16792 Federal Register / Vol. 72, No. 65 / Thursday, April 5, 2007 / Notices 

Dated: March 30, 2007. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–6340 Filed 4–4–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–07–06AP] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–4766 and 

send comments to Seleda Perryman, 

CDC Assistant Reports Clearance 

Officer, 1600 Clifton Road, MS–D74, 

Atlanta, GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Aerosol Generation by Cough—

NEW—The National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Federal Occupational Safety and 

Health Act of 1970, section 501, enables 

NIOSH to carry out research relevant to 

the health and safety of workers. NIOSH 

is conducting a two-year study of 

airborne clouds of particles or droplets 

called ‘‘aerosols’’. Some diseases like 

influenza and Severe Acute Respiratory 

Syndrome (SARS) can be spread when 

people produce infectious aerosols by 

coughing or sneezing. Aerosol 

transmission of infectious diseases is 

especially important to health-care 

workers and emergency responders, 

who face a much greater risk of 

exposure to these hazards than does the 

general public. Cough-generated 

aerosols are of particular concern 

because coughing is one of the most 

common symptoms of respiratory 

infections. However, substantial gaps 

exist in our understanding about the 

generation of aerosols during coughing. 

This lack of information hampers the 

ability of health scientists to model and 

predict the generation of infectious 

aerosols by coughing and to understand 

whether or not cough-generated aerosols 

are likely to be an important means of 

transmission of particular diseases. 

The purpose of this study is to gain 

a better understanding of the production 

of aerosols by coughing. The results of 

this research will give scientists and 

health professionals greater insight into 

the airborne transmission of disease and 

allow them to better assess the potential 

effectiveness of preventive measures. 

The first part of this study will 

measure the quantity and size 

distribution of aerosol produced during 

human coughs. To accomplish this, 

volunteers will cough into a spirometer, 

which is a commonly used piston-like 

medical device that measures the 

volume of air exhaled by a patient. After 

the volunteer coughs into the 

spirometer, the air in the spirometer 

will be drawn into a commercial aerosol 

measurement device. These experiments 

will also provide information on how 

much cough aerosols vary over time for 

individuals and how much aerosol 

generation varies between individuals. 

The second part of this study will 

determine how effectively surgical 

masks and N95 respirators block coughgenerated aerosols. N95 respirators are 

dust masks that are certified to filter out 

at least 95% of airborne material during 

normal breathing. N95 respirators are 

known to be more effective than surgical 

masks at filtering out airborne particles 

during inhalation, but it is not known 

whether masks or respirators are more 

effective at blocking cough-generated 

aerosols. For this work, masks and 

respirators will be placed in a special 

holder with a disposable mouthpiece, 

and human subjects will cough into the 

mouthpiece and through the mask. The 

aerosol produced by each subject will be 

analyzed before and after flowing 

through the mask. These experiments 

will determine how effective each mask 

or respirator is at preventing the release 

of cough-generated aerosols. 

Volunteers from part 1 may also 

participate in part 2 if they wish. There 

will be no costs to study participants 

other than their time. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Part 1 participants ............................................................................................ 20 5 1.5 150 

Part 2 participants ............................................................................................ 120 1 1.5 180 

Total .......................................................................................................... ........................ ........................ ........................ 330 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 65 / Thursday, April 5, 2007 / Notices 16793 

Dated: March 29, 2007. 

Joan F. Karr, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–6344 Filed 4–4–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notice of Hearing: Reconsideration of 

Disapproval of Minnesota State Plan 

Amendment 05–10 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of hearing. 

SUMMARY: This notice announces an 

administrative hearing to be held on 

May 30, 2007, at 233 N. Michigan 

Avenue, Suite 600, the Indiana Room, 

Chicago, IL 60601, to reconsider CMS’

decision to disapprove Minnesota State 

plan amendment 05–10. 

CLOSING DATE: Requests to participate in 

the hearing as a party must be received 

by the presiding officer by (15 days after 

publication). 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Scully-Hayes, Presiding 

Officer, CMS, Lord Baltimore Drive, 

Mail Stop LB–23–20, Baltimore, 

Maryland 21244. Telephone: (410) 786–

2055. 

SUPPLEMENTARY INFORMATION: This 

notice announces an administrative 

hearing to reconsider CMS’ decision to 

disapprove Minnesota State plan 

amendment (SPA) 05–10 which was 

submitted on September 21, 2005. This 

SPA was disapproved on December 29, 

2006. 

Under this SPA, the State proposed to 

revise coverage and reimbursement 

methodology for Early and Periodic 

Screening, Diagnosis, and Treatment 

services related to children’s mental 

health rehabilitative services and 

rehabilitative services pursuant to an 

Individualized Education Plan or 

Individual Family Service Plan. 

The amendment was disapproved 

because CMS found that the amendment 

violated the statute for reasons set forth 

in the disapproval letter. 

