pesticide at 

issue here, Aspergillus flavus NRRL 

21882, is not intended for residential 

applications. Instead, it is to be applied 

once per growing season to commercial 

agricultural fields. Pesticide drift is not 

expected to residential areas from the 

agricultural applications of the granular 

End-use Product which is applied at a 

very low rate (approximately 1 gram or 

0.002 pound of active ingredient per 

acre). Thus, non-occupational 

residential exposure is expected to be 

minimal to non-existent. 

In summary, the Agency considered 

dietary exposure (including drinking 

water), as well as non-occupational 

exposure to treated peanuts and corn, 

and concluded that aggregate exposure 

to Aspergillus flavus NRRL 21882 will 

not cause harm to the U.S. adult, 

population, infants and children. 

V. Cumulative Effects 

Section 408(b)(2)(D)(v) of the FFDCA 

requires the Agency to consider the 

cumulative effect of exposure to 

Aspergillus flavus NRRL 21882 and to 

other substances that have a common 

mechanism of toxicity. These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. Based on tests in 

mammalian systems, Aspergillus flavus 

NRRL 21882 does not appear to be toxic 

to humans via dietary and pulmonary 

exposure. Therefore, the requirement to 

consider cumulative effects does not 

apply. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

For the same reasons as stated in the 

rule issued on June 30, 2004 (69 FR 

39341), the Agency has determined that 

the additional margin of safety is not 

necessary to protect infants and 

children, and that not adding any 

additional margin of safety will be safe 

for infants and children. As a result, 

EPA has not used a margin of exposure 

(safety) approach to assess the safety of 

Aspergillus flavus NRRL 21882. 

VII. Other Considerations 

A. Endocrine Disruptors 

See Federal Register, June 30, 2004, 

(69 FR 39341). 

B. Analytical Method 

See Federal Register, June 30, 2004, 

(69 FR 39341). 

C. Codex Maximum Residue Level 

There is no Codex Maximum Residue 

Level (MRL) for residues of Aspergillus 

flavus NRRL 21882 on corn. 

VIII. Conclusions 

In summary, the Agency has 

determined that, based on available data 


ebenthall on PROD1PC60 with RULES
56998 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations 

and information, there is a reasonable 

certainty that the use of Aspergillus 

flavus NRRL 21882 on field, sweet and 

pop corn will not cause harm to the U.S. 

adult, children and infant populations 

via dietary, aggregate and cumulative 

exposure. Thus, an exemption from the 

requirement of a tolerance on field, 

sweet and pop corn is being granted. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

X. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 19, 2008. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.1254 is amended by 

revising paragraph (b) to read as follows: 

§ 180.1254 Aspergillus flavus NRRL 21882; 

exemption from requirement of a tolerance. 

*****

(b) An exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus NRRL 

21882 on corn, field, forage; corn, field, 

grain; corn, field, stover; corn, field, 

aspirated grain fractions; corn, sweet, 

kernel plus cob with husk removed; 

corn, sweet, forage; corn, sweet, stover; 

corn, pop, grain; and corn, pop, stover. 

[FR Doc. E8–22957 Filed 9–30–08; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1534–CN] 

42 CFR Part 413 

RIN 0938–AP11 

Medicare Program; Prospective 

Payment System and Consolidated 

Billing for Skilled Nursing Facilities; 

Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correction. 

SUMMARY: This document corrects 

technical errors that appeared in the 

August 8, 2008 Federal Register 

entitled, ‘‘Medicare Program; 

Prospective Payment System and 

Consolidated Billing for Skilled Nursing 

Facilities for FY 2009.’’ 

DATES: Effective Date: This correction is 

effective October 1, 2008. 

FOR FURTHER INFORMATION CONTACT: Bill 

Ullman, (410) 786–5667. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. E8–17948 of August 8, 

2008 (73 FR 46416), there were two 

technical errors that this notice serves to 

identify and correct. The corrections in 

this correction notice are effective as if 

they had been included in the document 

published on August 8, 2008. 

Accordingly, the corrections are 

effective October 1, 2008. 

II. Summary of Errors 

On page 46430 of the August 8, 2008 

final rule, we are correcting the title of 

Table 10. This table illustrates the 

skilled nursing facility (SNF) 

prospective payment system (PPS) 

payment rate computations for a 

hypothetical ‘‘XYZ’’ SNF located in 

Cedar Rapids, IA. In the table’s title, the 

wage index value for Cedar Rapids, IA 

is incorrectly identified as 0.8924. 

Accordingly, in section III of this 

document (‘‘Correction of Errors’’), we 

are correcting the wage index value in 

the title of Table 10 to reflect the correct 

wage index value of 0.8919. We note 


ebenthall on PROD1PC60 with RULES