The issues to be decided at the 

hearing are: 

• Whether the per diem (bundled) 

payment methodologies for mental 

health rehabilitative services described 

in Minnesota’s SPA 05–10 accurately 

reflect true costs or reasonable fees for 

the services included in the bundles; 

• Whether the amount or scope of 

services reimbursed through the 

bundled rate is sufficiently constant so 

that the proposed methodologies would 

be an economic and efficient method of 

payment; 

• Whether all of the component parts 

of the service are delivered as 

recommended within the scope of 

practice of the physician or licensed 

practitioner of the healing arts; 

• Whether the actual practitioners 

who will be furnishing services can be 

readily identified; and 

• Whether the bundled rates provide 

for direct payment to the actual 

practitioners who provide the service. 

Section 1116 of the Social Security 

Act and Federal regulations at 42 CFR 

part 430, establish Department 

procedures that provide an 

administrative hearing for 

reconsideration of a disapproval of a 

State plan or plan amendment. CMS is 

required to publish a copy of the notice 

to a State Medicaid agency that informs 

the agency of the time and place of the 

hearing, and the issues to be considered. 

If we subsequently notify the agency of 

additional issues that will be considered 

at the hearing, we will also publish that 

notice. 

Any individual or group that wants to 

participate in the hearing as a party 

must petition the presiding officer 

within 15 days after publication of this 

notice, in accordance with the 

requirements contained at 42 CFR 

430.76(b)(2). Any interested person or 

organization that wants to participate as 

amicus curiae must petition the 

presiding officer before the hearing 

begins in accordance with the 

requirements contained at 42 CFR 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The Notice to Minnesota Announcing 

an Administrative Hearing To 

Reconsider the Disapproval of Its SPA 

Reads as Follows 

Ms. Christine Bronson, 

Medicaid Director, 

Minnesota Department of Human Services, 

P.O. Box 64998, 

St. Paul, MN 55164–0998 

Dear Ms. Bronson: I am responding to your 

request for reconsideration of the decision to 

disapprove the Minnesota State plan 

amendment (SPA) 05–10, which was 

submitted on September 21, 2005, and 

disapproved on December 29, 2006. 

Under this SPA, the State proposed to 

revise coverage and reimbursement 

methodology for Early and Periodic 

Screening, Diagnosis, and Treatment services 

related to children’s mental health 

rehabilitative services and rehabilitative 

services pursuant to an Individualized 

Education Plan or Individual Family Service 

Plan. The Centers for Medicare & Medicaid 

Services (CMS) disapproved the SPA because 

the State did not document that its proposed 

reimbursement methodology meets the 

conditions specified in sections 1902(a)(10), 

1902(a)(30), and 1902(a)(32) of the Social 

Security Act (the Act). 

At issue in this reconsideration is whether 

Minnesota has demonstrated that the 

bundled rate methodology proposed in SPA 

05–10 is consistent with the requirements of 

section 1902(a)(30)(A) of the Act, which 

requires that States have methods and 

procedures to assure that payments to 

providers are consistent with efficiency, 

economy, and quality of care. A second issue 

is whether the State has shown that the 

payment methodology is for care and services 

that are within the scope, and meet the 

requirements, of section 1902(a)(10)(A) to 

make available ‘‘medical assistance,’’ which 

is defined at section 1905(a) and 

implementing requirements. Also at issue is 

whether the proposed payment methodology 

complies with the direct payment 

requirements of section 1902(a)(32) of the 

Act, which precludes payment to anyone 

other than the individual, person, or 

institution providing the care and service 

(with specified exceptions). We discuss each 

of these issues in more detail below in 

relation to SPA 05–10. 

Section 1902(a)(30)(A) of the Act requires 

that States have methods and procedures to 

assure that payments to providers are 

consistent with efficiency, economy, and 

quality of care. The per diem payment 

methodologies for mental health 

rehabilitative services described in SPA 05–

10 represent bundled payment 

methodologies under which the State pays a 

single rate for one or more of a group of 

different services furnished to an eligible 

individual during a fixed period of time. The 

State has failed to demonstrate that its 

methodologies are in compliance with 

section 1902(a)(30)(A), in that it has not 

shown: that these methodologies accurately 

reflect true costs or reasonable fees for the 

services included in the bundles; and that the 

amount or scope of services reimbursed 

through the bundled rate is sufficiently 

constant so that the proposed methodologies 

would be an economic and efficient method 

of payment. 

Section 1902(a)(10)(A) requires that State 

plans make available medical assistance, 

which is defined at section 1905(a) and in 

implementing regulations. For a number of 

categories of medical assistance, there are 

provider standards applicable to different 

types of care and services, and for 

rehabilitative services there is a requirement 

that rehabilitative services must be 

recommended by a physician or other 

licensed practitioner of the healing arts. 

Minnesota did not provide evidence of a 

method to identify that providers of the 

component parts of the care and services 

would meet all applicable provider 

requirements. Nor did Minnesota 

demonstrate a method to ensure that all of 

the component parts of the care and services 

furnished under the bundled payment 

methodology proposed in SPA 05–10, would 


jlentini on PROD1PC65 with NOTICES